Commonwealth Coat of Arms of Australia

PB 85 of 2024

 

National Health (Listing of Pharmaceutical Benefits) Amendment (Maximum Dispensed Quantities September Update) Instrument 2024

 

National Health Act 1953

 

I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 30 August 2024

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

 

Contents

1 Name...............................................1

2 Commencement.........................................1

3 Authority.............................................1

4 Schedules.............................................1

Schedule 1—Amendments 2

National Health (Listing of Pharmaceutical Benefits) Instrument 2024
(PB 26 of 2024). 2

 


1 Name

  1.            This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment (Maximum Dispensed Quantities September Update) Instrument 2024.
  2.            This Instrument may also be cited as PB 85 of 2024.

2 Commencement

  1.            Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

1 September 2024

1 September 2024

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

  1.            Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

.

  1.                    Schedule 1, Part 1, entries for Abatacept in the form Powder for I.V. infusion 250 mg

substitute:

Abatacept

Powder for I.V. infusion 250 mg

Injection

Orencia

BQ

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

PB(100)

  1.                    Schedule 1, Part 1, after entry for Acamprosate in the form Tablet (enteric coated) containing acamprosate calcium 333 mg [Brand: ACAMPROSATE VIATRIS]

insert:

Acamprosate

Tablet (enteric coated) containing acamprosate calcium 333 mg

Oral

ACAMPROSATE-WGR

WG

MP NP

C5366

 

180

1

 

180

 

 

  1.                    Schedule 1, Part 1, after entry for Aciclovir in the form Tablet 200 mg [Brand: Aciclovir Sandoz; Maximum Quantity: 90; Number of Repeats: 5]

insert:

Aciclovir

Tablet 200 mg

Oral

ACICLOVIR-WGR

WG

MP NP

C5942

 

90

5

 

90

 

 

  1.                    Schedule 1, Part 1, after entry for Aciclovir in the form Tablet 800 mg [Brand: Aciclovir Sandoz; Maximum Quantity: 35; Number of Repeats: 0]

insert:

Aciclovir

Tablet 800 mg

Oral

ACICLOVIR-WGR

WG

MP NP

C5959 C5967

 

35

0

 

35

 

 

  1.                    Schedule 1, Part 1, entries for Aclidinium

substitute:

Aclidinium

Powder for oral inhalation in breath actuated device 322 micrograms (as bromide) per dose, 60 doses

Inhalation by mouth

Bretaris Genuair

FK

MP NP

C4516

P4516

1

5

 

1

 

 

Aclidinium

Powder for oral inhalation in breath actuated device 322 micrograms (as bromide) per dose, 60 doses

Inhalation by mouth

Bretaris Genuair

FK

MP NP

C15634

P15634

2

5

 

1

 

 

  1.                    Schedule 1, Part 1, entries for Aclidinium with formoterol

substitute:

Aclidinium with formoterol

Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Brimica Genuair

FK

MP NP

C7798

P7798

1

5

 

1

 

 

Aclidinium with formoterol

Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Brimica Genuair

FK

MP NP

C15691

P15691

2

5

 

1

 

 

  1.                    Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre‑filled pen [Brands: Adalicip; Humira; and Yuflyma; Maximum Quantity: 4; Number of Repeats: 2]
    1.            omit from the column headed “Circumstances”: C12273          substitute: C15788
    2.            omit from the column headed “Purposes”: P12273          substitute: P15788
  2.                    Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre‑filled pen [Brands: Adalicip; Humira; and Yuflyma; Maximum Quantity: 4; Number of Repeats: 5]
    1.            omit from the column headed “Circumstances”: C12272 C12315
    2.            insert in numerical order in the column headed “Circumstances”: C15777 C15796
    3.            omit from the column headed “Purposes”: P12272 P12315
    4.            insert in numerical order in the column headed “Purposes”: P15777 P15796
  3.                    Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre‑filled pen [Brands: Adalicip; Humira; and Yuflyma; Maximum Quantity: 6; Number of Repeats: 0]
    1.            omit from the column headed “Circumstances”: C15249 C15309 C15319
    2.            insert in numerical order in the column headed “Circumstances”: C15764 C15765 C15795
    3.            omit from the column headed “Purposes”: P15249 P15309 P15319
    4.            insert in numerical order in the column headed “Purposes”: P15764 P15765 P15795
  4.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Brands: Abrilada; Amgevita; Hadlima; Hyrimoz; and Idacio; Maximum Quantity: 4; Number of Repeats: 2]
    1.            omit from the column headed “Circumstances”: C12273          substitute: C15788
    2.            omit from the column headed “Purposes”: P12273          substitute: P15788
  5.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Brands: Abrilada; Amgevita; Hadlima; Hyrimoz; and Idacio; Maximum Quantity: 4; Number of Repeats: 5]
    1.            omit from the column headed “Circumstances”: C12272 C12315
    2.            insert in numerical order in the column headed “Circumstances”: C15777 C15796
    3.            omit from the column headed “Purposes”: P12272 P12315
    4.            insert in numerical order in the column headed “Purposes”: P15777 P15796
  6.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre‑filled pen [Brands: Abrilada; Amgevita; Hadlima; Hyrimoz; and Idacio; Maximum Quantity: 6; Number of Repeats: 0]
    1.            omit from the column headed “Circumstances”: C15249 C15309 C15319
    2.            insert in numerical order in the column headed “Circumstances”: C15764 C15765 C15795
    3.            omit from the column headed “Purposes”: P15249 P15309 P15319
    4.            insert in numerical order in the column headed “Purposes”: P15764 P15765 P15795
  7.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Abrilada; Maximum Quantity: 2; Number of Repeats: 3]
    1.            insert in numerical order in the column headed “Circumstances”: C9064
    2.            insert in numerical order in the column headed “Circumstances”: C11861
    3.            insert in numerical order in the column headed “Circumstances”: C13650
    4.            insert in numerical order in the column headed “Circumstances”: C13694
    5.            insert in numerical order in the column headed “Purposes”: P9064
    6.              insert in numerical order in the column headed “Purposes”: P11861
    7.            insert in numerical order in the column headed “Purposes”: P13650
    8.            insert in numerical order in the column headed “Purposes”: P13694
  8.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre‑filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 2]
    1.            omit from the column headed “Circumstances”: C12273          substitute: C15788
    2.            omit from the column headed “Purposes”: P12273          substitute: P15788
  9.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre‑filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 5]
    1.            omit from the column headed “Circumstances”: C12306          substitute: C15797
    2.            omit from the column headed “Purposes”: P12306         substitute: P15797
  10.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre‑filled pen [Brand: Humira; Maximum Quantity: 3; Number of Repeats: 0]
    1.            omit from the column headed “Circumstances”: C15249 C15309 C15319
    2.            insert in numerical order in the column headed “Circumstances”: C15764 C15765 C15795
    3.            omit from the column headed “Purposes”: P15249 P15309 P15319
    4.            insert in numerical order in the column headed “Purposes”: P15764 P15765 P15795
  11.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre‑filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 2]
    1.            omit from the column headed “Circumstances”: C12273          substitute: C15788
    2.            omit from the column headed “Purposes”: P12273          substitute:  P15788
  12.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre‑filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 5]
    1.            omit from the column headed “Circumstances”: C12306           substitute: C15797
    2.            omit from the column headed “Purposes”: P12306           substitute: P15797
  13.                Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre‑filled syringe [Brand: Humira; Maximum Quantity: 3; Number of Repeats: 0]
    1.            omit from the column headed “Circumstances”: C15249 C15309 C15319
    2.            insert in numerical order in the column headed “Circumstances”: C15764 C15765 C15795
    3.            omit from the column headed “Purposes”: P15249 P15309 P15319
    4.            insert in numerical order in the column headed “Purposes”: P15764 P15765 P15795
  14.                Schedule 1, Part 1, entry for Alectinib
    1.            omit from the column headed “Circumstances”: C7345
    2.            insert in numerical order in the column headed “Circumstances”: C15759
  15.                Schedule 1, Part 1, after entry for Alendronic acid in the form Tablet 70 mg (as alendronate sodium) [Brand: Alendronate Sandoz; Maximum Quantity: 8; Number of Repeats: 5]

insert:

Alendronic acid

Tablet 70 mg (as alendronate sodium)

Oral

ALENDRONATE-WGR

WG

MP NP

C6310 C6323 C6327

P6310 P6323 P6327

4

5

 

4

 

 

Alendronic acid

Tablet 70 mg (as alendronate sodium)

Oral

ALENDRONATE-WGR

WG

MP NP

C14242 C14291 C14309

P14242 P14291 P14309

8

5

 

4

 

 

  1.                Schedule 1, Part 1, after entry for Allopurinol in the form Tablet 100 mg [Brand: Allopurinol Sandoz; Maximum Quantity: 400; Number of Repeats: 2]

insert:

Allopurinol

Tablet 100 mg

Oral

ALLOPURINOL-WGR

WG

MP NP

 

 

200

2

 

200

 

 

Allopurinol

Tablet 100 mg

Oral

ALLOPURINOL-WGR

WG

MP NP

 

P14238

400

2

 

200

 

 

  1.                Schedule 1, Part 1, after entry for Allopurinol in the form Tablet 300 mg [Brand: Allopurinol Sandoz; Maximum Quantity: 120; Number of Repeats: 2]

insert:

Allopurinol

Tablet 300 mg

Oral

ALLOPURINOL-WGR

WG

MP NP

 

 

60

2

 

60

 

 

Allopurinol

Tablet 300 mg

Oral

ALLOPURINOL-WGR

WG

MP NP

 

P14238

120

2

 

60

 

 

  1.                Schedule 1, Part 1, after entry for Allopurinol in the form Tablet 300 mg [Brand: Allosig; Maximum Quantity: 120; Number of Repeats: 2]

insert:

Allopurinol

Tablet 300 mg

Oral

APO-ALLOPURINOL

TX

MP NP

 

 

60

2

 

60

 

 

Allopurinol

Tablet 300 mg

Oral

APO-ALLOPURINOL

TX

MP NP

 

P14238

120

2

 

60

 

 

  1.                Schedule 1, Part 1, entries for Amantadine

substitute:

Amantadine

Capsule containing amantadine hydrochloride 100 mg

Oral

AMANTAMED

DZ

MP NP

C5132

P5132

100

5

 

100

 

 

Amantadine

Capsule containing amantadine hydrochloride 100 mg

Oral

AMANTAMED

DZ

MP NP

C15711

P15711

200

5

 

100

 

 

Amantadine

Capsule containing amantadine hydrochloride 100 mg

Oral

Symmetrel 100

NV

MP NP

C5132

P5132

100

5

 

100

 

 

Amantadine

Capsule containing amantadine hydrochloride 100 mg

Oral

Symmetrel 100

NV

MP NP

C15711

P15711

200

5

 

100

 

 

  1.                Schedule 1, Part 1, after entry for Amisulpride in the form Tablet 100 mg [Brand: Amisulpride Sandoz Pharma]

insert:

Amisulpride

Tablet 100 mg

Oral

AMISULPRIDE-WGR

WG

MP NP

C4246

 

30

5

 

30

 

 

  1.                Schedule 1, Part 1, after entry for Amisulpride in the form Tablet 200 mg [Brand: Amisulpride Sandoz Pharma]

insert:

Amisulpride

Tablet 200 mg

Oral

AMISULPRIDE-WGR

WG

MP NP

C4246

 

60

5

 

60

 

 

  1.                Schedule 1, Part 1, after entry for Amisulpride in the form Tablet 400 mg [Brand: Amisulpride Sandoz Pharma]

insert:

Amisulpride

Tablet 400 mg

Oral

AMISULPRIDE-WGR

WG

MP NP

C4246

 

60

5

 

60

 

 

  1.                Schedule 1, Part 1, after entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 10 mg [Brand: Amitriptyline Viatris 10]

insert:

Amitriptyline

Tablet containing amitriptyline hydrochloride 10 mg

Oral

AMITRIPTYLINE-WGR

WG

MP NP

 

 

50

2

 

50

 

 

  1.                Schedule 1, Part 1, after entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg [Brand: Amitriptyline Viatris 25]

insert:

Amitriptyline

Tablet containing amitriptyline hydrochloride 25 mg

Oral

AMITRIPTYLINE-WGR

WG

MP NP

 

 

50

2

 

50

 

 

  1.                Schedule 1, Part 1, after entry for Amlodipine in the form Tablet 5 mg (as besilate) [Brand: Amlodipine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Amlodipine

Tablet 5 mg (as besilate)

Oral

AMLODIPINE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Amlodipine

Tablet 5 mg (as besilate)

Oral

AMLODIPINE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, entry for Amlodipine in the form Tablet 5 mg (as besilate)

omit:

Amlodipine

Tablet 5 mg (as besilate)

Oral

BTC Amlodipine

JB

MP NP

 

 

30

5

 

30

 

 

Amlodipine

Tablet 5 mg (as besilate)

Oral

BTC Amlodipine

JB

MP NP

 

P14238

60

5

 

 

 

 

  1.                Schedule 1, Part 1, after entry for Amlodipine in the form Tablet 10 mg (as besilate) [Brand: Amlodipine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Amlodipine

Tablet 10 mg (as besilate)

Oral

AMLODIPINE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Amlodipine

Tablet 10 mg (as besilate)

Oral

AMLODIPINE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, entry for Amlodipine in the form Tablet 10 mg (as besilate)

omit:

Amlodipine

Tablet 10 mg (as besilate)

Oral

BTC Amlodipine

JB

MP NP

 

 

30

5

 

30

 

 

Amlodipine

Tablet 10 mg (as besilate)

Oral

BTC Amlodipine

JB

 

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, after entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Brand: AMILOXYN; Maximum Quantity: 40; Number of Repeats: 0]

insert:

Amoxicillin

Capsule 500 mg (as trihydrate)

Oral

AMOXICILLIN-WGR

WG

PDP MP NP MW

 

 

20

0

 

20

 

 

Amoxicillin

Capsule 500 mg (as trihydrate)

Oral

AMOXICILLIN-WGR

WG

MP NP

 

P10402

40 CN10402

0 CN10402

 

20

 

 

  1.                Schedule 1, Part 1, after entry for Amoxicillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL [Brand: NOUMED AMOXICILLIN; Maximum Quantity: 1; Number of Repeats: 1]

insert:

Amoxicillin

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Oral

AMOXICILLIN-WGR

WG

PDP

 

 

1

0

 

1

 

 

Amoxicillin

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Oral

AMOXICILLIN-WGR

WG

MP NP

 

 

1

1

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Amoxicillin in the form Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Brand: Curam; Maximum Quantity: 1; Number of Repeats: 1]

insert:

Amoxicillin with clavulanic acid

Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 100 mL (S19A)

Oral

CLAVULIN-125F (GlaxoSmithKline, Canada)

DZ

PDP

C5833 C5894

P5833 P5894

1

0

 

1

 

 

Amoxicillin with clavulanic acid

Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 100 mL (S19A)

Oral

CLAVULIN-125F (GlaxoSmithKline, Canada)

DZ

MP NP

C5832 C5893

P5832 P5893

1

1

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Brand: AMCLAVOX DUO 500/125; Maximum Quantity: 20; Number of Repeats: 0]

insert:

Amoxicillin with clavulanic acid

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMOXICILLIN/CLAVULANIC ACID-WGR 500/125

WG

MP NP

C5832 C5893

P5832 P5893

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMOXICILLIN/CLAVULANIC ACID-WGR 500/125

WG

PDP

C5833 C5894

P5833 P5894

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMOXICILLIN/CLAVULANIC ACID-WGR 500/125

WG

MP NP

C10405

P10405

20

0

 

10

 

 

  1.                Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit:

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AlphaClav Duo Forte

AF

MP NP

C5832 C5893

P5832 P5893

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AlphaClav Duo Forte

AF

PDP

C5833 C5894

P5833 P5894

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AlphaClav Duo Forte

AF

MP NP

C10413

P10413

20

0

 

10

 

 

  1.                Schedule 1, Part 1, after entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Brand: AMCLAVOX DUO FORTE 875/125; Maximum Quantity: 20; Number of Repeats: 0]

insert:

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMOXICILLIN/CLAVULANIC ACID-WGR 875/125

WG

MP NP

C5832 C5893

P5832 P5893

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMOXICILLIN/CLAVULANIC ACID-WGR 875/125

WG

PDP

C5833 C5894

P5833 P5894

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMOXICILLIN/CLAVULANIC ACID-WGR 875/125

WG

MP NP

C10413

P10413

20

0

 

10

 

 

  1.                Schedule 1, Part 1, after entry for Anastrozole in the form Tablet 1 mg [Brand: Anastrozole Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Anastrozole

Tablet 1 mg

Oral

ANASTROZOLE-WGR

WG

MP NP

C5464

P5464

30

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

ANASTROZOLE-WGR

WG

MP NP

C14943

P14943

60

5

 

30

 

 

  1.                Schedule 1, Part 1, entries for Apomorphine

substitute:

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

Injection

Movapo

TD

MP NP

C10844

P10844

180

5

 

5

 

 

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

Injection

Movapo

TD

MP

C11385 C11445

P11385 P11445

180

5

 

5

 

C(100)

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

Injection

Movapo

TD

MP NP

C15542

P15542

360

5

 

5

 

 

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

Injection

Apomine Solution for Infusion

IT

MP

C10830 C10863

P10830 P10863

90

5

 

5

 

C(100)

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

Injection

Apomine Solution for Infusion

IT

MP NP

C10844

P10844

90

5

 

5

 

 

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

Injection

Apomine Solution for Infusion

IT

MP NP

C15542

P15542

180

5

 

5

 

 

Apomorphine

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre‑filled syringe

Injection

Movapo PFS

TD

MP

C11385 C11445

P11385 P11445

180

5

 

5

 

C(100)

Apomorphine

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre‑filled syringe

Injection

Movapo PFS

TD

MP NP

C10844

P10844

180

5

 

5

 

 

Apomorphine

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre‑filled syringe

Injection

Movapo PFS

TD

MP NP

C15542

P15542

360

5

 

5

 

 

Apomorphine

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen

Injection

Apomine Intermittent

IT

MP

C10830 C10863

P10830 P10863

100

5

 

5

 

C(100)

Apomorphine

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen

Injection

Apomine Intermittent

IT

MP NP

C10844

P10844

100

5

 

5

 

 

Apomorphine

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen

Injection

Apomine Intermittent

IT

MP NP

C15542

P15542

200

5

 

5

 

 

Apomorphine

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen

Injection

Movapo Pen

TD

MP

C10830 C10863

P10830 P10863

100

5

 

5

 

C(100)

Apomorphine

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen

Injection

Movapo Pen

TD

MP NP

C10844

P10844

100

5

 

5

 

 

Apomorphine

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen

Injection

Movapo Pen

TD

MP NP

C15542

P15542

200

5

 

5

 

 

  1.                Schedule 1, Part 1, after entry for Aripiprazole in the form Tablet 10 mg [Brand: Aripiprazole Sandoz]

insert:

Aripiprazole

Tablet 10 mg

Oral

ARIPIPRAZOLE-WGR

WG

MP NP

C4246

 

30

5

 

30

 

 

  1.                Schedule 1, Part 1, after entry for Aripiprazole in the form Tablet 15 mg [Brand: Aripiprazole Sandoz]

insert:

Aripiprazole

Tablet 15 mg

Oral

ARIPIPRAZOLE-WGR

WG

MP NP

C4246

 

30

5

 

30

 

 

  1.                Schedule 1, Part 1, after entry for Aripiprazole in the form Tablet 20 mg [Brand: Aripiprazole Sandoz]

insert:

Aripiprazole

Tablet 20 mg

Oral

ARIPIPRAZOLE-WGR

WG

MP NP

C4246

 

30

5

 

30

 

 

  1.                Schedule 1, Part 1, after entry for Aripiprazole in the form Tablet 30 mg [Brand: Aripiprazole Sandoz]

insert:

Aripiprazole

Tablet 30 mg

Oral

ARIPIPRAZOLE-WGR

WG

MP NP

C4246

 

30

5

 

30

 

 

  1.                Schedule 1, Part 1, after entry for Atenolol in the form Tablet 50 mg [Brand: Atenolol Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Atenolol

Tablet 50 mg

Oral

ATENOLOL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Atenolol

Tablet 50 mg

Oral

ATENOLOL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, after entry for Atezolizumab in the form Solution for subcutaneous injection 1875 mg in 15 mL [Brand: Tecentriq SC; Maximum Quantity: 1; Number of Repeats: 7]

insert:

Atezolizumab

Solution for subcutaneous injection 1875 mg in 15 mL

Injection

Tecentriq SC

RO

MP

C10917

P10917

1

8

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Brand: Atorvastatin SZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Atorvastatin

Tablet 10 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 10 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium)

omit:

Atorvastatin

Tablet 10 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 10 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

P14238

60

5

 

60

 

 

  1.                Schedule 1, Part 1, after entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Brand: Atorvastatin SZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Atorvastatin

Tablet 20 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 20 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium)

omit:

Atorvastatin

Tablet 20 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 20 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

P14238

60

5

 

60

 

 

  1.                Schedule 1, Part 1, after entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Brand: Atorvastatin SZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Atorvastatin

Tablet 40 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 40 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium)

omit:

Atorvastatin

Tablet 40 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 40 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

P14238

60

5

 

60

 

 

  1.                Schedule 1, Part 1, after entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Brand: Atorvastatin SZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Atorvastatin

Tablet 80 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 80 mg (as calcium)

Oral

ATORVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.                Schedule 1, Part 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium)

omit:

Atorvastatin

Tablet 80 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Atorvastatin

Tablet 80 mg (as calcium)

Oral

Blooms the Chemist Atorvastatin

IB

MP NP

 

P14238

60

5

 

60

 

 

  1.                Schedule 1, Part 1, after entry for Azathioprine in the form Tablet 25 mg [Brand: Azathioprine Sandoz]

insert:

Azathioprine

Tablet 25 mg

Oral

AZATHIOPRINE-WGR

WG

MP NP

 

 

100

5

 

100

 

 

  1.                Schedule 1, Part 1, after entry for Azathioprine in the form Tablet 50 mg [Brand: Azathioprine Sandoz]

insert:

Azathioprine

Tablet 50 mg

Oral

AZATHIOPRINE-WGR

WG

MP NP

 

 

100

5

 

100

 

 

  1.                Schedule 1, Part 1, after entry for Azithromycin in the form Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL [Brand: Zithromax]

insert:

Azithromycin

Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL (S19A)

Oral

Azithromycin (Zydus, USA)

DZ

MP NP

C5637

 

1

0

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Azithromycin Viatris; Maximum Quantity: 2; Number of Repeats: 2]

insert:

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

AZITHROMYCIN-WGR

WG

MP NP

C5718 C5772

P5718 P5772

2

0

 

2

 

 

Azithromycin

Tablet 500 mg (as dihydrate)

Oral

AZITHROMYCIN-WGR

WG

MP NP

C5637

P5637

2

2

 

2

 

 

  1.                Schedule 1, Part 1, entries for Beclometasone

substitute:

Beclometasone

Pressurised inhalation containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 50

IL

MP NP

 

 

1

5

 

1

 

 

Beclometasone

Pressurised inhalation containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 50

IL

MP NP

 

P14238

2

5

 

1

 

 

Beclometasone

Pressurised inhalation containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 100

IL

MP NP

 

 

1

5

 

1

 

 

Beclometasone

Pressurised inhalation containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 100

IL

MP NP

 

P14238

2

5

 

1

 

 

Beclometasone

Pressurised inhalation in breath actuated device containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 50 Autohaler

IL

MP NP

C6348

P6348

1

5

 

1

 

 

Beclometasone

Pressurised inhalation in breath actuated device containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 50 Autohaler

IL

MP NP

C15600

P15600

2

5

 

1

 

 

Beclometasone

Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 100 Autohaler

IL

MP NP

C6348

P6348

1

5

 

1

 

 

Beclometasone

Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Qvar 100 Autohaler

IL

MP NP

C15600

P15600

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Beclometasone with formoterol 

substitute:

Beclometasone with formoterol

Pressurised inhalation containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per dose,120 dose

Inhalation by mouth

Fostair

EU

MP NP

C15469

P15469

1

5

 

1

 

 

Beclometasone with formoterol

Pressurised inhalation containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per dose,120 dose

Inhalation by mouth

Fostair

EU

MP NP

C15599

P15599

2

5

 

1

 

 

Beclometasone with formoterol

Pressurised inhalation containing beclometasone dipropionate 200 micrograms and formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Fostair 200/6

EU

MP NP

C11057

P11057

1

5

 

1

 

 

Beclometasone with formoterol

Pressurised inhalation containing beclometasone dipropionate 200 micrograms and formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Fostair 200/6

EU

MP NP

C15656

P15656

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Beclometasone with formoterol and glycopyrronium in the form Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses

substitute:

Beclometasone with formoterol and glycopyrronium

Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses

Inhalation by mouth

Trimbow

EU

MP NP

C12349

P12349

1

5

 

1

 

 

Beclometasone with formoterol and glycopyrronium

Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses

Inhalation by mouth

Trimbow

EU

MP NP

C15543

P15543

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Betaxolol in the form Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL [Brand: Betoptic; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Betaxolol

Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL

Application to the eye

Betoptic

NV

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Betaxolol in the form Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL [Brand: BetoQuin; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Betaxolol

Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL

Application to the eye

BetoQuin

NM

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL [Brand: Bimatoprost Sandoz; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Bimatoprost Sandoz

SZ

MP AO

 

P14238

2

5

 

1

 

 

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

BIMATOPROST-WGR

WG

MP AO

 

 

1

5

 

1

 

 

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

BIMATOPROST-WGR

WG

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL [Brand: Bimprozt; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Bimprozt

TY

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL [Brand: Bimtop; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Bimtop

AF

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL [Brand: Lumigan; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Lumigan

VE

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30 [Brand: Lumigan PF; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Bimatoprost

Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30

Application to the eye

Lumigan PF

VE

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Bimatoprost with timolol

substitute:

Bimatoprost with timolol

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL

Application to the eye

Ganfort 0.3/5

VE

AO

C5038

P5038

1

5


 

1


 


 

Bimatoprost with timolol

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL

Application to the eye

Ganfort 0.3/5

VE

MP

C4343

P4343

1

5


 

1


 


 

Bimatoprost with timolol

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL

Application to the eye

Ganfort 0.3/5

VE

MP AO

C15558

P15558

2

5


 

1


 


 

Bimatoprost with timolol``

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30

Application to the eye

GANfort PF 0.3/5

VE

MP

C4572

P4572

1

5


 

1


 


 

Bimatoprost with timolol

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30

Application to the eye

GANfort PF 0.3/5

VE

AO

C5038

P5038

1

5


 

1


 


 

Bimatoprost with timolol

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30

Application to the eye

GANfort PF 0.3/5

VE

MP AO

C15558

P15558

2

5


 

1


 


 

  1.                Schedule 1, Part 1, entries for Bisacodyl

substitute:

Bisacodyl

Suppositories 10 mg, 10

Rectal

Dulcolax

VZ

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879

P5640 P5775 P5819 P5823 P5851 P5866 P5879

3

5

 

1

 

 

Bisacodyl

Suppositories 10 mg, 10

Rectal

Petrus Bisacodyl Suppositories

PP

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879

P5640 P5775 P5819 P5823 P5851 P5866 P5879

3

5

 

1

 

 

Bisacodyl

Suppositories 10 mg, 10

Rectal

Dulcolax

VZ

MP NP

C15535 C15585 C15586 C15587 C15708 C15726 C15727

P15535 P15585 P15586 P15587 P15708 P15726 P15727

6

5

 

1

 

 

Bisacodyl

Suppositories 10 mg, 10

Rectal

Petrus Bisacodyl Suppositories

PP

MP NP

C15535 C15585 C15586 C15587 C15708 C15726 C15727

P15535 P15585 P15586 P15587 P15708 P15726 P15727

6

5

 

1

 

 

Bisacodyl

Suppositories 10 mg, 12

Rectal

Petrus Bisacodyl Suppositories

PP

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879

P5640 P5775 P5819 P5823 P5851 P5866 P5879

3

4

 

1

 

 

Bisacodyl

Suppositories 10 mg, 12

Rectal

Petrus Bisacodyl Suppositories

PP

MP NP

C15535 C15585 C15586 C15587 C15708 C15726 C15727

P15535 P15585 P15586 P15587 P15708 P15726 P15727

6

4

 

1

 

 

Bisacodyl

Tablet 5 mg

Oral

Lax‑Tab

AE

MP NP

C5613 C5640 C5685 C5720 C5775 C5776 C5804

P5613 P5640 P5685 P5720 P5775 P5776 P5804

200

2

 

200

 

 

Bisacodyl

Tablet 5 mg

Oral

Lax‑Tab

AE

MP NP

C15572 C15585 C15586 C15629 C15707 C15734 C15735

P15572 P15585 P15586 P15629 P15707 P15734 P15735

400

2

 

200

 

 

  1.                Schedule 1, Part 1, after entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg [Brand: Bisoprolol Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Bisoprolol

Tablet containing bisoprolol fumarate 2.5 mg

Oral

BISOPROLOL-WGR

WG

MP NP

C5324

P5324

28

5

 

28

 

 

Bisoprolol

Tablet containing bisoprolol fumarate 2.5 mg

Oral

BISOPROLOL-WGR

WG

MP NP

C14251

P14251

56

5

 

28

 

 

  1.                Schedule 1, Part 1, after entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg [Brand: Bisoprolol Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Bisoprolol

Tablet containing bisoprolol fumarate 5 mg

Oral

BISOPROLOL-WGR

WG

MP NP

C5324

P5324

28

5

 

28

 

 

Bisoprolol

Tablet containing bisoprolol fumarate 5 mg

Oral

BISOPROLOL-WGR

WG

MP NP

C14251

P14251

56

5

 

28

 

 

  1.                Schedule 1, Part 1, after entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg [Brand: Bisoprolol Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Bisoprolol

Tablet containing bisoprolol fumarate 10 mg

Oral

BISOPROLOL-WGR

WG

MP NP

C5324

P5324

28

5

 

28

 

 

Bisoprolol

Tablet containing bisoprolol fumarate 10 mg

Oral

BISOPROLOL-WGR

WG

MP NP

C14251

P14251

56

5

 

28

 

 

  1.                Schedule 1, Part 1, entry for Brigatinib in the form Pack containing 7 tablets 90 mg and 21 tablets 180 mg

omit from the column headed “Circumstances”: C10384            substitute:C15759

  1.                Schedule 1, Part 1, after entry for Brimonidine in the form Eye drops containing brimonidine tartrate 1.5 mg per mL, 5 mL [Brand: Alphagan P 1.5; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Brimonidine

Eye drops containing brimonidine tartrate 1.5 mg per mL, 5 mL

Application to the eye

Alphagan P 1.5

VE

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Brimonidine in the form Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL [Brand: Alphagan; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Brimonidine

Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

Application to the eye

Alphagan

VE

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Brimonidine in the form Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL [Brand: Enidin; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Brimonidine

Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

Application to the eye

Enidin

VB

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Brimonidine with timolol

substitute:

Brimonidine with timolol

Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Combigan

VE

AO

C5038

P5038

1

5

 

1

 

 

Brimonidine with timolol

Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Combigan

VE

MP

C4343

P4343

1

5

 

1

 

 

Brimonidine with timolol

Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Combigan

VE

MP AO

C15558

P15558

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Brinzolamide in the form Eye drops 10 mg per mL, 5 mL [Brand: Azopt; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Brinzolamide

Eye drops 10 mg per mL, 5 mL

Application to the eye

Azopt

NV

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Brinzolamide in the form Eye drops 10 mg per mL, 5 mL [Brand: BrinzoQuin; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Brinzolamide

Eye drops 10 mg per mL, 5 mL

Application to the eye

BrinzoQuin

NM

MP AO

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Brinzolamide with brimonidine

substitute:

Brinzolamide with brimonidine

Eye drops 10 mg brinzolamide with 2 mg brimonidine tartrate per mL, 5 mL

Application to the eye

Simbrinza 1%/0.2%

NV

MP

C5630

P5630

1

5

 

1

 

 

Brinzolamide with brimonidine

Eye drops 10 mg brinzolamide with 2 mg brimonidine tartrate per mL, 5 mL

Application to the eye

Simbrinza 1%/0.2%

NV

AO

C5038

P5038

1

5

 

1

 

 

Brinzolamide with brimonidine

Eye drops 10 mg brinzolamide with 2 mg brimonidine tartrate per mL, 5 mL

Application to the eye

Simbrinza 1%/0.2%

NV

MP AO

C15558

P15558

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Brinzolamide with timolol

substitute:

Brinzolamide with timolol

Eye drops 10 mg brinzolamide with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Azarga

NV

MP

C4343

P4343

1

5

 

1

 

 

Brinzolamide with timolol

Eye drops 10 mg brinzolamide with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Azarga

NV

AO

C5038

P5038

1

5

 

1

 

 

Brinzolamide with timolol

Eye drops 10 mg brinzolamide with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Azarga

NV

MP AO

C15558

P15558

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Bromocriptine in the form Tablet 2.5 mg (as mesilate) [Brand: Parlodel; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Budesonide

Capsule (enteric) 3 mg

Oral

Budenofalk

FD

MP NP

C15772

 

100

1

 

50

 

 

  1.                Schedule 1, Part 1, entries for Budesonide in the form Nebuliser suspension 500 micrograms in 2 mL single dose units, 30

substitute:

Budesonide

Nebuliser suspension 500 micrograms in 2 mL single dose units, 30

Inhalation

Pulmicort Respules

AP

MP NP

C6340

P6340

1

5

 

1

 

 

Budesonide

Nebuliser suspension 500 micrograms in 2 mL single dose units, 30

Inhalation

Pulmicort Respules

AP

MP NP

C15578

P15578

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Budesonide in the form Nebuliser suspension 1 mg in 2 mL single dose units, 30 

substitute:

Budesonide

Nebuliser suspension 1 mg in 2 mL single dose units, 30

Inhalation

Pulmicort Respules

AP

MP NP

C6340

P6340

1

5

 

1

 

 

Budesonide

Nebuliser suspension 1 mg in 2 mL single dose units, 30

Inhalation

Pulmicort Respules

AP

MP NP

C15578

P15578

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide in the form Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses [Brand: Pulmicort Turbuhaler; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Budesonide

Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses

Inhalation by mouth

Pulmicort Turbuhaler

AP

MP NP

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide in the form Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses [Brand: Pulmicort Turbuhaler; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Budesonide

Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses

Inhalation by mouth

Pulmicort Turbuhaler

AP

MP NP

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide in the form Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses [Brand: Pulmicort Turbuhaler; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Budesonide

Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses

Inhalation by mouth

Pulmicort Turbuhaler

AP

MP NP

 

P14238

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

substitute:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 100/6

AP

MP

C10538

P10538

1

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 100/6

AP

MP NP

C4380

P4380

1

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 100/6

AP

MP

C15577

P15577

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 100/6

AP

MP NP

C15755

P15755

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses [Brand: BiResp Spiromax; Maximum Quantity: 1; Number of Repeats: 5; Prescriber: MP]

insert:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

BiResp Spiromax

TB

MP NP

C15680

P15680

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

BiResp Spiromax

TB

MP

C15577

P15577

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses [Brand: DuoResp Spiromax; Maximum Quantity: 1; Number of Repeats: 5; Prescriber: MP]

insert:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

DuoResp Spiromax

EV

MP NP

C15680

P15680

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

DuoResp Spiromax

EV

MP

C15577

P15577

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses [Brand: Rilast TURBUHALER 200/6; Maximum Quantity: 1; Number of Repeats: 5; Prescriber: MP]

insert:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast TURBUHALER 200/6

XT

MP NP

C15680

P15680

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast TURBUHALER 200/6

XT

MP

C15577

P15577

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses [Brand: Symbicort Turbuhaler 200/6; Maximum Quantity: 1; Number of Repeats: 5; Prescriber: MP]

insert:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 200/6

AP

MP NP

C15680

P15680

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 200/6

AP

MP

C15577

P15577

2

5

 

1

 

 

  1.                Schedule 1, Part 1, entries for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses 

substitute:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

BiResp Spiromax

TB

MP NP

C7979 C10121

P7979 P10121

2

5

 

2

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

BiResp Spiromax

TB

MP NP

C15548 C15617

P15548 P15617

4

5

 

2

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Bufomix Easyhaler 400/12

OX

MP NP

C7979 C10121

P7979 P10121

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Bufomix Easyhaler 400/12

OX

MP NP

C15548 C15617

P15548 P15617

4

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

DuoResp Spiromax

EV

MP NP

C7979 C10121

P7979 P10121

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

DuoResp Spiromax

EV

MP NP

C7979 C10121

P7979 P10121

2

5

 

2

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

DuoResp Spiromax

EV

MP NP

C15548 C15617

P15548 P15617

4

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

DuoResp Spiromax

EV

MP NP

C15548 C15617

P15548 P15617

4

5

 

2

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Rilast TURBUHALER 400/12

XT

MP NP

C7979 C10121

P7979 P10121

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Rilast TURBUHALER 400/12

XT

MP NP

C15548 C15617

P15548 P15617

4

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Symbicort TURBUHALER 400/12

AP

MP NP

C7979 C10121

P7979 P10121

2

5

 

1

 

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Symbicort TURBUHALER 400/12

AP

MP NP

C15548 C15617

P15548 P15617

4

5

 

1

 

 

  1.                Schedule 1, Part 1, entry for Budesonide with formoterol

omit:

Budesonide with formoterol

Pressurised inhalation containing budesonide 50 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 50/3

AP

MP NP

C4397

 

2

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 50 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 50/3

AP

MP

C10538

 

2

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses [Brand: Rilast RAPIHALER 100/3; Maximum Quantity: 2; Number of Repeats: 5; Prescriber: MP]

insert:

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 100/3

XT

MP NP

C15702

P15702

4

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 100/3

XT

MP

C15577

P15577

4

5

 

1

 

 

  1.                Schedule 1, Part 1, after entry for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses [Brand: Symbicort Rapihaler 100/3; Maximum Quantity: 2; Number of Repeats: 5; Prescriber: MP]

insert:

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 100/3

AP

MP NP

C15702

P15702

4

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 100/3

AP

MP

C15577

P15577

4

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Budesonide with formoterol in the form Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

substitute:

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 200/6

XT

MP NP

C4404 C10121

P4404 P10121

2

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 200/6

XT

MP

C10538

P10538

2

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 200/6

XT

MP NP

C15548 C15615

P15548 P15615

4

5

1

 

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 200/6

XT

MP

C15577

P15577

4

5

1

 

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 200/6

AP

MP NP

C4404 C10121

P4404 P10121

2

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 200/6

AP

MP

C10538

P10538

2

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 200/6

AP

MP NP

C15548 C15615

P15548 P15615

4

5

 

1

 

 

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 200/6

AP

MP

C15577

P15577

4

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Budesonide with glycopyrronium and formoterol

substitute:

Budesonide with glycopyrronium and formoterol

Pressurised inhalation containing budesonide 160 micrograms with glycopyrronium 7.2 micrograms and formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

Inhalation by mouth

Breztri Aerosphere

AP

MP NP

C12349

P12349

1

5

 

1

 

 

Budesonide with glycopyrronium and formoterol

Pressurised inhalation containing budesonide 160 micrograms with glycopyrronium 7.2 micrograms and formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

Inhalation by mouth

Breztri Aerosphere

AP

MP NP

C15543

P15543

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Cabergoline in the form Tablet 1 mg

substitute:

Cabergoline

Tablet 1 mg

Oral

Cabaser

PF

MP NP

C5168

P5168

30

5

 

30

 

 

Cabergoline

Tablet 1 mg

Oral

Cabaser

PF

MP NP

C15636

P15636

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Cabergoline in the form Tablet 2 mg 

substitute:

Cabergoline

Tablet 2 mg

Oral

Cabaser

PF

MP NP

C5168

P5168

30

5

 

30

 

 

Cabergoline

Tablet 2 mg

Oral

Cabaser

PF

MP NP

C15636

P15636

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Cabozantinib

substitute:

Cabozantinib

Tablet 20 mg

Oral

Cabometyx

IS

MP

C15454 C15774

P15454 P15774

30

2

 

30

 

 

Cabozantinib

Tablet 20 mg

Oral

Cabometyx

IS

MP

C15479 C15518 C15757 C15775

P15479 P15518 P15757 P15775

30

5

 

30

 

 

Cabozantinib

Tablet 40 mg

Oral

Cabometyx

IS

MP

C15454 C15774

P15454 P15774

30

2

 

30

 

 

Cabozantinib

Tablet 40 mg

Oral

Cabometyx

IS

MP

C15479 C15518 C15757 C15775

C15479 C15518 C15757 C15775

30

5

 

30

 

 

Cabozantinib

Tablet 60 mg

Oral

Cabometyx

IS

MP

C15454 C15774

P15454 P15774

30

2

 

30

 

 

Cabozantinib

Tablet 60 mg

Oral

Cabometyx

IS

MP

C15479 C15518 C15757 C15775

C15479 C15518 C15757 C15775

30

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg

omit:

Candesartan

Tablet containing candesartan cilexetil 4 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 4 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg [Brand: Candesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Candesartan

Tablet containing candesartan cilexetil 4 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 4 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg

omit:

Candesartan

Tablet containing candesartan cilexetil 8 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 8 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg [Brand: Candesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Candesartan

Tablet containing candesartan cilexetil 8 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 8 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg

omit:

Candesartan

Tablet containing candesartan cilexetil 16 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 16 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg [Brand: Candesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Candesartan

Tablet containing candesartan cilexetil 16 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 16 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg

omit:

Candesartan

Tablet containing candesartan cilexetil 32 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 32 mg

Oral

Blooms the Chemist Candesartan

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg [Brand: Candesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Candesartan

Tablet containing candesartan cilexetil 32 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Candesartan

Tablet containing candesartan cilexetil 32 mg

Oral

CANDESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg [Brand: CANDESAN COMBI 16/12.5; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

Oral

CANDESARTAN HCTZ-WGR 16/12.5

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

Oral

CANDESARTAN HCTZ-WGR 16/12.5

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

omit:

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

Oral

Blooms the Chemist Candesartan HCTZ 32/12.5

IB

MP NP

C4374

P4374

30

5

 

30

 

 

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

Oral

Blooms the Chemist Candesartan HCTZ 32/12.5

IB

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg [Brand: CANDESAN COMBI 32/12.5; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

Oral

CANDESARTAN HCTZ-WGR 32/12.5

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

Oral

CANDESARTAN HCTZ-WGR 32/12.5

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

omit:

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

Oral

Blooms the Chemist Candesartan HCTZ 32/25

IB

MP NP

C4374

P4374

30

5

 

30

 

 

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

Oral

Blooms the Chemist Candesartan HCTZ 32/25

IB

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg [Brand: CANDESAN COMBI 32/25; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

Oral

CANDESARTAN HCTZ-WGR 32/25

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Candesartan with hydrochlorothiazide

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

Oral

CANDESARTAN HCTZ-WGR 32/25

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Capecitabine

omit:

Capecitabine

Tablet 500 mg

Oral

Capecitabine‑DRLA

RZ

MP

 

 

120

2

 

120

 

 

  1.            Schedule 1, Part 1, after entry for Carbamazepine in the form Tablet 100 mg [Brand: Carbamazepine Sandoz; Maximum Quantity: 200; Number of Repeats: 2]

insert:

Carbamazepine

Tablet 100 mg

Oral

Carbamazepine Sandoz

NM

MP NP

 

P14238

400

2

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Carbamazepine in the form Tablet 100 mg [Brand: Tegretol 100; Maximum Quantity: 200; Number of Repeats: 2]

insert:

Carbamazepine

Tablet 100 mg

Oral

Tegretol 100

NV

MP NP

 

P14238

400

2

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Carbamazepine in the form Tablet 200 mg [Brand: Carbamazepine Sandoz; Maximum Quantity: 200; Number of Repeats: 2]

insert:

Carbamazepine

Tablet 200 mg

Oral

Carbamazepine Sandoz

NM

MP NP

 

P14238

400

2

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Carbamazepine in the form Tablet 200 mg [Brand: Tegretol 200; Maximum Quantity: 200; Number of Repeats: 2]

insert:

Carbamazepine

Tablet 200 mg

Oral

Tegretol 200

NV

MP NP

 

P14238

400

2

 

100

 

 

  1.            Schedule 1, Part 1, entries for Carbomer

substitute:

Carbomer

Eye gel 2 mg per g, 10 g

Application to the eye

Optifresh eye gel

PP

MP NP AO

C15560

P15560

1

5

 

1

 

 

Carbomer

Eye gel 2 mg per g, 10 g

Application to the eye

Optifresh eye gel

PP

MP NP AO

C15556

P15556

2

5

 

1

 

 

Carbomer

Eye gel 2 mg per g, 10 g

Application to the eye

PAA

UL

MP NP AO

C15560

P15560

1

5

 

1

 

 

Carbomer

Eye gel 2 mg per g, 10 g

Application to the eye

PAA

UL

MP NP AO

C15556

P15556

2

5

 

1

 

 

Carbomer

Eye gel 2 mg per g, 10 g

Application to the eye

Viscotears

UO

MP NP AO

C15560

P15560

1

5

 

1

 

 

Carbomer

Eye gel 2 mg per g, 10 g

Application to the eye

Viscotears

UO

MP NP AO

C15556

P15556

2

5

 

1

 

 

Carbomer

Eye gel 2 mg per g, single dose units 0.6 mL, 30

Application to the eye

Viscotears Gel PF

UO

MP NP AO

C6172

P6172

3

5

 

1

 

 

Carbomer

Eye gel 2 mg per g, single dose units 0.6 mL, 30

Application to the eye

Viscotears Gel PF

UO

MP NP AO

C15559

P15559

6

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Carmellose

substitute:

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 10 mL

Application to the eye

Evolve Carmellose

CX

MP NP AO

C6172

P6172

1

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 10 mL

Application to the eye

Evolve Carmellose

CX

MP NP AO

C15559

P15559

2

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 15 mL

Application to the eye

Refresh Tears Plus

VE

AO NP

 

 

1

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 15 mL

Application to the eye

Refresh Tears Plus

VE

MP

C15560

P15560

1

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, 15 mL

Application to the eye

Refresh Tears Plus

VE

MP

C15640

P15640

1

11

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30

Application to the eye

Cellufresh

VE

MP NP AO

C6172

P6172

3

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 31

Application to the eye

Cellufresh

VE

MP NP AO

C15559

P15559

6

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, 15 mL

Application to the eye

Refresh Liquigel

VE

AO NP

 

 

1

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, 15 mL

Application to the eye

Refresh Liquigel

VE

MP

C15560

P15560

1

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, 15 mL

Application to the eye

Refresh Liquigel

VE

MP

C15640

P15640

1

11

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30

Application to the eye

Celluvisc

VE

MP NP AO

C6172

P6172

3

5

 

1

 

 

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 31

Application to the eye

Celluvisc

VE

MP NP AO

C15559

P15559

6

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Carvedilol in the form Tablet 6.25 mg [Brand: Carvedilol Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Carvedilol

Tablet 6.25 mg

Oral

CARVEDILOL-WGR

WG

MP NP

C5324 C5394

P5324 P5394

60

5

 

60

 

 

Carvedilol

Tablet 6.25 mg

Oral

CARVEDILOL-WGR

WG

MP NP

C14251 C14270

P14251 P14270

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Carvedilol in the form Tablet 12.5 mg [Brand: Carvedilol Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Carvedilol

Tablet 12.5 mg

Oral

CARVEDILOL-WGR

WG

MP NP

C5324 C5394

P5324 P5394

60

5

 

60

 

 

Carvedilol

Tablet 12.5 mg

Oral

CARVEDILOL-WGR

WG

MP NP

C14251 C14270

P14251 P14270

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Carvedilol in the form Tablet 25 mg [Brand: Carvedilol Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Carvedilol

Tablet 25 mg

Oral

CARVEDILOL-WGR

WG

MP NP

C5324 C5394

P5324 P5394

60

5

 

60

 

 

Carvedilol

Tablet 25 mg

Oral

CARVEDILOL-WGR

WG

MP NP

C14251 C14270

P14251 P14270

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Cefalexin in the form Capsule 500 mg (as monohydrate) [Brand: Cephalexin generichealth; Maximum Quantity: 40; Number of Repeats: 1]

insert:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

CEPHALEXIN-WGR

WG

MP NP MW PDP

 

 

20

0

 

20

 

 

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

CEPHALEXIN-WGR

WG

MP NP MW

 

P10410

40 CN10410

0 CN10410

 

20

 

 

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

CEPHALEXIN-WGR

WG

MP

 

P6188

40 CN6188

1 CN6188

 

20

 

 

  1.            Schedule 1, Part 1, after entry for Celecoxib in the form Capsule 100 mg [Brand: Celecoxib Sandoz]

insert:

Celecoxib

Capsule 100 mg

Oral

CELECOXIB-WGR

WG

MP NP

C4907 C4962

 

60

3

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Celecoxib in the form Capsule 200 mg [Brand: Celecoxib Sandoz]

insert:

Celecoxib

Capsule 200 mg

Oral

CELECOXIB-WGR

WG

MP NP

C4907 C4962

 

30

3

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ceritinib

omit from the column headed “Circumstances”: C6732 C7369            substitute: C7346 C15759

  1.            Schedule 1, Part 1, after entry for Ciclesonide in the form Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation) [Brand: Alvesco 80; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Ciclesonide

Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Alvesco 80

EU

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Ciclesonide in the form Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation) [Brand: Alvesco 160; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Ciclesonide

Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Alvesco 160

EU

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Ciclosporin in the form Capsule 25 mg [Brand: APO-Ciclosporin; Maximum Quantity: 120; Number of Repeats: 3]

insert:

Ciclosporin

Capsule 25 mg

Oral

CICLOSPORIN-WGR

WG

MP

 

 

60

3

 

30

 

 

Ciclosporin

Capsule 25 mg

Oral

CICLOSPORIN-WGR

WG

MP

 

P14238

120

3

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ciclosporin in the form Capsule 50 mg [Brand: APO-Ciclosporin; Maximum Quantity: 120; Number of Repeats: 3]

insert:

Ciclosporin

Capsule 50 mg

Oral

CICLOSPORIN-WGR

WG

MP

 

 

60

3

 

30

 

 

Ciclosporin

Capsule 50 mg

Oral

CICLOSPORIN-WGR

WG

MP

 

P14238

120

3

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ciclosporin in the form Capsule 100 mg [Brand: APO-Ciclosporin; Maximum Quantity: 120; Number of Repeats: 3]

insert:

Ciclosporin

Capsule 100 mg

Oral

CICLOSPORIN-WGR

WG

MP

 

 

60

3

 

30

 

 

Ciclosporin

Capsule 100 mg

Oral

CICLOSPORIN-WGR

WG

MP

 

P14238

120

3

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride) [Brand: Ciprofloxacin Sandoz]

insert:

Ciprofloxacin

Tablet 250 mg (as hydrochloride)

Oral

CIPROFLOXACIN-WGR

WG

MP NP

C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780

 

14

0

 

14

 

 

  1.            Schedule 1, Part 1, after entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride) [Brand: Ciprofloxacin Sandoz]

insert:

Ciprofloxacin

Tablet 500 mg (as hydrochloride)

Oral

CIPROFLOXACIN-WGR

WG

MP NP

C5614 C5615 C5687 C5688 C5689 C5722 C5780

 

14

0

 

14

 

 

  1.            Schedule 1, Part 1, after entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride) [Brand: Ciprofloxacin Sandoz]

insert:

Ciprofloxacin

Tablet 750 mg (as hydrochloride)

Oral

CIPROFLOXACIN-WGR

WG

MP NP

C5614 C5615 C5687 C5688 C5689 C5722 C5780

 

14

0

 

14

 

 

  1.            Schedule 1, Part 1, entries for Citalopram

substitute:

Citalopram

Tablet 10 mg (as hydrobromide)

Oral

Celapram

AF

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 10 mg (as hydrobromide)

Oral

Celapram

AF

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 10 mg (as hydrobromide)

Oral

Talam

RW

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 10 mg (as hydrobromide)

Oral

Talam

RW

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

APO‑Citalopram

TX

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

APO‑Citalopram

TX

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

APX‑Citalopram

TY

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

APX‑Citalopram

TY

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Celapram

AF

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Celapram

AF

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Cipramil

LU

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Cipramil

LU

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Citalopram Sandoz

SZ

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Citalopram Sandoz

SZ

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

NOUMED CITALOPRAM

VO

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

NOUMED CITALOPRAM

VO

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Talam

RW

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

Talam

RW

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

APO‑Citalopram

TX

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

APO‑Citalopram

TX

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

Celapram

AF

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

Celapram

AF

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

Citalopram Sandoz

SZ

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

Citalopram Sandoz

SZ

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

NOUMED CITALOPRAM

VO

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

NOUMED CITALOPRAM

VO

MP NP

C15666

P15666

56

2

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

Talam

RW

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

Talam

RW

MP NP

C15666

P15666

56

2

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Clindamycin in the form Capsule 150 mg (as hydrochloride) [Brand: Clindamycin LU; Maximum Quantity: 48; Number of Repeats: 1]

insert:

Clindamycin

Capsule 150 mg (as hydrochloride)

Oral

CLINDAMYCIN-WGR

WG

PDP

C5487

P5487

24

0

 

24

 

 

 

Clindamycin

Capsule 150 mg (as hydrochloride)

Oral

CLINDAMYCIN-WGR

WG

MP NP MW

C5470

P5470

48

1

 

24

 

 

 

  1.            Schedule 1, Part 1, after entry for Clomipramine in the form Tablet containing clomipramine hydrochloride 25 mg [Brand: APO-Clomipramine]

insert:

Clomipramine

Tablet containing clomipramine hydrochloride 25 mg

Oral

CLOMIPRAMINE-WGR

WG

MP NP

C6250 C6251 C6299

 

50

2

 

50

 

 

  1.            Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

omit:

Clopidogrel

Tablet 75 mg (as besilate)

Oral

BTC Clopidogrel

JB

MP NP

 

 

28

5

 

28

 

 

Clopidogrel

Tablet 75 mg (as besilate)

Oral

BTC Clopidogrel

JB

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Clonidine in the form Tablet containing clonidine hydrochloride 150 micrograms [Brand: Catapres; Maximum Quantity: 200; Number of Repeats: 5]

insert:

Clopidogrel

Tablet 75 mg (as besilate)

Oral

CLOPIDOGREL-WGR

WG

MP NP

 

 

28

5

 

28

 

 

Clopidogrel

Tablet 75 mg (as besilate)

Oral

CLOPIDOGREL-WGR

WG

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, entries for Colestyramine in the form Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50

substitute:

Colestyramine

Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50

Oral

Questran Lite

GO

MP NP

 

 

2

5

 

1

 

 

Colestyramine

Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50

Oral

Questran Lite

GO

MP NP

 

P14238

4

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Crizotinib

substitute:

Crizotinib

Capsule 200 mg

Oral

Xalkori

PF

MP

C13186 C15776 C15803

 

60

3

 

60

 

 

Crizotinib

Capsule 250 mg

Oral

Xalkori

PF

MP

C13186 C15776 C15803

 

60

3

 

60

 

 

  1.            Schedule 1, Part 1, entries for Desvenlafaxine

substitute:

Desvenlafaxine

Tablet (extended release) 50 mg (as succinate)

Oral

Pristiq

PF

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (extended release) 50 mg (as succinate)

Oral

Pristiq

PF

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (extended release) 100 mg (as succinate)

Oral

Pristiq

PF

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (extended release) 100 mg (as succinate)

Oral

Pristiq

PF

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

BTC Desvenlafaxine

BG

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

BTC Desvenlafaxine

BG

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

Desfax

AF

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

Desfax

AF

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

DESVEN

RW

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

DESVEN

RW

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

Desvenlafaxine Sandoz

SZ

MP NP

C5650

 

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

Desvenlafaxine Sandoz

SZ

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

DESVENLAFAXINE-WGR XR

WG

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg

Oral

DESVENLAFAXINE-WGR XR

WG

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg (as benzoate)

Oral

APO-Desvenlafaxine MR

TX

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg (as benzoate)

Oral

APO-Desvenlafaxine MR

TX

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg (as benzoate)

Oral

Desvenlafaxine GH XR

GQ

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 50 mg (as benzoate)

Oral

Desvenlafaxine GH XR

GQ

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

BTC Desvenlafaxine

BG

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

BTC Desvenlafaxine

BG

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

Desfax

AF

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

Desfax

AF

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

DESVEN

RW

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

DESVEN

RW

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

Desvenlafaxine Sandoz

SZ

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

Desvenlafaxine Sandoz

SZ

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

DESVENLAFAXINE-WGR XR

WG

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg

Oral

DESVENLAFAXINE-WGR XR

WG

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg (as benzoate)

Oral

APO-Desvenlafaxine MR

TX

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg (as benzoate)

Oral

APO-Desvenlafaxine MR

TX

MP NP

C15553

P15553

56

2

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg (as benzoate)

Oral

Desvenlafaxine GH XR

GQ

MP NP

C5650

P5650

28

5

 

28

 

 

Desvenlafaxine

Tablet (modified release) 100 mg (as benzoate)

Oral

Desvenlafaxine GH XR

GQ

MP NP

C15553

P15553

56

2

 

28

 

 

  1.            Schedule 1, Part 1, entries for Diazepam

substitute:

Diazepam

Oral liquid 10 mg per 10 mL, 100 mL

Oral

Diazepam Elixir

ON

MP NP

C4244

 

1

0

 

1

 

 

Diazepam

Tablet 2 mg

Oral

Antenex 2

AF

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 2 mg

Oral

Antenex 2

AF

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 2 mg

Oral

APO-Diazepam

TX

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 2 mg

Oral

APO-Diazepam

TX

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 2 mg

Oral

APX-Diazepam

TY

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 2 mg

Oral

APX-Diazepam

TY

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 2 mg

Oral

DIAZEPAM-WGR

WG

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 2 mg

Oral

DIAZEPAM-WGR

WG

MP NP

 

P6176

50 CN6176

3 CN6176

 

50

 

 

Diazepam

Tablet 2 mg

Oral

Valpam 2

RW

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 2 mg

Oral

Valpam 2

RW

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 5 mg

Oral

Antenex 5

AF

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 5 mg

Oral

Antenex 5

AF

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 5 mg

Oral

APO-Diazepam

TX

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 5 mg

Oral

APO-Diazepam

TX

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 5 mg

Oral

APX-Diazepam

TY

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 5 mg

Oral

APX-Diazepam

TY

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 5 mg

Oral

DIAZEPAM-WGR

WG

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 5 mg

Oral

DIAZEPAM-WGR

WG

MP NP

 

P6176

50 CN6176

3 CN6176

 

50

 

 

Diazepam

Tablet 5 mg

Oral

NOUMED DIAZEPAM

VO

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 5 mg

Oral

NOUMED DIAZEPAM

VO

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 5 mg

Oral

Valium

IX

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 5 mg

Oral

Valium

IX

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

Diazepam

Tablet 5 mg

Oral

Valpam 5

RW

MP NP PDP

 

 

50

0

 

50

 

 

Diazepam

Tablet 5 mg

Oral

Valpam 5

RW

MP NP

 

P6176

50
CN6176

3
CN6176

 

50

 

 

  1.            Schedule 1, Part 1, after entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Brand: Diclofenac Sandoz; Maximum Quantity: 100; Number of Repeats: 3]

insert:

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

DICLOFENAC-WGR

WG

PDP

 

 

100

0

 

50

 

 

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

DICLOFENAC-WGR

WG

MP NP

 

 

100

3

 

50

 

 

  1.            Schedule 1, Part 1, after entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Brand: Diclofenac Sandoz; Maximum Quantity: 50; Number of Repeats: 3]

insert:

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

DICLOFENAC-WGR

WG

PDP

 

 

50

0

 

50

 

 

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

DICLOFENAC-WGR

WG

MP NP

 

 

50

3

 

50

 

 

  1.            Schedule 1, Part 1, entries for Diltiazem

substitute:

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

Cardizem CD

SW

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

Cardizem CD

SW

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

Diltiazem Sandoz CD

SZ

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

Vasocardol CD

AV

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

Vasocardol CD

AV

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

Cardizem CD

SW

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

Cardizem CD

SW

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

Diltiazem Sandoz CD

SZ

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

Vasocardol CD

AV

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

Vasocardol CD

AV

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Cardizem CD

SW

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Cardizem CD

SW

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Diltiazem Sandoz CD

SZ

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Diltiazem Sandoz CD

SZ

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Vasocardol CD

AV

MP NP

 

 

30

5

 

30

 

 

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Vasocardol CD

AV

MP NP

 

P14238

60

5

 

30

 

 

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Cardizem

SW

MP NP

 

 

90

5

 

90

 

 

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Cardizem

SW

MP NP

 

P14238

180

5

 

90

 

 

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Vasocardol

AV

MP NP

 

 

90

5

 

90

 

 

Diltiazem

Tablet containing diltiazem hydrochloride 60 mg

Oral

Vasocardol

AV

MP NP

 

P14238

180

5

 

90

 

 

  1.            Schedule 1, Part 1, after entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg [Brand: Donepezil Sandoz; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 5]

insert:

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

DONEPEZIL-WGR

WG

MP NP

C13938

 

28

5

 

28

 

 

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

DONEPEZIL-WGR

WG

MP

C13938 C13940 C13941

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg [Brand: Donepezil Sandoz; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 5]

insert:

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

DONEPEZIL-WGR

WG

MP NP

C13938

 

28

5

 

28

 

 

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

DONEPEZIL-WGR

WG

MP

C13940 C13941

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, entries for Dorzolamide

substitute:

Dorzolamide

Eye drops 20 mg (as hydrochloride) per mL, 5 mL

Application to the eye

Trusamide

AF

AO MP

 

 

1

5

 

1

 

 

Dorzolamide

Eye drops 20 mg (as hydrochloride) per mL, 5 mL

Application to the eye

Trusamide

AF

AO MP

 

P14238

2

5

 

1

 

 

Dorzolamide

Eye drops 20 mg (as hydrochloride) per mL, 5 mL

Application to the eye

Trusopt

MF

AO MP

 

 

1

5

 

1

 

 

Dorzolamide

Eye drops 20 mg (as hydrochloride) per mL, 5 mL

Application to the eye

Trusopt

MF

AO MP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Dorzolamide with timolol

substitute:

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Cosdor

AF

MP

C4343

P4343

1

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Cosdor

AF

AO

C5038

P5038

1

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Cosdor

AF

AO MP

C15558

P15558

2

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Cosopt

MF

MP

C4343

P4343

1

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Cosopt

MF

AO

C5038

P5038

1

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Cosopt

MF

AO MP

C15558

P15558

2

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Vizo-PF Dorzolatim

AE

MP

C4343

P4343

1

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Vizo-PF Dorzolatim

AE

AO

C5038

P5038

1

5

 

1

 

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Vizo-PF Dorzolatim

AE

AO MP

C15558

P15558

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Doxycycline

substitute:

Doxycycline

Capsule 50 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx

YN

MP NP

C4475 C4529 C4539

P4475 P4529 P4539

25

5

 

25

 

 

Doxycycline

Capsule 50 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx

YN

MP NP

C15596 C15659 C15686

P15596 P15659 P15686

50

2

 

25

 

 

Doxycycline

Capsule 50 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

MP NP

C4475 C4529 C4539

P4475 P4529 P4539

25

5

 

25

 

 

Doxycycline

Capsule 50 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

MP NP

C15596 C15659 C15686

P15596 P15659 P15686

50

2

 

25

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx

YN

PDP

 

 

7

0

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx

YN

MP NP

 

 

7

1

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx

YN

MP NP

 

P4514

28

0

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx

YN

MP

 

P6200

28

5

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx

YN

MP

 

P15625

56

2

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

PDP

 

 

7

0

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

MP NP

 

 

7

1

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

MP NP

 

P4485

21

0

 

21

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

MP NP

 

P4514

28

0

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

MP

 

P6200

28

5

 

7

 

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Mayne Pharma Doxycycline

YT

MP

 

P15625

56

2

 

7

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP NP

C4475 C4529 C4539

P4475 P4529 P4539

25

5

 

25

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP NP

C15596 C15659 C15686

P15596 P15659 P15686

50

2

 

25

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

Doxsig

RW

MP NP

C4475 C4529 C4539

P4475 P4529 P4539

25

5

 

25

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

Doxsig

RW

MP NP

C15596 C15659 C15686

P15596 P15659 P15686

50

2

 

25

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

MP NP

C4475 C4529 C4539

P4475 P4529 P4539

25

5

 

25

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

MP NP

C15596 C15659 C15686

P15596 P15659 P15686

50

2

 

25

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

Doxylin 50

AF

MP NP

C4475 C4529 C4539

P4475 P4529 P4539

25

5

 

25

 

 

Doxycycline

Tablet 50 mg (as hyclate)

Oral

Doxylin 50

AF

MP NP

C15596 C15659 C15686

P15596 P15659 P15686

50

2

 

25

 

 

Doxycycline

Tablet 50 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

MP NP

C4475 C4529 C4539

P4475 P4529 P4539

25

5

 

25

 

 

Doxycycline

Tablet 50 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

MP NP

C15596 C15659 C15686

P15596 P15659 P15686

50

2

 

25

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline

TX

PDP

 

 

7

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP NP

 

 

7

1

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP NP

 

P4485

21

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP NP

 

P4485

21

0

 

21

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP NP

 

P4514

28

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP

 

P6200

28

5

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline

TX

MP

 

P15625

56

2

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxsig

RW

PDP

 

 

7

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxsig

RW

MP NP

 

 

7

1

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxsig

RW

MP NP

 

P4485

21

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxsig

RW

MP NP

 

P4485

21

0

 

21

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxsig

RW

MP NP

 

P4514

28

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxsig

RW

MP

 

P6200

28

5

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxsig

RW

MP

 

P15625

56

2

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

PDP

 

 

7

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

MP NP

 

 

7

1

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

MP NP

 

P4485

21

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

MP NP

 

P4514

28

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

MP

 

P6200

28

5

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

DOXYCYCLINE-WGR

WG

MP

 

P15625

56

2

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxylin 100

AF

PDP

 

 

7

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxylin 100

AF

MP NP

 

 

7

1

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxylin 100

AF

MP NP

 

P4485

21

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxylin 100

AF

MP NP

 

P4485

21

0

 

21

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxylin 100

AF

MP NP

 

P4514

28

0

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxylin 100

AF

MP

 

P6200

28

5

 

7

 

 

Doxycycline

Tablet 100 mg (as hyclate)

Oral

Doxylin 100

AF

MP

 

P15625

56

2

 

7

 

 

Doxycycline

Tablet 100 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

PDP

 

 

7

0

 

7

 

 

Doxycycline

Tablet 100 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

MP NP

 

 

7

1

 

7

 

 

Doxycycline

Tablet 100 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

MP NP

 

P4485

21

0

 

7

 

 

Doxycycline

Tablet 100 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

MP NP

 

P4514

28

0

 

7

 

 

Doxycycline

Tablet 100 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

MP

 

P6200

28

5

 

7

 

 

Doxycycline

Tablet 100 mg (as monohydrate)

Oral

Doxycycline Sandoz

HX

MP

 

P15625

56

2

 

7

 

 

  1.            Schedule 1, Part 1, after entry for Enalapril in the form Tablet containing enalapril maleate 5 mg [Brand: Enalapril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

ENALAPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

ENALAPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Enalapril in the form Tablet containing enalapril maleate 10 mg [Brand: Enalapril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Enalapril

Tablet containing enalapril maleate 10 mg

Oral

ENALAPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Enalapril

Tablet containing enalapril maleate 10 mg

Oral

ENALAPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Enalapril in the form Tablet containing enalapril maleate 20 mg [Brand: Enalapril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Enalapril

Tablet containing enalapril maleate 20 mg

Oral

ENALAPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Enalapril

Tablet containing enalapril maleate 20 mg

Oral

ENALAPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Entacapone

substitute:

Entacapone

Tablet 200 mg

Oral

Comtan

SZ

MP NP

C5133

P5133

200

4

 

100

 

 

Entacapone

Tablet 200 mg

Oral

Comtan

SZ

MP NP

C15602

P15602

400

4

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Entecavir in the form Tablet 0.5 mg (as monohydrate) [Brand: Entecavir Viatris]

insert:

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

ENTECAVIR-WGR

WG

MP NP

C4993 C5036

 

60

5

 

30

 

D(100)

  1.            Schedule 1, Part 1, after entry for Entecavir in the form Tablet 1 mg (as monohydrate) [Brand: Entecavir Viatris]

insert:

Entecavir

Tablet 1 mg (as monohydrate)

Oral

ENTECAVIR-WGR

WG

MP NP

C5037 C5044

 

60

5

 

30

 

D(100)

  1.            Schedule 1, Part 1, entry for Entrectinib

omit from the column headed “Circumstances”: C13184 C1327             subsitute: C13186 C15776

  1.            Schedule 1, Part 1, entry for Eprosartan with hydrochlorothiazide

substitute:

Eprosartan with hydrochlorothiazide

Tablet 600 mg eprosartan (as mesilate) with 12.5 mg hydrochlorothiazide

Oral

Teveten Plus 600/12.5

GO

MP NP

C4374

P4374

28

5

 

28

 

 

Eprosartan with hydrochlorothiazide

Tablet 600 mg eprosartan (as mesilate) with 12.5 mg hydrochlorothiazide

Oral

Teveten Plus 600/12.5

GO

MP NP

C15624

P15624

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Erythromycin in the form Capsule 250 mg (containing enteric coated pellets) [Brand: Mayne Pharma Erythromycin; Maximum Quantity: 50; Number of Repeats: 5]

insert:

Erythromycin

Capsule 250 mg (containing enteric coated pellets)

Oral

Mayne Pharma Erythromycin

YT

MP

 

P15710

100 CN15710

2 CN15710

 

25

 

 

  1.            Schedule 1, Part 1, entries for Escitalopram

substitute:

Escitalopram

Oral solution 20 mg (as oxalate) per mL, 15 mL

Oral

Lexapro

LU

MP NP

C4680 C4681 C4707 C4721 C4747

P4680 P4681 P4707 P4721 P4747

1

5

 

1

 

 

Escitalopram

Oral solution 20 mg (as oxalate) per mL, 15 mL

Oral

Lexapro

LU

MP NP

C15606 C15639 C15670 C15698 C15751

P15606 P15639 P15670 P15698 P15751

2

2

 

1

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

APO-Escitalopram

TX

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

APO-Escitalopram

TX

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

APX-Escitalopram

TY

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

APX-Escitalopram

TY

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Blooms Escitalopram

BG

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Blooms Escitalopram

BG

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Cilopam-S

ZS

MP NP

C4755

P4755

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Cilopam-S

ZS

MP NP

C15666

P15666

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Escitalopram GH

HQ

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Escitalopram GH

HQ

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Escitalopram Sandoz

HX

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Escitalopram Sandoz

HX

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Esipram

CF

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Esipram

CF

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Lexam 10

RW

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Lexam 10

RW

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Lexapro

LU

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Lexapro

LU

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

LoxaLate

AF

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

LoxaLate

AF

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

NOUMED ESCITALOPRAM

VO

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

NOUMED ESCITALOPRAM

VO

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

APO-Escitalopram

TX

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

APO-Escitalopram

TX

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

APX-Escitalopram

TY

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

APX-Escitalopram

TY

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Blooms Escitalopram

BG

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Blooms Escitalopram

BG

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Cilopam-S

ZS

MP NP

C4755

P4755

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Cilopam-S

ZS

MP NP

C15666

P15666

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Escitalopram GH

HQ

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Escitalopram GH

HQ

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Escitalopram Sandoz

HX

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Escitalopram Sandoz

HX

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Esipram

CF

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Esipram

CF

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Lexam 20

RW

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Lexam 20

RW

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Lexapro

LU

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

Lexapro

LU

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

LoxaLate

AF

MP NP

C4755

P4755

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

LoxaLate

AF

MP NP

C15666

P15666

56

2

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

NOUMED ESCITALOPRAM

VO

MP NP

C4690 C4703 C4755 C4756 C4757

P4690 P4703 P4755 P4756 P4757

28

5

 

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

NOUMED ESCITALOPRAM

VO

MP NP

C15550 C15551 C15666 C15669 C15696

P15550 P15551 P15666 P15669 P15696

56

2

 

28

 

 

  1.            Schedule 1, Part 1, entries for Esomeprazole

substitute:

Esomeprazole

Capsule (enteric) 20 mg (as magnesium)

Oral

Noxicid Caps

AL

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Capsule (enteric) 20 mg (as magnesium)

Oral

Noxicid Caps

AL

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Capsule (enteric) 20 mg (as magnesium)

Oral

Noxicid Caps

AL

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Capsule (enteric) 20 mg (as magnesium)

Oral

Noxicid Caps

AL

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Capsule (enteric) 20 mg (as magnesium)

Oral

Noxicid Caps

AL

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Capsule (enteric) 40 mg (as magnesium)

Oral

Noxicid Caps

AL

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Capsule (enteric) 40 mg (as magnesium)

Oral

Noxicid Caps

AL

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Capsule (enteric) 40 mg (as magnesium)

Oral

Noxicid Caps

AL

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Capsule (enteric) 40 mg (as magnesium)

Oral

Noxicid Caps

AL

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Capsule (enteric) 40 mg (as magnesium)

Oral

Noxicid Caps

AL

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP NP

C8776 C8780 C8827

P8776 P8780 P8827

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP

C11310

P11310

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP NP

C15530 C15658 C15682

P15530 P15658 P15682

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP

C15531

P15531

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole

TY

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GH

GQ

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole GxP

AF

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Mylan

AL

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole Viatris

MQ

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

ESOMEPRAZOLE-WGR

WG

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esopreze

BG

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexazole

RW

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexium

AP

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Nexole

RF

MP

C15705

P15705

120

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP NP

C8902

P8902

30

1

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP NP

C8777 C8778

P8777 P8778

30

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP

C11370

P11370

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP NP

C15655 C15704

P15655 P15704

60

5

 

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

NOUMED ESOMEPRAZOLE

VO

MP

C15705

P15705

120

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Estradiol with norethisterone in the form Transdermal patches containing 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8

insert:

Estradiol with norethisterone

Transdermal patches containing 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8

Transdermal

Estalis continuous 50/250

SZ

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Exemestane in the form Tablet 25 mg [Brand: Exemestane Sandoz; Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Exemestane

Tablet 25 mg

Oral

EXEMESTANE-WGR

WG

MP

C4796

P4796

30

5

 

30

 

 

Exemestane

Tablet 25 mg

Oral

EXEMESTANE-WGR

WG

MP NP

C5522

P5522

30

5

 

30

 

 

Exemestane

Tablet 25 mg

Oral

EXEMESTANE-WGR

WG

MP

C15031

P15031

60

5

 

30

 

 

Exemestane

Tablet 25 mg

Oral

EXEMESTANE-WGR

WG

MP NP

C14992

P14992

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ezetimibe in the form Tablet 10 mg [Brand: Ezetimibe Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ezetimibe

Tablet 10 mg

Oral

EZETIMIBE-WGR

WG

MP NP

C7966 C7990 C7996

P7966 P7990 P7996

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

EZETIMIBE-WGR

WG

MP NP

C14249 C14283 C14310

P14249 P14283 P14310

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ezetimibe with simvastatin in the form Tablet 10 mg-10 mg [Brand: EZETIMIBE/SIMVASTATIN SANDOZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/10

WG

MP NP

C7958

P7958

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/10

WG

MP NP

C14269

P14269

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ezetimibe with simvastatin in the form Tablet 10 mg-20 mg [Brand: EZETIMIBE/SIMVASTATIN SANDOZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/20

WG

MP NP

C7958

P7958

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/20

WG

MP NP

C14269

P14269

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ezetimibe with simvastatin in the form Tablet 10 mg-40 mg [Brand: EZETIMIBE/SIMVASTATIN SANDOZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/40

WG

MP NP

C7957

P7957

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/40

WG

MP NP

C14284

P14284

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ezetimibe with simvastatin in the form Tablet 10 mg-80 mg [Brand: EZETIMIBE/SIMVASTATIN SANDOZ; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/80

WG

MP NP

C7957

P7957

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/80

WG

MP NP

C14284

P14284

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Famciclovir in the form Tablet 250 mg [Brand: Ezovir; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Famciclovir

Tablet 250 mg

Oral

FAMCICLOVIR-WGR

WG

MP NP

C5937

P5937

20

1

 

20

 

 

Famciclovir

Tablet 250 mg

Oral

FAMCICLOVIR-WGR

WG

MP NP

C5951

P5951

21

0

 

21

 

 

Famciclovir

Tablet 250 mg

Oral

FAMCICLOVIR-WGR

WG

MP NP

C5971

P5971

56

5

 

56

 

 

  1.            Schedule 1, Part 1, after entry for Famciclovir in the form Tablet 500 mg [Brand: Ezovir; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Famciclovir

Tablet 500 mg

Oral

FAMCICLOVIR-WGR

WG

MP NP

C5943

P5943

30

0

 

30

 

 

Famciclovir

Tablet 500 mg

Oral

FAMCICLOVIR-WGR

WG

MP NP

C5947 C5948 C5949 C5954

P5947 P5948 P5949 P5954

56

5

 

56

 

 

  1.            Schedule 1, Part 1, after entry for Fenofibrate in the form Tablet 48 mg  [Brand: Fenofibrate Viatris; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Fenofibrate

Tablet 48 mg

Oral

FENOFIBRATE-WGR

WG

MP NP

 

 

60

5

 

60

 

 

Fenofibrate

Tablet 48 mg

Oral

FENOFIBRATE-WGR

WG

MP NP

 

P14238

120

5

 

60

 

 

  1.            Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 145 mg

omit:

Fenofibrate

Tablet 145 mg

Oral

Blooms the Chemist Fenofibrate

IB

MP NP

 

 

30

5

 

30

 

 

Fenofibrate

Tablet 145 mg

Oral

Blooms the Chemist Fenofibrate

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Fenofibrate in the form Tablet 145 mg [Brand: Fenofibrate Viatris; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Fenofibrate

Tablet 145 mg

Oral

FENOFIBRATE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Fenofibrate

Tablet 145 mg

Oral

FENOFIBRATE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Fluoxetine

substitute:

Fluoxetine

Capsule 10 mg (Medreich) (S19A)

Oral

Fluoxetine Capsules 10 mg (Medreich, UK)

LM

MP NP

C14828 C14832

 

30

5

 

30

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

APO-Fluoxetine

TX

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

APO-Fluoxetine

TX

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Blooms the Chemist Fluoxetine

BG

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Blooms the Chemist Fluoxetine

BG

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

FLUOTEX

RF

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

FLUOTEX

RF

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Fluoxetine APOTEX

TY

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Fluoxetine APOTEX

TY

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Fluoxetine generichealth

GQ

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Fluoxetine generichealth

GQ

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Fluoxetine Sandoz

SZ

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Fluoxetine Sandoz

SZ

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

NOUMED FLUOXETINE

VO

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

NOUMED FLUOXETINE

VO

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Prozac 20

LY

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Prozac 20

LY

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Zactin

AF

MP NP

C4755 C6277

P4755 P6277

28

5

 

28

 

 

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

Zactin

AF

MP NP

C15582 C15666

C15582 C15666

56

2

 

28

 

 

Fluoxetine

Tablet, dispersible, 20 mg (as hydrochloride)

Oral

Zactin Tablet

AF

MP NP

C4755 C6277

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone furoate in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms per dose, 30 doses

insert:

Fluticasone furoate

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms per dose, 30 doses

Inhalation by mouth

Arnuity Ellipta

GK

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone furoate in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms per dose, 30 doses

insert:

Fluticasone furoate

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms per dose, 30 doses

Inhalation by mouth

Arnuity Ellipta

GK

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Fluticasone furoate with umeclidinium and vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

substitute:

Fluticasone furoate with umeclidinium and vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Trelegy Ellipta 100/62.5/25

GK

MP NP

C12349

P12349

1

5

 

1

 

 

Fluticasone furoate with umeclidinium and vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Trelegy Ellipta 100/62.5/25

GK

MP NP

C15543

P15543

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Fluticasone furoate with umeclidinium and vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

substitute:

Fluticasone furoate with umeclidinium and vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Trelegy Ellipta 200/62.5/25

GK

MP NP

C12603

P12603

1

5

 

1

 

 

Fluticasone furoate with umeclidinium and vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Trelegy Ellipta 200/62.5/25

GK

MP NP

C15601

P15601

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Fluticasone furoate with vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

substitute:

Fluticasone furoate with vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Breo Ellipta 100/25

GK

MP NP

C4711 C10121

P4711 P10121

1

5

 

1

 

 

Fluticasone furoate with vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Breo Ellipta 100/25

GK

MP NP

C15546 C15548

P15546 P15548

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Fluticasone furoate with vilanterol in the form Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

substitute:

Fluticasone furoate with vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Breo Ellipta 200/25

GK

MP NP

C4731

P4731

1

5

 

1

 

 

Fluticasone furoate with vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Breo Ellipta 200/25

GK

MP NP

C15692

P15692

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone propionate in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses [Brand: Axotide Junior Accuhaler]

insert:

Fluticasone propionate

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses

Inhalation by mouth

Axotide Junior Accuhaler

TX

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone propionate in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses [Brand: Flixotide Junior Accuhaler]

insert:

Fluticasone propionate

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses

Inhalation by mouth

Flixotide Junior Accuhaler

GK

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone propionate in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses [Brand: Axotide Accuhaler]

insert:

Fluticasone propionate

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses

Inhalation by mouth

Axotide Accuhaler

TX

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone propionate in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses [Brand: Flixotide Accuhaler]

insert:

Fluticasone propionate

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses

Inhalation by mouth

Flixotide Accuhaler

GK

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

substitute:

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Axotide Junior

TX

MP NP

C14180

P14180

1

5

 

1

 

 

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Axotide Junior

TX

MP NP

C14238

P14238

2

5

 

1

 

 

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Flixotide Junior

GK

MP NP

C14180

P14180

1

5

 

1

 

 

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Flixotide Junior

GK

MP NP

C14238

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation) [Brand: Axotide]

insert:

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Axotide

TX

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation) [Brand: Flixotide]

insert:

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Flixotide

GK

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation) [Brand: Fluticasone Cipla Inhaler]

insert:

Fluticasone propionate

Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Fluticasone Cipla Inhaler

LR

MP NP

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with formoterol in the form Pressurised inhalation containing fluticasone propionate 50 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

substitute:

Fluticasone propionate with formoterol

Pressurised inhalation containing fluticasone propionate 50 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

Inhalation by mouth

flutiform 50/5

MF

MP NP

C4395

P4395

1

5

 

1

 

 

Fluticasone propionate with formoterol

Pressurised inhalation containing fluticasone propionate 50 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

Inhalation by mouth

flutiform 50/5

MF

MP NP

C15635

P15635

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with formoterol in the form Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

substitute:

Fluticasone propionate with formoterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

Inhalation by mouth

flutiform 125/5

MF

MP NP

C4395

P4395

1

5

 

1

 

 

Fluticasone propionate with formoterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

Inhalation by mouth

flutiform 125/5

MF

MP NP

C15635

P15635

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with formoterol in the form Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses

substitute:

Fluticasone propionate with formoterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses

Inhalation by mouth

flutiform 250/10

MF

MP NP

C4395

P4395

1

5

 

1

 

 

Fluticasone propionate with formoterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses

Inhalation by mouth

flutiform 250/10

MF

MP NP

C15635

P15635

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

substitute:

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

PAVTIDE ACCUHALER 100/50

TX

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

PAVTIDE ACCUHALER 100/50

TX

MP NP

C15604

P15604

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Seretide Accuhaler 100/50

GK

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Seretide Accuhaler 100/50

GK

MP NP

C15604

P15604

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

substitute:

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Fluticasone Salmeterol Ciphaler 250/50

LR

MP NP

C15138

P15138

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Fluticasone Salmeterol Ciphaler 250/50

LR

MP NP

C15693

P15693

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

PAVTIDE ACCUHALER 250/50

TX

MP NP

C15138

P15138

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

PAVTIDE ACCUHALER 250/50

TX

MP NP

C15693

P15693

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Salflumix Easyhaler 250/50

OX

MP NP

C15138

P15138

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Salflumix Easyhaler 250/50

OX

MP NP

C15693

P15693

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

SalplusF DPI 250/50

SZ

MP NP

C15138

P15138

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

SalplusF DPI 250/50

SZ

MP NP

C15693

P15693

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Seretide Accuhaler 250/50

GK

MP NP

C15138

P15138

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Seretide Accuhaler 250/50

GK

MP NP

C15693

P15693

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses 

substitute:

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Fluticasone Salmeterol Ciphaler 500/50

LR

MP NP

C10121 C15118

P10121 P15118

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Fluticasone Salmeterol Ciphaler 500/50

LR

MP NP

C15548 C15714

P15548 P15714

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

PAVTIDE ACCUHALER 500/50

TX

MP NP

C10121 C15118

P10121 P15118

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

PAVTIDE ACCUHALER 500/50

TX

MP NP

C15548 C15714

P15548 P15714

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Salflumix Easyhaler 500/50

OX

MP NP

C10121 C15118

P10121 P15118

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Salflumix Easyhaler 500/50

OX

MP NP

C15548 C15714

P15548 P15714

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

SalplusF DPI 500/50

SZ

MP NP

C10121 C15118

P10121 P15118

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

SalplusF DPI 500/50

SZ

MP NP

C15548 C15714

P15548 P15714

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Seretide Accuhaler 500/50

GK

MP NP

C10121 C15118

P10121 P15118

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Seretide Accuhaler 500/50

GK

MP NP

C15548 C15714

P15548 P15714

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) 

substitute:

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

PAVTIDE MDI 50/25

TX

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

PAVTIDE MDI 50/25

TX

MP NP

C15604

P15604

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Seretide MDI 50/25

GK

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Seretide MDI 50/25

GK

MP NP

C15604

P15604

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) 

substitute:

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Evocair MDI

AF

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Evocair MDI

AF

MP NP

C15604

P15604

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Fluticasone + Salmeterol Cipla 125/25

LR

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Fluticasone + Salmeterol Cipla 125/25

LR

MP NP

C15604

P15604

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Pavtide

TX

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Pavtide

TX

MP NP

C15604

P15604

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

SalplusF Inhaler 125/25

SZ

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

SalplusF Inhaler 125/25

SZ

MP NP

C15604

P15604

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Seretide MDI 125/25

GK

MP NP

C4930

P4930

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Seretide MDI 125/25

GK

MP NP

C15604

P15604

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) 

substitute:

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Evocair MDI

AF

MP NP

C4930 C10121

P4930 P10121

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Evocair MDI

AF

MP NP

C15548 C15715

P15548 P15715

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Fluticasone + Salmeterol Cipla 250/25

LR

MP NP

C4930 C10121

P4930 P10121

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Fluticasone + Salmeterol Cipla 250/25

LR

MP NP

C15548 C15715

P15548 P15715

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Pavtide

TX

MP NP

C4930 C10121

P4930 P10121

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Pavtide

TX

MP NP

C15548 C15715

P15548 P15715

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

SalplusF Inhaler 250/25

SZ

MP NP

C4930 C10121

P4930 P10121

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

SalplusF Inhaler 250/25

SZ

MP NP

C15548 C15715

P15548 P15715

2

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Seretide MDI 250/25

GK

MP NP

C4930 C10121

P4930 P10121

1

5

 

1

 

 

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Seretide MDI 250/25

GK

MP NP

C15548 C15715

P15548 P15715

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Fluvoxamine

substitute:

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

APO-Fluvoxamine

TX

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

APO-Fluvoxamine

TX

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

Faverin 50

RW

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

Faverin 50

RW

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

FLUVOXAMINE-WGR

WG

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

FLUVOXAMINE-WGR

WG

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

Luvox

GO

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

Luvox

GO

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

Movox 50

AL

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 50 mg

Oral

Movox 50

AL

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

APO-Fluvoxamine

TX

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

APO-Fluvoxamine

TX

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

Faverin 100

RW

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

Faverin 100

RW

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

FLUVOXAMINE-WGR

WG

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

FLUVOXAMINE-WGR

WG

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

Luvox

GO

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

Luvox

GO

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

Movox 100

AF

MP NP

C4755 C6277

P4755 P6277

30

5

 

30

 

 

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

Oral

Movox 100

AF

MP NP

C15582 C15666

P15582 P15666

60

2

 

30

 

 

  1.            Schedule 1, Part 1, entries for Folinic acid

substitute:

Folinic acid

Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

Injection

Leucovorin Calcium (Pfizer Australia Pty Ltd)

PF

MP

 

 

10

2

 

10

 

 

Folinic acid

Tablet containing calcium folinate equivalent to 15 mg folinic acid

Oral

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

C5938

 

10

0

 

10

 

 

Folinic acid

Tablet containing calcium folinate equivalent to 15 mg folinic acid

Oral

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

C5973

 

10

0

 

10

 

C(100)

  1.            Schedule 1, Part 1, entries Formoterol

substitute:

Formoterol

Capsule containing powder for oral inhalation containing formoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer)

Inhalation by mouth

Foradile

SZ

MP NP

C6355

P6355

60

5

 

60

 

 

Formoterol

Capsule containing powder for oral inhalation containing formoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer)

Inhalation by mouth

Foradile

SZ

MP NP

C15607

P15607

120

5

 

60

 

 

Formoterol

Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 6 micrograms per dose, 60 doses

Inhalation by mouth

Oxis Turbuhaler

AP

MP NP

C6355

P6355

1

5

 

1

 

 

Formoterol

Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 6 micrograms per dose, 60 doses

Inhalation by mouth

Oxis Turbuhaler

AP

MP NP

C15607

P15607

2

5

 

1

 

 

Formoterol

Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Oxis Turbuhaler

AP

MP NP

C6355

P6355

1

5

 

1

 

 

Formoterol

Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Oxis Turbuhaler

AP

MP NP

C15607

P15607

2

5

 

1

 

 

  1.            Schedule 1, Part 1, omit entry for Fosinopril with hydrochlorothiazide
  2.            Schedule 1, Part 1, after entry for Furosemide in the form Tablet 20 mg [Brand: Frusemix-M; Maximum Quantity: 200; Number of Repeats: 1; Pack Quantity: 100]

insert:

Furosemide

Tablet 20 mg

Oral

FUROSEMIDE-WGR

WG

MP NP

 

 

100

1

 

100

 

 

Furosemide

Tablet 20 mg

Oral

FUROSEMIDE-WGR

WG

MP NP

 

P14238

200

1

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Furosemide in the form Tablet 40 mg [Brand: Frusemix; Maximum Quantity: 200; Number of Repeats: 1]

insert:

Furosemide

Tablet 40 mg

Oral

FUROSEMIDE-WGR

WG

MP NP

 

 

100

1

 

100

 

 

Furosemide

Tablet 40 mg

Oral

FUROSEMIDE-WGR

WG

MP NP

 

P14238

200

1

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Gabapentin in the form Capsule 300 mg [Brand: Gabapentin Sandoz]

insert:

Gabapentin

Capsule 300 mg

Oral

GABAPENTIN-WGR

WG

MP NP

C4928

 

100

5

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Gabapentin in the form Capsule 400 mg [Brand: Gabapentin Sandoz]

insert:

Gabapentin

Capsule 400 mg

Oral

GABAPENTIN-WGR

WG

MP NP

C4928

 

100

5

 

100

 

 

  1.            Schedule 1, Part 1, entry for Ganciclovir in the form Powder for I.V. infusion 500 mg (as sodium) [Brand: Cymevene; Authorised Prescriber: MP; Maximum Quantity: 10; Number of Repeats: 1]
    1.            omit from the column headed “Circumstances”: C4972 C4999
    2.            omit from the column headed “Circumstances”: C9404 C9526
    3.            insert in numerical order in the column headed “Circumstances”: C15782 C15784 C15800 C15814
  2.            Schedule 1, Part 1, entry for Ganciclovir in the form Powder for I.V. infusion 500 mg (as sodium) [Brand: GANCICLOVIR SXP; Authorised Prescriber: MP; Maximum Quantity: 10; Number of Repeats: 1]
    1.            omit from the column headed “Circumstances”: C4972 C4999
    2.            omit from the column headed “Circumstances”: C9404 C9526
    3.            insert in numerical order in the column headed “Circumstances”: C15782 C15784 C15800 C15814
  3.            Schedule 1, Part 1, entry for Glimepiride in the form Tablet 1 mg

omit:

Glimepiride

Tablet 1 mg

Oral

Amaryl

SW

MP NP

 

 

30

5

 

30

 

 

Glimepiride

Tablet 1 mg

Oral

Amaryl

SW

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Glimepiride in the form Tablet 1 mg [Brand: Glimepiride Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Glimepiride

Tablet 1 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Glimepiride

Tablet 1 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Glimepiride in the form Tablet 2 mg [Brand: Glimepiride Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Glimepiride

Tablet 2 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Glimepiride

Tablet 2 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Glimepiride in the form Tablet 3 mg [Brand: Glimepiride Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Glimepiride

Tablet 3 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Glimepiride

Tablet 3 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Glimepiride in the form Tablet 4 mg [Brand: Glimepiride Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Glimepiride

Tablet 4 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Glimepiride

Tablet 4 mg

Oral

GLIMEPIRIDE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Glyceryl trinitrate in the form Transdermal patch 18 mg

insert:

Glyceryl trinitrate

Transdermal patch 18 mg

Transdermal

Minitran 5

IL

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Glyceryl trinitrate in the form Transdermal patch 36 mg

insert:

Glyceryl trinitrate

Transdermal patch 36 mg

Transdermal

Minitran 10

IL

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Glyceryl trinitrate in the form Transdermal patch 54 mg

insert:

Glyceryl trinitrate

Transdermal patch 54 mg

Transdermal

Minitran 15

IL

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Glycopyrronium

substitute:

Glycopyrronium

Capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler)

Inhalation by mouth

seebri breezhaler

NV

MP NP

C4516

P4516

30

5

 

30

 

 

Glycopyrronium

Capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler)

Inhalation by mouth

seebri breezhaler

NV

MP NP

C15634

P15634

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Granisetron in the form Concentrated injection 3 mg (as hydrochloride) in 3 mL

omit:

Granisetron

Concentrated injection 3 mg (as hydrochloride) in 3 mL

Injection

Granisetron Kabi

PK

MP NP

C4077 C4092

 

1

0

V4077

1

 

 

Granisetron

Concentrated injection 3 mg (as hydrochloride) in 3 mL

Injection

Granisetron Kabi

PK

MP

C4139

 

1

0

V4139

1

 

C(100)

  1.            Schedule 1, Part 1, entry for Haloperidol decanoate in each of the forms: I.M. injection equivalent to 50 mg haloperidol in 1 mL ampoule; and I.M. injection equivalent to 150 mg haloperidol in 3 mL ampoule

omit from the column headed “Responsible Person”: JC            substitute: IX

  1.            Schedule 1, Part 1, entries for Hyaluronic acid

substitute:

Hyaluronic acid

Eye drops containing sodium hyaluronate 1 mg per mL, 10 mL

Application to the eye

Hylo-Fresh

AE

MP NP AO

C4105

P4105

1

5

 

1

 

 

Hyaluronic acid

Eye drops containing sodium hyaluronate 1 mg per mL, 10 mL

Application to the eye

Hylo-Fresh

AE

MP NP AO

C15559

P15559

2

5

 

1

 

 

Hyaluronic acid

Eye drops containing sodium hyaluronate 2 mg per mL, 10 mL

Application to the eye

Hylo-Forte

AE

MP NP AO

C4105

P4105

1

5

 

1

 

 

Hyaluronic acid

Eye drops containing sodium hyaluronate 2 mg per mL, 10 mL

Application to the eye

Hylo-Forte

AE

MP NP AO

C15559

P15559

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Hydrocortisone in the form Tablet 20 mg [Brand: Hydrocortisone Viatris 20]

insert:

Hydrocortisone

Tablet 20 mg

Oral

Hydrocortisone Viatris 20

AL

MP NP

 

P14238

120

4

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Hydrocortisone in the form Tablet 20 mg [Brand: Hysone 20]

insert:

Hydrocortisone

Tablet 20 mg

Oral

Hysone 20

AF

MP NP

 

P14238

120

4

 

60

 

 

  1.            Schedule 1, Part 1, entries for Hypromellose

substitute:

Hypromellose

0.3% w/v eye drops, 10 mL (preservative free)

Application to the eye

Evolve Hypromellose

CX

MP NP AO

C6172

P6172

1

5


 

1


 


 

Hypromellose

0.3% w/v eye drops, 10 mL (preservative free)

Application to the eye

Evolve Hypromellose

CX

MP NP AO

C15559

P15559

2

5


 

1


 


 

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the eye

Genteal

AQ

MP NP AO

C15560

P15560

1

5


 

1


 


 

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the eye

Genteal

AQ

MP NP AO

C15556

P15556

2

5


 

1


 


 

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the eye

In a Wink Moisturising

IQ

MP NP AO

C15560

P15560

1

5


 

1


 


 

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the eye

In a Wink Moisturising

IQ

MP NP AO

C15556

P15556

2

5


 

1


 


 

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the eye

Revive Tears

PP

MP NP AO

C15560

P15560

1

5


 

1


 


 

Hypromellose

Eye drops 3 mg per mL, 10 mL

Application to the eye

Revive Tears

PP

MP NP AO

C15556

P15556

2

5


 

1


 


 

Hypromellose

Eye drops 5 mg per mL, 15 mL

Application to the eye

Methopt

AF

MP NP AO

C15560

P15560

1

5


 

1


 


 

Hypromellose

Eye drops 5 mg per mL, 15 mL

Application to the eye

Methopt

AF

MP NP AO

C15556

P15556

2

5


 

1


 


 

  1.            Schedule 1, Part 1, entries for Hypromellose with carbomer 980

substitute:

Hypromellose with carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the eye

Genteal gel

AQ

MP NP AO

C15560

P15560

1

5

 

1

 

 

Hypromellose with carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the eye

Genteal gel

AQ

MP

C15640

P15640

1

11

 

1

 

 

Hypromellose with carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the eye

HPMC PAA

IQ

MP NP AO

C15560

P15560

1

5

 

1

 

 

Hypromellose with carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the eye

HPMC PAA

IQ

MP

C15640

P15640

1

11

 

1

 

 

  1.            Schedule 1, Part 1, entries for Hypromellose with dextran

substitute:

Hypromellose with dextran

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

Application to the eye

Poly-Tears

IQ

MP NP AO

C15560

P15560

1

5

 

1

 

 

Hypromellose with dextran

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

Application to the eye

Poly-Tears

IQ

MP NP AO

C15556

P15556

2

5

 

1

 

 

Hypromellose with dextran

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

Application to the eye

Tears Naturale

AQ

MP NP AO

C15560

P15560

1

5

 

1

 

 

Hypromellose with dextran

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

Application to the eye

Tears Naturale

AQ

MP NP AO

C15556

P15556

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Ibuprofen

substitute:

Ibuprofen

Tablet 400 mg

Oral

APO-Ibuprofen 400

TX

MP NP MW PDP

 

 

30

0

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

APO-Ibuprofen 400

TX

PDP

 

P6256 P6282

90

0

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

APO-Ibuprofen 400

TX

MP NP

 

P6149 P6214 P6283

90

3

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

Brufen

GO

MP NP MW PDP

 

 

30

0

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

Brufen

GO

PDP

 

P6256 P6282

90

0

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

Brufen

GO

MP NP

 

P6149 P6214 P6283

90

3

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

MEDICHOICE Ibuprofen 400 mg

NB

MP NP MW PDP

 

 

30

0

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

MEDICHOICE Ibuprofen 400 mg

NB

PDP

 

P6256 P6282

90

0

 

30

 

 

Ibuprofen

Tablet 400 mg

Oral

MEDICHOICE Ibuprofen 400 mg

NB

MP NP

 

P6149 P6214 P6283

90

3

 

30

 

 

  1.            Schedule 1, Part 1, entries for Imatinib

substitute:

Imatinib

Capsule 100 mg (as mesilate)

Oral

ARX-IMATINIB

XT

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

60

2

 

60

 

 

Imatinib

Capsule 100 mg (as mesilate)

Oral

ARX-IMATINIB

XT

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Capsule 100 mg (as mesilate)

Oral

Imatinib-APOTEX

TX

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

60

2

 

60

 

 

Imatinib

Capsule 100 mg (as mesilate)

Oral

Imatinib-APOTEX

TX

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Capsule 100 mg (as mesilate)

Oral

IMATINIB-DRLA

RZ

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

60

2

 

60

 

 

Imatinib

Capsule 100 mg (as mesilate)

Oral

IMATINIB-DRLA

RZ

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Capsule 400 mg (as mesilate)

Oral

Imatinib GH

GQ

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

30

2

 

30

 

 

Imatinib

Capsule 400 mg (as mesilate)

Oral

Imatinib GH

GQ

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Capsule 400 mg (as mesilate)

Oral

Imatinib-APOTEX

TX

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

30

2

 

30

 

 

Imatinib

Capsule 400 mg (as mesilate)

Oral

Imatinib-APOTEX

TX

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Capsule 400 mg (as mesilate)

Oral

IMATINIB-DRLA

RZ

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

30

2

 

30

 

 

Imatinib

Capsule 400 mg (as mesilate)

Oral

IMATINIB-DRLA

RZ

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Gilmat

CR

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

60

2

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Gilmat

CR

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Glivec

NV

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

60

2

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Glivec

NV

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

IMATINIB RBX

RA

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

60

2

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

IMATINIB RBX

RA

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Imatinib Sandoz

SZ

MP

C9203 C9207 C12525 C12527 C12542 C12543

P9203 P9207 P12525 P12527 P12542 P12543

60

2

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Imatinib Sandoz

SZ

MP

C9204 C9206 C9209 C9240 C9243 C9274 C9276 C9296 C12536 C12541

P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Imatinib-Teva

TB

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

60

2

 

60

 

 

Imatinib

Tablet 100 mg (as mesilate)

Oral

Imatinib-Teva

TB

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

60

5

 

60

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Gilmat

CR

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

30

2

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Gilmat

CR

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Glivec

NV

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

30

2

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Glivec

NV

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

IMATINIB RBX

RA

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

30

2

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

IMATINIB RBX

RA

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Imatinib Sandoz

SZ

MP

C9203 C9207 C12525 C12527 C12542 C12543

P9203 P9207 P12525 P12527 P12542 P12543

30

2

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Imatinib Sandoz

SZ

MP

C9204 C9206 C9209 C9240 C9243 C9274 C9276 C9296 C12536 C12541

P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Imatinib-Teva

TB

MP

C9203 C9207 C9319 C12525 C12527 C12542 C12543 C13132

P9203 P9207 P9319 P12525 P12527 P12542 P12543 P13132

30

2

 

30

 

 

Imatinib

Tablet 400 mg (as mesilate)

Oral

Imatinib-Teva

TB

MP

C9204 C9206 C9209 C9238 C9240 C9243 C9274 C9276 C9278 C9296 C12536 C12541

P9204 P9206 P9209 P9238 P9240 P9243 P9274 P9276 P9278 P9296 P12536 P12541

30

5

 

30

 

 

Imatinib

Tablet 600 mg (as mesilate)

Oral

Imatab

JU

MP

C9203 C9207 C12525 C12527 C12542 C12543 C12685 C13132

P9203 P9207 P12525 P12527 P12542 P12543 P12685 P13132

30

2

 

30

 

 

Imatinib

Tablet 600 mg (as mesilate)

Oral

Imatab

JU

MP

C9209 C9240 C12536 C12541

P9209 P9240 P12536 P12541

30

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Indacaterol

substitute:

Indacaterol

Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler)

Inhalation by mouth

Onbrez

NV

MP NP

C6366

P6366

30

5

 

30

 

 

Indacaterol

Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler)

Inhalation by mouth

Onbrez

NV

MP NP

C15736

P15736

60

5

 

30

 

 

Indacaterol

Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler)

Inhalation by mouth

Onbrez

NV

MP NP

C6366

P6366

30

5

 

30

 

 

Indacaterol

Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler)

Inhalation by mouth

Onbrez

NV

MP NP

C15736

P15736

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Indacaterol with glycopyrronium

substitute:

Indacaterol with glycopyrronium

Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 50 micrograms (as bromide) (for use in Breezhaler)

Inhalation by mouth

ultibro breezhaler 110/50

NV

MP NP

C7798

P7798

30

5

 

30

 

 

Indacaterol with glycopyrronium

Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 5 micrograms (as bromide) (for use in Breezhaler)

Inhalation by mouth

ultibro breezhaler 110/50

NV

MP NP

C15691

P15691

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Indacaterol with glycopyrronium and mometasone

substitute:

Indacaterol with glycopyrronium and mometasone

Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 136 micrograms (for use in Breezhaler)

Inhalation by mouth

Enerzair Breezhaler

NV

MP NP

C12603

P12603

30

5

 

30

 

 

Indacaterol with glycopyrronium and mometasone

Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 136 micrograms (for use in Breezhaler)

Inhalation by mouth

Enerzair Breezhaler

NV

MP NP

C15601

P15601

60

5

 

30

 

 

Indacaterol with glycopyrronium and mometasone

Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 68 micrograms (for use in Breezhaler)

Inhalation by mouth

Enerzair Breezhaler

NV

MP NP

C12603

P12603

30

5

 

30

 

 

Indacaterol with glycopyrronium and mometasone

Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 68 micrograms (for use in Breezhaler)

Inhalation by mouth

Enerzair Breezhaler

NV

MP NP

C15601

P15601

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Indacaterol with mometasone

substitute:

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 127.5 micrograms (for use in Breezhaler)

Inhalation by mouth

Atectura Breezhaler

NV

MP NP

C11360

P11360

30

5

 

30

 

 

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 127.5 micrograms (for use in Breezhaler)

Inhalation by mouth

Atectura Breezhaler

NV

MP NP

C15653

P15653

60

5

 

30

 

 

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 260 micrograms (for use in Breezhaler)

Inhalation by mouth

Atectura Breezhaler

NV

MP NP

C11360

P11360

30

5

 

30

 

 

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 260 micrograms (for use in Breezhaler)

Inhalation by mouth

Atectura Breezhaler

NV

MP NP

C15653

P15653

60

5

 

30

 

 

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 62.5 micrograms (for use in Breezhaler)

Inhalation by mouth

Atectura Breezhaler

NV

MP NP

C11360

P11360

30

5

 

30

 

 

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 62.5 micrograms (for use in Breezhaler)

Inhalation by mouth

Atectura Breezhaler

NV

MP NP

C15653

P15653

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Irbesartan in the form Tablet 75 mg
    1.            omit:

Irbesartan

Tablet 75 mg

Oral

Avapro

AV

MP NP

 

 

30

5

 

30

 

 

Irbesartan

Tablet 75 mg

Oral

Avapro

AV

MP NP

 

P14238

60

5

 

30

 

 

  1.            omit:

Irbesartan

Tablet 75 mg

Oral

Blooms the Chemist Irbesartan

IB

MP NP

 

 

30

5

 

30

 

 

Irbesartan

Tablet 75 mg

Oral

Blooms the Chemist Irbesartan

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Irbesartan in the form Tablet 75 mg [Brand: Irbesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Irbesartan

Tablet 75 mg

Oral

IRBESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Irbesartan

Tablet 75 mg

Oral

IRBESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Irbesartan in the form Tablet 150 mg

omit:

Irbesartan

Tablet 150 mg

Oral

Blooms the Chemist Irbesartan

IB

MP NP

 

 

30

5

 

30

 

 

Irbesartan

Tablet 150 mg

Oral

Blooms the Chemist Irbesartan

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Irbesartan in the form Tablet 150 mg [Brand: Irbesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Irbesartan

Tablet 150 mg

Oral

IRBESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Irbesartan

Tablet 150 mg

Oral

IRBESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Irbesartan in the form Tablet 300 mg [Brand: Irbesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Irbesartan

Tablet 300 mg

Oral

IRBESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Irbesartan

Tablet 300 mg

Oral

IRBESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Irbesartan with hydrochlorothiazide in the form Tablet 150 mg-12.5 mg [Brand: Irbesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Irbesartan with hydrochlorothiazide

Tablet 150 mg-12.5 mg

Oral

IRBESARTAN HCTZ-WGR 150/12.5

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Irbesartan with hydrochlorothiazide

Tablet 150 mg-12.5 mg

Oral

IRBESARTAN HCTZ-WGR 150/12.5

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-12.5 mg [Brand: Irbesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Irbesartan with hydrochlorothiazide

Tablet 300 mg-12.5 mg

Oral

IRBESARTAN HCTZ-WGR 300/12.5

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Irbesartan with hydrochlorothiazide

Tablet 300 mg-12.5 mg

Oral

IRBESARTAN HCTZ-WGR 300/12.5

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-25 mg [Brand: Irbesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Irbesartan with hydrochlorothiazide

Tablet 300 mg-25 mg

Oral

IRBESARTAN HCTZ-WGR 300/25

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Irbesartan with hydrochlorothiazide

Tablet 300 mg-25 mg

Oral

IRBESARTAN HCTZ-WGR 300/25

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Isosorbide mononitrate in the form Tablet 60 mg (sustained release) [Brand: ISOBIDE MR; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Isosorbide mononitrate

Tablet 60 mg (sustained release)

Oral

ISOSORBIDE MR-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Isosorbide mononitrate

Tablet 60 mg (sustained release)

Oral

ISOSORBIDE MR-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Isotretinoin in the form Capsule 10 mg [Brand: Isotretinoin Lupin]

insert:

Isotretinoin

Capsule 10 mg

Oral

ISOTRETINOIN-WGR

WG

MP

C5224

 

60

3

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Isotretinoin in the form Capsule 20 mg [Brand: Isotretinoin Lupin]

insert:

Isotretinoin

Capsule 20 mg

Oral

ISOTRETINOIN-WGR

WG

MP

C5224

 

60

3

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Ivabradine in the form Tablet 5 mg (as hydrochloride) [Brand: Coralan]

insert:

Ivabradine

Tablet 5 mg (as hydrochloride)

Oral

IVABRADINE-WGR

WG

MP NP

C4979

 

56

5

 

56

 

 

  1.            Schedule 1, Part 1, after entry for Lamotrigine in the form Tablet 25 mg [Brand: Lamotrigine GH; Maximum Quantity: 112; Number of Repeats: 5]

insert:

Lamotrigine

Tablet 25 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C11081

P11081

56

5

 

56

 

 

Lamotrigine

Tablet 25 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C14855

P14855

112

5

 

56

 

 

  1.            Schedule 1, Part 1, after entry for Lamotrigine in the form Tablet 50 mg [Brand: Lamotrigine GH; Maximum Quantity: 112; Number of Repeats: 5]

insert:

Lamotrigine

Tablet 50 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C11081

P11081

56

5

 

56

 

 

Lamotrigine

Tablet 50 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C14855

P14855

112

5

 

56

 

 

  1.            Schedule 1, Part 1, after entry for Lamotrigine in the form Tablet 100 mg [Brand: Lamotrigine GH; Maximum Quantity: 112; Number of Repeats: 5]

insert:

Lamotrigine

Tablet 100 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C11081

P11081

56

5

 

56

 

 

Lamotrigine

Tablet 100 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C14855

P14855

112

5

 

56

 

 

  1.            Schedule 1, Part 1, after entry for Lamotrigine in the form Tablet 200 mg [Brand: Lamotrigine GH; Maximum Quantity: 112; Number of Repeats: 5]

insert:

Lamotrigine

Tablet 200 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C11081

P11081

56

5

 

56

 

 

Lamotrigine

Tablet 200 mg

Oral

LAMOTRIGINE-WGR

WG

MP NP

C14855

P14855

112

5

 

56

 

 

  1.            Schedule 1, Part 1, entries for Lansoprazole

substitute:

Lansoprazole

Capsule 15 mg

Oral

Zopral

AF

MP NP

C5444 C5512

P5444 P5512

30

5

 

30

 

 

Lansoprazole

Capsule 15 mg

Oral

Zopral

AF

MP NP

C15574 C15633

P15574 P15633

60

5

 

30

 

 

Lansoprazole

Capsule 30 mg

Oral

APO-Lansoprazole

TX

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

APO-Lansoprazole

TX

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

APO-Lansoprazole

TX

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

APO-Lansoprazole

TX

MP

C15531

P15531

112

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Lanzopran

RA

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Lanzopran

RA

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Lanzopran

RA

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Lanzopran

RA

MP

C15531

P15531

112

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

NOUMED LANSOPRAZOLE

VO

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

NOUMED LANSOPRAZOLE

VO

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

NOUMED LANSOPRAZOLE

VO

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

NOUMED LANSOPRAZOLE

VO

MP

C15531

P15531

112

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Zopral

AF

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Zopral

AF

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Zopral

AF

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Capsule 30 mg

Oral

Zopral

AF

MP

C15531

P15531

112

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT

TX

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT

TX

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

Lansoprazole ODT GH

GQ

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

Lansoprazole ODT GH

GQ

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

Zopral ODT

AF

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

Zopral ODT

AF

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

Zoton FasTabs

PF

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Lansoprazole

Tablet 15 mg (orally disintegrating)

Oral

Zoton FasTabs

PF

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT

TX

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT

TX

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT

TX

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT

TX

MP

C15531

P15531

112

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Lansoprazole ODT GH

GQ

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Lansoprazole ODT GH

GQ

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Lansoprazole ODT GH

GQ

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Lansoprazole ODT GH

GQ

MP

C15531

P15531

112

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zopral ODT

AF

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zopral ODT

AF

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zopral ODT

AF

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zopral ODT

AF

MP

C15531

P15531

112

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zoton FasTabs

PF

MP NP

C8774 C8775

P8774 P8775

28

1

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zoton FasTabs

PF

MP NP

C8776 C8780

P8776 P8780

28

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zoton FasTabs

PF

MP NP

C11310 C15530 C15658

P11310 P15530 P15658

56

5

 

28

 

 

Lansoprazole

Tablet 30 mg (orally disintegrating)

Oral

Zoton FasTabs

PF

MP

C15531

P15531

112

5

 

28

 

 

  1.            Schedule 1, Part 1, entry for Larotrectinib in the form Capsule 25 mg (as sulfate) [Brand: Vitrakvi; Maximum Quantity: 56; Number of Repeats: 5]
    1.            omit from the column headed “Circumstances”: C12980
    2.            insert in numerical order in the column headed “Circumstances”: C15781
    3.            omit from the column headed “Purposes”: P12980
    4.            insert in numerical order in the column headed “Purposes”: P15781
  2.            Schedule 1, Part 1, entry for Larotrectinib in the form Capsule 100 mg (as sulfate) [Brand: Vitrakvi; Maximum Quantity: 56; Number of Repeats: 5]
    1.            omit from the column headed “Circumstances”: C12980
    2.            insert in numerical order in the column headed “Circumstances”: C15781
    3.            omit from the column headed “Purposes”: P12980
    4.            insert in numerical order in the column headed “Purposes”: P15781
  3.            Schedule 1, Part 1, entry for Larotrectinib in the form Oral solution 20 mg per mL (as sulfate), 50 mL, 2 [Brand: Vitrakvi; Maximum Quantity: 1; Number of Repeats: 5]
    1.            omit from the column headed “Circumstances”: C12980
    2.            insert in numerical order in the column headed “Circumstances”: C15781
    3.            omit from the column headed “Purposes”: P12980
    4.            insert in numerical order in the column headed “Purposes”: P15781
  4.            Schedule 1, Part 1, entries for Latanoprost

substitute:

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

APO-Latanoprost

TX

MP AO

 

 

1

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

APO-Latanoprost

TX

MP AO

 

P14238

2

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

Latanoprost Sandoz

SZ

MP AO

 

 

1

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

Latanoprost Sandoz

SZ

MP AO

 

P14238

2

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

LATANOPROST-WGR

WG

MP AO

 

 

1

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

LATANOPROST-WGR

WG

MP AO

 

P14238

2

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

Xalaprost

AF

MP AO

 

 

1

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

Xalaprost

AF

MP AO

 

P14238

2

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

Xalatan

AS

MP AO

 

 

1

5

 

1

 

 

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

Xalatan

AS

MP AO

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Latanoprost with timolol

substitute:

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

APO-Latanoprost/Timolol 0.05/5

TX

AO

C5038

P5038

1

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

APO-Latanoprost/Timolol 0.05/5

TX

MP

C4343

P4343

1

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

APO-Latanoprost/Timolol 0.05/5

TX

MP AO

C15558

P15558

2

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Xalacom

AS

AO

C5038

P5038

1

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Xalacom

AS

MP

C4343

P4343

1

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Xalacom

AS

MP AO

C15558

P15558

2

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Xalamol 50/5

AF

AO

C5038

P5038

1

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Xalamol 50/5

AF

MP

C4343

P4343

1

5

 

1

 

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Xalamol 50/5

AF

MP AO

C15558

P15558

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Leflunomide in the form Tablet 10 mg

omit:

Leflunomide

Tablet 10 mg

Oral

Arabloc

AV

MP

C13753 C13771

P13753 P13771

30

5

 

30

 

 

Leflunomide

Tablet 10 mg

Oral

Arabloc

AV

MP

C14941 C14942

P14941 P14942

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Leflunomide in the form Tablet 10 mg [Brand: Leflunomide Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Leflunomide

Tablet 10 mg

Oral

LEFLUNOMIDE-WGR

WG

MP

C13753 C13771

P13753 P13771

30

5

 

30

 

 

Leflunomide

Tablet 10 mg

Oral

LEFLUNOMIDE-WGR

WG

MP

C14941 C14942

P14941 P14942

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Leflunomide in the form Tablet 20 mg [Brand: Leflunomide Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Leflunomide

Tablet 20 mg

Oral

LEFLUNOMIDE-WGR

WG

MP

C13753 C13771

P13753 P13771

30

5

 

30

 

 

Leflunomide

Tablet 20 mg

Oral

LEFLUNOMIDE-WGR

WG

MP

C14941 C14942

P14941 P14942

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg

omit:

Lercanidipine

Tablet containing lercanidipine hydrochloride 10 mg

Oral

BTC Lercanidipine

JB

MP NP

 

 

28

5

 

28

 

 

Lercanidipine

Tablet containing lercanidipine hydrochloride 10 mg

Oral

BTC Lercanidipine

JB

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg [Brand: Lercanidipine APOTEX; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Lercanidipine

Tablet containing lercanidipine hydrochloride 10 mg

Oral

LERCANIDIPINE-WGR

WG

MP NP

 

 

28

5

 

28

 

 

Lercanidipine

Tablet containing lercanidipine hydrochloride 10 mg

Oral

LERCANIDIPINE-WGR

WG

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 20 mg

omit:

Lercanidipine

Tablet containing lercanidipine hydrochloride 20 mg

Oral

BTC Lercanidipine

JB

MP NP

 

 

28

5

 

28

 

 

Lercanidipine

Tablet containing lercanidipine hydrochloride 20 mg

Oral

BTC Lercanidipine

JB

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 20 mg [Brand: Lercanidipine APOTEX; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Lercanidipine

Tablet containing lercanidipine hydrochloride 20 mg

Oral

LERCANIDIPINE-WGR

WG

MP NP

 

 

28

5

 

28

 

 

Lercanidipine

Tablet containing lercanidipine hydrochloride 20 mg

Oral

LERCANIDIPINE-WGR

WG

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Letrozole in the form Tablet 2.5 mg [Brand: Letrozole Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Letrozole

Tablet 2.5 mg

Oral

LETROZOLE-WGR

WG

MP NP

C5464

P5464

30

5

 

30

 

 

Letrozole

Tablet 2.5 mg

Oral

LETROZOLE-WGR

WG

MP NP

C14943

P14943

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Levetiracetam in the form Tablet 250 mg [Brand: Levetiracetam Viatris; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Levetiracetam

Tablet 250 mg

Oral

LEVETIRACETAM-WGR

WG

MP NP

C11116

P11116

60

5

 

60

 

 

Levetiracetam

Tablet 250 mg

Oral

LEVETIRACETAM-WGR

WG

MP NP

C14964

P14964

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Levetiracetam in the form Tablet 500 mg [Brand: Levetiracetam SZ; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Levetiracetam

Tablet 500 mg

Oral

LEVETIRACETAM-WGR

WG

MP NP

C11116

P11116

60

5

 

60

 

 

Levetiracetam

Tablet 500 mg

Oral

LEVETIRACETAM-WGR

WG

MP NP

C14964

P14964

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Levetiracetam in the form Tablet 1 g [Brand: Levetiracetam Viatris; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Levetiracetam

Tablet 1 g

Oral

LEVETIRACETAM-WGR

WG

MP NP

C11116

P11116

60

5

 

60

 

 

Levetiracetam

Tablet 1 g

Oral

LEVETIRACETAM-WGR

WG

MP NP

C14964

P14964

120

5

 

60

 

 

  1.            Schedule 1, Part 1, entries for Levodopa with benserazide

substitute:

Levodopa with benserazide

Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar 62.5

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar 62.5

RO

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

RO

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release)

Oral

Madopar HBS

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release)

Oral

Madopar HBS

RO

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with benserazide

Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

RO

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with benserazide

Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 62.5

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 62.5

RO

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with benserazide

Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 125

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 125

RO

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with benserazide

Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

RO

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with benserazide

Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

RO

MP NP

 

 

100

5

 

100

 

 

Levodopa with benserazide

Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

RO

MP NP

 

P14238

200

5

 

100

 

 

  1.            Schedule 1, Part 1, entries for Levodopa with carbidopa

substitute:

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra intestinal

Duodopa

VE

MP

C10138 C10161

P10138 P10161

28

5

 

7

 

C(100)

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra intestinal

Duodopa

VE

MP NP

C10197

P10197

28

5

 

7

 

 

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra intestinal

Duodopa

VE

MP

C10363 C10375

P10363 P10375

56

5

 

7

 

C(100)

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra intestinal

Duodopa

VE

MP NP

C10386

P10386

56

5

 

7

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

TX

MP NP

 

 

100

5

 

100

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

TX

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Kinson

AF

MP NP

 

 

100

5

 

100

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Kinson

AF

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

SINADOPA 100/25

RW

MP NP

 

 

100

5

 

100

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

SINADOPA 100/25

RW

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Sinemet 100/25

AL

MP NP

 

 

100

5

 

100

 

 

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Sinemet 100/25

AL

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

TX

MP NP

 

 

100

5

 

100

 

 

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

TX

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

SINADOPA 250/25

RW

MP NP

 

 

100

5

 

100

 

 

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

SINADOPA 250/25

RW

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

Sinemet

AL

MP NP

 

 

100

5

 

100

 

 

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

Sinemet

AL

MP NP

 

P14238

200

5

 

100

 

 

Levodopa with carbidopa

Tablet (modified release) 200 mg-50 mg (as monohydrate)

Oral

Sinemet CR

AL

MP NP

C5253

P5253

100

5

 

100

 

 

Levodopa with carbidopa

Tablet (modified release) 200 mg-50 mg (as monohydrate)

Oral

Sinemet CR

AL

MP NP

C15608

P15608

200

5

 

100

 

 

  1.            Schedule 1, Part 1, entries for Levodopa with carbidopa and entacapone

substitute:

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Stalevo 50/12.5/200mg

SZ

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Stalevo 50/12.5/200mg

SZ

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Stalevo 75/18.75/200mg

SZ

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Stalevo 75/18.75/200mg

SZ

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Stalevo 100/25/200mg

SZ

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Stalevo 100/25/200mg

SZ

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Stalevo 125/31.25/200mg

SZ

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Stalevo 125/31.25/200mg

SZ

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Stalevo 150/37.5/200mg

SZ

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Stalevo 150/37.5/200mg

SZ

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Carlevent

TX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

HX

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Lecteva

TB

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Stalevo 200/50/200mg

SZ

MP NP

C5212 C5288

P5212 P5288

200

4

 

100

 

 

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Stalevo 200/50/200mg

SZ

MP NP

C15564 C15565

P15564 P15565

400

4

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Levonorgestrel with ethinylestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets [Brand: Lenest 30 ED]

insert:

Levonorgestrel with ethinylestradiol

Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets

Oral

LEVETH 150/30 ED

WG

MP NP

 

 

4

2

 

4

 

 

  1.            Schedule 1, Part 1, after entry for Lisinopril in the form Tablet 5 mg [Brand: Lisinopril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Lisinopril

Tablet 5 mg

Oral

LISINOPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Lisinopril

Tablet 5 mg

Oral

LISINOPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Lisinopril in the form Tablet 10 mg [Brand: Lisinopril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Lisinopril

Tablet 10 mg

Oral

LISINOPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Lisinopril

Tablet 10 mg

Oral

LISINOPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Lisinopril in the form Tablet 20 mg [Brand: Lisinopril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Lisinopril

Tablet 20 mg

Oral

LISINOPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Lisinopril

Tablet 20 mg

Oral

LISINOPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Lorlatinib in each of the forms: Tablet 25 mg; and Tablet 100 mg
    1.            omit from the column headed “Circumstances”: C13716
    2.            insert in numerical order in the column headed “Circumstances”: C15804
  2.            Schedule 1, Part 1, after entry for Lurasidone in the form Tablet containing lurasidone hydrochloride 40 mg [Brand: LURASIDONE SUN]

insert:

Lurasidone

Tablet containing lurasidone hydrochloride 40 mg

Oral

LURASIDONE-WGR

WG

MP NP

C4246

 

30

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Lurasidone in the form Tablet containing lurasidone hydrochloride 80 mg [Brand: LURASIDONE SUN]

insert:

Lurasidone

Tablet containing lurasidone hydrochloride 80 mg

Oral

LURASIDONE-WGR

WG

MP NP

C4246

 

30

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Macrogol 3350 in the form Powder for oral solution 510 g [Brand: OsmoLax; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Macrogol 3350

Powder for oral solution 510 g

Oral

OsmoLax

KY

MP NP

C15539 C15593 C15661 C15709 C15729

P15539 P15593 P15661 P15709 P15729

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: APO-MACROGOL plus ELECTROLYTES; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

APO-MACROGOL plus ELECTROLYTES

TX

MP NP

C15688 C15730 C15745 C15746 C15747

P15688 P15730 P15745 P15746 P15747

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: APOHEALTH Macrogol with Electrolytes; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

APOHEALTH Macrogol with Electrolytes

GX

MP NP

C15688 C15730 C15745 C15746 C15747

P15688 P15730 P15745 P15746 P15747

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: Chemists' Own Macrogol with Electrolytes; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Chemists' Own Macrogol with Electrolytes

RW

MP NP

C15688 C15730 C15745 C15746 C15747

P15688 P15730 P15745 P15746 P15747

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: Macrovic; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Macrovic

RF

MP NP

C15688 C15730 C15745 C15746 C15747

P15688 P15730 P15745 P15746 P15747

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: Molaxole; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Molaxole

GO

MP NP

C15688 C15730 C15745 C15746 C15747

P15688 P15730 P15745 P15746 P15747

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: Movicol; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Movicol

NE

MP NP

C15688 C15730 C15745 C15746 C15747

P15688 P15730 P15745 P15746 P15747

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Meloxicam in the form Capsule 7.5 mg [Brand: Meloxicam Sandoz]

insert:

Meloxicam

Capsule 7.5 mg

Oral

MELOXICAM-WGR

WG

MP NP

C4907 C4962

 

30

3

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Meloxicam in the form Capsule 15 mg [Brand: Meloxicam Sandoz]

insert:

Meloxicam

Capsule 15 mg

Oral

MELOXICAM-WGR

WG

MP NP

C4907 C4962

 

30

3

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Meloxicam in the form Tablet 7.5 mg [Brand: Meloxicam Viatris]

insert:

Meloxicam

Tablet 7.5 mg

Oral

MELOXICAM-WGR

WG

MP NP

C4907 C4962

 

30

3

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Meloxicam in the form Tablet 15 mg [Brand: Meloxicam Viatris]

insert:

Meloxicam

Tablet 15 mg

Oral

MELOXICAM-WGR

WG

MP NP

C4907 C4962

 

30

3

 

30

 

 

  1.            Schedule 1, Part 1, entries for Mesna

substitute:

Mesna

Solution for I.V. injection 400 mg in 4 mL ampoule

Injection

Uromitexan

BX

MP

C5106

 

15

5

 

15

 

 

Mesna

Solution for I.V. injection 400 mg in 4 mL ampoule

Injection

Uromitexan

BX

MP

C5130

 

15

5

 

15

 

C(100)

Mesna

Solution for I.V. injection 1 g in 10 mL ampoule

Injection

Uromitexan

BX

MP

C5106

 

15

5

 

15

 

 

Mesna

Solution for I.V. injection 1 g in 10 mL ampoule

Injection

Uromitexan

BX

MP

C5130

 

15

5

 

15

 

C(100)

  1.            Schedule 1, Part 1, after entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg [Brand: Metex XR; Maximum Quantity: 240; Number of Repeats: 5]

insert:

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

METFORMIN-WGR XR

WG

MP NP

 

 

120

5

 

120

 

 

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

METFORMIN-WGR XR

WG

MP NP

 

P14238

240

5

 

120

 

 

  1.            Schedule 1, Part 1, after entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g [Brand: METEX XR; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

METFORMIN-WGR XR

WG

MP NP

 

 

60

5

 

60

 

 

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

METFORMIN-WGR XR

WG

MP NP

 

P14238

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg [Brand: Metformin Sandoz; Maximum Quantity: 200; Number of Repeats: 5]

insert:

Metformin

Tablet containing metformin hydrochloride 500 mg

Oral

METFORMIN-WGR

WG

MP NP

 

 

100

5

 

100

 

 

Metformin

Tablet containing metformin hydrochloride 500 mg

Oral

METFORMIN-WGR

WG

MP NP

 

P14238

200

5

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg [Brand: Diaformin 850; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Metformin

Tablet containing metformin hydrochloride 850 mg

Oral

Diaformin Viatris

MQ

MP NP

 

 

60

5

 

60

 

 

Metformin

Tablet containing metformin hydrochloride 850 mg

Oral

Diaformin Viatris

MQ

MP NP

 

P14238

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg [Brand: Metformin Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Metformin

Tablet containing metformin hydrochloride 850 mg

Oral

METFORMIN-WGR

WG

MP NP

 

 

60

5

 

60

 

 

Metformin

Tablet containing metformin hydrochloride 850 mg

Oral

METFORMIN-WGR

WG

MP NP

 

P14238

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Metformin in the form Tablet containing metformin hydrochloride 1 g [Brand: Diaformin 1000; Maximum Quantity: 180; Number of Repeats: 5]

insert:

Metformin

Tablet containing metformin hydrochloride 1 g

Oral

Diaformin Viatris

MQ

MP NP

 

 

90

5

 

90

 

 

Metformin

Tablet containing metformin hydrochloride 1 g

Oral

Diaformin Viatris

MQ

MP NP

 

P14238

180

5

 

90

 

 

  1.            Schedule 1, Part 1, entry for Methylprednisolone

omit:

Methylprednisolone

Powder for injection 40 mg (as sodium succinate) (S19A)

Injection

Solu-Medrone

LM

MP NP

 

 

5

0

 

1

 

 

  1.            Schedule 1, Part 1, entries for Metoclopramide in the form Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

substitute:

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

APO-Metoclopramide

TX

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

APO-Metoclopramide

TX

MP NP

 

P11683

100

5

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

EMEXLON

RW

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

EMEXLON

RW

MP NP

 

P11683

100

5

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Maxolon

IL

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Maxolon

IL

MP NP

 

P11683

100

5

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

METOCLOPRAMIDE-WGR

WG

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

METOCLOPRAMIDE-WGR

WG

MP NP

 

P11683

100

5

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Pramin

AF

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Pramin

AF

MP NP

 

P11683

100

5

 

25

 

 

  1.            Schedule 1, Part 1, after entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg [Brand: Metoprolol Sandoz; Maximum Quantity: 200; Number of Repeats: 5]

insert:

Metoprolol

Tablet containing metoprolol tartrate 50 mg

Oral

METOPROLOL-WGR

WG

MP NP

 

 

100

5

 

100

 

 

Metoprolol

Tablet containing metoprolol tartrate 50 mg

Oral

METOPROLOL-WGR

WG

MP NP

 

P14238

200

5

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg [Brand: Metoprolol Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Metoprolol

Tablet containing metoprolol tartrate 100 mg

Oral

METOPROLOL-WGR

WG

MP NP

 

 

60

5

 

60

 

 

Metoprolol

Tablet containing metoprolol tartrate 100 mg

Oral

METOPROLOL-WGR

WG

MP NP

 

P14238

120

5

 

60

 

 

  1.            Schedule 1, Part 1, entries for Mianserin

substitute:

Mianserin

Tablet containing mianserin hydrochloride 10 mg

Oral

Lumin 10

AF

MP NP

C6278

P6278

50

5

 

50

 

 

Mianserin

Tablet containing mianserin hydrochloride 10 mg

Oral

Lumin 10

AF

MP NP

C15580

P15580

100

2

 

50

 

 

Mianserin

Tablet containing mianserin hydrochloride 20 mg

Oral

Lumin 20

AF

MP NP

C6278

P6278

50

5

 

50

 

 

Mianserin

Tablet containing mianserin hydrochloride 20 mg

Oral

Lumin 20

AF

MP NP

C15580

P15580

100

2

 

50

 

 

  1.            Schedule 1, Part 1, after entry for Mifepristone and misoprostol

insert:

Migalastat

Capsule containing 150 mg migalastat hydrochloride (equivalent to 123 mg migalastat)

Oral

Galafold

FT

MP

C15787 C15801 C15808

 

14

5

 

14

 

 

  1.            Schedule 1, Part 1, entries for Minocycline

substitute:

Minocycline

Tablet 50 mg (as hydrochloride)

Oral

Akamin 50

AF

MP NP

C5995

P5995

60

5

 

60

 

 

Minocycline

Tablet 50 mg (as hydrochloride)

Oral

Akamin 50

AF

MP NP

C15657

P15657

120

2

 

60

 

 

Minocycline

Tablet 50 mg (as hydrochloride)

Oral

Minomycin-50

AS

MP NP

C5995

P5995

60

5

 

60

 

 

Minocycline

Tablet 50 mg (as hydrochloride)

Oral

Minomycin-50

AS

MP NP

C15657

P15657

120

2

 

60

 

 

  1.            Schedule 1, Part 1, entries for Mirtazapine

substitute:

Mirtazapine

Tablet 15 mg

Oral

APX-Mirtazapine

TY

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

APX-Mirtazapine

TY

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

Axit 15

AF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

Axit 15

AF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

Blooms The Chemist Mirtazapine

BG

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

Blooms The Chemist Mirtazapine

BG

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

MIRTANZA

RF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

MIRTANZA

RF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

Mirtazapine Sandoz

SZ

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

Mirtazapine Sandoz

SZ

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

MIRTAZAPINE-WGR

WG

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 15 mg

Oral

MIRTAZAPINE-WGR

WG

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 15 mg (orally disintegrating)

Oral

MIRTANZA ODT

RF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 15 mg (orally disintegrating)

Oral

MIRTANZA ODT

RF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

APX-Mirtazapine

TY

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

APX-Mirtazapine

TY

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Avanza

AL

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Avanza

AL

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Axit 30

AF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Axit 30

AF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Blooms The Chemist Mirtazapine

BG

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Blooms The Chemist Mirtazapine

BG

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

MIRTANZA

RF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

MIRTANZA

RF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Mirtazapine Sandoz

SZ

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

Mirtazapine Sandoz

SZ

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

MIRTAZAPINE-WGR

WG

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

MIRTAZAPINE-WGR

WG

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

NOUMED MIRTAZAPINE

VO

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg

Oral

NOUMED MIRTAZAPINE

VO

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 30 mg (orally disintegrating)

Oral

MIRTANZA ODT

RF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 30 mg (orally disintegrating)

Oral

MIRTANZA ODT

RF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

APX-Mirtazapine

TY

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

APX-Mirtazapine

TY

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

Axit 45

AF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

Axit 45

AF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

Blooms The Chemist Mirtazapine

BG

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

Blooms The Chemist Mirtazapine

BG

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

MIRTANZA

RF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

MIRTANZA

RF

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

Mirtazapine Sandoz

SZ

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

Mirtazapine Sandoz

SZ

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

MIRTAZAPINE-WGR

WG

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

MIRTAZAPINE-WGR

WG

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

NOUMED MIRTAZAPINE

VO

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg

Oral

NOUMED MIRTAZAPINE

VO

MP NP

C15553

P15553

60

2

 

30

 

 

Mirtazapine

Tablet 45 mg (orally disintegrating)

Oral

MIRTANZA ODT

RF

MP NP

C5650

P5650

30

5

 

30

 

 

Mirtazapine

Tablet 45 mg (orally disintegrating)

Oral

MIRTANZA ODT

RF

MP NP

C15553

P15553

60

2

 

30

 

 

  1.            Schedule 1, Part 1, entries for Moclobemide

substitute:

Moclobemide

Tablet 150 mg

Oral

Amira 150

AF

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

Amira 150

AF

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

Aurorix

GO

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

Aurorix

GO

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

Clobemix

XT

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

Clobemix

XT

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

Moclobemide Sandoz

SZ

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

Moclobemide Sandoz

SZ

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

MOCLOBEMIDE-WGR

WG

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 150 mg

Oral

MOCLOBEMIDE-WGR

WG

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Amira 300

AF

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Amira 300

AF

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Aurorix 300 mg

GO

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Aurorix 300 mg

GO

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Clobemix

XT

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Clobemix

XT

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Moclobemide Sandoz

SZ

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

Moclobemide Sandoz

SZ

MP NP

C15553

P15553

120

2

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

MOCLOBEMIDE-WGR

WG

MP NP

C5650

P5650

60

5

 

60

 

 

Moclobemide

Tablet 300 mg

Oral

MOCLOBEMIDE-WGR

WG

MP NP

C15553

P15553

120

2

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Modafinil in the form Tablet 100 mg [Brand: Modafinil Viatris]

insert:

Modafinil

Tablet 100 mg

Oral

MODAFINIL-WGR

WG

MP

C10935 C10968 C10970

 

120

5

 

60

 

 

  1.            Schedule 1, Part 1, entries for Montelukast

substitute:

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

MONTELAIR 4

RF

MP NP

C6666

P6666

28

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

MONTELAIR 4

RF

MP NP

C15642

P15642

56

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast APOTEX

GX

MP NP

C6666

P6666

28

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast APOTEX

GX

MP NP

C15642

P15642

56

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Lupin

HQ

MP NP

C6666

P6666

28

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Lupin

HQ

MP NP

C15642

P15642

56

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Mylan

AF

MP NP

C6666

P6666

28

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Mylan

AF

MP NP

C15642

P15642

56

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Sandoz 4

SZ

MP NP

C6666

P6666

28

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Sandoz 4

SZ

MP NP

C15642

P15642

56

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Viatris

AL

MP NP

C6666

P6666

28

5

 

28

 

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Viatris

AL

MP NP

C15642

P15642

56

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

MONTELAIR 5

RF

MP NP

C6674 C7781

P6674 P7781

28

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

MONTELAIR 5

RF

MP NP

C15643 C15644

P15643 P15644

56

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast APOTEX

GX

MP NP

C6674 C7781

P6674 P7781

28

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast APOTEX

GX

MP NP

C15643 C15644

P15643 P15644

56

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Lupin

HQ

MP NP

C6674 C7781

P6674 P7781

28

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Lupin

HQ

MP NP

C15643 C15644

P15643 P15644

56

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Mylan

AF

MP NP

C6674 C7781

P6674 P7781

28

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Mylan

AF

MP NP

C15643 C15644

P15643 P15644

56

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Sandoz 5

SZ

MP NP

C6674 C7781

P6674 P7781

28

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Sandoz 5

SZ

MP NP

C15643 C15644

P15643 P15644

56

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Viatris

AL

MP NP

C6674 C7781

P6674 P7781

28

5

 

28

 

 

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

Montelukast Viatris

AL

MP NP

C15643 C15644

P15643 P15644

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Moxonidine in the form Tablet 200 micrograms [Brand: Moxonidine Viatris; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Moxonidine

Tablet 200 micrograms

Oral

MOXONIDINE-WGR

WG

MP NP

C4944

P4944

30

5

 

30

 

 

Moxonidine

Tablet 200 micrograms

Oral

MOXONIDINE-WGR

WG

MP NP

C14289

P14289

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Moxonidine in the form Tablet 400 micrograms [Brand: Moxonidine Viatris; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Moxonidine

Tablet 400 micrograms

Oral

MOXONIDINE-WGR

WG

MP NP

C4944

P4944

30

5

 

30

 

 

Moxonidine

Tablet 400 micrograms

Oral

MOXONIDINE-WGR

WG

MP NP

C14289

P14289

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Nitrazepam

substitute:

Nitrazepam

Tablet 5 mg

Oral

Alodorm

AF

MP NP PDP

 

 

25

0

 

25

 

 

Nitrazepam

Tablet 5 mg

Oral

Alodorm

AF

MP NP

 

P6175

50
CN6175

3
CN6175

 

25

 

 

Nitrazepam

Tablet 5 mg

Oral

Alodorm

AF

MP NP

 

P5661 P5771 P5941 P5950

50
CN5661 CN5771 CN5941 CN5950

5
CN5661 CN5771 CN5941 CN5950

 

25

 

 

Nitrazepam

Tablet 5 mg

Oral

Mogadon

IL

MP NP PDP

 

 

25

0

 

25

 

 

Nitrazepam

Tablet 5 mg

Oral

Mogadon

IL

MP NP

 

P6175

50
CN6175

3
CN6175

 

25

 

 

Nitrazepam

Tablet 5 mg

Oral

Mogadon

IL

MP NP

 

P5661 P5771 P5941 P5950

50
CN5661 CN5771 CN5941 CN5950

5
CN5661 CN5771 CN5941 CN5950

 

25

 

 

  1.            Schedule 1, Part 1, entries for Nizatidine

substitute:

Nizatidine

Capsule 150 mg

Oral

Nizac

RF

MP NP

 

 

60

5

 

60

 

 

Nizatidine

Capsule 150 mg

Oral

Nizac

RF

MP NP

 

P14238

120

5

 

60

 

 

Nizatidine

Capsule 150 mg

Oral

Tacidine

AF

MP NP

 

 

60

5

 

60

 

 

Nizatidine

Capsule 150 mg

Oral

Tacidine

AF

MP NP

 

P14238

120

5

 

60

 

 

Nizatidine

Capsule 150 mg

Oral

Tazac

RW

MP NP

 

 

60

5

 

60

 

 

Nizatidine

Capsule 150 mg

Oral

Tazac

RW

MP NP

 

P14238

120

5

 

60

 

 

Nizatidine

Capsule 300 mg

Oral

Nizac

RF

MP NP

 

 

30

5

 

30

 

 

Nizatidine

Capsule 300 mg

Oral

Nizac

RF

MP NP

 

P14238

60

5

 

30

 

 

Nizatidine

Capsule 300 mg

Oral

Tacidine

AF

MP NP

 

 

30

5

 

30

 

 

Nizatidine

Capsule 300 mg

Oral

Tacidine

AF

MP NP

 

P14238

60

5

 

30

 

 

Nizatidine

Capsule 300 mg

Oral

Tazac

RW

MP NP

 

 

30

5

 

30

 

 

Nizatidine

Capsule 300 mg

Oral

Tazac

RW

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Octreotide in the form Injection 500 micrograms (as acetate) in 1 mL

substitute:

Octreotide

Injection 500 micrograms (as acetate) in 1 mL

Injection

Octreotide Acetate Omega (Canada)

GQ

MP

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

5

 

D(100)

Octreotide

Injection 500 micrograms (as acetate) in 1 mL

Injection

Octreotide GH

HQ

MP

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

5

 

D(100)

Octreotide

Injection 500 micrograms (as acetate) in 1 mL

Injection

Octreotide (SUN)

RA

MP

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

5

 

D(100)

Octreotide

Injection 500 micrograms (as acetate) in 1 mL

Injection

Sandostatin 0.5

NV

MP

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

5

 

D(100)

  1.            Schedule 1, Part 1, entry for Olanzapine in the form Tablet 2.5 mg

omit:

Olanzapine

Tablet 2.5 mg

Oral

NOUMED OLANZAPINE

VO

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, entry for Olanzapine in the form Tablet 5 mg

omit:

Olanzapine

Tablet 5 mg

Oral

NOUMED OLANZAPINE

VO

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Olanzapine in the form Tablet 5 mg (orally disintegrating) [Brand: APO-Olanzapine ODT]

insert:

Olanzapine

Tablet 5 mg (orally disintegrating)

Oral

OLANZAPINE ODT-WGR

WG

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, entry for Olanzapine in the form Tablet 7.5 mg

omit:

Olanzapine

Tablet 7.5 mg

Oral

NOUMED OLANZAPINE

VO

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, entry for Olanzapine in the form Tablet 10 mg

omit:

Olanzapine

Tablet 10 mg

Oral

NOUMED OLANZAPINE

VO

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Olanzapine in the form Tablet 10 mg (orally disintegrating) [Brand: Olanzapine ODT generichealth 10]

insert:

Olanzapine

Tablet 10 mg (orally disintegrating)

Oral

OLANZAPINE ODT-WGR

WG

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Olanzapine in the form Tablet 15 mg (orally disintegrating) [Brand: APO-Olanzapine ODT]

insert:

Olanzapine

Tablet 15 mg (orally disintegrating)

Oral

OLANZAPINE ODT-WGR

WG

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Olanzapine in the form Tablet 20 mg (orally disintegrating) [Brand: APO-Olanzapine ODT]

insert:

Olanzapine

Tablet 20 mg (orally disintegrating)

Oral

OLANZAPINE ODT-WGR

WG

MP NP

C5856 C5869

 

28

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan in the form Tablet containing olmesartan medoxomil 20 mg [Brand: Olmesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan

Tablet containing olmesartan medoxomil 20 mg

Oral

OLMESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Olmesartan

Tablet containing olmesartan medoxomil 20 mg

Oral

OLMESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan in the form Tablet containing olmesartan medoxomil 40 mg [Brand: Olmesartan Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan

Tablet containing olmesartan medoxomil 40 mg

Oral

OLMESARTAN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Olmesartan

Tablet containing olmesartan medoxomil 40 mg

Oral

OLMESARTAN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan in the form Tablet containing olmesartan medoxomil 40 mg [Brand: Pharmacor Olmesartan 40; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)

Oral

APO-OLMESARTAN/AMLODIPINE 20/5

TY

MP NP

C4373

P4373

30

5

 

30

 

 

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)

Oral

APO-OLMESARTAN/AMLODIPINE 20/5

TY

MP NP

C14257

P14257

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) [Brand: Olmesartan/Amlodipine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)

Oral

OLMESARTAN AMLODIPINE-WGR 20/5

WG

MP NP

C4373

P4373

30

5

 

30

 

 

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)

Oral

OLMESARTAN AMLODIPINE-WGR 20/5

WG

MP NP

C14257

P14257

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) [Brand: Olmesartan/Amlodipine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)

Oral

OLMESARTAN AMLODIPINE-WGR 40/10

WG

MP NP

C4373

P4373

30

5

 

30

 

 

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)

Oral

OLMESARTAN AMLODIPINE-WGR 40/10

WG

MP NP

C14839

P14839

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) [Brand: Olmesartan/Amlodipine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)

Oral

OLMESARTAN AMLODIPINE-WGR 40/5

WG

MP NP

C4373

P4373

30

5

 

30

 

 

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)

Oral

OLMESARTAN AMLODIPINE-WGR 40/5

WG

MP NP

C14839

P14839

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg [Brand: Olmesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg

Oral

OLMESARTAN HCTZ-WGR 20/12.5

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg

Oral

OLMESARTAN HCTZ-WGR 20/12.5

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg [Brand: Olmesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg

Oral

OLMESARTAN HCTZ-WGR 40/12.5

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg

Oral

OLMESARTAN HCTZ-WGR 40/12.5

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg [Brand: Olmesartan/HCT Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

Oral

OLMESARTAN HCTZ-WGR 40/25

WG

MP NP

C4374

P4374

30

5

 

30

 

 

Olmesartan with hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

Oral

OLMESARTAN HCTZ-WGR 40/25

WG

MP NP

C14255

P14255

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Omeprazole

substitute:

Omeprazole

Capsule 20 mg

Oral

APO-Omeprazole

TX

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

APO-Omeprazole

TX

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

APO-Omeprazole

TX

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

APO-Omeprazole

TX

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

APO-Omeprazole

TX

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Maxor

AF

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Maxor

AF

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Maxor

AF

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Maxor

AF

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Maxor

AF

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Omeprazole Sandoz

HX

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Omeprazole Sandoz

HX

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Omeprazole Sandoz

HX

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Omeprazole Sandoz

HX

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Omeprazole Sandoz

HX

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pemzo

RW

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pemzo

RW

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pemzo

RW

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pemzo

RW

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pemzo

RW

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pharmacor Omeprazole 20

CR

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pharmacor Omeprazole 20

CR

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pharmacor Omeprazole 20

CR

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pharmacor Omeprazole 20

CR

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Pharmacor Omeprazole 20

CR

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Probitor

SZ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Probitor

SZ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Probitor

SZ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Probitor

SZ

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Capsule 20 mg

Oral

Probitor

SZ

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Tablet 10 mg (as magnesium)

Oral

Losec Tablets

PB

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Omeprazole

Tablet 10 mg (as magnesium)

Oral

Losec Tablets

PB

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

APO-Omeprazole

TX

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

APO-Omeprazole

TX

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

APO-Omeprazole

TX

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

APO-Omeprazole

TX

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

APO-Omeprazole

TX

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Maxor EC Tabs

AF

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Maxor EC Tabs

AF

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Maxor EC Tabs

AF

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Maxor EC Tabs

AF

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Maxor EC Tabs

AF

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Ozmep

RW

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Ozmep

RW

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Ozmep

RW

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Ozmep

RW

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Tablet 20 mg

Oral

Ozmep

RW

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Acimax Tablets

FJ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Acimax Tablets

FJ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Acimax Tablets

FJ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Acimax Tablets

FJ

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Acimax Tablets

FJ

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Losec Tablets

PB

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Losec Tablets

PB

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Losec Tablets

PB

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Losec Tablets

PB

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Losec Tablets

PB

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omepral

FQ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omepral

FQ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omepral

FQ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omepral

FQ

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omepral

FQ

MP

C15531

P15531

120

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omeprazole Sandoz

SZ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omeprazole Sandoz

SZ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omeprazole Sandoz

SZ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omeprazole Sandoz

SZ

MP

C11310

P11310

60

5

 

30

 

 

Omeprazole

Tablet 20 mg (as magnesium)

Oral

Omeprazole Sandoz

SZ

MP

C15531

P15531

120

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Brand: Ondansetron-DRLA; Maximum Quantity: 10; Number of Repeats: 1]

insert:

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

ONDANSETRON-WGR

WG

MP NP

C4118

P4118

4

0

V4118

4

 

 

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

ONDANSETRON-WGR

WG

MP

C5778

P5778

4

0

V5778

4

 

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

ONDANSETRON-WGR

WG

MP NP

C15193

P15193

10

1

 

10

 

 

  1.            Schedule 1, Part 1, after entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Brand: Ondansetron ODT-DRLA; Maximum Quantity: 10; Number of Repeats: 1]

insert:

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

ONDANSETRON ODT-WGR

WG

MP NP

C5618

P5618

4

0

V5618

4

 

 

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

ONDANSETRON ODT-WGR

WG

MP

C5743

P5743

4

0

V5743

4

 

C(100)

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

ONDANSETRON ODT-WGR

WG

MP NP

C15193

P15193

10

1

 

10

 

 

  1.            Schedule 1, Part 1, after entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Brand: Ondansetron-DRLA; Maximum Quantity: 10; Number of Repeats: 1]

insert:

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

ONDANSETRON-WGR

WG

MP NP

C4118

P4118

4

0

V4118

4

 

 

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

ONDANSETRON-WGR

WG

MP

C5778

P5778

4

0

V5778

4

 

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

ONDANSETRON-WGR

WG

MP NP

C15193

P15193

10

1

 

10

 

 

  1.            Schedule 1, Part 1, after entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Brand: Ondansetron ODT-DRLA; Maximum Quantity: 10; Number of Repeats: 1]

insert:

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

ONDANSETRON ODT-WGR

WG

MP NP

C5618

P5618

4

0

V5618

4

 

 

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

ONDANSETRON ODT-WGR

WG

MP

C5778

P5778

4

0

V5778

4

 

C(100)

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

ONDANSETRON ODT-WGR

WG

MP NP

C15193

P15193

10

1

 

10

 

 

  1.            Schedule 1, Part 1, after entry for Oxazepam in the form Tablet 30 mg [Brand: Murelax; Maximum Quantity: 50; Number of Repeats: 5]

insert:

Oxazepam

Tablet 30 mg

Oral

OXAZEPAM-WGR

WG

MP NP PDP

 

 

25

0

 

25

 

 

Oxazepam

Tablet 30 mg

Oral

OXAZEPAM-WGR

WG

MP NP

 

P6176

50 CN6176

3 CN6176

 

25

 

 

Oxazepam

Tablet 30 mg

Oral

OXAZEPAM-WGR

WG

MP NP

 

P6217 P6230 P6262

50 CN6217 CN6230 CN6262

5 CN6217 CN6230 CN6262

 

25

 

 

  1.            Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 150 mg

substitute:

Oxcarbazepine

Tablet 150 mg

Oral

Trileptal

NV

MP NP

C5183

P5183

100

5

 

100

 

 

Oxcarbazepine

Tablet 150 mg

Oral

Trileptal

NV

MP NP

C14932

P14932

200

5

 

100

 

 

  1.            Schedule 1, Part 1, entries for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [Brand: Mayne Pharma Oxycodone IR]

omit from the column headed “Responsible Person” (all instances): YN  substitute (all instances): SZ

  1.            Schedule 1, Part 1, entries for Pantoprazole

substitute:

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole

TX

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole

TX

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

BTC Pantoprazole

BG

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

BTC Pantoprazole

BG

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

VO

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

VO

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Ozpan

RA

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Ozpan

RA

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Panthron

ZS

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Panthron

ZS

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Pantoprazole APOTEX

TY

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Pantoprazole APOTEX

TY

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Pantoprazole generichealth

HQ

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Pantoprazole generichealth

HQ

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Pantoprazole Sandoz

SZ

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Pantoprazole Sandoz

SZ

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

PANTOPRAZOLE-WGR

WG

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

PANTOPRAZOLE-WGR

WG

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Salpraz

AF

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Salpraz

AF

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Sozol

RW

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

Sozol

RW

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole

TX

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole

TX

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole

TX

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole

TX

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole

TX

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

BTC Pantoprazole

BG

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

BTC Pantoprazole

BG

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

BTC Pantoprazole

BG

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

BTC Pantoprazole

BG

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

BTC Pantoprazole

BG

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

I-Pantoprazole

CR

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

I-Pantoprazole

CR

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

I-Pantoprazole

CR

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

I-Pantoprazole

CR

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

I-Pantoprazole

CR

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

VO

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

VO

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

VO

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

VO

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

NOUMED PANTOPRAZOLE

VO

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Ozpan

RA

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Ozpan

RA

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Ozpan

RA

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Ozpan

RA

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Ozpan

RA

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Panthron

ZS

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Panthron

ZS

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Panthron

ZS

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Panthron

ZS

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Panthron

ZS

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole APOTEX

TY

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole APOTEX

TY

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole APOTEX

TY

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole APOTEX

TY

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole APOTEX

TY

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole generichealth

HQ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole generichealth

HQ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole generichealth

HQ

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole generichealth

HQ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole generichealth

HQ

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole Sandoz

SZ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole Sandoz

SZ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole Sandoz

SZ

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole Sandoz

SZ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Pantoprazole Sandoz

SZ

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

PANTOPRAZOLE-WGR

WG

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

PANTOPRAZOLE-WGR

WG

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

PANTOPRAZOLE-WGR

WG

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

PANTOPRAZOLE-WGR

WG

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

PANTOPRAZOLE-WGR

WG

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Salpraz

AF

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Salpraz

AF

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Salpraz

AF

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Salpraz

AF

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Salpraz

AF

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Somac

NQ

MP

C15531

P15531

120

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Sozol

RW

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Sozol

RW

MP NP

C8776 C8780 C8866

P8776 P8780 P8866

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Sozol

RW

MP

C11310

P11310

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Sozol

RW

MP NP

C15530 C15658 C15678

P15530 P15658 P15678

60

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

Sozol

RW

MP

C15531

P15531

120

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Paraffin

substitute:

Paraffin

Eye drops containing liquid paraffin, glycerol, tyloxapol, poloxamer-188, trometamol hydrochloride, trometamol, cetalkonium chloride, 10 mL (preservative free)

Application to the eye

Cationorm

CS

MP NP AO

C6172

P6172

1

5

 

1

 

 

Paraffin

Eye drops containing liquid paraffin, glycerol, tyloxapol, poloxamer-188, trometamol hydrochloride, trometamol, cetalkonium chloride, 10 mL (preservative free)

Application to the eye

Cationorm

CS

MP NP AO

C15559

P15559

2

5

 

1

 

 

Paraffin

Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Poly Visc

IQ

MP NP AO

 

 

2

5

 

1

 

 

Paraffin

Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Poly Visc

IQ

MP NP AO

 

P14238

4

5

 

1

 

 

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Poly Visc

IQ

MP NP AO

 

 

1

5

 

1

 

 

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Poly Visc

IQ

MP NP AO

 

P14238

2

5

 

1

 

 

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Refresh Night Time

VE

MP NP AO

 

 

1

5

 

1

 

 

Paraffin

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

Application to the eye

Refresh Night Time

VE

MP NP AO

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Paroxetine

substitute:

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

APO-Paroxetine

TX

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

APO-Paroxetine

TX

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

APX-Paroxetine

TY

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

APX-Paroxetine

TY

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Aropax

AS

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Aropax

AS

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Blooms The Chemist Paroxetine

BG

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Blooms The Chemist Paroxetine

BG

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Extine 20

RW

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Extine 20

RW

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Noumed Paroxetine

VO

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Noumed Paroxetine

VO

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Paroxetine GH

GQ

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Paroxetine GH

GQ

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Paroxetine Sandoz

SZ

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Paroxetine Sandoz

SZ

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

PAROXETINE-WGR

WG

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

PAROXETINE-WGR

WG

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Paxtine

AF

MP NP

C4755 C6277 C6636

P4755 P6277 P6636

30

5

 

30

 

 

Paroxetine

Tablet 20 mg (as hydrochloride)

Oral

Paxtine

AF

MP NP

C15582 C15666 C15722

P15582 P15666 P15722

60

2

 

30

 

 

  1.            Schedule 1, Part 1, entries for Perfluorohexyloctane

substitute:

Perfluorohexyloctane

Eye drops, 3 mL

Application to the eye

Novatears

AE

MP NP AO

C6172

P6172

1

5

 

1

 

 

Perfluorohexyloctane

Eye drops, 3 mL

Application to the eye

Novatears

AE

MP NP AO

C15559

P15559

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg [Brand: Perindopril Arginine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Perindopril

Tablet containing perindopril arginine 2.5 mg

Oral

Perindopril Arginine-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril arginine 2.5 mg

Oral

Perindopril Arginine-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Perindopril in the form Tablet containing perindopril arginine 5 mg [Brand: Perindopril Arginine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Perindopril

Tablet containing perindopril arginine 5 mg

Oral

Perindopril Arginine-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril arginine 5 mg

Oral

Perindopril Arginine-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Perindopril in the form Tablet containing perindopril arginine 10 mg [Brand: Perindopril Arginine Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Perindopril

Tablet containing perindopril arginine 10 mg

Oral

Perindopril Arginine-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril arginine 10 mg

Oral

Perindopril Arginine-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

omit:

Perindopril

Tablet containing perindopril erbumine 2 mg

Oral

BTC Perindopril

JB

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril erbumine 2 mg

Oral

BTC Perindopril

JB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [Brand: Perindo; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Perindopril

Tablet containing perindopril erbumine 2 mg

Oral

PERINDOPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril erbumine 2 mg

Oral

PERINDOPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

omit:

Perindopril

Tablet containing perindopril erbumine 4 mg

Oral

BTC Perindopril

JB

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril erbumine 4 mg

Oral

BTC Perindopril

JB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [Brand: Perindo; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Perindopril

Tablet containing perindopril erbumine 4 mg

Oral

PERINDOPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril erbumine 4 mg

Oral

PERINDOPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

omit:

Perindopril

Tablet containing perindopril erbumine 8 mg

Oral

BTC Perindopril

JB

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril erbumine 8 mg

Oral

BTC Perindopril

JB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [Brand: Perindo; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Perindopril

Tablet containing perindopril erbumine 8 mg

Oral

PERINDOPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Perindopril

Tablet containing perindopril erbumine 8 mg

Oral

PERINDOPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg [Brand: Perindo Combi 4/1.25; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Perindopril with indapamide

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

Oral

PERINDOPRIL/INDAPAMIDE-WGR 4/1.25

WG

MP NP

C4375

P4375

30

5

 

30

 

 

Perindopril with indapamide

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

Oral

PERINDOPRIL/INDAPAMIDE-WGR 4/1.25

WG

MP NP

C14267

P14267

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Pilocarpine

substitute:

Pilocarpine

Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL

Application to the eye

Isopto Carpine

NV

MP AO

 

 

1

5

 

1

 

 

Pilocarpine

Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL

Application to the eye

Isopto Carpine

NV

MP AO

 

P14238

2

5

 

1

 

 

Pilocarpine

Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL

Application to the eye

Isopto Carpine

NV

MP AO

 

 

1

5

 

1

 

 

Pilocarpine

Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL

Application to the eye

Isopto Carpine

NV

MP AO

 

P14238

2

5

 

1

 

 

Pilocarpine

Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL

Application to the eye

Isopto Carpine

NV

MP AO

 

 

1

5

 

1

 

 

Pilocarpine

Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL

Application to the eye

Isopto Carpine

NV

MP AO

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride) [Brand: APOTEX-Pioglitazone; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

XT

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

XT

MP NP

C15290

P15290

56

5

 

28

 

 

  1.            Schedule 1, Part 1, entries for Polyethylene glycol 400 with propylene glycol

substitute:

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, 15 mL

Application to the eye

Optix

PP

MP NP AO

C15560

P15560

1

5

 

1

 

 

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, 15 mL

Application to the eye

Optix

PP

MP NP AO

C15556

P15556

2

5

 

1

 

 

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, 15 mL

Application to the eye

Systane

AQ

MP NP AO

C15560

P15560

1

5

 

1

 

 

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, 15 mL

Application to the eye

Systane

AQ

MP NP AO

C15556

P15556

2

5

 

1

 

 

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 30

Application to the eye

Systane

AQ

MP NP AO

C6172

P6172

2

5

 

1

 

 

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 30

Application to the eye

Systane

AQ

MP NP AO

C15559

P15559

4

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Posaconazole in the form Tablet (modified release) 100 mg [Brand: Posaconazole Sandoz]

insert:

Posaconazole

Tablet (modified release) 100 mg

Oral

POSACONAZOLE-WGR

WG

MP NP

C5169 C5395 C5396

 

24

0

 

24

 

 

  1.            Schedule 1, Part 1, entries for Pramipexole

substitute:

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

APO-Pramipexole ER

TX

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

APO-Pramipexole ER

TX

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

Sifrol ER

BY

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

Sifrol ER

BY

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

SIMIPEX XR

RW

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

SIMIPEX XR

RW

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

APO-Pramipexole ER

TX

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

APO-Pramipexole ER

TX

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

Sifrol ER

BY

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

Sifrol ER

BY

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

SIMIPEX XR

RW

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

SIMIPEX XR

RW

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

APO-Pramipexole ER

TX

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

APO-Pramipexole ER

TX

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

Sifrol ER

BY

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

Sifrol ER

BY

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

SIMIPEX XR

RW

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

SIMIPEX XR

RW

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

APO-Pramipexole ER

TX

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

APO-Pramipexole ER

TX

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

Sifrol ER

BY

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

Sifrol ER

BY

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

SIMIPEX XR

RW

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

SIMIPEX XR

RW

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

APO-Pramipexole ER

TX

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

APO-Pramipexole ER

TX

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

Sifrol ER

BY

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

Sifrol ER

BY

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

SIMIPEX XR

RW

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

SIMIPEX XR

RW

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

APO-Pramipexole ER

TX

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

APO-Pramipexole ER

TX

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

Sifrol ER

BY

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

Sifrol ER

BY

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

SIMIPEX XR

RW

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

SIMIPEX XR

RW

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

APO-Pramipexole ER

TX

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

APO-Pramipexole ER

TX

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

Sifrol ER

BY

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

Sifrol ER

BY

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

SIMIPEX XR

RW

MP NP

C5131

P5131

30

5

 

30

 

 

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

SIMIPEX XR

RW

MP NP

C15568

P15568

60

5

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

APO-Pramipexole

TX

MP NP

C5363

P5363

30

0

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

APO-Pramipexole

TX

MP NP

C5411

P5411

30

2

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Sifrol

BY

MP NP

C5363

P5363

30

0

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Sifrol

BY

MP NP

C5411

P5411

30

2

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simipex 0.125

RW

MP NP

C5363

P5363

30

0

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simipex 0.125

RW

MP NP

C5411

P5411

30

2

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simpral

AF

MP NP

C5363

P5363

30

0

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simpral

AF

MP NP

C5411

P5411

30

2

 

30

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

APO-Pramipexole

TX

MP NP

C5411

P5411

100

2

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

APO-Pramipexole

TX

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

APO-Pramipexole

TX

MP NP

C15570

P15570

200

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Sifrol

BY

MP NP

C5411

P5411

100

2

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Sifrol

BY

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Sifrol

BY

MP NP

C15570

P15570

200

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simipex 0.25

RW

MP NP

C5411

P5411

100

2

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simipex 0.25

RW

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simipex 0.25

RW

MP NP

C15570

P15570

200

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simpral

AF

MP NP

C5411

P5411

100

2

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simpral

AF

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simpral

AF

MP NP

C15570

P15570

200

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

APO-Pramipexole

TX

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

APO-Pramipexole

TX

MP NP

C15570

P15570

200

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Sifrol

BY

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Sifrol

BY

MP NP

C15570

P15570

200

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simipex 1

RW

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simipex 1

RW

MP NP

C15570

P15570

200

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simpral

AF

MP NP

C5363

P5363

100

5

 

100

 

 

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simpral

AF

MP NP

C15570

P15570

200

5

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Brand: Pravastatin Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Pravastatin

Tablet containing pravastatin sodium 10 mg

Oral

PRAVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Pravastatin

Tablet containing pravastatin sodium 10 mg

Oral

PRAVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Brand: Pravastatin Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Pravastatin

Tablet containing pravastatin sodium 20 mg

Oral

PRAVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Pravastatin

Tablet containing pravastatin sodium 20 mg

Oral

PRAVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Brand: Pravastatin Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Pravastatin

Tablet containing pravastatin sodium 40 mg

Oral

PRAVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Pravastatin

Tablet containing pravastatin sodium 40 mg

Oral

PRAVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Pregabalin

substitute:

Pregabalin

Capsule 25 mg

Oral

APO-Pregabalin

TX

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

Blooms The Chemist Pregabalin

IB

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

BTC Pregabalin

BG

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

Lyrica

UJ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

Lyzalon

AF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

Neuroccord

CR

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

NOUMED PREGABALIN

VO

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

Prebalin

RF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

PREGABALIN-DRLA

RZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

Pregabalin Lupin

HQ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

Pregabalin Sandoz

SZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 25 mg

Oral

PREGABALIN-WGR

WG

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

APO-Pregabalin

TX

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

BTC Pregabalin

BG

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

Lyrica

UJ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

Lyzalon

AF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

Neuroccord

CR

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

NOUMED PREGABALIN

VO

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

Prebalin

RF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

PREGABALIN-DRLA

RZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

Pregabalin Lupin

HQ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

Pregabalin Sandoz

SZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 75 mg

Oral

PREGABALIN-WGR

WG

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

APO-Pregabalin

TX

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Blooms The Chemist Pregabalin

IB

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

BTC Pregabalin

BG

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Cipla Pregabalin

LR

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Lyrica

UJ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Lyzalon

AF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Neuroccord

CR

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

NOUMED PREGABALIN

VO

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Prebalin

RF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

PREGABALIN-DRLA

RZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Pregabalin Lupin

HQ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

Pregabalin Sandoz

SZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 150 mg

Oral

PREGABALIN-WGR

WG

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

APO-Pregabalin

TX

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

Blooms The Chemist Pregabalin

IB

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

BTC Pregabalin

BG

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

Lyrica

UJ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

Lyzalon

AF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

Neuroccord

CR

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

NOUMED PREGABALIN

VO

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

Prebalin

RF

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

PREGABALIN-DRLA

RZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

Pregabalin Lupin

HQ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

Pregabalin Sandoz

SZ

MP NP

C4172

 

56

5

 

56

 

 

Pregabalin

Capsule 300 mg

Oral

PREGABALIN-WGR

WG

MP NP

C4172

 

56

5

 

56

 

 

  1.            Schedule 1, Part 1, entries for Prochlorperazine

substitute:

Prochlorperazine

Injection containing prochlorperazine mesilate 12.5 mg in 1 mL

Injection

Stemetil

SW

MP NP PDP

 

 

10

0

 

10

 

 

Prochlorperazine

Tablet containing prochlorperazine maleate 5 mg

Oral

APO-Prochlorperazine

TX

MP NP PDP

 

 

25

0

 

25

 

 

Prochlorperazine

Tablet containing prochlorperazine maleate 5 mg

Oral

ProCalm

RW

MP NP PDP

 

 

25

0

 

25

 

 

Prochlorperazine

Tablet containing prochlorperazine maleate 5 mg

Oral

Prochlorperazine GH

GQ

MP NP PDP

 

 

25

0

 

25

 

 

Prochlorperazine

Tablet containing prochlorperazine maleate 5 mg

Oral

PROCHLORPERAZINE-WGR

WG

MP NP PDP

 

 

25

0

 

25

 

 

Prochlorperazine

Tablet containing prochlorperazine maleate 5 mg

Oral

Stemetil

SW

MP NP PDP

 

 

25

0

 

25

 

 

Prochlorperazine

Tablet containing prochlorperazine maleate 5 mg (S19A)

Oral

Stemetil (Ireland)

OJ

MP NP PDP

 

 

25

0

 

250

 

 

  1.            Schedule 1, Part 1, after entry for Propranolol in the form Tablet containing propranolol hydrochloride 10 mg [Brand: Inderal; Maximum Quantity: 200; Number of Repeats: 5]

insert:

Propranolol

Tablet containing propranolol hydrochloride 10 mg

Oral

PROPRANOLOL-WGR

WG

MP NP

 

 

100

5

 

100

 

 

Propranolol

Tablet containing propranolol hydrochloride 10 mg

Oral

PROPRANOLOL-WGR

WG

MP NP

 

P14238

200

5

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Propranolol in the form Tablet containing propranolol hydrochloride 40 mg [Brand: Inderal; Maximum Quantity: 200; Number of Repeats: 5]

insert:

Propranolol

Tablet containing propranolol hydrochloride 40 mg

Oral

PROPRANOLOL-WGR

WG

MP NP

 

 

100

5

 

100

 

 

Propranolol

Tablet containing propranolol hydrochloride 40 mg

Oral

PROPRANOLOL-WGR

WG

MP NP

 

P14238

200

5

 

100

 

 

  1.            Schedule 1, Part 1, after entry for Pyridostigmine in the form Tablet containing pyridostigmine bromide 10 mg

insert:

Pyridostigmine

Tablet containing pyridostigmine bromide 10 mg

Oral

Mestinon

IL

MP

 

P14238

200

5

 

50

 

 

  1.            Schedule 1, Part 1, after entry for Pyridostigmine in the form Tablet containing pyridostigmine bromide 60 mg

insert:

Pyridostigmine

Tablet containing pyridostigmine bromide 60 mg

Oral

Mestinon

IL

MP

 

P14238

300

5

 

150

 

 

  1.            Schedule 1, Part 1, after entry for Pyridostigmine in the form Tablet containing pyridostigmine bromide 180 mg (modified release)

insert:

Pyridostigmine

Tablet containing pyridostigmine bromide 180 mg (modified release)

Oral

Mestinon Timespan

IL

MP

 

P14238

200

5

 

50

 

 

  1.            Schedule 1, Part 1, entries for Rabeprazole

substitute:

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

APO-Rabeprazole

TX

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

APO-Rabeprazole

TX

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Parbezol

RW

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Parbezol

RW

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Pariet

JC

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Pariet

JC

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Rabeprazole Sandoz

SZ

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

Rabeprazole Sandoz

SZ

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

RABEPRAZOLE-WGR

WG

MP NP

C5444 C5512

P5444 P5512

28

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

RABEPRAZOLE-WGR

WG

MP NP

C15574 C15633

P15574 P15633

56

5

 

28

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

APO-Rabeprazole

TX

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

APO-Rabeprazole

TX

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

APO-Rabeprazole

TX

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

APO-Rabeprazole

TX

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

APO-Rabeprazole

TX

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Noumed Rabeprazole

VO

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Noumed Rabeprazole

VO

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Noumed Rabeprazole

VO

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Noumed Rabeprazole

VO

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Noumed Rabeprazole

VO

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Parbezol

RW

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Parbezol

RW

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Parbezol

RW

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Parbezol

RW

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Parbezol

RW

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Pariet

JC

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Pariet

JC

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Pariet

JC

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Pariet

JC

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Pariet

JC

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Mylan

AF

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Mylan

AF

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Mylan

AF

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Mylan

AF

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Mylan

AF

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Sandoz

SZ

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Sandoz

SZ

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Sandoz

SZ

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Sandoz

SZ

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole Sandoz

SZ

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole SUN

RN

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole SUN

RN

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole SUN

RN

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole SUN

RN

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Rabeprazole SUN

RN

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

RABEPRAZOLE-WGR

WG

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

RABEPRAZOLE-WGR

WG

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

RABEPRAZOLE-WGR

WG

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

RABEPRAZOLE-WGR

WG

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

RABEPRAZOLE-WGR

WG

MP

C15531

P15531

120

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Zabep

AL

MP NP

C8774 C8775

P8774 P8775

30

1

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Zabep

AL

MP NP

C8776 C8780

P8776 P8780

30

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Zabep

AL

MP NP

C15530 C15658

P15530 P15658

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Zabep

AL

MP

C11310

P11310

60

5

 

30

 

 

Rabeprazole

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

Zabep

AL

MP

C15531

P15531

120

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ramipril in the form Capsule 10 mg [Brand: Ramipril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ramipril

Capsule 10 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Ramipril

Capsule 10 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ramipril in the form Tablet 1.25 mg [Brand: Ramipril Viatris; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ramipril

Tablet 1.25 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Ramipril

Tablet 1.25 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ramipril in the form Tablet 2.5 mg [Brand: Ramipril Viatris; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ramipril

Tablet 2.5 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Ramipril

Tablet 2.5 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ramipril in the form Tablet 5 mg [Brand: Ramipril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ramipril

Tablet 5 mg

Oral

Ramipril Viatris

AL

MP NP

 

 

30

5

 

30

 

 

Ramipril

Tablet 5 mg

Oral

Ramipril Viatris

AL

MP NP

 

P14238

60

5

 

30

 

 

Ramipril

Tablet 5 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Ramipril

Tablet 5 mg

Oral

RAMIPRIL-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Ramipril in the form Tablet 10 mg [Brand: Ramipril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Ramipril

Tablet 10 mg

Oral

RAMIPRIL TABS-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Ramipril

Tablet 10 mg

Oral

RAMIPRIL TABS-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Rasagiline

substitute:

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Alziras

RW

MP NP

C5339

P5339

30

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Alziras

RW

MP NP

C15648

P15648

60

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Azilect

TB

MP NP

C5339

P5339

30

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Azilect

TB

MP NP

C15648

P15648

60

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Pharmacor Rasagiline

CR

MP NP

C5339

P5339

30

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Pharmacor Rasagiline

CR

MP NP

C15648

P15648

60

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Rasagiline Lupin

HQ

MP NP

C5339

P5339

30

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Rasagiline Lupin

HQ

MP NP

C15648

P15648

60

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Rasagiline Sandoz

SZ

MP NP

C5339

P5339

30

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Rasagiline Sandoz

SZ

MP NP

C15648

P15648

60

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Rasagiline-Teva

EV

MP NP

C5339

P5339

30

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

Rasagiline-Teva

EV

MP NP

C15648

P15648

60

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

RASAGILINE-WGR

WG

MP NP

C5339

P5339

30

5

 

30

 

 

Rasagiline

Tablet 1 mg (as mesilate)

Oral

RASAGILINE-WGR

WG

MP NP

C15648

P15648

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Ravulizumab

substitute:

Ravulizumab

Solution concentrate for I.V. infusion 1,100 mg in 11 mL

Injection

Ultomiris

XI

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

Ravulizumab

Solution concentrate for I.V. infusion 300 mg in 3 mL

Injection

Ultomiris

XI

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

  1.            Schedule 1, Part 1, entry for Reboxetine

substitute:

Reboxetine

Tablet 4 mg (as mesilate)

Oral

Edronax

PF

MP NP

C5650

C5650

60

5

 

60

 

 

Reboxetine

Tablet 4 mg (as mesilate)

Oral

Edronax

PF

MP NP

C15553

P15553

120

2

 

60

 

 

  1.            Schedule 1, Part 1, entry for Rifabutin

substitute:

Rifabutin

Capsule 150 mg

Oral

Mycobutin

PF

MP NP

C6350 C6356 C9560 C9622

 

120

5

 

30

 

D(100)

  1.            Schedule 1, Part 1, entries for Riluzole

substitute:

Riluzole

Oral suspension 50 mg per 10 mL, 300 mL

Oral

Teglutik

CS

MP NP

C5341 C8738

C5341 C8738

2

5

 

1

 

 

Riluzole

Oral suspension 50 mg per 10 mL, 300 mL

Oral

Teglutik

CS

MP NP

C15719

P15719

4

5

 

1

 

 

Riluzole

Tablet 50 mg

Oral

APO-Riluzole

TX

MP NP

C5341 C8738

C5341 C8738

56

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

APO-Riluzole

TX

MP NP

C15719

P15719

112

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

Pharmacor Riluzole

CR

MP NP

C5341 C8738

C5341 C8738

56

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

Pharmacor Riluzole

CR

MP NP

C15719

P15719

112

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

Rilutek

SW

MP NP

C5341 C8738

C5341 C8738

56

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

Rilutek

SW

MP NP

C15719

P15719

112

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

Riluzole Sandoz

SZ

MP NP

C5341 C8738

C5341 C8738

56

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

Riluzole Sandoz

SZ

MP NP

C15719

P15719

112

5

 

56

 

 

  1.            Schedule 1, Part 1, entries for Risdiplam

substitute:

Risdiplam

Powder for oral solution 750 micrograms per mL, 80 mL

Oral

Evrysdi

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

  1.            Schedule 1, Part 1, after entry for Risedronic acid in the form Tablet containing risedronate sodium 35 mg [Brand: Risedronate Sandoz; Maximum Quantity: 8; Number of Repeats: 5]

insert:

Risedronic acid

Tablet containing risedronate sodium 35 mg

Oral

RISEDRONATE-WGR

WG

MP NP

C6310 C6323 C6327

P6310 P6323 P6327

4

5

 

4

 

 

Risedronic acid

Tablet containing risedronate sodium 35 mg

Oral

RISEDRONATE-WGR

WG

MP NP

C14234 C14235 C14263

P14234 P14235 P14263

8

5

 

4

 

 

  1.            Schedule 1, Part 1, after entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Brand: Risperdal; Maximum Quantity: 1; Number of Repeats: 5]

insert:

Risperidone

Oral solution 1 mg per mL, 100 mL

Oral

Risperidone Lupin

GQ

MP NP

C6898 C6899 C10020 C10021

P6898 P6899 P10020 P10021

1

2

 

1

 

 

Risperidone

Oral solution 1 mg per mL, 100 mL

Oral

Risperidone Lupin

GQ

MP NP

C4246 C5907

P4246 P5907

1

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Rituximab

substitute:

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Riximyo

SZ

MP

 

 

6

0

 

2

 

D(100)

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Riximyo

SZ

MP

 

 

See Note 3

See Note 3

 

2

 

D(100)

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Ruxience

PF

MP

 

 

6

0

 

1

 

D(100)

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Ruxience

PF

MP

 

 

See Note 3

See Note 3

 

1

 

D(100)

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Truxima

EW

MP

 

 

6

0

 

2

 

D(100)

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Truxima

EW

MP

 

 

See Note 3

See Note 3

 

2

 

D(100)

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

Riximyo

SZ

MP

 

 

2

1

 

1

 

D(100)

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

Riximyo

SZ

MP

 

 

See Note 3

See Note 3

 

1

 

D(100)

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

Ruxience

PF

MP

 

 

2

1

 

1

 

D(100)

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

Ruxience

PF

MP

 

 

See Note 3

See Note 3

 

1

 

D(100)

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

Truxima

EW

MP

 

 

2

1

 

1

 

D(100)

Rituximab

Solution for I.V. infusion 500 mg in 50 mL

Injection

Truxima

EW

MP

 

 

See Note 3

See Note 3

 

1

 

D(100)

  1.            Schedule 1, Part 1, after entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) [Brand: Rizatriptan ODT GH]

insert:

Rizatriptan

Tablet (orally disintegrating) 10 mg (as benzoate)

Oral

RIZATRIPTAN ODT-WGR

WG

MP NP

C5708

 

4

5

 

2

 

 

  1.            Schedule 1, Part 1, after entry for Romosozumab in the form Injection 105 mg in 1.17 mL single use pre-filled syringe

insert:

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

APO-ROSUVASTATIN

TX

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

APO-ROSUVASTATIN

TX

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium)

omit:

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Brand: Rosuvastatin Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium)

omit:

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Brand: Rosuvastatin Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium)

omit:

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Brand: Rosuvastatin Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium)

omit:

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

Blooms the Chemist Rosuvastatin

IB

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, after entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Brand: Rosuvastatin Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

ROSUVASTATIN-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entries for Rotigotine

substitute:

Rotigotine

Transdermal patch 4.5 mg

Transdermal

Neupro

UC

MP

C4190

P4190

28

5

 

28

 

 

Rotigotine

Transdermal patch 4.5 mg

Transdermal

Neupro

UC

MP

C15675

P15675

56

5

 

28

 

 

Rotigotine

Transdermal patch 9 mg

Transdermal

Neupro

UC

MP

C4204

P4204

28

5

 

28

 

 

Rotigotine

Transdermal patch 9 mg

Transdermal

Neupro

UC

MP

C15649

P15649

56

5

 

28

 

 

Rotigotine

Transdermal patch 13.5 mg

Transdermal

Neupro

UC

MP

C4204

P4204

28

5

 

28

 

 

Rotigotine

Transdermal patch 13.5 mg

Transdermal

Neupro

UC

MP

C15649

P15649

56

5

 

28

 

 

Rotigotine

Transdermal patch 18 mg

Transdermal

Neupro

UC

MP

C4204

P4204

28

5

 

28

 

 

Rotigotine

Transdermal patch 18 mg

Transdermal

Neupro

UC

MP

C15649

P15649

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Roxithromycin in the form Tablet 150 mg [Brand: Roxithromycin Sandoz; Maximum Quantity: 20; Number of Repeats: 0]

insert:

Roxithromycin

Tablet 150 mg

Oral

ROXITHROMYCIN-WGR

WG

MP NP PDP

 

 

10

0

 

10

 

 

Roxithromycin

Tablet 150 mg

Oral

ROXITHROMYCIN-WGR

WG

MP NP

 

P10404

20 CN10404

0 CN10404

 

10

 

 

  1.            Schedule 1, Part 1, after entry for Roxithromycin in the form Tablet 300 mg [Brand: Roxithromycin Sandoz; Maximum Quantity: 10; Number of Repeats: 0]

insert:

Roxithromycin

Tablet 300 mg

Oral

ROXITHROMYCIN-WGR

WG

MP NP PDP

 

 

5

0

 

5

 

 

Roxithromycin

Tablet 300 mg

Oral

ROXITHROMYCIN-WGR

WG

MP NP

 

P10404

10 CN10404

0 CN10404

 

5

 

 

  1.            Schedule 1, Part 1, entries for Sacituzumab govitecan

substitute:

Sacituzumab govitecan

Powder for injection 180 mg

Injection

Trodelvy

GI

MP

C12656

 

See Note 3

See Note 3

 

1

 

D(100)

Sacituzumab govitecan

Powder for injection 180 mg

Injection

Trodelvy

GI

MP

C12669

 

See Note 3

See Note 3

 

1

 

D(100)

  1.            Schedule 1, Part 1, entries for Safinamide

substitute:

Safinamide

Tablet 50 mg

Oral

Xadago

CS

MP NP

C8624

P8624

30

5

 

30

 

 

Safinamide

Tablet 50 mg

Oral

Xadago

CS

MP NP

C15699

P15699

60

5

 

30

 

 

Safinamide

Tablet 100 mg

Oral

Xadago

CS

MP NP

C8624

P8624

30

5

 

30

 

 

Safinamide

Tablet 100 mg

Oral

Xadago

CS

MP NP

C15699

P15699

60

5

 

30

 

 

  1.            Schedule 1, Part 1, entry for Salmeterol

substitute:

Salmeterol

Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Serevent Accuhaler

GK

MP NP

C6355

P6355

1

5

 

1

 

 

Salmeterol

Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Serevent Accuhaler

GK

MP NP

C15607

P15607

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

substitute:

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

NV

MP

C15799 C15806 C15807 C15810

P15799 P15806 P15807 P15810

2

3

 

2

 

 

  1.            Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

substitute:

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

NV

MP

C6696 C8830 C8892 C9063 C9105 C15767 C15779

P6696 P8830 P8892 P9063 P9105 P15767 P15779

2

5

 

2

 

 

  1.            Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]

substitute:

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

NV

MP

C9069 C9078 C9155 C11089 C11096 C11138 C11154 C14430 C14462 C15280 C15296 C15307 C15768 C15805 C15812

P9069 P9078 P9155 P11089 P11096 P11138 P11154 P14430 P14462 P15280 P15296 P15307 P15768 P15805 P15812

8

0

 

2

 

 

  1.            Schedule 1, Part 1, entries for Selegiline

substitute:

Selegiline

Tablet containing selegiline hydrochloride 5 mg

Oral

Eldepryl

OX

MP NP

C5338

P5338

100

5

 

100

 

 

Selegiline

Tablet containing selegiline hydrochloride 5 mg

Oral

Eldepryl

OX

MP NP

C15700

P15700

200

5

 

100

 

 

  1.            Schedule 1, Part 1, entries for Selexipag in the form Tablet 800 micrograms

substitute:

Selexipag

Tablet 800 micrograms

Oral

Uptravi

JC

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

60

 

D(100)

  1.            Schedule 1, Part 1, entries for Selinexor

substitute:

Selinexor

Tablet 20 mg

Oral

Xpovio

TG

MP

C14021 C14045

P14021 P14045

16

2

 

16

 

D(100)

Selinexor

Tablet 20 mg

Oral

Xpovio

TG

MP

C14023 C14024

P14023 P14024

20

2

 

20

 

D(100)

Selinexor

Tablet 20 mg

Oral

Xpovio

TG

MP

C14031 C14039

P14031 P14039

32

2

 

32

 

D(100)

  1.            Schedule 1, Part 1, entries for Sertraline

substitute:

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

APO-Sertraline

TX

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

APO-Sertraline

TX

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Blooms The Chemist Sertraline

BG

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Blooms The Chemist Sertraline

BG

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Eleva 50

AF

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Eleva 50

AF

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

NOUMED SERTRALINE

VO

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

NOUMED SERTRALINE

VO

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Sertra 50

RW

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Sertra 50

RW

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Sertraline generichealth

GQ

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Sertraline generichealth

GQ

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Sertraline Sandoz

SZ

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Sertraline Sandoz

SZ

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

SERTRALINE-WGR

WG

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

SERTRALINE-WGR

WG

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Setrona

RA

MP NP

C4755

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Setrona

RA

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Zoloft

UJ

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Zoloft

UJ

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

APO-Sertraline

TX

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

APO-Sertraline

TX

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Blooms The Chemist Sertraline

BG

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Blooms The Chemist Sertraline

BG

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Eleva 100

AF

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Eleva 100

AF

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

NOUMED SERTRALINE

VO

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

NOUMED SERTRALINE

VO

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Sertra 100

RW

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Sertra 100

RW

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Sertraline generichealth

GQ

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Sertraline generichealth

GQ

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Sertraline Sandoz

SZ

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Sertraline Sandoz

SZ

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

SERTRALINE-WGR

WG

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

SERTRALINE-WGR

WG

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Setrona

RA

MP NP

C4755

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Setrona

RA

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Zoloft

UJ

MP NP

C4755 C6277 C6289

P4755 P6277 P6289

30

5

 

30

 

 

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Zoloft

UJ

MP NP

C15582 C15583 C15666

P15582 P15583 P15666

60

2

 

30

 

 

  1.            Schedule 1, Part 1, entry for Sofosbuvir with velpatasvir and voxilaprevir

omit:

Sofosbuvir with velpatasvir and voxilaprevir

Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir and 100 mg voxilaprevir

Oral

Vosevi

GI

MP NP

C10248

 

28

2

 

28

 

C(100)

  1.            Schedule 1, Part 1, after entry for Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate in the form Enemas 3.125 g-450 mg-45 mg in 5 mL, 12 [Brand: Micolette; Maximum Quantity: 2; Number of Repeats: 3]

insert:

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Enemas 3.125 g-450 mg-45 mg in 5 mL, 12

Rectal

Micolette

AE

MP NP

C15572 C15585 C15586 C15629 C15707 C15734 C15735

P15572 P15585 P15586 P15629 P15707 P15734 P15735

4

2

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Sotalol in the form Tablet containing sotalol hydrochloride 80 mg [Brand: Sotalol Sandoz]

insert:

Sotalol

Tablet containing sotalol hydrochloride 80 mg

Oral

SOTALOL-WGR

WG

MP NP

C5664

 

60

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Sotalol in the form Tablet containing sotalol hydrochloride 160 mg [Brand: Sotalol Sandoz]

insert:

Sotalol

Tablet containing sotalol hydrochloride 160 mg

Oral

SOTALOL-WGR

WG

MP NP

C5664

 

60

5

 

60

 

 

  1.            Schedule 1, Part 1, entries for Soy lecithin

substitute:

Soy lecithin

Eye spray 10 mg per mL, 10 mL

Application

tearsagain

RB

MP NP AO

C6172

P6172

2

5

 

1

 

 

Soy lecithin

Eye spray 10 mg per mL, 10 mL

Application

tearsagain

RB

MP NP AO

C15559

P15559

4

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Brand: Sumatriptan Sandoz]

insert:

Sumatriptan

Tablet 50 mg (as succinate)

Oral

SUMATRIPTAN-WGR

WG

MP NP

C5259

 

4

5

 

4

 

 

  1.            Schedule 1, Part 1, after entry for Telmisartan in the form Tablet 40 mg [Brand: Telmisartan Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan

Tablet 40 mg

Oral

TELMISARTAN-WGR

WG

MP NP

 

 

28

5

 

28

 

 

Telmisartan

Tablet 40 mg

Oral

TELMISARTAN-WGR

WG

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Telmisartan in the form Tablet 80 mg [Brand: Telmisartan Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan

Tablet 80 mg

Oral

TELMISARTAN-WGR

WG

MP NP

 

 

28

5

 

28

 

 

Telmisartan

Tablet 80 mg

Oral

TELMISARTAN-WGR

WG

MP NP

 

P14238

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Telmisartan with hydrochlorothiazide in the form Tablet 40 mg-12.5 mg [Brand: Telmisartan/HCT Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan with hydrochlorothiazide

Tablet 40 mg-12.5 mg

Oral

TELMISARTAN HCTZ-WGR 40/12.5

WG

MP NP

C4374

P4374

28

5

 

28

 

 

Telmisartan with hydrochlorothiazide

Tablet 40 mg-12.5 mg

Oral

TELMISARTAN HCTZ-WGR 40/12.5

WG

MP NP

C14255

P14255

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg [Brand: Telmisartan/HCT Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan with hydrochlorothiazide

Tablet 80 mg-12.5 mg

Oral

TELMISARTAN HCTZ-WGR 80/12.5

WG

MP NP

C4374

P4374

28

5

 

28

 

 

Telmisartan with hydrochlorothiazide

Tablet 80 mg-12.5 mg

Oral

TELMISARTAN HCTZ-WGR 80/12.5

WG

MP NP

C14255

P14255

56

5

 

28

 

 

  1.            Schedule 1, Part 1, after entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-25 mg [Brand: Telmisartan/HCT Sandoz; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Telmisartan with hydrochlorothiazide

Tablet 80 mg-25 mg

Oral

TELMISARTAN HCTZ-WGR 80/25

WG

MP NP

C4374

P4374

28

5

 

28

 

 

Telmisartan with hydrochlorothiazide

Tablet 80 mg-25 mg

Oral

TELMISARTAN HCTZ-WGR 80/25

WG

MP NP

C14255

P14255

56

5

 

28

 

 

  1.            Schedule 1, Part 1, entries for Temazepam

substitute:

Temazepam

Tablet 10 mg

Oral

APO-Temazepam

TX

MP NP PDP

 

 

25

0

 

25

 

 

Temazepam

Tablet 10 mg

Oral

APO-Temazepam

TX

MP NP

 

P6175

50
CN6175

3
CN6175

 

25

 

 

Temazepam

Tablet 10 mg

Oral

APO-Temazepam

TX

MP NP

 

P5661 P5941 P5950

50
CN5661 CN5941 CN5950

5
CN5661 CN5941 CN5950

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Normison

AS

MP NP PDP

 

 

25

0

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Normison

AS

MP NP

 

P6175

50
CN6175

3
CN6175

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Normison

AS

MP NP

 

P5661 P5941 P5950

50
CN5661 CN5941 CN5950

5
CN5661 CN5941 CN5950

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Temaze

AF

MP NP PDP

 

 

25

0

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Temaze

AF

MP NP

 

P6175

50
CN6175

3
CN6175

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Temaze

AF

MP NP

 

P5661 P5941 P5950

50
CN5661 CN5941 CN5950

5
CN5661 CN5941 CN5950

 

25

 

 

Temazepam

Tablet 10 mg

Oral

TEMAZEPAM-WGR

WG

MP NP PDP

 

 

25

0

 

25

 

 

Temazepam

Tablet 10 mg

Oral

TEMAZEPAM-WGR

WG

MP NP

 

P6175

50
CN6175

3
CN6175

 

25

 

 

Temazepam

Tablet 10 mg

Oral

TEMAZEPAM-WGR

WG

MP NP

 

P5661 P5941 P5950

50
CN5661 CN5941 CN5950

5
CN5661 CN5941 CN5950

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Temtabs

LN

MP NP PDP

 

 

25

0

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Temtabs

LN

MP NP

 

P6175

50
CN6175

3
CN6175

 

25

 

 

Temazepam

Tablet 10 mg

Oral

Temtabs

LN

MP NP

 

P5661 P5941 P5950

50
CN5661 CN5941 CN5950

5
CN5661 CN5941 CN5950

 

25

 

 

  1.            Schedule 1, Part 1, entries for Terbinafine

substitute:

Terbinafine

Cream containing terbinafine hydrochloride 10 mg per g, 15 g

Application

Lamisil

NP

MP NP

C6412 C6434

 

2

3

 

1

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

APO-Terbinafine

TX

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

APO-Terbinafine

TX

MP NP

C6395

P6395

42

1

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Lamisil (Novartis Pharmaceuticals Australia Pty Limited)

NV

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Lamisil (Novartis Pharmaceuticals Australia Pty Limited)

NV

MP NP

C6395

P6395

42

1

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

NOUMED TERBINAFINE

VO

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

NOUMED TERBINAFINE

VO

MP NP

C6395

P6395

42

1

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Tamsil

RW

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Tamsil

RW

MP NP

C6395

P6395

42

1

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Terbinafine-DRLA

RZ

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Terbinafine-DRLA

RZ

MP NP

C6395

P6395

42

1

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Terbinafine Sandoz

SZ

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Terbinafine Sandoz

SZ

MP NP

C6395

P6395

42

1

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

TERBINAFINE-WGR

WG

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

TERBINAFINE-WGR

WG

MP NP

C6395

P6395

42

1

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Tinasil

AF

MP NP

C6404 C6453

P6404 P6453

42

0

 

42

 

 

Terbinafine

Tablet 250 mg (as hydrochloride)

Oral

Tinasil

AF

MP NP

C6395

P6395

42

1

 

42

 

 

  1.            Schedule 1, Part 1, entries for Teriparatide

substitute:

Teriparatide

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen

Injection

Teriparatide Lupin

GQ

MP

C12270 C12492

P12270 P12492

1

5

 

1

 

 

Teriparatide

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen

Injection

Teriparatide Lupin

GQ

MP

C15536

P15536

2

2

 

1

 

 

Teriparatide

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen

Injection

Terrosa

FX

MP

C12270 C12492

P12270 P12492

1

5

 

1

 

 

Teriparatide

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen

Injection

Terrosa

FX

MP

C15536

P15536

2

2

 

1

 

 

  1.            Schedule 1, Part 1, entry for Testosterone in the form Transdermal cream 50 mg per mL, 50 mL

substitute:

Testosterone

Transdermal cream 50 mg per mL, 50 mL

Transdermal

AndroForte 5

LX

MP

C11838 C11891 C11947 C11962 C11963

P11838 P11891 P11947 P11962 P11963

1

1

 

1

 

 

Testosterone

Transdermal cream 50 mg per mL, 50 mL

Transdermal

AndroForte 5

LX

MP

C15622 C15623 C15654 C15739 C15756

P15622 P15623 P15654 P15739 P15756

2

1

 

1

 

 

  1.            Schedule 1, Part 1, entries for Tetrabenazine

substitute:

Tetrabenazine

Tablet 25 mg

Oral

iNova Pharmaceuticals (Australia) Pty Ltd

IL

MP NP

C5340

P5340

112

5

 

112

 

 

Tetrabenazine

Tablet 25 mg

Oral

iNova Pharmaceuticals (Australia) Pty Ltd

IL

MP NP

C15673

P15673

224

5

 

112

 

 

Tetrabenazine

Tablet 25 mg

Oral

Tetrabenazine SUN

RA

MP NP

C5340

P5340

112

5

 

112

 

 

Tetrabenazine

Tablet 25 mg

Oral

Tetrabenazine SUN

RA

MP NP

C15673

P15673

224

5

 

112

 

 

  1.            Schedule 1, Part 1, entries for Thalidomide

substitute:

Thalidomide

Capsule 50 mg

Oral

Thalomid

CJ

MP

C5914 C9290

 

112

0

 

28

 

D(100)

Thalidomide

Capsule 100 mg

Oral

Thalomid

CJ

MP

C5914 C9290

 

56

0

 

28

 

D(100)

  1.            Schedule 1, Part 1, entries for Tiotropium

substitute:

Tiotropium

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

Inhalation by mouth

Braltus

TB

MP NP

C6352

P6352

30

5

 

30

 

 

Tiotropium

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

Inhalation by mouth

Braltus

TB

MP NP

C15611

P15611

60

5

 

30

 

 

Tiotropium

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

Inhalation by mouth

Spiriva

BY

MP NP

C6352

P6352

30

5

 

30

 

 

Tiotropium

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

Inhalation by mouth

Spiriva

BY

MP NP

C15611

P15611

60

5

 

30

 

 

Tiotropium

Capsule containing powder for oral inhalation 1 micrograms (as bromide monohydrate) (for use in LupinHaler)

Inhalation by mouth

Tiotropium Lupin

GQ

MP NP

C6352

P6352

30

5

 

30

 

 

Tiotropium

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)

Inhalation by mouth

Tiotropium Lupin

GQ

MP NP

C15611

P15611

60

5

 

30

 

 

Tiotropium

Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations)

Inhalation by mouth

Spiriva Respimat

BY

MP NP

C5509 C8606 C12599

P5509 P8606 P12599

1

5

 

1

 

 

Tiotropium

Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations)

Inhalation by mouth

Spiriva Respimat

BY

MP NP

C15566 C15753 C15754

P15566 P15753 P15754

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Tiotropium with olodaterol

substitute:

Tiotropium with olodaterol

Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses

Inhalation by mouth

Spiolto Respimat

BY

MP NP

C7798

P7798

1

5

 

1

 

 

Tiotropium with olodaterol

Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses

Inhalation by mouth

Spiolto Respimat

BY

MP NP

C15691

P15691

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Tocilizumab in the form Concentrate for injection 80 mg in 4 mL

substitute:

Tocilizumab

Concentrate for injection 80 mg in 4 mL

Injection

Actemra

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

PB(100)

  1.            Schedule 1, Part 1, entries for Tocilizumab in the form Concentrate for injection 200 mg in 10 mL

substitute:

Tocilizumab

Concentrate for injection 200 mg in 10 mL

Injection

Actemra

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

PB(100)

  1.            Schedule 1, Part 1, entries for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL

substitute:

Tocilizumab

Concentrate for injection 400 mg in 20 mL

Injection

Actemra

RO

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

PB(100)

  1.            Schedule 1, Part 1, after entry for Topiramate in the form Tablet 25 mg [Brand: Topiramate Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Topiramate

Tablet 25 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C5325 C5516

P5325 P5516

60

5

 

60

 

 

Topiramate

Tablet 25 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C14901 C14973

P14901 P14973

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Topiramate in the form Tablet 50 mg [Brand: Topiramate Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Topiramate

Tablet 50 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C5325 C5516

P5325 P5516

60

5

 

60

 

 

Topiramate

Tablet 50 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C14901 C14973

P14901 P14973

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Topiramate in the form Tablet 100 mg [Brand: Topiramate Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Topiramate

Tablet 100 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C5325 C5516

P5325 P5516

60

5

 

60

 

 

Topiramate

Tablet 100 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C14901 C14973

P14901 P14973

120

5

 

60

 

 

  1.            Schedule 1, Part 1, after entry for Topiramate in the form Tablet 200 mg [Brand: Topiramate Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Topiramate

Tablet 200 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C5516

P5516

60

5

 

60

 

 

Topiramate

Tablet 200 mg

Oral

TOPIRAMATE-WGR

WG

MP NP

C14973

P14973

120

5

 

60

 

 

  1.            Schedule 1, Part 1, entries for Trabectedin

substitute:

Trabectedin

Powder for I.V. infusion 1 mg

Injection

Yondelis

ZL

MP

C14196

P14196

See Note 3

See Note 3

 

1

 

D(100)

Trabectedin

Powder for I.V. infusion 1 mg

Injection

Yondelis

ZL

MP

C14197

P14197

See Note 3

See Note 3

 

1

 

D(100)

  1.            Schedule 1, Part 1, entries for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

substitute:

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

APO-Tramadol

TX

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

APO-Tramadol

TX

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

APO-Tramadol

TX

PDP

C10768

P10768

20

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramadol Sandoz

SZ

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramadol Sandoz

SZ

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramadol Sandoz

SZ

PDP

C10768

P10768

20

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

TRAMADOL-WGR

WG

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

TRAMADOL-WGR

WG

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

TRAMADOL-WGR

WG

PDP

C10768

P10768

20

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramal

CS

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramal

CS

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramal

CS

PDP

C10768

P10768

20

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramedo

AF

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramedo

AF

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Tramedo

AF

PDP

C10768

P10768

20

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Zydol

RW

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Zydol

RW

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

Zydol

RW

PDP

C10768

P10768

20

0

 

20

 

 

  1.            Schedule 1, Part 1, after entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg [Brand: Tramadol SR generichealth]

insert:

Tramadol

Tablet (sustained release) containing tramadol hydrochloride 100 mg

Oral

TRAMADOL-WGR SR

WG

MP NP

C10748 C10752 C10755

 

20

0

V10748 V10752 V10755

20

 

 

  1.            Schedule 1, Part 1, after entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg [Brand: Tramadol SR generichealth]

insert:

Tramadol

Tablet (sustained release) containing tramadol hydrochloride 150 mg

Oral

TRAMADOL-WGR SR

WG

MP NP

C10748 C10752 C10755

 

20

0

V10748 V10752 V10755

20

 

 

  1.            Schedule 1, Part 1, after entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg [Brand: Tramadol SR generichealth]

insert:

Tramadol

Tablet (sustained release) containing tramadol hydrochloride 200 mg

Oral

TRAMADOL-WGR SR

WG

MP NP

C10748 C10752 C10755

 

20

0

V10748 V10752 V10755

20

 

 

  1.            Schedule 1, Part 1, after entry for Tranylcypromine

insert:

Tranylcypromine

Tablet 10 mg (as sulfate)

Oral

Parnate

GH

MP

 

P14238

100

1

 

50

 

 

  1.            Schedule 1, Part 1, entry for Trastuzumab

substitute:

Trastuzumab

Powder for I.V. infusion 60 mg

Injection

Trazimera

PF

MP

C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831

 

See Note 3

See Note 3

V15820 V15831

1

 

PB(100)

Trastuzumab

Powder for I.V. infusion 150 mg

Injection

Herzuma

EW

MP

C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831

 

See Note 3

See Note 3

V15820 V15831

1

 

PB(100)

Trastuzumab

Powder for I.V. infusion 150 mg

Injection

Kanjinti

JU

MP

C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831

 

See Note 3

See Note 3

V15820 V15831

1

 

PB(100)

Trastuzumab

Powder for I.V. infusion 150 mg

Injection

Ogivri

SZ

MP

C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831

 

See Note 3

See Note 3

V15820 V15831

1

 

PB(100)

Trastuzumab

Powder for I.V. infusion 150 mg

Injection

Trazimera

PF

MP

C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831

 

See Note 3

See Note 3

V15820 V15831

1

 

PB(100)

Trastuzumab

Powder for I.V. infusion 420 mg

Injection

Kanjinti

JU

MP

C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831

 

See Note 3

See Note 3

V15820 V15831

1

 

PB(100)

Trastuzumab

Powder for I.V. infusion 440 mg with diluent

Injection

Herzuma

EW

MP

C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831

 

See Note 3

See Note 3

V15820 V15831

1

 

PB(100)

Trastuzumab

Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL

Injection

Herceptin SC

RO

MP

C9353

P9353

1

0

 

1

 

 

Trastuzumab

Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL

Injection

Herceptin SC

RO

MP

C9462 C10212

P9462 P10212

1

3

 

1

 

 

  1.            Schedule 1, Part 1, entry for Trastuzumab deruxtecan

substitute:

Trastuzumab deruxtecan

Powder for I.V. infusion 100 mg

Injection

Enhertu

AP

MP

C15826 C15832

 

See Note 3

See Note 3

V15826 V15832

1

 

D(100)

  1.            Schedule 1, Part 1, entries forTrastuzumab emtansine

substitute:

Trastuzumab emtansine

Powder for I.V. infusion 100 mg

Injection

Kadcyla

RO

MP

C15818 C15819 C15827 C15828

 

See Note 3

See Note 3

V15818 V15819 V15827 V15828

1

 

D(100)

Trastuzumab emtansine

Powder for I.V. infusion 160 mg

Injection

Kadcyla

RO

MP

C15818 C15819 C15827 C15828

 

See Note 3

See Note 3

V15818 V15819 V15827 V15828

1

 

D(100)

  1.            Schedule 1, Part 1, entries for Travoprost

substitute:

Travoprost

Eye drops 40 micrograms per mL, 2.5 mL

Application to the eye

Travatan

NV

MP AO

 

 

1

5

 

1

 

 

Travoprost

Eye drops 40 micrograms per mL, 2.5 mL

Application to the eye

Travatan

NV

MP AO

 

P14238

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entries for Travoprost with timolol

substitute:

Travoprost with timolol

Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Duotrav

NV

AO

C5038

P5038

1

5

 

1

 

 

Travoprost with timolol

Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Duotrav

NV

MP

C4343

P4343

1

5

 

1

 

 

Travoprost with timolol

Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Duotrav

NV

MP AO

C15558

P15558

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Triglycerides, long chain with glucose polymer

omit:

Triglycerides, long chain with glucose polymer

Oral liquid 250 mL, 18 (ProZero)

Oral

ProZero

VF

MP NP

C4438


 

6

5


 

1


 


 

  1.            Schedule 1, Part 1, after entry for Trimethoprim in the form Tablet 300 mg [Brand: Trimethoprim Viatris; Maximum Quantity: 28; Number of Repeats: 0]

insert:

Trimethoprim

Tablet 300 mg

Oral

TRIMETHOPRIM-WGR

WG

MP NP

 

 

7

1

 

7

 

 

Trimethoprim

Tablet 300 mg

Oral

TRIMETHOPRIM-WGR

WG

MP

 

P4243

14
CN4243

2
CN4243

 

7

 

 

Trimethoprim

Tablet 300 mg

Oral

TRIMETHOPRIM-WGR

WG

MP

 

P6163

28

0

 

7

 

 

  1.            Schedule 1, Part 1, entry for Umeclidinium

substitute:

Umeclidinium

Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses

Inhalation by mouth

Incruse Ellipta

GK

MP NP

C4516

P4516

1

5

 

1

 

 

Umeclidinium

Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses

Inhalation by mouth

Incruse Ellipta

GK

MP NP

C15634

P15634

2

5

 

1

 

 

  1.            Schedule 1, Part 1, entry for Umeclidinium with vilanterol

substitute:

Umeclidinium with vilanterol

Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Anoro Ellipta 62.5/25

GK

MP NP

C7798

P7798

1

5

 

1

 

 

Umeclidinium with vilanterol

Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

Inhalation by mouth

Anoro Ellipta 62.5/25

GK

MP NP

C15691

P15691

2

5

 

1

 

 

  1.            Schedule 1, Part 1, after entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Brand: Valaciclovir SZ]

insert:

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

VALACICLOVIR-WGR

WG

MP NP

C5960

P5960

20

0

 

10

 

 

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

VALACICLOVIR-WGR

WG

MP NP

C5940 C5961

P5940 P5961

30

5

 

30

 

 

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

VALACICLOVIR-WGR

WG

MP NP

C5962 C5968

P5962 P5968

42

0

 

42

 

 

  1.            Schedule 1, Part 1, entry for Valganciclovir in the form Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL [Authorised Prescriber: MP; Maximum Quantity: 11; Number of Repeats: 5]

omit from the column headed “Circumstances”: C4989 C9316          substitute: C15782 C15784 C15800 C15814

  1.            Schedule 1, Part 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride) [Brand: Valganciclovir Sandoz; Authorised Prescriber: MP; Maximum Quantity: 120; Number of Repeats: 5]

omit from the column headed “Circumstances”: C4989 C9316          substitute: C15782 C15784 C15800 C15814

  1.            Schedule 1, Part 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride) [Brand: Valganciclovir Viatris; Authorised Prescriber: MP; Maximum Quantity: 120; Number of Repeats: 5]

omit from the column headed “Circumstances”: C4989 C9316           substitute: C15782 C15784 C15800 C15814

  1.            Schedule 1, Part 1, after entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride) [Brand: Elaxine SR 37.5]

insert:

Venlafaxine

Capsule (modified release) 37.5 mg (as hydrochloride)

Oral

VENLAFAXINE XR-WGR

WG

MP NP

C5650

 

28

0

 

28

 

 

  1.            Schedule 1, Part 1, entries for Venlafaxine in the form Capsule (modified release) 75 mg (as hydrochloride)

substitute:

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

APO-Venlafaxine XR

TX

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

APO-Venlafaxine XR

TX

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Efexor-XR

UJ

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Efexor-XR

UJ

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Elaxine SR 75

RW

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Elaxine SR 75

RW

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Enlafax-XR

AF

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Enlafax-XR

AF

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Sandoz Venlafaxine XR

HX

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Sandoz Venlafaxine XR

HX

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Venlafaxine generichealth XR

GQ

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

Venlafaxine generichealth XR

GQ

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

VENLAFAXINE XR-WGR

WG

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

Oral

VENLAFAXINE XR-WGR

WG

MP NP

C15553

P15553

56

2

 

28

 

 

  1.            Schedule 1, Part 1, entries for Venlafaxine in the form Capsule (modified release) 150 mg (as hydrochloride)

substitute:

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

APO-Venlafaxine XR

TX

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

APO-Venlafaxine XR

TX

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Efexor-XR

UJ

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Efexor-XR

UJ

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Elaxine SR 150

RW

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Elaxine SR 150

RW

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Enlafax-XR

AF

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Enlafax-XR

AF

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Sandoz Venlafaxine XR

HX

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Sandoz Venlafaxine XR

HX

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Venlafaxine generichealth XR

GQ

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

Venlafaxine generichealth XR

GQ

MP NP

C15553

P15553

56

2

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

VENLAFAXINE XR-WGR

WG

MP NP

C5650

P5650

28

5

 

28

 

 

Venlafaxine

Capsule (modified release) 150 mg (as hydrochloride)

Oral

VENLAFAXINE XR-WGR

WG

MP NP

C15553

P15553

56

2

 

28

 

 

 

  1.            Schedule 1, Part 2, omit entry for Bisacodyl
  2.            Schedule 1, Part 2, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
    •                            insert:

Budesonide with formoterol

Pressurised inhalation containing budesonide 50 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 50/3

AP

1

 

 

  1.            Schedule 1, Part 2, omit entry for Ketoconazole
  2.            Schedule 1, Part 2, after entry for Somatropin
    •                            insert:

Triglycerides, long chain with glucose polymer

Oral liquid 250 mL, 18 (ProZero)

Oral

ProZero

VF

1

 

 

  1.            Schedule 3 after details relevant for Responsible Person code FQ
    •                            insert:

FT

AMICUS THERAPEUTICS PTY LTD

87 621 776 476

  1.            Schedule 3
    •                            omit:

JB

Apotex Pty Ltd

52 096 916 148

  1.            Schedule 3 after details relevant for Responsible Person code WA
    •                            insert:

WG

WAGNER PHARMACEUTICALS PTY LTD

48 670 339 867

  1.            Schedule 3
    •                            omit:

ZP

Medis Pharma Pty Ltd

67 109 225 747

  1.            Schedule 4, Part 1, entry for Circumstances Code “C4389”

omit from the column headed “Listed Drug”: Fosinopril with hydrochlorothiazide

  1.            Schedule 4, Part 1, omit entry for Circumstances Code “C4894”
  2.            Schedule 4, Part 1, omit entry for Circumstances Code “C4972”
  3.            Schedule 4, Part 1, omit entry for Circumstances Code “C4989”
  4.            Schedule 4, Part 1, omit entry for Circumstances Code “C4999”
  5.            Schedule 4, Part 1, omit entry for Circumstances Code “C5713”
  6.            Schedule 4, Part 1, omit entry for Circumstances Code “C6073”
  7.            Schedule 4, Part 1, omit entry for Circumstances Code “C6079”
  8.            Schedule 4, Part 1, omit entry for Circumstances Code “C6097”
  9.            Schedule 4, Part 1, omit entry for Circumstances Code “C6098”
  10.            Schedule 4, Part 1, omit entry for Circumstances Code “C6120”
  11.            Schedule 4, Part 1, omit entry for Circumstances Code “C6153”
  12.            Schedule 4, Part 1, omit entry for Circumstances Code “C6185”
  13.            Schedule 4, Part 1, omit entry for Circumstances Code “C6732”
  14.            Schedule 4, Part 1, omit entry for Circumstances Code “C7345”
  15.            Schedule 4, Part 1, entry for Circumstances Code “C7346”

insert in alphabetical order in the column headed “Listed Drug”: Ceritinib

  1.            Schedule 4, Part 1, omit entry for Circumstances Code “C7369”
  2.            Schedule 4, Part 1, omit entry for Circumstances Code “C7631”
  3.            Schedule 4, Part 1, omit entry for Circumstances Code “C7640”
  4.            Schedule 4, Part 1, omit entry for Circumstances Code “C9316”
  5.            Schedule 4, Part 1, omit entry for Circumstances Code “C9404”
  6.            Schedule 4, Part 1, omit entry for Circumstances Code “C9526”
  7.            Schedule 4, Part 1, omit entry for Circumstances Code “C10293”
  8.            Schedule 4, Part 1, omit entry for Circumstances Code “C10295”
  9.            Schedule 4, Part 1, omit entry for Circumstances Code “C10296”
  10.            Schedule 4, Part 1, omit entry for Circumstances Code “C10384”
  11.            Schedule 4, Part 1, omit entry for Circumstances Code “C11880”
  12.            Schedule 4, Part 1, omit entry for Circumstances Code “C12272”
  13.            Schedule 4, Part 1, omit entry for Circumstances Code “C12273”
  14.            Schedule 4, Part 1, omit entry for Circumstances Code “C12306”
  15.            Schedule 4, Part 1, omit entry for Circumstances Code “C12315”
  16.            Schedule 4, Part 1, omit entry for Circumstances Code “C12980”
  17.            Schedule 4, Part 1, omit entry for Circumstances Code “C12989”
  18.            Schedule 4, Part 1, omit entry for Circumstances Code “C13004”
  19.            Schedule 4, Part 1, omit entry for Circumstances Code “C13017”
  20.            Schedule 4, Part 1, omit entry for Circumstances Code “C13184”
  21.            Schedule 4, Part 1, entry for Circumstances Code “C13186”

insert in alphabetical order in the column headed “Listed Drug”: Entrectinib

  1.            Schedule 4, Part 1, omit entry for Circumstances Code “C13233”
  2.            Schedule 4, Part 1, omit entry for Circumstances Code “C13250”
  3.            Schedule 4, Part 1, omit entry for Circumstances Code “C13251”
  4.            Schedule 4, Part 1, omit entry for Circumstances Code “C13276”
  5.            Schedule 4, Part 1, omit entry for Circumstances Code “C13716”
  6.            Schedule 4, Part 1, omit entry for Circumstances Code “C14188”
  7.            Schedule 4, Part 1, entry for Circumstances Code “C14238”

omit entry for Circumstances Code “C14238” and substitute:

C14238

P14238

CN14238

Acarbose

Allopurinol

Amlodipine

Amlodipine with atorvastatin

Atenolol

Atorvastatin

Baclofen

Beclometasone

Betaxolol

Bimatoprost

Brimonidine

Brinzolamide

Budesonide

Candesartan

Carbamazepine

Carbimazole

Chlortalidone

Ciclesonide

Ciclosporin

Clonidine

Clopidogrel

Clopidogrel with aspirin

Colestyramine

Cortisone

Cyproterone

Dexamethasone

Diltiazem

Dorzolamide

Enalapril

Eprosartan

Estradiol

Estradiol and estradiol with dydrogesterone

Estradiol and estradiol with norethisterone

Estradiol with norethisterone

Estriol

Ethosuximide

Everolimus

Felodipine

Fenofibrate

Fluticasone furoate

Fluticasone propionate

Fluvastatin

Furosemide

Gemfibrozil

Glibenclamide

Gliclazide

Glimepiride

Glipizide

Glyceryl trinitrate

Hydrochlorothiazide

Hydrochlorothiazide with amiloride

Hydrocortisone

Indapamide

Irbesartan

Isosorbide dinitrate

Isosorbide mononitrate

Labetalol

Latanoprost

Lercanidipine

Levodopa with benserazide

Levodopa with carbidopa

Lisinopril

Medroxyprogesterone

Metformin

Methenamine

Methotrexate

Metoprolol

Mycophenolic acid

Nicorandil

Nifedipine

Nizatidine

Norethisterone

Olmesartan

Pancreatic extract

Paraffin

Penicillamine

Perindopril

Perindopril with indapamide

Phenytoin

Pilocarpine

Pizotifen

Potassium chloride

Potassium chloride with potassium bicarbonate

Pravastatin

Prazosin

Prednisolone

Prednisone

Probenecid

Propranolol

Propylthiouracil

Pyridostigmine

Ramipril

Rosuvastatin

Simvastatin

Sirolimus

Sodium bicarbonate

Spironolactone

Sulfasalazine

Sulthiame

Tacrolimus

Telmisartan

Toremifene

Trandolapril

Tranylcypromine

Travoprost

Valproic acid

Valsartan

Verapamil

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

  1.            Schedule 4, Part 1, omit entry for Circumstances Code “C14470”
  2.            Schedule 4, Part 1, omit entry for Circumstances Code “C15249”
  3.            Schedule 4, Part 1, entry for Circumstances Code “C15261”

omit entry for Circumstances Code “C15261” and substitute:

C15261

P15261

CN15261

Alogliptin

Linagliptin

Saxagliptin

Sitagliptin

Vildagliptin

Diabetes mellitus type 2

The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND

The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin.

Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.

Compliance with Authority Required procedures - Streamlined Authority Code 15261

  1.            Schedule 4, Part 1, omit entry for Circumstances Code “C15279”
  2.            Schedule 4, Part 1, omit entry for Circumstances Code “C15280”
  3.            Schedule 4, Part 1, omit entry for Circumstances Code “C15295”
  4.            Schedule 4, Part 1, omit entry for Circumstances Code “C15296”
  5.            Schedule 4, Part 1, omit entry for Circumstances Code “C15307”
  6.            Schedule 4, Part 1, omit entry for Circumstances Code “C15309”
  7.            Schedule 4, Part 1, omit entry for Circumstances Code “C15316”
  8.            Schedule 4, Part 1, omit entry for Circumstances Code “C15317”
  9.            Schedule 4, Part 1, omit entry for Circumstances Code “C15319”
  10.            Schedule 4, Part 1, omit entry for Circumstances Code “C15325”
  11.            Schedule 4, Part 1, omit entry for Circumstances Code “C15328”
  12.            Schedule 4, Part 1, after entry for Circumstances Code “C15527”
    •                            insert:

C15530

P15530

CN15530

Esomeprazole

Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

Gastro-oesophageal reflux disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor.

Compliance with Authority Required procedures - Streamlined Authority Code 15530

C15531

P15531

CN15531

Esomeprazole

Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

Complex gastro-oesophageal reflux disease (GORD)

One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Must be treated by a gastroenterologist; OR

Must be treated by a surgeon with expertise in the upper gastrointestinal tract; OR

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist's name documented in the patient's medical records for auditing purposes; OR

Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist's name documented in the patient's medical records for auditing purposes.

The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND

Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR

Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR

Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR

Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.

Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.

Compliance with Authority Required procedures

C15535

P15535

CN15535

Bisacodyl

Terminal malignant neoplasia

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must identify as Aboriginal or Torres Strait Islander.

 

C15536

P15536

CN15536

Teriparatide

Severe established osteoporosis

Continuing treatment

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously been issued with an authority prescription for this drug; AND

The treatment must not exceed a lifetime maximum of 18 months therapy.

Must be treated by a specialist; OR

Must be treated by a consultant physician.

Compliance with Authority Required procedures - Streamlined Authority Code 15536

C15539

P15539

CN15539

Macrogol 3350

Chronic constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be inadequately controlled with first line interventions such as bulk-forming agents.

 

C15542

P15542

CN15542

Apomorphine

Parkinson disease

Maintenance therapy

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND

Patient must have been commenced on treatment in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 15542

C15543

P15543

CN15543

Beclometasone with formoterol and glycopyrronium

Budesonide with glycopyrronium and formoterol

Fluticasone furoate with umeclidinium and vilanterol

Chronic obstructive pulmonary disease (COPD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; OR

Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition.

Patient must not be undergoing treatment with this product in each of the following circumstances: (i) treatment of asthma in the absence of a COPD diagnosis, (ii) initiation of bronchodilator therapy in COPD, (iii) use as reliever therapy for asthma, (iv) dosed at an interval/frequency that differs to that recommended in the approved Product Information.

Compliance with Authority Required procedures - Streamlined Authority Code 15543

C15546

P15546

CN15546

Fluticasone furoate with vilanterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 15546

C15548

P15548

CN15548

Budesonide with formoterol

Fluticasone furoate with vilanterol

Fluticasone propionate with salmeterol

Chronic obstructive pulmonary disease (COPD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND

Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.

Compliance with Authority Required procedures - Streamlined Authority Code 15548

C15550

P15550

CN15550

Escitalopram

Moderate to severe generalised anxiety disorder (GAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must have been assessed by a psychiatrist.

 

C15551

P15551

CN15551

Escitalopram

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.

 

C15553

P15553

CN15553

Desvenlafaxine

Mirtazapine

Moclobemide

Reboxetine

Venlafaxine

Major depressive disorders

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15556

P15556

CN15556

Carbomer

Hypromellose

Hypromellose with dextran

Polyethylene glycol 400 with propylene glycol

Severe dry eye syndrome

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15558

P15558

CN15558

Bimatoprost with timolol

Brimonidine with timolol

Brinzolamide with brimonidine

Brinzolamide with timolol

Dorzolamide with timolol

Latanoprost with timolol

Travoprost with timolol

Elevated intra-ocular pressure

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must have been inadequately controlled with monotherapy; AND

Patient must have open-angle glaucoma; OR

Patient must have ocular hypertension.

 

C15559

P15559

CN15559

Carbomer

Carmellose

Hyaluronic acid

Hypromellose

Paraffin

Perfluorohexyloctane

Polyethylene glycol 400 with propylene glycol

Soy lecithin

Severe dry eye syndrome

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures - Streamlined Authority Code 15559

C15560

P15560

CN15560

Carbomer

Carmellose

Carmellose with glycerin

Hypromellose

Hypromellose with carbomer 980

Hypromellose with dextran

Polyethylene glycol 400 with propylene glycol

Severe dry eye syndrome

 

C15564

P15564

CN15564

Levodopa with carbidopa and entacapone

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be being treated with levodopa decarboxylase inhibitor combinations; AND

Patient must be experiencing fluctuations in motor function due to end-of-dose effect.

 

C15565

P15565

CN15565

Levodopa with carbidopa and entacapone

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be stabilised on concomitant treatment with levodopa decarboxylase inhibitor combinations and entacapone.

 

C15566

P15566

CN15566

Tiotropium

Severe asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND

The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.

Patient must be at least 18 years of age.

Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

 

C15568

P15568

CN15568

Pramipexole

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15570

P15570

CN15570

Pramipexole

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15572

P15572

CN15572

Bisacodyl

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Terminal malignant neoplasia

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15574

P15574

CN15574

Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

Gastro-oesophageal reflux disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15575

P15575

CN15575

Omeprazole

Pantoprazole

Zollinger-Ellison syndrome

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15577

P15577

CN15577

Budesonide with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition.

Must be treated by a respiratory physician; OR

Must be treated by a paediatrician.

Compliance with Authority Required procedures - Streamlined Authority Code 15577

C15578

P15578

CN15578

Budesonide

Severe chronic asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must require long-term steroid therapy; AND

Patient must not be able to use other forms of inhaled steroid therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 15578

C15580

P15580

CN15580

Mianserin

Severe depression

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15582

P15582

CN15582

Fluoxetine

Fluvoxamine

Paroxetine

Sertraline

Obsessive-compulsive disorder

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15583

P15583

CN15583

Sertraline

Panic disorder

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must be for use when other treatments have failed; OR

The treatment must be for use when other treatments are inappropriate.

 

C15585

P15585

CN15585

Bisacodyl

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function.

 

C15586

P15586

CN15586

Bisacodyl

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be receiving palliative care.

 

C15587

P15587

CN15587

Bisacodyl

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.

Patient must identify as Aboriginal or Torres Strait Islander.

 

C15593

P15593

CN15593

Macrogol 3350

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be receiving palliative care.

 

C15596

P15596

CN15596

Doxycycline

Bronchiectasis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must be aged 8 years or older.

 

C15599

P15599

CN15599

Beclometasone with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.

Patient must be at least 18 years of age.

Compliance with Authority Required procedures - Streamlined Authority Code 15599

C15600

P15600

CN15600

Beclometasone

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug

 

C15601

P15601

CN15601

Fluticasone furoate with umeclidinium and vilanterol

Indacaterol with glycopyrronium and mometasone

Severe asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique.

Patient must be at least 18 years of age.

Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.

Compliance with Authority Required procedures - Streamlined Authority Code 15601

C15602

P15602

CN15602

Entacapone

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND

Patient must be experiencing fluctuations in motor function due to end-of-dose effect.

 

C15604

P15604

CN15604

Fluticasone propionate with salmeterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 4 years or older.

Compliance with Authority Required procedures - Streamlined Authority Code 15604

C15606

P15606

CN15606

Escitalopram

Moderate to severe generalised anxiety disorder (GAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.

 

C15607

P15607

CN15607

Formoterol

Salmeterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must experience frequent episodes of the condition; AND

Patient must be currently receiving treatment with oral corticosteroids; OR

Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.

 

C15608

P15608

CN15608

Levodopa with carbidopa

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be one in which fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor.

 

C15611

P15611

CN15611

Tiotropium

Chronic obstructive pulmonary disease (COPD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15615

P15615

CN15615

Budesonide with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 15615

C15617

P15617

CN15617

Budesonide with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Compliance with Authority Required procedures - Streamlined Authority Code 15617

C15622

P15622

CN15622

Testosterone

Androgen deficiency

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have an established pituitary or testicular disorder.

Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.

The treatment must be applied to the scrotum area.

The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

C15623

P15623

CN15623

Testosterone

Pubertal induction

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must be under 18 years of age.

Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.

The treatment must be applied to the scrotum area.

The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

C15624

P15624

CN15624

Eprosartan with hydrochlorothiazide

Hypertension

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must not be for the initiation of anti-hypertensive therapy; AND

The condition must be inadequately controlled with an angiotensin II antagonist; OR

The condition must be inadequately controlled with a thiazide diuretic.

 

C15625

P15625

CN15625

Doxycycline

Severe acne

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15629

P15629

CN15629

Bisacodyl

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.

 

C15633

P15633

CN15633

Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

Scleroderma oesophagus

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15634

P15634

CN15634

Aclidinium

Glycopyrronium

Umeclidinium

Chronic obstructive pulmonary disease (COPD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15635

P15635

CN15635

Fluticasone propionate with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 15635

C15636

P15636

CN15636

Cabergoline

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15639

P15639

CN15639

Escitalopram

Major depressive disorders

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15640

P15640

CN15640

Carmellose

Carmellose with glycerin

Hypromellose with carbomer 980

Severe dry eye syndrome

Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements.

 

C15642

P15642

CN15642

Montelukast

Asthma

First-line prevention

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must be aged 2 to 5 years inclusive.

The condition must be frequent intermittent; OR

The condition must be mild persistent; AND

The treatment must be the single preventer agent; AND

The treatment must be an alternative to sodium cromoglycate; OR

The treatment must be an alternative to nedocromil sodium.

Compliance with Authority Required procedures - Streamlined Authority Code 15642

C15643

P15643

CN15643

Montelukast

Asthma

First-line prevention

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be frequent intermittent; OR

The condition must be mild persistent; AND

The treatment must be the single preventer agent; AND

The treatment must be an alternative to sodium cromoglycate; OR

The treatment must be an alternative to nedocromil sodium.

Patient must be aged 6 to 14 years inclusive.

Compliance with Authority Required procedures - Streamlined Authority Code 15643

C15644

P15644

CN15644

Montelukast

Asthma

Prevention of condition

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be exercise-induced; AND

The treatment must be as an alternative to adding salmeterol xinafoate; OR

The treatment must be an alternative to adding formoterol fumarate; AND

The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND

Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms.

Patient must be aged 6 to 14 years inclusive.

Compliance with Authority Required procedures - Streamlined Authority Code 15644

C15648

C15648

CN15648

Rasagiline

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15649

P15649

CN15649

Rotigotine

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.

 

C15653

P15653

CN15653

Indacaterol with mometasone

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 15653

C15654

P15654

CN15654

Testosterone

Micropenis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must be under 18 years of age.

Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.

The treatment must be applied to the scrotum area.

The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

C15655

P15655

CN15655

Esomeprazole

Scleroderma oesophagus

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor.

Compliance with Authority Required procedures

C15656

P15656

CN15656

Beclometasone with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 18 years or older.

Compliance with Authority Required procedures - Streamlined Authority Code 15656

C15657

P15657

CN15657

Minocycline

Severe acne

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must not be responding to other tetracyclines.

 

C15658

P15658

CN15658

Esomeprazole

Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

Scleroderma oesophagus

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 15658

C15659

P15659

CN15659

Doxycycline

Chronic bronchitis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must be aged 8 years or older.

 

C15661

P15661

CN15661

Macrogol 3350

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND

The condition must be unresponsive to other oral therapies.

 

C15666

P15666

CN15666

Citalopram

Escitalopram

Fluoxetine

Fluvoxamine

Paroxetine

Sertraline

Major depressive disorders

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15669

P15669

CN15669

Escitalopram

Moderate to severe generalised anxiety disorder (GAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.

 

C15670

P15670

CN15670

Escitalopram

Moderate to severe generalised anxiety disorder (GAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must have been assessed by a psychiatrist.

 

C15673

P15673

CN15673

Tetrabenazine

Hyperkinetic extrapyramidal disorders

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 15673

C15675

P15675

CN15675

Rotigotine

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.

 

C15678

P15678

CN15678

Omeprazole

Pantoprazole

Zollinger-Ellison syndrome

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 15678

C15680

P15680

CN15680

Budesonide with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 15680

C15682

P15682

CN15682

Esomeprazole

Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Compliance with Authority Required procedures - Streamlined Authority Code 15682

C15686

P15686

CN15686

Doxycycline

Severe acne

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15688

P15688

PN15688

Macrogol 3350

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be receiving palliative care.

 

C15691

P15691

CN15691

Aclidinium with formoterol

Indacaterol with glycopyrronium

Tiotropium with olodaterol

Umeclidinium with vilanterol

Chronic obstructive pulmonary disease (COPD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); OR

Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); OR

Patient must have been stabilised on a combination of a LAMA and a LABA.

Compliance with Authority Required procedures - Streamlined Authority Code 15691

C15692

P15692

CN15692

Fluticasone furoate with vilanterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 15692

C15693

P15693

CN15693

Fluticasone propionate with salmeterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Compliance with Authority Required procedures - Streamlined Authority Code 15693

C15696

P15696

CN15696

Escitalopram

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must have been assessed by a psychiatrist.

 

C15698

P15698

CN15698

Escitalopram

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must have been assessed by a psychiatrist.

 

C15699

P15699

CN15699

Safinamide

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.

 

C15700

P15700

CN15700

Selegiline

Late stage Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.

 

C15702

P15702

CN15702

Budesonide with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist.

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 15702

C15704

P15704

CN15704

Esomeprazole

Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor.

Compliance with Authority Required procedures

C15705

P15705

CN15705

Esomeprazole

Complex gastro-oesophageal reflux disease (GORD)

One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Must be treated by a gastroenterologist; OR

Must be treated by a surgeon with expertise in the upper gastrointestinal tract.

The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND

Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR

Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR

Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR

Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.

Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.

Compliance with Authority Required procedures

C15707

P15707

CN15707

Bisacodyl

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Anorectal congenital abnormalities

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15708

P15708

CN15708

Bisacodyl

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.

Patient must identify as Aboriginal or Torres Strait Islander.

 

C15709

P15709

CN15709

Macrogol 3350

Faecal impaction

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be inadequately controlled with first line interventions such as bulk-forming agents.

 

C15710

P15710

CN15710

Erythromycin

Severe acne

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be one in which tetracycline therapy is inappropriate.

Compliance with Authority Required procedures - Streamlined Authority Code 15710

C15711

P15711

CN15711

Amantadine

Parkinson disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must not be drug induced.

 

C15714

P15714

CN15714

Fluticasone propionate with salmeterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Compliance with Authority Required procedures - Streamlined Authority Code 15714

C15715

P15715

CN15715

Fluticasone propionate with salmeterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.

Patient must be aged 4 years or older.

Compliance with Authority Required procedures - Streamlined Authority Code 15715

C15719

P15719

CN15719

Riluzole

Amyotrophic lateral sclerosis

Continuing treatment

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must be ambulatory; OR

Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND

Patient must not have undergone a tracheostomy; AND

Patient must not have experienced respiratory failure.

Compliance with Authority Required procedures

C15722

P15722

CN15722

Paroxetine

Panic disorder

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15726

P15726

CN15726

Bisacodyl

Anorectal congenital abnormalities

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must identify as Aboriginal or Torres Strait Islander.

 

C15727

P15727

CN15727

Bisacodyl

Megacolon

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must identify as Aboriginal or Torres Strait Islander.

 

C15729

P15729

CN15729

Macrogol 3350

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have malignant neoplasia.

 

C15730

P15730

CN15730

Macrogol 3350

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND

The condition must be unresponsive to other oral therapies.

 

C15734

P15734

CN15734

Bisacodyl

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.

 

C15735

P15735

CN15735

Bisacodyl

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Megacolon

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15736

P15736

CN15736

Indacaterol

Chronic obstructive pulmonary disease (COPD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15739

P15739

CN15739

Testosterone

Androgen deficiency

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must not have an established pituitary or testicular disorder; AND

The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs.

Patient must be aged 40 years or older.

Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.

The treatment must be applied to the scrotum area.

Androgen deficiency is defined as:

(i) testosterone level of less than 6 nmol per litre; OR

(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).

Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.

The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.

The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

C15745

P15745

CN15745

Macrogol 3350

Constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have malignant neoplasia.

 

C15746

P15746

CN15746

Macrogol 3350

Chronic constipation

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be inadequately controlled with first line interventions such as bulk-forming agents.

 

C15747

P15747

CN15747

Macrogol 3350

Faecal impaction

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be inadequately controlled with first line interventions such as bulk-forming agents.

 

C15751

P15751

CN15751

Escitalopram

Moderate to severe social anxiety disorder (social phobia, SAD)

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND

Patient must not have responded to non-pharmacological therapy; AND

Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.

 

C15753

P15753

CN15753

Tiotropium

Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease

Long-term maintenance treatment

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

 

C15754

P15754

CN15754

Tiotropium

Severe asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists.

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; OR

Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND

The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated.

Patient must be aged 6 to 17 years inclusive.

Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative

Compliance with Authority Required procedures - Streamlined Authority Code 15754

C15755

P15755

CN15755

Budesonide with formoterol

Asthma

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 15755

C15756

P15756

CN15756

Testosterone

Constitutional delay of growth or puberty

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

Patient must be under 18 years of age.

Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.

The treatment must be applied to the scrotum area.

The name of the specialist must be included in the authority application.

Compliance with Authority Required procedures

C15757

P15757

CN15757

Cabozantinib

Stage IV renal cell carcinoma (RCC)

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for maintenance treatment

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2024; AND

Patient must have had a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records if not already documented; AND

Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 15757

C15759

P15759

CN15759

Alectinib

Brigatinib

Ceritinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be as monotherapy; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.

Compliance with Authority Required procedures

C15764

P15764

CN15764

Adalimumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 1 (new patient)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR

Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR

Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND

Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must not receive more than 16 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient) or Initial 2 (recommencement of treatment) - balance of supply

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count; and

(iii) the name of the antibiotic/s received for two separate courses each of three months; or

(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.

Compliance with Written Authority Required procedures

C15765

P15765

CN15765

Adalimumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

Patient must not receive more than 16 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count.

Compliance with Written Authority Required procedures

C15767

P15767

C15767

Secukinumab

Moderate to severe hidradenitis suppurativa

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated a response to treatment with this drug for this condition.

Must be treated by a dermatologist.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

Compliance with Written Authority Required procedures

C15768

P15768

C15768

Secukinumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND

Patient must not receive more than 20 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count.

Details of two completed prescriptions should be submitted with every initial application for this drug.

One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.

This restriction is intended for induction dosing only.

Compliance with Written Authority Required procedures

C15772

P15772

CN15772

Budesonide

Mild to moderate Crohn disease

The condition must affect the ileum; OR

The condition must affect the ascending colon; OR

The condition must affect the ileum and ascending colon.

The total duration of therapy should be no more than 10 weeks in any single course.

Compliance with Authority Required procedures - Streamlined Authority Code 15772

C15774

P15774

CN15774

Cabozantinib

Stage IV renal cell carcinoma (RCC)

Initial treatment

The condition must be each of: (i) classified as having an intermediate to poor survival risk score according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), (ii) untreated with a tyrosine kinase inhibitor; OR

Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) despite treatment with a tyrosine kinase inhibitor, irrespective of the current IMDC survival risk score; AND

Patient must have a WHO performance status of 2 or less; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Patient must be undergoing treatment with this drug for the first time at the time of the first PBS prescription.

Compliance with Authority Required procedures - Streamlined Authority Code 15774

C15775

P15775

CN15775

Cabozantinib

Stage IV renal cell carcinoma (RCC)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 15775

C15776

C15776

CN15776

Crizotinib

Entrectinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND

Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR

Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.

Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.

If the application is submitted through HPOS form upload or mail, it must include:

(a) details of the proposed prescription; and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

The following must be documented in the patient's medical records:

(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

C15777

P15777

CN15777

Adalimumab

Moderate to severe hidradenitis suppurativa

First continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated a response to treatment with this drug for this condition.

Must be treated by a dermatologist.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

Compliance with Written Authority Required procedures

C15779

P15779

CN15779

Secukinumab

Moderate to severe hidradenitis suppurativa

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 June 2024; AND

Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug for this condition; AND

Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment if the patient has been treated with this drug for this condition for 16 weeks or longer; AND

Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; OR

Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; OR

Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Must be treated by a dermatologist.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Assessment of disease severity must not have been more than 4 weeks old at the time treatment with this drug was initiated.

The authority application must be made in writing and must include:

(a) details of the proposed prescription; and

(b) completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count; and

(iii) the name of the antibiotic/s received for two separate courses each of three months; or

(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics

(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 16 weeks or more of treatment.

A patient may qualify for PBS-subsidised treatment under this restriction once only.

For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Written Authority Required procedures

C15781

C15781

CN15781

Larotrectinib

Solid tumours with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion

Continuing treatment

Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing for solid tumours (of any type) with confirmed NTRK gene fusion where treatment with this drug is/was initiated in a child; OR

Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing for solid tumours (of certain specified types) with confirmed NTRK gene fusion which either includes: (i) mammary analogue secretory carcinoma of the salivary gland, (ii) secretory breast carcinoma.

The treatment must cease to be a PBS benefit upon radiographic progression; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Where radiographic progression is observed, mark any remaining repeat prescriptions with the word 'cancelled'.

Compliance with Authority Required procedures

C15782

P15782

CN15782

Ganciclovir

Valganciclovir

Cytomegalovirus infection and disease

Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 15782

C15784

P15784

CN15784

Ganciclovir

Valganciclovir

Cytomegalovirus infection and disease

Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 15784

C15787

P15787

CN15787

Migalastat

Fabry disease

Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)

Patient must have previously received treatment with this drug for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024; OR

Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024; AND

Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant prior to commencing treatment with this drug; AND

Patient must have/have had an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2prior to commencing treatment with this drug.

Must be treated by a physician with expertise in the management of Fabry disease.

Patient must be at least 12 years of age.

A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C15788

P15788

CN15788

Adalimumab

Moderate to severe hidradenitis suppurativa

Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment.

Must be treated by a dermatologist.

A maximum of 12 weeks of treatment will be authorised under this restriction.

Compliance with Authority Required procedures

C15795

P15795

CN15795

Adalimumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND

Patient must not receive more than 16 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count.

Compliance with Written Authority Required procedures

C15796

P15796

CN15796

Adalimumab

Moderate to severe hidradenitis suppurativa

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have demonstrated a response to treatment with this drug for this condition.

Must be treated by a dermatologist.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

Compliance with Written Authority Required procedures

C15797

P15797

CN15797

Adalimumab

Moderate to severe hidradenitis suppurativa

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated a response to treatment with this drug for this condition.

Must be treated by a dermatologist.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

Compliance with Written Authority Required procedures

C15799

P15799

CN15799

Secukinumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

Patient must not receive more than 20 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count.

Details of two completed prescriptions should be submitted with every initial application for this drug.

One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.

Compliance with Written Authority Required procedures

C15800

P15800

CN15800

Ganciclovir

Valganciclovir

Cytomegalovirus infection and disease

Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 15800

C15801

P15801

CN15801

Migalastat

Fabry disease

Continuing treatment

Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; AND

Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by migalastat.

Must be treated by a physician with expertise in the management of Fabry disease.

Compliance with Authority Required procedures

C15803

P15803

CN15803

Crizotinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.

Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.

If the application is submitted through HPOS form upload or mail, it must include:

(a) details of the proposed prescription; and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

The following must be documented in the patient's medical records:

(a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.

Compliance with Written Authority Required procedures

C15804

P15804

CN15804

Lorlatinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.

Compliance with Authority Required procedures

C15805

P15805

CN15805

Secukinumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

Patient must not receive more than 20 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count.

Details of two completed prescriptions should be submitted with every initial application for this drug.

One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.

This restriction is intended for induction dosing only.

Compliance with Written Authority Required procedures

C15806

P15806

CN15806

Secukinumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND

Patient must not receive more than 20 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

A response to treatment is defined as:

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count.

Details of two completed prescriptions should be submitted with every initial application for this drug.

One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.

Compliance with Written Authority Required procedures

C15807

P15807

CN15807

Secukinumab

Moderate to severe hidradenitis suppurativa

Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; OR

Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND

The treatment must provide no more than the balance of up to 20 weeks treatment.

Must be treated by a dermatologist.

Compliance with Authority Required procedures

C15808

P15808

CN15808

Migalastat

Fabry disease

Initial treatment

Patient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity; AND

Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant; AND

Patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2; AND

Patient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; OR

Patient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; OR

Patient must have Fabry-related cardiac disease confirmed by at least one of the following: (i) left ventricular hypertrophy, as evidenced by cardiac magnetic resonance imagining (MRI) or echocardiogram data, in the absence of hypertension, (ii) significant life-threatening arrhythmia or conduction defect, (iii) Late gadolinium enhancement or a low T1 on cardiac MRI; OR

Patient must have Fabry-related either: (i) ischaemic disease, (ii) cerebrovascular disease as shown on objective testing with no other cause or risk factors identified; OR

Patient must have Fabry-related uncontrolled chronic pain despite the use of recommended doses of appropriate analgesia and antiepileptic medications for peripheral neuropathy; OR

Patient must have significant Fabry-related gastrointestinal symptoms despite the use of the recommended doses of appropriate pharmacological therapies.

Must be treated by a physician with expertise in the management of Fabry disease.

Patient must be at least 12 years of age.

If hypertension is present in patients relying their eligibility on Fabry-related cardiac disease, the prescriber must treat it optimally for at least 6 months prior to submitting the first PBS authority application.

Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C15810

P15810

CN15810

Secukinumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 1 (new patient)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR

Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR

Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND

Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must not receive more than 20 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count; and

(iii) the name of the antibiotic/s received for two separate courses each of three months; or

(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.

The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.

Details of two completed prescriptions should be submitted with every initial application for this drug.

One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.

Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

C15812

P15812

CN15812

Secukinumab

Moderate to severe hidradenitis suppurativa

Initial treatment - Initial 1 (new patient)

Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND

Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR

Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR

Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND

Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must not receive more than 20 weeks of treatment under this restriction.

Must be treated by a dermatologist.

Assessment of disease severity must be no more than 4 weeks old at the time of application.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include:

(1) details of the proposed prescription(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:

(i) the Hurley stage grading; and

(ii) the AN count; and

(iii) the name of the antibiotic/s received for two separate courses each of three months; or

(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.

The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.

This restriction is intended for induction dosing only.

Details of two completed prescriptions should be submitted with every initial application for this drug.

One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.

Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

C15814

P15814

CN15814

Ganciclovir

Valganciclovir

Cytomegalovirus infection and disease

Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 15814

C15818

P15818

P15818

Trastuzumab emtansine

Early HER2 positive breast cancer

Initial adjuvant treatment

The treatment must be prescribed within 12 weeks after surgery; AND

Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND

Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.

Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:

(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.

The pathology report must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Written Authority Required procedures

C15819

P15819

P15819

Trastuzumab emtansine

Early HER2 positive breast cancer

Continuing adjuvant treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Authority Required procedures

C15820

P15820

CN15820

Trastuzumab

Early HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

HER2 positivity must be demonstrated by in situ hybridisation (ISH).

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 15820

C15826

P15826

CN15826

Trastuzumab deruxtecan

Metastatic (Stage IV) HER2 positive breast cancer

Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND

The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; OR

The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND

Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only.

Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR

Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.

Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:

1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable).

2) Details of prior HER2 directed drug regimens prescribed for the patient.

3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable).

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Authority Required procedures

C15827

P15827

CN15827

Trastuzumab emtansine

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND

Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

The treatment must not exceed a lifetime total of one continuous course for this PBS indication.

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Authority Required procedures

C15828

P15828

CN15828

Trastuzumab emtansine

Metastatic (Stage IV) HER2 positive breast cancer

Initial treatment

Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND

The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR

The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND

Patient must have a WHO performance status of 0 or 1; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.

The following information must be provided by the prescriber at the time of application:

(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH).

(b) dates of treatment with trastuzumab and pertuzumab;

(c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or

(d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.

All reports must be documented in the patient's medical records.

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Authority Required procedures

C15831

P15831

CN15831

Trastuzumab

Early HER2 positive breast cancer

Initial treatment (weekly regimen)

Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

HER2 positivity must be demonstrated by in situ hybridisation (ISH).

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Authority Required procedures - Streamlined Authority Code 15831

C15832

P15832

CN15832

Trastuzumab deruxtecan

Unresectable and/or metastatic HER2-low breast cancer

Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease; AND

Patient must have received prior chemotherapy in the metastatic setting; OR

Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND

Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; AND

Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only.

Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR

Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.

HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH).

Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:

1) Evidence of HER2-low status

2) Details of prior drug regimens prescribed for the patient

3) Cardiac function test results

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.

Compliance with Authority Required procedures

  1.            Schedule 4, Part 2, after entry for Variation Code “V15457”
    •                            insert:

V15818

Trastuzumab emtansine

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15819

Trastuzumab emtansine

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15820

Trastuzumab

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15826

Trastuzumab deruxtecan

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15827

Trastuzumab emtansine

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15828

Trastuzumab emtansine

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15831

Trastuzumab

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15832

Trastuzumab deruxtecan

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

V15818

Trastuzumab emtansine

Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg

  1.            Schedule 5,

omit table and substitute:

Listed Drug

Schedule Equivalent Group

Form

Manner of Administration

Brand

Abacavir with lamivudine

GRP-21981

Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

Oral

ABACAVIR/LAMIVUDINE 600/300 SUN
Abacavir/Lamivudine Mylan
Abacavir/Lamivudine Viatris
Kivexa

Acalabrutinib

GRP-27509

Capsule 100 mg

Oral

Calquence

Acalabrutinib

GRP-27509

Tablet 100 mg

Oral

CALQUENCE

Acamprosate

GRP-22403

Tablet (enteric coated) containing acamprosate calcium 333 mg

Oral

ACAMPROSATE VIATRIS
ACAMPROSATE-WGR
APO-Acamprosate
Campral

Acarbose

GRP-20709

Tablet 100 mg

Oral

Acarbose Viatris
GLYBOSAY

Acarbose

GRP-20718

Tablet 50 mg

Oral

Acarbose Viatris
GLYBOSAY

Aciclovir

GRP-22959

Eye ointment 30 mg per g, 4.5 g

Application to the eye

ViruPOS
XOROX

Aciclovir

GRP-15446

Tablet 200 mg

Oral

ACICLOVIR-WGR
APO-Aciclovir
ARX-ACICLOVIR
Aciclovir APOTEX
Aciclovir GH
Aciclovir Sandoz

Aciclovir

GRP-19838

Tablet 800 mg

Oral

ACICLOVIR-WGR
APO-Aciclovir
ARX-ACICLOVIR
Aciclovir APOTEX
Aciclovir Sandoz

Acitretin

GRP-19579

Capsule 10 mg

Oral

Neotigason
ZETIN

Acitretin

GRP-19580

Capsule 25 mg

Oral

Neotigason
ZETIN

Adalimumab

GRP-25059

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

Adalimumab

GRP-25059

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Abrilada
Amgevita

Adalimumab

GRP- 25060

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip
Humira
Yuflyma

Adalimumab

GRP- 25060

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada
Amgevita
Hadlima
Hyrimoz
Idacio

Adalimumab

GRP- 25058

Injection 40 mg in 0.4 mL pre-filled syringe

Injection

Adalicip
Humira
Yuflyma

Adalimumab

GRP- 25058

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada
Amgevita
Hadlima
Hyrimoz
Idacio

Adefovir

GRP-28116

Tablet containing adefovir dipivoxil 10 mg

Oral

APO-Adefovir

Adefovir

GRP-28116

Tablet containing adefovir dipivoxil 10 mg (S19A)

Oral

Adefovir Dipivoxil Tablets 10 mg (SigmaPharm Laboratories)

Adrenaline (epinephrine)

GRP-22361

I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector

Injection

Adrenaline Viatris
Anapen 300
EpiPen

Adrenaline (epinephrine)

GRP-22391

I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector

Injection

Adrenaline Jr Viatris
Anapen Junior 150
EpiPen Jr.

Aflibercept

GRP-24277

Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)

Injection

Eylea

Aflibercept

GRP-24277

Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe

Injection

Eylea

Alendronic acid

GRP-19660

Tablet 70 mg (as alendronate sodium)

Oral

ALENDRONATE-WGR
APO-Alendronate
Alendronate Sandoz
Fonat

Allopurinol

GRP-15579

Tablet 100 mg

Oral

ALLOPURINOL-WGR
APO-ALLOPURINOL
Allopurinol APOTEX
Allopurinol Sandoz
Allosig
NOUMED ALLOPURINOL
Progout 100
Zyloprim

Allopurinol

GRP-19808

Tablet 300 mg

Oral

ALLOPURINOL-WGR
APO-ALLOPURINOL
Allopurinol APOTEX
Allopurinol Sandoz
Allosig
NOUMED ALLOPURINOL
Progout 300
Zyloprim

Alprazolam

GRP-21739

Tablet 500 micrograms

Oral

Alprax 0.5
Kalma 0.5

Alprazolam

GRP-21744

Tablet 1 mg

Oral

Alprax 1
Kalma 1

Amantadine

GRP-28296

Capsule containing amantadine hydrochloride 100 mg

Oral

AMANTAMED
Symmetrel 100

Ambrisentan

GRP-24436

Tablet 5 mg

Oral

Ambrisentan Viatris
Cipla Ambrisentan
PULMORIS
Volibris

Ambrisentan

GRP-24438

Tablet 10 mg

Oral

Ambrisentan Viatris
Cipla Ambrisentan
PULMORIS
Volibris

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

GRP-27823

Oral powder 400 g (Alfamino)

Oral

Alfamino

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

GRP-27823

Oral powder with 2'-fucosyllactose and lacto-N-neotetraose, 400 g (Alfamino)

Oral

Alfamino

Amiodarone

GRP-19644

Tablet containing amiodarone hydrochloride 100 mg

Oral

Aratac 100
Cordarone X 100

Amiodarone

GRP-19926

Tablet containing amiodarone hydrochloride 200 mg

Oral

APO-Amiodarone
Amdarone
Amiodarone Sandoz
Aratac 200
Cordarone X 200

Amisulpride

GRP-19672

Tablet 200 mg

Oral

AMISULPRIDE-WGR
APO-Amisulpride
Amisulpride Sandoz Pharma
Solian 200
Sulprix

Amisulpride

GRP-19732

Tablet 400 mg

Oral

AMISULPRIDE-WGR
APO-Amisulpride
Amipride 400
Amisulpride Sandoz Pharma
Solian 400
Sulprix

Amisulpride

GRP-19930

Tablet 100 mg

Oral

AMISULPRIDE-WGR
APO-Amisulpride
Amisulpride Sandoz Pharma
Solian 100
Sulprix

Amitriptyline

GRP-19959

Tablet containing amitriptyline hydrochloride 25 mg

Oral

AMITRIPTYLINE-WGR
APO-Amitriptyline 25
APX-Amitriptyline
Amitriptyline Lupin
Amitriptyline Viatris 25
ENTRIP
Endep 25

Amitriptyline

GRP-19960

Tablet containing amitriptyline hydrochloride 10 mg

Oral

AMITRIPTYLINE-WGR
APO-Amitriptyline 10
APX-Amitriptyline
Amitriptyline Lupin
Amitriptyline Viatris 10
ENTRIP
Endep 10

Amitriptyline

GRP-19962

Tablet containing amitriptyline hydrochloride 50 mg

Oral

APO-Amitriptyline 50
APX-Amitriptyline
Amitriptyline Lupin
Amitriptyline Viatris 50
ENTRIP
Endep 50

Amlodipine

GRP-19712

Tablet 5 mg (as besilate)

Oral

AMLODIPINE-WGR
APO-Amlodipine
APX-AMLODIPINE
Amlo 5
Amlodipine APOTEX
Amlodipine GH
Amlodipine Sandoz
Blooms Amlodipine
Blooms the Chemist Amlodipine
NOUMED AMLODIPINE
Nordip
Norvasc
Pharmacor Amlodipine

Amlodipine

GRP-19809

Tablet 10 mg (as besilate)

Oral

AMLODIPINE-WGR
APO-Amlodipine
Amlo 10
Amlodipine APOTEX
Amlodipine GH
Amlodipine Sandoz
Blooms Amlodipine
Blooms the Chemist Amlodipine
NOUMED AMLODIPINE
Nordip
Norvasc
Pharmacor Amlodipine

Amlodipine with atorvastatin

GRP-19632

Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

Oral

Cadivast 5/80
Caduet 5/80

Amlodipine with atorvastatin

GRP-19666

Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)

Oral

Cadivast 10/20
Caduet 10/20

Amlodipine with atorvastatin

GRP-19713

Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)

Oral

Cadivast 10/10
Caduet 10/10

Amlodipine with atorvastatin

GRP-19788

Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

Oral

Cadivast 5/40
Caduet 5/40

Amlodipine with atorvastatin

GRP-19849

Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

Oral

Cadivast 10/40
Caduet 10/40

Amlodipine with atorvastatin

GRP-19927

Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

Oral

Cadivast 10/80
Caduet 10/80

Amlodipine with valsartan

GRP-19839

Tablet 5 mg (as besilate)-80 mg

Oral

Amlodipine/Valsartan Novartis 5/80
Exforge 5/80

Amlodipine with valsartan

GRP-22201

Tablet 10 mg (as besilate)-160 mg

Oral

Amlodipine/Valsartan Novartis 10/160
Exforge 10/160

Amlodipine with valsartan

GRP-22208

Tablet 5 mg (as besilate)-320 mg

Oral

Amlodipine/Valsartan Novartis 5/320
Exforge 5/320

Amlodipine with valsartan

GRP-22209

Tablet 5 mg (as besilate)-160 mg

Oral

Amlodipine/Valsartan Novartis 5/160
Exforge 5/160

Amlodipine with valsartan

GRP-22211

Tablet 10 mg (as besilate)-320 mg

Oral

Amlodipine/Valsartan Novartis 10/320
Exforge 10/320

Amlodipine with valsartan and hydrochlorothiazide

GRP-19956

Tablet 5 mg (as besilate)-160 mg-12.5 mg

Oral

Amlodipine/Valsartan/HCT Novartis 5/160/12.5
Exforge HCT 5/160/12.5

Amlodipine with valsartan and hydrochlorothiazide

GRP-22202

Tablet 10 mg (as besilate)-160 mg-25 mg

Oral

Amlodipine/Valsartan/HCT Novartis 10/160/25
Exforge HCT 10/160/25

Amlodipine with valsartan and hydrochlorothiazide

GRP-22203

Tablet 10 mg (as besilate)-160 mg-12.5 mg

Oral

Amlodipine/Valsartan/HCT Novartis 10/160/12.5
Exforge HCT 10/160/12.5

Amlodipine with valsartan and hydrochlorothiazide

GRP-22204

Tablet 5 mg (as besilate)-160 mg-25 mg

Oral

Amlodipine/Valsartan/HCT Novartis 5/160/25
Exforge HCT 5/160/25

Amlodipine with valsartan and hydrochlorothiazide

GRP-22207

Tablet 10 mg (as besilate)-320 mg-25 mg

Oral

Amlodipine/Valsartan/HCT Novartis 10/320/25
Exforge HCT 10/320/25

Amoxicillin

GRP-19635

Tablet 1 g (as trihydrate)

Oral

Amoxycillin Sandoz
Maxamox

Amoxicillin

GRP-20061

Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

Oral

APO-Amoxycillin
Amoxil
NOUMED AMOXICILLIN

Amoxicillin

GRP-20029

Capsule 250 mg (as trihydrate)

Oral

AMILOXYN
APO-Amoxycillin
Alphamox 250
Amoxil
Cilamox

Amoxicillin

GRP-20241

Capsule 500 mg (as trihydrate)

Oral

AMILOXYN
AMOXICILLIN-WGR
APO-Amoxycillin
Alphamox 500
Amoxil
Amoxycillin Sandoz
Amoxycillin generichealth 500
Blooms The Chemist Amoxicillin
Cilamox
NOUMED AMOXICILLIN

Amoxicillin

GRP-26767

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Oral

AMOXICILLIN-WGR
APO-Amoxycillin
Amoxil Forte
Amoxycillin Sandoz
Cilamox
NOUMED AMOXICILLIN

Amoxicillin with clavulanic acid

GRP-20135

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMCLAVOX DUO 500/125
AMOXICILLIN/CLAVULANIC ACID-WGR 500/125
APO-AMOXY/CLAV 500/125
APO-Amoxycillin/ Clavulanic Acid 500/125
APX-Amoxicillin/Clavulanic Acid
AlphaClav Duo
Alphaclav Duo Viatris
Amoxycillin/Clavulanic Acid 500/125 APOTEX
Augmentin Duo
Curam Duo 500/125

Amoxicillin with clavulanic acid

GRP-26768

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

AMCLAVOX DUO FORTE 875/125
AMOXICILLIN/CLAVULANIC ACID-WGR 875/125
APO-AMOXY/CLAV 875/125
APO-Amoxycillin and Clavulanic Acid
APX-Amoxicillin/Clavulanic Acid
Alphaclav Duo Forte Viatris
AmoxyClav generichealth 875/125
Augmentin Duo forte
Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125
Curam Duo Forte 875/125

Amoxicillin with clavulanic acid

GRP-28006

Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

Oral

Augmentin Duo 400
Curam Duo

Amoxicillin with clavulanic acid

GRP-29087

Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 100 mL (S19A)

Oral

CLAVULIN-125F (GlaxoSmithKline, Canada)

Amoxicillin with clavulanic acid

GRP-29087

Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

Oral

Curam

Anastrozole

GRP-19931

Tablet 1 mg

Oral

ANASTROZOLE-WGR
APO-Anastrozole
Anastrozole GH
Anastrozole Sandoz
Arianna 1

Apomorphine

GRP-22998

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen

Injection

Apomine Intermittent
Movapo Pen

Aprepitant

GRP-23389

Capsule 165 mg

Oral

APREPITANT SCP
Aprepitant APOTEX

Aripiprazole

GRP-20893

Tablet 10 mg

Oral

APO-Aripiprazole
ARIPIPRAZOLE-WGR
ARIZOLE
Abilify
Abyraz
Aripiprazole GH
Aripiprazole Sandoz
Tevaripiprazole

Aripiprazole

GRP-20895

Tablet 15 mg

Oral

APO-Aripiprazole
ARIPIPRAZOLE-WGR
ARIZOLE
Abilify
Abyraz
Aripic Aripiprazole
Aripiprazole GH
Aripiprazole Sandoz
Tevaripiprazole

Aripiprazole

GRP-20908

Tablet 30 mg

Oral

APO-Aripiprazole
ARIPIPRAZOLE-WGR
ARIZOLE
Abilify
Abyraz
Aripic Aripiprazole
Aripiprazole GH
Aripiprazole Sandoz
Tevaripiprazole

Aripiprazole

GRP-20910

Tablet 20 mg

Oral

APO-Aripiprazole
ARIPIPRAZOLE-WGR
ARIZOLE
Abilify
Abyraz
Aripic Aripiprazole
Aripiprazole GH
Aripiprazole Sandoz
Tevaripiprazole

Atenolol

GRP-19895

Tablet 50 mg

Oral

APO-Atenolol
APX-Atenolol
ATENOLOL-WGR
Atenolol GH
Atenolol Sandoz
Blooms The Chemist Atenolol
Noten
Tenormin
Tensig

Atomoxetine

GRP-20889

Capsule 25 mg (as hydrochloride)

Oral

APO-Atomoxetine
Atomoxetine Sandoz

Atomoxetine

GRP-20897

Capsule 10 mg (as hydrochloride)

Oral

APO-Atomoxetine
Atomoxetine Sandoz

Atomoxetine

GRP-20900

Capsule 40 mg (as hydrochloride)

Oral

APO-Atomoxetine
Atomoxetine Sandoz

Atomoxetine

GRP-20901

Capsule 80 mg (as hydrochloride)

Oral

APO-Atomoxetine
Atomoxetine Sandoz

Atomoxetine

GRP-20902

Capsule 100 mg (as hydrochloride)

Oral

APO-Atomoxetine
Atomoxetine Sandoz

Atomoxetine

GRP-20903

Capsule 60 mg (as hydrochloride)

Oral

APO-Atomoxetine
Atomoxetine Sandoz

Atomoxetine

GRP-20905

Capsule 18 mg (as hydrochloride)

Oral

APO-Atomoxetine
Atomoxetine Sandoz

Atorvastatin

GRP-19975

Tablet 20 mg (as calcium)

Oral

APO-Atorvastatin
ATORVASTATIN-WGR
Atorvachol
Atorvastatin SZ
BTC Atorvastatin
Lipitor
Lorstat 20
NOUMED ATORVASTATIN
Pharmacor Atorvastatin
Trovas

Atorvastatin

GRP-19978

Tablet 10 mg (as calcium)

Oral

APO-Atorvastatin
ATORVASTATIN-WGR
Atorvachol
Atorvastatin SZ
BTC Atorvastatin
Lipitor
Lorstat 10
NOUMED ATORVASTATIN
Pharmacor Atorvastatin
Trovas

Atorvastatin

GRP-20048

Tablet 40 mg (as calcium)

Oral

APO-Atorvastatin
ATORVASTATIN-WGR
Atorvachol
Atorvastatin SZ
BTC Atorvastatin
Lipitor
Lorstat 40
NOUMED ATORVASTATIN
Pharmacor Atorvastatin
Trovas

Atorvastatin

GRP-20251

Tablet 80 mg (as calcium)

Oral

APO-Atorvastatin
ATORVASTATIN-WGR
Atorvachol
Atorvastatin GH
Atorvastatin SZ
BTC Atorvastatin
Lipitor
Lorstat 80
NOUMED ATORVASTATIN
Pharmacor Atorvastatin
Trovas

Atovaquone with proguanil

GRP-27571

Tablet containing atovaquone 250 mg with proguanil hydrochloride 100 mg

Oral

AtovaquoPro Lupin 250/100
Malarone

Azacitidine

GRP-20703

Powder for injection 100 mg

Injection

AZACITIDINE EUGIA
Azacitidine Accord
Azacitidine Dr.Reddy's
Azacitidine Juno
Azacitidine MSN
Azacitidine Sandoz
Azacitidine-Teva

Azathioprine

GRP-19674

Tablet 50 mg

Oral

APO-Azathioprine
AZATHIOPRINE-WGR
Azapin
Azathioprine Sandoz
Imazan
Imuran
NOUMED AZATHIOPRINE
Thioprine 50

Azathioprine

GRP-19937

Tablet 25 mg

Oral

APO-Azathioprine
AZATHIOPRINE-WGR
Azathioprine Sandoz
Imuran
NOUMED AZATHIOPRINE

Azithromycin

GRP-19990

Tablet 500 mg (as dihydrate)

Oral

APO-Azithromycin
AZITHROMYCIN-WGR
Azithromycin Mylan
Azithromycin Sandoz
Azithromycin Viatris
ZITHRO
Zithromax

Azithromycin

GRP-29088

Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL

Oral

Zithromax

Azithromycin

GRP-29088

Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL (S19A)

Oral

Azithromycin (Zydus, USA)

Baclofen

GRP-21530

Intrathecal injection 10 mg in 5 mL

Injection

Bacthecal
Lioresal Intrathecal
Sintetica Baclofen Intrathecal

Baclofen

GRP-19905

Tablet 25 mg

Oral

APO-Baclofen
Clofen 25
Lioresal 25
Stelax 25

Baclofen

GRP-19941

Tablet 10 mg

Oral

APO-Baclofen
Clofen 10
Lioresal 10
Stelax 10

Benzathine benzylpenicillin

GRP-28213

Powder for injection 1,200,000 units with diluent 5 mL (S19A)

Injection

Extencilline Benzathine Benzylpenicillin (France)

Benzathine benzylpenicillin

GRP-28213

Injection containing 1,200,000 units benzathine benzylpenicillin tetrahydrate in 2.3 mL single use pre-filled syringe

Injection

Bicillin L-A

Betamethasone

GRP-19733

Cream 500 micrograms (as valerate) per g, 15 g

Application

Betnovate 1/2
Cortival 1/2

Betamethasone

GRP-19946

Cream 200 micrograms (as valerate) per g, 100 g

Application

Betnovate 1/5
Cortival 1/5

Betamethasone

GRP-19782

Cream 200 micrograms (as valerate) per g, 100 g

Application

Antroquoril
Celestone-M

Betamethasone

GRP-19864

Cream 500 micrograms (as dipropionate) per g, 15 g

Application

Diprosone
Eleuphrat

Betamethasone

GRP-19903

Ointment 500 micrograms (as dipropionate) per g, 15 g

Application

Diprosone
Eleuphrat

Betaxolol

GRP-20098

Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL

Application to the eye

BetoQuin
Betoptic

Bicalutamide

GRP-19638

Tablet 50 mg

Oral

APO-Bicalutamide
Bicalox
Calutex
Cosamide 50
Cosudex

Bimatoprost

GRP-21740

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

BIMATOPROST-WGR
Bimatoprost Sandoz
Bimprozt
Bimtop
Lumigan

Bisacodyl

GRP-20157

Suppositories 10 mg, 10

Rectal

Dulcolax
Petrus Bisacodyl Suppositories

Bisoprolol

GRP-19779

Tablet containing bisoprolol fumarate 2.5 mg

Oral

APO-Bisoprolol
BISOPROLOL-WGR
Bicard 2.5
Bicor
Bisoprolol Sandoz
Bisoprolol generichealth
Bispro 2.5
Cipla Bisoprolol
NOUMED BISOPROLOL

Bisoprolol

GRP-19812

Tablet containing bisoprolol fumarate 5 mg

Oral

APO-Bisoprolol
BISOPROLOL-WGR
Bicard 5
Bicor
Bisoprolol Sandoz
Bisoprolol generichealth
Bispro 5
Cipla Bisoprolol
NOUMED BISOPROLOL

Bisoprolol

GRP-19813

Tablet containing bisoprolol fumarate 10 mg

Oral

APO-Bisoprolol
BISOPROLOL-WGR
Bicard 10
Bicor
Bisoprolol Sandoz
Bisoprolol generichealth
Bispro 10
Cipla Bisoprolol
NOUMED BISOPROLOL

Bivalirudin

GRP-21165

Powder for I.V. injection 250 mg (as trifluoroacetate)

Injection

BIVALIRUDIN ARX
Bivalirudin APOTEX

Bosentan

GRP-21629

Tablet 125 mg (as monohydrate)

Oral

BOSENTAN DR.REDDY'S
BOSLEER
Bosentan APO
Bosentan GH
Bosentan Mylan
Bosentan RBX

Bosentan

GRP-21635

Tablet 62.5 mg (as monohydrate)

Oral

BOSENTAN DR.REDDY'S
BOSLEER
Bosentan APO
Bosentan Mylan
Bosentan RBX

Brimonidine

GRP-20314

Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

Application to the eye

Alphagan
Enidin

Brinzolamide

GRP-20064

Eye drops 10 mg per mL, 5 mL

Application to the eye

Azopt
BrinzoQuin

Budesonide with formoterol

GRP-22143

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

BiResp Spiromax
Bufomix Easyhaler 400/12
DuoResp Spiromax
Rilast TURBUHALER 400/12
Symbicort TURBUHALER 400/12

Budesonide with formoterol

GRP-22141

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

BiResp Spiromax
DuoResp Spiromax
Rilast TURBUHALER 200/6
Symbicort Turbuhaler 200/6

Budesonide with formoterol

GRP-27568

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 100/3
Symbicort Rapihaler 100/3

Budesonide with formoterol

GRP-27583

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 200/6
Symbicort Rapihaler 200/6

Buprenorphine

GRP-22372

Transdermal patch 20 mg

Transdermal

B-Patch
Bupredermal
Buprenorphine Sandoz
Norspan

Buprenorphine

GRP-22373

Transdermal patch 10 mg

Transdermal

B-Patch
Bupredermal
Buprenorphine Sandoz
Norspan

Buprenorphine

GRP-22384

Transdermal patch 5 mg

Transdermal

B-Patch
Bupredermal
Buprenorphine Sandoz
Norspan

Buprenorphine

GRP-22459

Transdermal patch 15 mg

Transdermal

B-Patch
Bupredermal
Buprenorphine Sandoz
Norspan

Buprenorphine

GRP-24286

Transdermal patch 25 mg

Transdermal

Bupredermal
Buprenorphine Sandoz
Norspan

Buprenorphine

GRP-24274

Transdermal patch 30 mg

Transdermal

Bupredermal
Buprenorphine Sandoz
Norspan

Buprenorphine

GRP-24293

Transdermal patch 40 mg

Transdermal

Bupredermal
Buprenorphine Sandoz
Norspan

Calcipotriol with betamethasone

GRP-21266

Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

Application

Calcipotriol/Betamethasone Sandoz 50/500
Daivobet

Calcitriol

GRP-19708

Capsule 0.25 microgram

Oral

APO-Calcitriol
CALITROL
Calciprox
Kosteo
Rocaltrol
Sical

Candesartan

GRP-19554

Tablet containing candesartan cilexetil 8 mg

Oral

APO-Candesartan
Adesan
Atacand
BTC Candesartan
CANDESAN
CANDESARTAN-WGR
Candesartan Sandoz

Candesartan

GRP-19564

Tablet containing candesartan cilexetil 32 mg

Oral

APO-Candesartan
Adesan
Atacand
BTC Candesartan
CANDESAN
CANDESARTAN-WGR
Candesartan Sandoz

Candesartan

GRP-19566

Tablet containing candesartan cilexetil 4 mg

Oral

APO-Candesartan
Adesan
Atacand
BTC Candesartan
CANDESAN
CANDESARTAN-WGR
Candesartan Sandoz

Candesartan

GRP-19568

Tablet containing candesartan cilexetil 16 mg

Oral

APO-Candesartan
Adesan
Atacand
BTC Candesartan
CANDESAN
CANDESARTAN-WGR
Candesartan Sandoz

Candesartan with hydrochlorothiazide

GRP-19559

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

Oral

APO-Candesartan HCTZ 32/25
Adesan HCT 32/25
Atacand Plus 32/25
BTC Candesartan HCT
CANDESAN COMBI 32/25
CANDESARTAN HCTZ-WGR 32/25
Candesartan/HCT Sandoz
NOUMED CANDESARTAN/HCT

Candesartan with hydrochlorothiazide

GRP-19563

Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

Oral

APO-Candesartan HCTZ 32/12.5
Adesan HCT 32/12.5
Atacand Plus 32/12.5
BTC Candesartan HCT
CANDESAN COMBI 32/12.5
CANDESARTAN HCTZ-WGR 32/12.5
Candesartan/HCT Sandoz
NOUMED CANDESARTAN/HCT

Candesartan with hydrochlorothiazide

GRP-19567

Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

Oral

APO-Candesartan HCTZ 16/12.5
Adesan HCT 16/12.5
Atacand Plus 16/12.5
BTC Candesartan HCT
Blooms the Chemist Candesartan HCTZ 16/12.5
CANDESAN COMBI 16/12.5
CANDESARTAN HCTZ-WGR 16/12.5
Candesartan/HCT Sandoz
NOUMED CANDESARTAN/HCT

Capecitabine

GRP-19591

Tablet 500 mg

Oral

Capecitabine Alphapharm
Capecitabine Sandoz
Xelabine

Carbamazepine

GRP-14653

Tablet 200 mg

Oral

Carbamazepine Sandoz
Tegretol 200

Carbamazepine

GRP-19583

Tablet 100 mg

Oral

Carbamazepine Sandoz
Tegretol 100

Carbimazole

GRP-24069

Tablet 5 mg

Oral

Neo-Mercazole
THIRAZOL
WP Carbimazole

Carbomer

GRP-20037

Eye gel 2 mg per g, 10 g

Application to the eye

Optifresh eye gel
PAA
Viscotears

Carvedilol

GRP-19636

Tablet 12.5 mg

Oral

APO-Carvedilol
CARVEDILOL-WGR
Carvedilol Sandoz
Carvidol
Dicarz
Dilatrend 12.5
Vedilol 12.5
Volirop 12.5

Carvedilol

GRP-19677

Tablet 25 mg

Oral

APO-Carvedilol
CARVEDILOL-WGR
Carvedilol Sandoz
Carvidol
Dicarz
Dilatrend 25
Vedilol 25
Volirop 25

Carvedilol

GRP-19703

Tablet 3.125 mg

Oral

APO-Carvedilol
Carvidol
Vedilol 3.125
Volirop 3.125

Carvedilol

GRP-19799

Tablet 6.25 mg

Oral

APO-Carvedilol
CARVEDILOL-WGR
Carvedilol Sandoz
Carvidol
Dicarz
Dilatrend 6.25
Vedilol 6.25
Volirop 6.25

Cefaclor

GRP-19974

Tablet (sustained release) 375 mg (as monohydrate)

Oral

Ceclor CD
Karlor CD
Keflor CD

Cefaclor

GRP-20159

Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Oral

Aclor 125
Ceclor
Cefaclor SUN
Keflor

Cefaclor

GRP-20181

Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

Oral

Aclor 250
Ceclor
Cefaclor SUN
Keflor

Cefalexin

GRP-20166

Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Oral

Cefalexin Sandoz
Ibilex 125
Keflex

Cefalexin

GRP-20033

Capsule 250 mg (as monohydrate)

Oral

APO-Cephalexin
Ibilex 250
Keflex

Cefalexin

GRP-20298

Capsule 500 mg (as monohydrate)

Oral

APO-Cephalexin
Blooms The Chemist Cefalexin
CEPHALEXIN-WGR
Cefalexin Sandoz
Cephalex 500
Cephalexin generichealth
Ibilex 500
Keflex
NOUMED CEFALEXIN

Cefalexin

GRP-27406

Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL

Oral

Cefalexin Sandoz
Ibilex 250
Keflex

Cefuroxime

GRP-22638

Tablet 250 mg (as axetil)

Oral

Pharmacor Cefuroxime
Zinnat

Celecoxib

GRP-19618

Capsule 100 mg

Oral

APX-Celecoxib
Blooms the Chemist Celecoxib
CELECOXIB-WGR
Celaxib
Celebrex
Celecoxib APOTEX
Celecoxib GH
Celecoxib Sandoz
Celexi
NOUMED CELECOXIB

Celecoxib

GRP-19623

Capsule 200 mg

Oral

APX-Celecoxib
Blooms the Chemist Celecoxib
CELECOXIB-WGR
Celaxib
Celebrex
Celecoxib APOTEX
Celecoxib GH
Celecoxib Sandoz
Celexi
NOUMED CELECOXIB

Ciclosporin

GRP-20026

Capsule 100 mg

Oral

APO-Ciclosporin
CICLOSPORIN-WGR
Cyclosporin Sandoz
Neoral 100

Ciclosporin

GRP-20143

Capsule 50 mg

Oral

APO-Ciclosporin
CICLOSPORIN-WGR
Cyclosporin Sandoz
Neoral 50

Ciclosporin

GRP-20032

Capsule 25 mg

Oral

APO-Ciclosporin
CICLOSPORIN-WGR
Cyclosporin Sandoz
Neoral 25

Cinacalcet

GRP-24882

Tablet 30 mg (as hydrochloride)

Oral

Cinacalcet Viatris
Pharmacor Cinacalcet

Cinacalcet

GRP-24888

Tablet 60 mg (as hydrochloride)

Oral

Cinacalcet Viatris
Pharmacor Cinacalcet

Cinacalcet

GRP-24892

Tablet 90 mg (as hydrochloride)

Oral

Cinacalcet Viatris
Pharmacor Cinacalcet

Ciprofloxacin

GRP-19988

Eye drops 3 mg (as hydrochloride) per mL, 5 mL

Application to the eye

CiloQuin
Ciloxan

Ciprofloxacin

GRP-19723

Tablet 750 mg (as hydrochloride)

Oral

APO-Ciprofloxacin
APX-Ciprofloxacin
C-Flox 750
CIPROFLOXACIN-WGR
Ciprofloxacin Sandoz
Ciprol 750
NOUMED CIPROFLOXACIN

Ciprofloxacin

GRP-19859

Tablet 500 mg (as hydrochloride)

Oral

APO-Ciprofloxacin
APX-Ciprofloxacin
C-Flox 500
CIPROFLOXACIN-WGR
Cifran
Ciprofloxacin Sandoz
Ciprol 500
NOUMED CIPROFLOXACIN

Ciprofloxacin

GRP-19910

Tablet 250 mg (as hydrochloride)

Oral

APO-Ciprofloxacin
APX-Ciprofloxacin
C-Flox 250
CIPROFLOXACIN-WGR
Ciprofloxacin Sandoz
Ciprol 250

Citalopram

GRP-19656

Tablet 40 mg (as hydrobromide)

Oral

APO-Citalopram
Celapram
Citalopram Sandoz
NOUMED CITALOPRAM
Talam

Citalopram

GRP-19940

Tablet 20 mg (as hydrobromide)

Oral

APO-Citalopram
APX-Citalopram
Celapram
Cipramil
Citalopram Sandoz
NOUMED CITALOPRAM
Talam

Citalopram

GRP-19953

Tablet 10 mg (as hydrobromide)

Oral

Celapram
Talam

Clarithromycin

GRP-19649

Tablet 250 mg

Oral

Clarithro 250
Clarithromycin Sandoz
Kalixocin
Klacid
NOUMED CLARITHROMYCIN

Clindamycin

GRP-19995

Capsule 150 mg (as hydrochloride)

Oral

APO-Clindamycin
CLINDAMYCIN-WGR
Calindamin
Clindamycin LU
Clindamyk
Dalacin C

Clomipramine

GRP-19890

Tablet containing clomipramine hydrochloride 25 mg

Oral

APO-Clomipramine
Anafranil 25
CLOMIPRAMINE-WGR
Placil

Clonazepam

GRP-22717

Tablet 500 micrograms

Oral

Paxam 0.5
Rivotril

Clonidine

GRP-21381

Tablet containing clonidine hydrochloride 100 micrograms

Oral

APO-Clonidine
Catapres 100
Clonidine Lupin

Clopidogrel

GRP-17110

Tablet 75 mg (as besilate)

Oral

CLOPIDOGREL-WGR
Clovix 75
Plidogrel

Clopidogrel

GRP-17110

Tablet 75 mg (as hydrogen sulfate)

Oral

Blooms Clopidogrel
Clopidogrel Lupin
Clopidogrel Sandoz Pharma
Clopidogrel Winthrop
Iscover
Piax
Plavicor 75

Clopidogrel with aspirin

GRP-19773

Tablet 75 mg (as hydrogen sulfate)-100 mg

Oral

APX-Clopidogrel/Aspirin 75/100
Clopidogrel Winthrop plus aspirin
DuoCover
DuoPlidogrel
Piax Plus Aspirin

Codeine with paracetamol

GRP-20169

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

APO- Paracetamol/Codeine 500/30
APX-Paracetamol/Codeine
Codalgin Forte
Codapane Forte 500/30
Comfarol Forte
Panadeine Forte
Paracetamol/Codeine GH 500/30
Prodeine Forte

Colchicine

GRP-19820

Tablet 500 micrograms

Oral

Colcine
Colgout
Lengout

Cyproterone

GRP-19722

Tablet containing cyproterone acetate 50 mg

Oral

ANTERONE 50
Androcur
Cyproterone Sandoz
Pharmacor Cyproterone 50

Cyproterone

GRP-19842

Tablet containing cyproterone acetate 100 mg

Oral

ANTERONE 100
Androcur-100
Cyproterone Sandoz
Pharmacor Cyproterone 100

Dabigatran etexilate

GRP-28121

Capsule 110 mg (as mesilate)

Oral

ARX-Dabigatran
Dabigatran Sandoz
PHARMACOR DABIGATRAN
Pradaxa

Dabigatran etexilate

GRP-28118

Capsule 150 mg (as mesilate)

Oral

ARX-Dabigatran
Dabigatran Sandoz
PHARMACOR DABIGATRAN
Pradaxa

Dabigatran etexilate

GRP-28127

Capsule 75 mg (as mesilate)

Oral

ARX-Dabigatran
Pradaxa

Darunavir

GRP-24212

Tablet 600 mg

Oral

Darunavir Juno

Darunavir

GRP-24212

Tablet 600 mg (as ethanolate)

Oral

Prezista

Darunavir

GRP-25566

Tablet 800 mg

Oral

Darunavir Juno

Darunavir

GRP-25566

Tablet 800 mg (as ethanolate)

Oral

Prezista

Dasatinib

GRP-25848

Tablet 70 mg

Oral

DASATINIB-TEVA
Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib SUN
Dasatinib Viatris
Sprycel
TE-DASATINIB

Dasatinib

GRP-25853

Tablet 50 mg

Oral

DASATINIB-TEVA
Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib SUN
Dasatinib Viatris
Sprycel
TE-DASATINIB

Dasatinib

GRP-25849

Tablet 20 mg

Oral

DASATINIB-TEVA
Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib SUN
Dasatinib Viatris
Sprycel
TE-DASATINIB

Dasatinib

GRP-25880

Tablet 100 mg

Oral

DASATINIB-TEVA
Dasatinib ARX
Dasatinib Dr.Reddy's
Dasatinib SUN
Dasatinib Viatris
Sprycel
TE-DASATINIB

Deferasirox

GRP-25387

Tablet 180 mg

Oral

DEFERASIROX-TEVA
Deferasirox ARX
Deferasirox Sandoz
Eferas
Jadenu
Pharmacor Deferasirox FC

Deferasirox

GRP-25385

Tablet 90 mg

Oral

DEFERASIROX-TEVA
Deferasirox ARX
Deferasirox Sandoz
Eferas
Jadenu
Pharmacor Deferasirox FC

Deferasirox

GRP-25395

Tablet 360 mg

Oral

DEFERASIROX-TEVA
Deferasirox ARX
Deferasirox Sandoz
Eferas
Jadenu
Pharmacor Deferasirox FC

Deferasirox

GRP-28209

Tablet, dispersible, 125 mg

Oral

Deferasirox Juno
Pharmacor Deferasirox

Deferasirox

GRP-28219

Tablet, dispersible, 500 mg

Oral

Deferasirox Juno
Pharmacor Deferasirox

Deferasirox

GRP-28210

Tablet, dispersible, 250 mg

Oral

Deferasirox Juno
Pharmacor Deferasirox

Desmopressin

GRP-24629

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL, USP (Apotex)

Nasal

Desmopressin Nasal Spray USP (Apotex)

Desmopressin

GRP-24629

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL

Nasal

Minirin Nasal Spray

Desvenlafaxine

GRP-16219

Tablet (extended release) 100 mg (as succinate)

Oral

Pristiq

Desvenlafaxine

GRP-16219

Tablet (modified release) 100 mg

Oral

BTC Desvenlafaxine
DESVEN
DESVENLAFAXINE-WGR XR
Desfax
Desvenlafaxine Sandoz

Desvenlafaxine

GRP-16219

Tablet (modified release) 100 mg (as benzoate)

Oral

APO-Desvenlafaxine MR
Desvenlafaxine GH XR

Desvenlafaxine

GRP-16220

Tablet (extended release) 50 mg (as succinate)

Oral

Pristiq

Desvenlafaxine

GRP-16220

Tablet (modified release) 50 mg

Oral

BTC Desvenlafaxine
DESVEN
DESVENLAFAXINE-WGR XR
Desfax
Desvenlafaxine Sandoz

Desvenlafaxine

GRP-16220

Tablet (modified release) 50 mg (as benzoate)

Oral

APO-Desvenlafaxine MR
Desvenlafaxine GH XR

Dexamethasone with framycetin and gramicidin

GRP-19777

Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL

Application to the ear

Otodex
Sofradex

Diazepam

GRP-20001

Tablet 5 mg

Oral

APO-Diazepam
APX-Diazepam
Antenex 5
DIAZEPAM-WGR
NOUMED DIAZEPAM
Valium
Valpam 5

Diazepam

GRP-20081

Tablet 2 mg

Oral

APO-Diazepam
APX-Diazepam
Antenex 2
DIAZEPAM-WGR
Valpam 2

Diclofenac

GRP-20116

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

APO-Diclofenac
Clonac 50
DICLOFENAC-WGR
Diclofenac Sandoz
Fenac EC
Voltaren 50

Diclofenac

GRP-20112

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

APO-Diclofenac
Clonac 25
DICLOFENAC-WGR
Diclofenac Sandoz
Fenac EC
Voltaren 25

Dicloxacillin

GRP-20360

Capsule 500 mg (as sodium)

Oral

DICLOXACILLIN VIATRIS 500
Dicloxacillin Mylan 500
Distaph 500

Dicloxacillin

GRP-22402

Capsule 250 mg (as sodium)

Oral

DICLOXACILLIN VIATRIS 250
Dicloxacillin Mylan 250
Distaph 250

Digoxin

GRP-19717

Tablet 250 micrograms

Oral

Lanoxin
Sigmaxin

Digoxin

GRP-19774

Tablet 62.5 micrograms

Oral

Lanoxin-PG
Sigmaxin-PG

Diltiazem

GRP-19652

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

Oral

Cardizem CD
Diltiazem Sandoz CD
Vasocardol CD

Diltiazem

GRP-19869

Tablet containing diltiazem hydrochloride 60 mg

Oral

Cardizem
Vasocardol

Diltiazem

GRP-19894

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

Oral

Cardizem CD
Diltiazem Sandoz CD
Vasocardol CD

Diltiazem

GRP-19934

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

Oral

Cardizem CD
Diltiazem Sandoz CD
Vasocardol CD

Dimethyl fumarate

GRP-26010

Capsule (modified release) 120 mg

Oral

APO-DIMETHYL FUMARATE
Dimethyl Fumarate MSN
Dimethyl Fumarate Sandoz
Pharmacor Dimethyl Fumarate
Tecfidera

Dimethyl fumarate

GRP-26012

Capsule (modified release) 240 mg

Oral

APO-DIMETHYL FUMARATE
Dimethyl Fumarate MSN
Dimethyl Fumarate Sandoz
Pharmacor Dimethyl Fumarate
Tecfidera
Trazent

Diphenoxylate with atropine

GRP-19655

Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate monohydrate 25 micrograms

Oral

Lofenoxal
Lomotil

Disopyramide

GRP-27397

Capsule 100 mg

Oral

Rythmodan

Disopyramide

GRP-27397

Capsule 100 mg (s19A)

Oral

Rythmodan (Canada)

Domperidone

GRP-26945

Tablet 10 mg

Oral

APO-DOMPERIDONE
Motilium

Donepezil

GRP-20245

Tablet containing donepezil hydrochloride 10 mg

Oral

APO-Donepezil
Arazil
Aricept
Aridon 10
Aridon APN 10
DONEPEZIL-WGR
Donepezil GH
Donepezil Sandoz
NOUMED DONEPEZIL

Donepezil

GRP-20096

Tablet containing donepezil hydrochloride 5 mg

Oral

APO-Donepezil
Arazil
Aricept
Aridon 5
Aridon APN 5
DONEPEZIL-WGR
Donepezil GH
Donepezil Sandoz
NOUMED DONEPEZIL

Dorzolamide

GRP-19989

Eye drops 20 mg (as hydrochloride) per mL, 5 mL

Application to the eye

Trusamide
Trusopt

Dorzolamide with timolol

GRP-19979

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

Application to the eye

Cosdor
Cosopt
Vizo-PF Dorzolatim

Dosulepin

GRP-22377

Capsule containing dosulepin hydrochloride 25 mg

Oral

Dosulepin Viatris
Dothep 25

Dosulepin

GRP-22392

Tablet containing dosulepin hydrochloride 75 mg

Oral

Dosulepin Viatris 75
Dothep 75

Doxorubicin - pegylated liposomal

GRP-19578

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

Injection

Caelyx
Liposomal Doxorubicin SUN

Doxycycline

GRP-14639

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx
Mayne Pharma Doxycycline

Doxycycline

GRP-14639

Tablet 100 mg (as hyclate)

Oral

APX-Doxycycline
DOXYCYCLINE-WGR
Doxsig
Doxylin 100

Doxycycline

GRP-14639

Tablet 100 mg (as monohydrate)

Oral

Doxycycline Sandoz

Doxycycline

GRP-15635

Capsule 50 mg (as hyclate) (containing enteric coated pellets)

Oral

Doryx
Mayne Pharma Doxycycline

Doxycycline

GRP-15635

Tablet 50 mg (as hyclate)

Oral

APX-Doxycycline
DOXYCYCLINE-WGR
Doxsig
Doxylin 50

Doxycycline

GRP-15635

Tablet 50 mg (as monohydrate)

Oral

Doxycycline Sandoz

Duloxetine

GRP-19918

Capsule 30 mg (as hydrochloride)

Oral

APO-Duloxetine
Cymbalta
DYTREX 30
Duloxecor
Duloxetine Sandoz
Duloxetine Sandoz 30
Tixol

Duloxetine

GRP-19957

Capsule 60 mg (as hydrochloride)

Oral

APO-Duloxetine
Cymbalta
DYTREX 60
Duloxecor
Duloxetine Sandoz
Duloxetine Sandoz 60
Tixol

Dutasteride

GRP-21860

Capsule 500 micrograms

Oral

APO-Dutasteride
Avodart

Dutasteride with tamsulosin

GRP-24027

Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms

Oral

Doubluts
Duodart 500ug/400ug

Enalapril

GRP-19633

Tablet containing enalapril maleate 20 mg

Oral

APO-Enalapril
Acetec
ENALAPRIL-WGR
Enalapril Sandoz
Enalapril generichealth
Malean
Renitec 20

Enalapril

GRP-19752

Tablet containing enalapril maleate 5 mg

Oral

APO-Enalapril
Acetec
ENALAPRIL-WGR
Enalapril Sandoz
Malean

Enalapril

GRP-19843

Tablet containing enalapril maleate 10 mg

Oral

APO-Enalapril
Acetec
ENALAPRIL-WGR
Enalapril Sandoz
Malean
Renitec

Enalapril with hydrochlorothiazide

GRP-19645

Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg

Oral

Enalapril/HCT Sandoz
Renitec Plus 20/6

Enoxaparin

GRP-22367

Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe

Injection

Clexane Safety-Lock
Exarane

Enoxaparin

GRP-22371

Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe

Injection

Clexane Safety-Lock
Exarane

Enoxaparin

GRP-22357

Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe

Injection

Clexane Safety-Lock
Exarane

Enoxaparin

GRP-22378

Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe

Injection

Clexane Safety-Lock
Exarane

Enoxaparin

GRP-22387

Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe

Injection

Clexane Safety-Lock
Exarane

Enoxaparin

GRP-28012

Injection containing enoxaparin sodium 120 mg (12,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe

Injection

Clexane Forte Safety-Lock
Exarane Forte

Enoxaparin

GRP-28013

Injection containing enoxaparin sodium 150 mg (15,000 I.U. anti-Xa) in 1 mL pre-filled syringe

Injection

Clexane Forte Safety-Lock
Exarane Forte

Entecavir

GRP-21166

Tablet 0.5 mg (as monohydrate)

Oral

ENTAC
ENTECAVIR APO
ENTECAVIR RBX
ENTECAVIR-WGR
ENTECLUDE
Entecavir GH
Entecavir Mylan
Entecavir Sandoz
Entecavir Viatris

Entecavir

GRP-21170

Tablet 1 mg (as monohydrate)

Oral

ENTECAVIR APO
ENTECAVIR RBX
ENTECAVIR-WGR
ENTECLUDE
Entecavir Mylan
Entecavir Sandoz
Entecavir Viatris

Eplerenone

GRP-20704

Tablet 50 mg

Oral

APO-Eplerenone
ESPLER
Inpler
Inspra

Eplerenone

GRP-20711

Tablet 25 mg

Oral

APO-Eplerenone
ESPLER
Inpler
Inspra

Epoprostenol

GRP-28614

Powder for I.V. infusion 1.5 mg (as sodium)

Injection

Veletri

Epoprostenol

GRP-28614

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

Epoprostenol

GRP-28616

Powder for I.V. infusion 500 micrograms (as sodium)

Injection

Veletri

Epoprostenol

GRP-28616

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

Erlotinib

GRP-24881

Tablet 100 mg (as hydrochloride)

Oral

Erlotinib APOTEX
Erlotinib Sandoz

Erlotinib

GRP-24895

Tablet 25 mg (as hydrochloride)

Oral

Erlotinib APOTEX
Erlotinib Sandoz

Erlotinib

GRP-24897

Tablet 150 mg (as hydrochloride)

Oral

Erlotinib APOTEX
Erlotinib Sandoz

Escitalopram

GRP-19665

Tablet 20 mg (as oxalate)

Oral

APO-Escitalopram
APX-Escitalopram
Blooms Escitalopram
Cilopam-S
Escitalopram GH
Escitalopram Sandoz
Esipram
Lexam 20
Lexapro
LoxaLate
NOUMED ESCITALOPRAM

Escitalopram

GRP-19817

Tablet 10 mg (as oxalate)

Oral

APO-Escitalopram
APX-Escitalopram
Blooms Escitalopram
Cilopam-S
Escitalopram GH
Escitalopram Sandoz
Esipram
Lexam 10
Lexapro
LoxaLate
NOUMED ESCITALOPRAM

Esomeprazole

GRP-17061

Capsule (enteric) 40 mg (as magnesium)

Oral

Noxicid Caps

Esomeprazole

GRP-17061

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole
ESOMEPRAZOLE-WGR
Esomeprazole GH
Esomeprazole GxP
Esomeprazole Mylan
Esomeprazole RBX
Esomeprazole Viatris
Esopreze
NOUMED ESOMEPRAZOLE
Nexazole
Nexium
Nexole

Esomeprazole

GRP-17188

Capsule (enteric) 20 mg (as magnesium)

Oral

Noxicid Caps

Esomeprazole

GRP-17188

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

APO-Esomeprazole
ESOMEPRAZOLE-WGR
Esomeprazole GH
Esomeprazole GxP
Esomeprazole Mylan
Esomeprazole RBX
Esomeprazole Viatris
Esopreze
NOUMED ESOMEPRAZOLE
Nexazole
Nexium
Nexole

Esomeprazole and clarithromycin and amoxicillin

GRP-20639

Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate)

Oral

Nexium Hp7

Esomeprazole and clarithromycin and amoxicillin

GRP-20639

Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate)

Oral

ESOMEPRAZOLE SANDOZ Hp7

Estradiol

GRP-28649

Transdermal patches 585 micrograms, 8

Transdermal

Estradiol Transdermal System (Sandoz, USA)
Estradot 37.5

Estradiol

GRP-28651

Transdermal patches 1.17 mg, 8

Transdermal

Estradiol Transdermal System (Sandoz, USA)
Estradot 75

Estradiol

GRP-28652

Transdermal patches 1.56 mg, 8

Transdermal

Estradiol Transdermal System (Sandoz, USA)
Estradot 100

Estradiol

GRP-27217

Pessary (modified release) 10 micrograms (as hemihydrate)

Vaginal

Estro-Pess
Vagifem Low

Etanercept

GRP- 26053

Injection 50 mg in 1 mL single use auto-injector, 4

Injection

Brenzys
Enbrel

Etanercept

GRP- 26053

Injections 50 mg in 1 mL single use pre-filled syringes, 4

Injection

Brenzys
Enbrel

Ethosuximide

GRP-23067

Capsule 250 mg

Oral

Zarontin

Ethosuximide

GRP-23067

Capsule 250 mg (s19A)

Oral

Ethosuximide Essential Generics (UK)

Everolimus

GRP-25323

Tablet 1 mg

Oral

Certican
Everocan

Everolimus

GRP-25324

Tablet 0.25 mg

Oral

Certican
Everocan

Everolimus

GRP-25326

Tablet 0.5 mg

Oral

Certican
Everocan

Everolimus

GRP-25328

Tablet 0.75 mg

Oral

Certican
Everocan

Exemestane

GRP-20304

Tablet 25 mg

Oral

APO-Exemestane
Aromasin
EXEMESTANE-WGR
Exemestane GH
Exemestane Sandoz

Ezetimibe

GRP-22396

Tablet 10 mg

Oral

APO-Ezetimibe
BTC Ezetimibe
EZEMICHOL
EZETIMIBE-WGR
Ezetimibe GH
Ezetimibe Sandoz
Ezetrol
Pharmacor Ezetimibe 10
Zient 10mg

Ezetimibe and rosuvastatin

GRP-22369

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+40mg
Pharmacor Ezetimibe Rosuvastatin Composite Pack
Rosuzet Composite Pack

Ezetimibe and rosuvastatin

GRP-22388

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+10mg
Pharmacor Ezetimibe Rosuvastatin Composite Pack
Rosuzet Composite Pack

Ezetimibe and rosuvastatin

GRP-22395

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+20mg
Pharmacor Ezetimibe Rosuvastatin Composite Pack
Rosuzet Composite Pack

Ezetimibe and rosuvastatin

GRP-22399

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+5mg
Rosuzet Composite Pack

Ezetimibe with atorvastatin

GRP-23702

Tablet 10 mg-40 mg

Oral

Atozet
Ezetast
Ezetimibe/Atorvastatin GH 10/40

Ezetimibe with atorvastatin

GRP-23705

Tablet 10 mg-80 mg

Oral

Atozet
Ezetast
Ezetimibe/Atorvastatin GH 10/80

Ezetimibe with atorvastatin

GRP-23706

Tablet 10 mg-20 mg

Oral

Atozet
Ezetast
Ezetimibe/Atorvastatin GH 10/20

Ezetimibe with atorvastatin

GRP-23708

Tablet 10 mg-10 mg

Oral

Atozet
Ezetast
Ezetimibe/Atorvastatin GH 10/10

Ezetimibe with simvastatin

GRP-22376

Tablet 10 mg-40 mg

Oral

APO-Ezetimibe/Simvastatin 10/40
EZETIMIBE/SIMVASTATIN SANDOZ
EZETIMIBE/SIMVASTATIN-WGR 10/40
EZETORIN
EzSimva GH 10/40
Pharmacor Ezetimibe Simvastatin 10/40
Vytorin
Zeklen 10/40 mg
Zimybe 10/40

Ezetimibe with simvastatin

GRP-22381

Tablet 10 mg-10 mg

Oral

APO-Ezetimibe/Simvastatin 10/10
EZETIMIBE/SIMVASTATIN SANDOZ
EZETIMIBE/SIMVASTATIN-WGR 10/10
EZETORIN
EzSimva GH 10/10
Pharmacor Ezetimibe Simvastatin 10/10
Vytorin
Zeklen 10/10 mg
Zimybe 10/10

Ezetimibe with simvastatin

GRP-22383

Tablet 10 mg-20 mg

Oral

APO-Ezetimibe/Simvastatin 10/20
EZETIMIBE/SIMVASTATIN SANDOZ
EZETIMIBE/SIMVASTATIN-WGR 10/20
EZETORIN
EzSimva GH 10/20
Pharmacor Ezetimibe Simvastatin 10/20
Vytorin
Zeklen 10/20 mg
Zimybe 10/20

Ezetimibe with simvastatin

GRP-22393

Tablet 10 mg-80 mg

Oral

APO-Ezetimibe/Simvastatin 10/80
EZETIMIBE/SIMVASTATIN SANDOZ
EZETIMIBE/SIMVASTATIN-WGR 10/80
EZETORIN
EzSimva GH 10/80
Pharmacor Ezetimibe Simvastatin 10/80
Vytorin
Zeklen 10/80 mg
Zimybe 10/80

Famciclovir

GRP-19771

Tablet 125 mg

Oral

APO-Famciclovir
Famvir
Favic 125

Famciclovir

GRP-19828

Tablet 250 mg

Oral

APO-Famciclovir
Ezovir
FAMCICLOVIR-WGR
Famvir
Favic 250

Famciclovir

GRP-19913

Tablet 500 mg

Oral

APO-Famciclovir
Ezovir
FAMCICLOVIR-WGR
Famvir
Favic 500

Felodipine

GRP-19647

Tablet 10 mg (extended release)

Oral

Felodil XR 10
Felodur ER 10 mg
Fendex ER
Plendil ER

Felodipine

GRP-19691

Tablet 2.5 mg (extended release)

Oral

Felodur ER 2.5 mg
Fendex ER
Plendil ER

Felodipine

GRP-19853

Tablet 5 mg (extended release)

Oral

Felodil XR 5
Felodur ER 5 mg
Fendex ER
Plendil ER

Fenofibrate

GRP-20716

Tablet 145 mg

Oral

APO-Fenofibrate
BTC Fenofibrate
FENOFIBRATE RBX
FENOFIBRATE-WGR
Fenocol
Fenofibrate Cipla
Fenofibrate Sandoz
Fenofibrate Viatris
Lipidil

Fenofibrate

GRP-20725

Tablet 48 mg

Oral

APO-Fenofibrate
FENOFIBRATE RBX
FENOFIBRATE-WGR
Fenofibrate Cipla
Fenofibrate Viatris
Lipidil

Fentanyl

GRP-15510

Transdermal patch 7.65 mg

Transdermal

Denpax

Fentanyl

GRP-15510

Transdermal patch 12.375 mg

Transdermal

Fenpatch 75

Fentanyl

GRP-15510

Transdermal patch 12.6 mg

Transdermal

APO-Fentanyl
Durogesic 75
Fentanyl Sandoz

Fentanyl

GRP-15577

Transdermal patch 2.55 mg

Transdermal

Denpax

Fentanyl

GRP-15577

Transdermal patch 4.125 mg

Transdermal

Fenpatch 25

Fentanyl

GRP-15577

Transdermal patch 4.2 mg

Transdermal

APO-Fentanyl
Durogesic 25
Fentanyl Sandoz

Fentanyl

GRP-15659

Transdermal patch 5.10 mg

Transdermal

Denpax

Fentanyl

GRP-15659

Transdermal patch 8.25 mg

Transdermal

Fenpatch 50

Fentanyl

GRP-15659

Transdermal patch 8.4 mg

Transdermal

APO-Fentanyl
Durogesic 50
Fentanyl Sandoz

Fentanyl

GRP-15747

Transdermal patch 10.20 mg

Transdermal

Denpax

Fentanyl

GRP-15747

Transdermal patch 16.5 mg

Transdermal

Fenpatch 100

Fentanyl

GRP-15747

Transdermal patch 16.8 mg

Transdermal

APO-Fentanyl
Durogesic 100
Fentanyl Sandoz

Fentanyl

GRP-15898

Transdermal patch 1.28 mg

Transdermal

Denpax

Fentanyl

GRP-15898

Transdermal patch 2.063 mg

Transdermal

Fenpatch 12

Fentanyl

GRP-15898

Transdermal patch 2.1 mg

Transdermal

APO-Fentanyl
Durogesic 12
Fentanyl Sandoz

Filgrastim

GRP-23379

Injection 300 micrograms in 0.5 mL single-use pre-filled syringe

Injection

Nivestim
Zarzio

Filgrastim

GRP-23385

Injection 480 micrograms in 0.5 mL single-use pre-filled syringe

Injection

Nivestim
Zarzio

Fingolimod

GRP-26766

Capsule 500 micrograms (as hydrochloride)

Oral

AKM Fingolimod
FINGOLIS
Fingolimod SUN
Fingolimod Sandoz
Fingolimod-Teva
Fynod
Gilenya
Pharmacor Fingolimod

Flecainide

GRP-19776

Tablet containing flecainide acetate 100 mg

Oral

APO-Flecainide
Flecainide Sandoz
Flecatab
Tambocor

Flecainide

GRP-21022

Tablet containing flecainide acetate 50 mg

Oral

APO-Flecainide
Flecainide Sandoz
Flecatab
Tambocor

Flucloxacillin

GRP-23238

Capsule 250 mg (as sodium monohydrate)

Oral

Flopen
Flopen Viatris
Staphylex 250

Flucloxacillin

GRP-23239

Capsule 500 mg (as sodium monohydrate)

Oral

Flopen
Flopen Viatris
Staphylex 500

Fluconazole

GRP-19858

Capsule 200 mg

Oral

Diflucan
Dizole 200
Fluconazole APOTEX
Fluconazole Sandoz
Fluzole 200
Ozole

Fluconazole

GRP-19877

Capsule 50 mg

Oral

Diflucan
Dizole 50
Fluconazole Sandoz
Ozole

Fluconazole

GRP-19878

Capsule 100 mg

Oral

Diflucan
Dizole 100
Fluconazole Sandoz
Ozole

Fludrocortisone

GRP-25994

Tablet containing fludrocortisone acetate 100 micrograms

Oral

FLUDROCORTISONE MEDSURGE
Florinef

Fluoxetine

GRP-24550

Capsule 20 mg (as hydrochloride)

Oral

APO-Fluoxetine
Blooms the Chemist Fluoxetine
FLUOTEX
Fluoxetine APOTEX
Fluoxetine Sandoz
Fluoxetine generichealth
NOUMED FLUOXETINE
Prozac 20
Zactin

Fluticasone propionate

GRP-21526

Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Axotide
Flixotide
Fluticasone Cipla Inhaler

Fluticasone propionate

GRP-21532

Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Axotide
Flixotide
Fluticasone Cipla Inhaler

Fluticasone propionate

GRP-24883

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses

Inhalation by mouth

Axotide Junior Accuhaler
Flixotide Junior Accuhaler

Fluticasone propionate

GRP-24884

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses

Inhalation by mouth

Axotide Accuhaler
Flixotide Accuhaler

Fluticasone propionate

GRP-24885

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Axotide Junior
Flixotide Junior

Fluticasone propionate with salmeterol

GRP-21522

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Evocair MDI
Fluticasone + Salmeterol Cipla 250/25
Pavtide
SalplusF Inhaler 250/25
Seretide MDI 250/25

Fluticasone propionate with salmeterol

GRP-21527

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

Evocair MDI
Fluticasone + Salmeterol Cipla 125/25
Pavtide
SalplusF Inhaler 125/25
Seretide MDI 125/25

Fluticasone propionate with salmeterol

GRP-24889

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

PAVTIDE ACCUHALER 100/50
Seretide Accuhaler 100/50

Fluticasone propionate with salmeterol

GRP-24890

Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

Inhalation by mouth

PAVTIDE MDI 50/25
Seretide MDI 50/25

Fluticasone propionate with salmeterol

GRP-24904

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Fluticasone Salmeterol Ciphaler 250/50
PAVTIDE ACCUHALER 250/50
Salflumix Easyhaler 250/50
SalplusF DPI 250/50
Seretide Accuhaler 250/50

Fluticasone propionate with salmeterol

GRP-24913

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

Inhalation by mouth

Fluticasone Salmeterol Ciphaler 500/50
PAVTIDE ACCUHALER 500/50
Salflumix Easyhaler 500/50
SalplusF DPI 500/50
Seretide Accuhaler 500/50

Fluvoxamine

GRP-19729

Tablet containing fluvoxamine maleate 50 mg

Oral

APO-Fluvoxamine
FLUVOXAMINE-WGR
Faverin 50
Luvox
Movox 50

Fluvoxamine

GRP-19862

Tablet containing fluvoxamine maleate 100 mg

Oral

APO-Fluvoxamine
FLUVOXAMINE-WGR
Faverin 100
Luvox
Movox 100

Folic acid

GRP-20411

Tablet 500 micrograms

Oral

Foltabs 500
Megafol 0.5

Follitropin alfa

GRP-25866

Injection 300 I.U. in 0.5 mL multi-dose cartridge

Injection

Gonal-f Pen
Ovaleap

Follitropin alfa

GRP-25867

Injection 450 I.U. in 0.75 mL multi-dose cartridge

Injection

Gonal-f Pen
Ovaleap

Follitropin alfa

GRP-25879

Injection 900 I.U. in 1.5 mL multi-dose cartridge

Injection

Gonal-f Pen
Ovaleap

Follitropin beta

GRP-27212

Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge

Injection

Puregon 600 IU/0.72 mL
Recagon

Follitropin beta

GRP-27211

Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge

Injection

Puregon 900 IU/1.08 mL
Recagon

Follitropin beta

GRP-27207

Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge

Injection

Puregon 300 IU/0.36 mL
Recagon

Fosaprepitant

GRP-27398

Powder for I.V. infusion 150 mg

Injection

Emend IV
FOSAPREPITANT MEDSURGE
FOSAPREPITANT MSN
FOSAPREPITANT-AFT

Fosinopril

GRP-19769

Tablet containing fosinopril sodium 20 mg

Oral

APO-Fosinopril
Monace 20

Fosinopril

GRP-19785

Tablet containing fosinopril sodium 10 mg

Oral

APO-Fosinopril
Monace 10

Fremanezumab

GRP-26651

Solution for injection 225 mg in 1.5 mL single dose pre-filled pen

Injection

Ajovy

Fremanezumab

GRP-26651

Solution for injection 225 mg in 1.5 mL single dose pre-filled syringe

Injection

Ajovy

Fulvestrant

GRP-25877

Injection 250 mg in 5 mL pre-filled syringe

Injection

FULVESTRANT ACCORD
FULVESTRANT EVER PHARMA
Fulvestrant Sandoz

Furosemide

GRP-15441

Tablet 20 mg

Oral

APO-Frusemide
FUROSEMIDE-WGR
Frusemix-M
UREMIDE 20

Furosemide

GRP-19673

Tablet 40 mg

Oral

APO-Frusemide
FUROSEMIDE-WGR
Frusax
Frusemix
NOUMED FUROSEMIDE
Uremide

Gabapentin

GRP-19792

Capsule 400 mg

Oral

APX-Gabapentin
GAPENTIN
Gabacor
Gabapentin Sandoz
Gabapentin generichealth
Neurontin
Nupentin 400

Gabapentin

GRP-19876

Tablet 600 mg

Oral

GAPENTIN
Gabapentin APOTEX
Neurontin
Pharmacor Gabapentin 600

Gabapentin

GRP-20038

Capsule 100 mg

Oral

APX-Gabapentin
GAPENTIN
Gabacor
Neurontin
Nupentin 100

Gabapentin

GRP-20089

Tablet 800 mg

Oral

GAPENTIN
Gabapentin APOTEX
Neurontin
Pharmacor Gabapentin 800

Gabapentin

GRP-20136

Capsule 300 mg

Oral

APX-Gabapentin
GABAPENTIN-WGR
GAPENTIN
Gabacor
Gabapentin Sandoz
Gabapentin generichealth
Neurontin
Nupentin 300

Galantamine

GRP-19984

Capsule (prolonged release) 24 mg (as hydrobromide)

Oral

APO-Galantamine MR
Galantyl
Gamine XR
Reminyl

Galantamine

GRP-20010

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

APO-Galantamine MR
Galantyl
Gamine XR
Reminyl

Galantamine

GRP-20219

Capsule (prolonged release) 16 mg (as hydrobromide)

Oral

APO-Galantamine MR
Galantyl
Gamine XR
Reminyl

Ganciclovir

GRP-22142

Powder for I.V. infusion 500 mg (as sodium)

Injection

Cymevene
GANCICLOVIR SXP

Ganirelix

GRP-24916

Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe

Injection

GANIRELIX SUN
Ganirelix Theramex
Orgalutran

Gemfibrozil

GRP-20148

Tablet 600 mg

Oral

Ausgem
Lipigem

Glatiramer

GRP-26552

Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled pen

Injection

Copaxone

Glatiramer

GRP-26552

Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled syringe

Injection

Copaxone
GLATIRAMER ACETATE-TEVA
Glatira

Gliclazide

GRP-19611

Tablet 60 mg (modified release)

Oral

ARDIX GLICLAZIDE 60mg MR
Diamicron 60mg MR
Gliclazide Lupin MR
Pharmacor Gliclazide MR

Gliclazide

GRP-19637

Tablet 30 mg (modified release)

Oral

APO-Gliclazide MR
Gliclazide MR Viatris
Glyade MR
Pharmacor Gliclazide MR

Gliclazide

GRP-19933

Tablet 80 mg

Oral

APO-Gliclazide
APX-Gliclazide
Glyade
Nidem

Glimepiride

GRP-19711

Tablet 2 mg

Oral

ARX-GLIMEPIRIDE
GLIMEPIRIDE-WGR
Glimepiride APOTEX
Glimepiride Sandoz

Glimepiride

GRP-19770

Tablet 3 mg

Oral

ARX-GLIMEPIRIDE
GLIMEPIRIDE-WGR
Glimepiride APOTEX
Glimepiride Sandoz

Glimepiride

GRP-19855

Tablet 4 mg

Oral

ARX-GLIMEPIRIDE
GLIMEPIRIDE-WGR
Glimepiride APOTEX
Glimepiride Sandoz

Glimepiride

GRP-19887

Tablet 1 mg

Oral

ARX-GLIMEPIRIDE
GLIMEPIRIDE-WGR
Glimepiride APOTEX
Glimepiride Sandoz

Glipizide

GRP-19686

Tablet 5 mg

Oral

Melizide
Minidiab

Granisetron

GRP-20012

Concentrated injection 3 mg (as hydrochloride) in 3 mL

Injection

Granisetron-AFT
Kytril

Hydrocortisone

GRP-20005

Ointment containing hydrocortisone acetate 10 mg per g, 50 g

Application

Cortic-DS 1%
Sigmacort

Hydrocortisone

GRP-20194

Cream containing hydrocortisone acetate 10 mg per g, 50 g

Application

Cortic-DS 1%
Sigmacort

Hydrocortisone

GRP-22370

Tablet 4 mg

Oral

Hydrocortisone Viatris 4
Hysone 4

Hydrocortisone

GRP-22397

Tablet 20 mg

Oral

Hydrocortisone Viatris 20
Hysone 20

Hydromorphone

GRP-23240

Injection containing hydromorphone hydrochloride 10 mg in 1 mL

Injection

Dilaudid-HP
HYDROMORPHONE JUNO-HP
Hydromorphone-hameln-HP
MEDSURGE HYDROMORPHONE HP 10 mg/1 mL

Hydromorphone

GRP-23244

Injection containing hydromorphone hydrochloride 2 mg in 1 mL

Injection

Dilaudid
HYDROMORPHONE JUNO
Hydromorphone-hameln
MEDSURGE HYDROMORPHONE 2 mg/1 mL

Hydromorphone

GRP-28212

Oral solution containing hydromorphone hydrochloride 1mg per mL, 1mL (S19A)

Oral

Hydromorphone hydrochloride oral solution, USP (Medsurge)

Hydromorphone

GRP-28212

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL

Oral

Hikma

Hydroxocobalamin

GRP-17689

Injection 1 mg (as acetate) in 1 mL

Injection

Cobal-B12
Vita-B12

Hydroxocobalamin

GRP-17689

Injection 1 mg (as chloride) in 1 mL

Injection

Hydroxo-B12
Neo-B12

Hydroxycarbamide

GRP-24269

Capsule 500 mg

Oral

HYDROXYCARBAMIDE MEDSURGE
Hydrea

Hydroxychloroquine

GRP-19846

Tablet containing hydroxychloroquine sulfate 200 mg

Oral

APO- Hydroxychloroquine
Hequinel
Hydroxychloroquine GH
Plaquenil

Hyoscine

GRP-21879

Injection containing hyoscine butylbromide 20 mg in 1 mL

Injection

Buscopan
HYOSCINE BUTYLBROMIDE MEDSURGE
HYOSCINE BUTYLBROMIDE SXP
HYOSCINE BUTYLBROMIDE-AFT

Hypromellose

GRP-22878

Eye drops 3 mg per mL, 10 mL

Application to the eye

Genteal
In a Wink Moisturising
Revive Tears

Hypromellose with carbomer 980

GRP-20137

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the eye

Genteal gel
HPMC PAA

Hypromellose with dextran

GRP-20049

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

Application to the eye

Poly-Tears
Tears Naturale

Ibuprofen

GRP-21741

Tablet 400 mg

Oral

APO-Ibuprofen 400
Brufen
MEDICHOICE Ibuprofen 400 mg

Icatibant

GRP-24276

Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe

Injection

Cipla Icatibant
Fyzant
Icatibant Lupin

Imatinib

GRP-21074

Capsule 100 mg (as mesilate)

Oral

ARX-IMATINIB
IMATINIB-DRLA
Imatinib-APOTEX

Imatinib

GRP-21074

Tablet 100 mg (as mesilate)

Oral

Gilmat
Glivec
IMATINIB RBX
Imatinib Sandoz
Imatinib-Teva

Imatinib

GRP- 21079

Capsule 400 mg (as mesilate)

Oral

IMATINIB-DRLA
Imatinib GH
Imatinib-APOTEX

Imatinib

GRP- 21079

Tablet 400 mg (as mesilate)

Oral

Gilmat
Glivec
IMATINIB RBX
Imatinib Sandoz
Imatinib-Teva

Imipramine

GRP-24222

Tablet containing imipramine hydrochloride 25 mg

Oral

Tofranil 25

Imipramine

GRP-24222

Tablet containing imipramine hydrochloride 25 mg (s19A)

Oral

Imipramine (Leading)

Imiquimod

GRP-17129

Cream 50 mg per g, 2 g, 2

Application

Aldara Pump

Imiquimod

GRP-17129

Cream 50 mg per g, 250 mg single use sachets, 12

Application

APO-Imiquimod
Aldara
Aldiq

Indapamide

GRP-19607

Tablet containing indapamide hemihydrate 1.5 mg (sustained release)

Oral

APO-Indapamide SR
Natrilix SR
Odaplix SR
Tenaxil SR

Indapamide

GRP-19781

Tablet containing indapamide hemihydrate 2.5 mg

Oral

Dapa-Tabs
Insig

Indometacin

GRP-20071

Capsule 25 mg

Oral

Arthrexin
Indocid

Infliximab

GRP-20382

Powder for I.V. infusion 100 mg

Injection

Inflectra
Remicade
Renflexis

Ipratropium

GRP-19679

Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30

Inhalation

Atrovent Adult
Ipratrin Adult

Ipratropium

GRP-19908

Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30

Inhalation

Atrovent
Ipratrin

Irbesartan

GRP-19646

Tablet 75 mg

Oral

APO-Irbesartan
AVSARTAN
Abisart 75
Blooms Irbesartan
IRBESARTAN-WGR
Irbesartan GH
Irbesartan Sandoz
Karvea
Noumed Irbesartan

Irbesartan

GRP-19659

Tablet 150 mg

Oral

APO-Irbesartan
AVSARTAN
Abisart 150
Avapro
Blooms Irbesartan
IRBESARTAN-WGR
Irbesartan GH
Irbesartan Sandoz
Karvea
Noumed Irbesartan

Irbesartan

GRP-19742

Tablet 300 mg

Oral

APO-Irbesartan
AVSARTAN
Abisart 300
Avapro
Blooms Irbesartan
Blooms the Chemist Irbesartan
IRBESARTAN-WGR
Irbesartan GH
Irbesartan Sandoz
Karvea
Noumed Irbesartan

Irbesartan with hydrochlorothiazide

GRP-19699

Tablet 300 mg-25 mg

Oral

APO-Irbesartan HCTZ
AVSARTAN HCT 300/25
Abisart HCTZ 300/25
Avapro HCT 300/25
Blooms the Chemist Irbesartan HCTZ 300/25
IRBESARTAN HCTZ-WGR 300/25
Irbesartan/HCT Sandoz
Karvezide 300/25

Irbesartan with hydrochlorothiazide

GRP-19743

Tablet 300 mg-12.5 mg

Oral

APO-Irbesartan HCTZ
AVSARTAN HCT 300/12.5
Abisart HCTZ 300/12.5
Avapro HCT 300/12.5
Blooms the Chemist Irbesartan HCTZ 300/12.5
IRBESARTAN HCTZ-WGR 300/12.5
Irbesartan/HCT Sandoz
Karvezide 300/12.5

Irbesartan with hydrochlorothiazide

GRP-19958

Tablet 150 mg-12.5 mg

Oral

APO-Irbesartan HCTZ
AVSARTAN HCT 150/12.5
Abisart HCTZ 150/12.5
Avapro HCT 150/12.5
Blooms the Chemist Irbesartan HCTZ 150/12.5
IRBESARTAN HCTZ-WGR 150/12.5
Irbesartan/HCT Sandoz
Karvezide 150/12.5

Isosorbide mononitrate

GRP-19675

Tablet 120 mg (sustained release)

Oral

Imdur 120 mg
Monodur 120 mg

Isosorbide mononitrate

GRP-19856

Tablet 60 mg (sustained release)

Oral

APO-Isosorbide Mononitrate
Duride
ISOBIDE MR
ISOSORBIDE MR-WGR
Imdur Durule

Isotretinoin

GRP-19603

Capsule 40 mg

Oral

Dermatane
Oratane

Isotretinoin

GRP-19867

Capsule 10 mg

Oral

APO-Isotretinoin
Dermatane
ISOTRETINOIN-WGR
Isotretinoin GX
Isotretinoin Lupin
Oratane

Isotretinoin

GRP-22820

Capsule 20 mg

Oral

APO-Isotretinoin
Dermatane
ISOTRETINOIN-WGR
Isotretinoin GX
Isotretinoin Lupin
Oratane
Pharmacor Isotretinoin
Roaccutane

Itraconazole

GRP-21159

Capsule 100 mg

Oral

APO-Itraconazole
ITRANOX
Itracap

Ivabradine

GRP-22577

Tablet 5 mg (as hydrochloride)

Oral

APO-Ivabradine
Coralan
IVABRADINE-WGR

Ivabradine

GRP-22578

Tablet 7.5 mg (as hydrochloride)

Oral

APO-Ivabradine
Coralan

Ketoprofen

GRP-20014

Capsule 200 mg (sustained release)

Oral

Orudis SR 200
Oruvail SR

Lacosamide

GRP-26166

Tablet 100 mg

Oral

Lacoress
Lacosam
Lacosamide ARX
Lacosamide Lupin
Lacosamide Sandoz
Vimcosa
Vimpat

Lacosamide

GRP-26170

Tablet 150 mg

Oral

Lacoress
Lacosam
Lacosamide ARX
Lacosamide Lupin
Lacosamide Sandoz
Vimcosa
Vimpat

Lacosamide

GRP-26173

Tablet 200 mg

Oral

Lacoress
Lacosam
Lacosamide ARX
Lacosamide Lupin
Lacosamide Sandoz
Vimcosa
Vimpat

Lacosamide

GRP-26169

Tablet 50 mg

Oral

Lacoress
Lacosam
Lacosamide ARX
Lacosamide Lupin
Lacosamide Sandoz
Vimcosa
Vimpat

Lamivudine

GRP-19748

Tablet 300 mg

Oral

3TC
Lamivudine Alphapharm

Lamivudine

GRP-19806

Tablet 100 mg

Oral

Zeffix
Zetlam

Lamivudine

GRP-19929

Tablet 150 mg

Oral

3TC
Lamivudine Alphapharm

Lamivudine with zidovudine

GRP-19570

Tablet 150 mg-300 mg

Oral

Combivir
Lamivudine/Zidovudine Viatris 150/300

Lamotrigine

GRP-19640

Tablet 200 mg

Oral

APX-Lamotrigine
LAMITAN
LAMOTRIGINE-WGR
Lamictal
Lamotrigine GH
Logem
NOUMED LAMOTRIGINE
Reedos 200
Sandoz Lamotrigine

Lamotrigine

GRP-19706

Tablet 100 mg

Oral

APX-Lamotrigine
LAMITAN
LAMOTRIGINE-WGR
Lamictal
Lamotrigine GH
Logem
NOUMED LAMOTRIGINE
Reedos 100
Sandoz Lamotrigine

Lamotrigine

GRP-19758

Tablet 50 mg

Oral

APX-Lamotrigine
LAMITAN
LAMOTRIGINE-WGR
Lamictal
Lamotrigine GH
Logem
NOUMED LAMOTRIGINE
Reedos 50
Sandoz Lamotrigine

Lamotrigine

GRP-19807

Tablet 25 mg

Oral

APX-Lamotrigine
LAMITAN
LAMOTRIGINE-WGR
Lamictal
Lamotrigine GH
Logem
NOUMED LAMOTRIGINE
Reedos 25
Sandoz Lamotrigine

Lanreotide

GRP-27570

Injection 90 mg (as acetate) in single dose pre-filled syringe

Injection

Mytolac
Somatuline Autogel

Lanreotide

GRP-27567

Injection 120 mg (as acetate) in single dose pre-filled syringe

Injection

Mytolac
Somatuline Autogel

Lanreotide

GRP-27569

Injection 60 mg (as acetate) in single dose pre-filled syringe

Injection

Mytolac
Somatuline Autogel

Lansoprazole

GRP-14641

Capsule 30 mg

Oral

APO-Lansoprazole
Lanzopran
NOUMED LANSOPRAZOLE
Zopral

Lansoprazole

GRP-14641

Tablet 30 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT
Lansoprazole ODT GH
Zopral ODT
Zoton FasTabs

Lansoprazole

GRP-19832

Tablet 15 mg (orally disintegrating)

Oral

APO-Lansoprazole ODT
Lansoprazole ODT GH
Zopral ODT
Zoton FasTabs

Latanoprost

GRP-20084

Eye drops 50 micrograms per mL, 2.5 mL

Application to the eye

APO-Latanoprost
LATANOPROST-WGR
Latanoprost Sandoz
Xalaprost
Xalatan

Latanoprost with timolol

GRP-20063

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

APO-Latanoprost/Timolol 0.05/5
Xalacom
Xalamol 50/5

Leflunomide

GRP-19639

Tablet 20 mg

Oral

APO-LEFLUNOMIDE
Arava
Ataris 20
LEFLUNOMIDE-WGR
Leflunomide APOTEX
Leflunomide Sandoz
Leflunomide generichealth
Lunava 20

Leflunomide

GRP-19866

Tablet 10 mg

Oral

APO-LEFLUNOMIDE
Arava
Ataris 10
LEFLUNOMIDE-WGR
Leflunomide APOTEX
Leflunomide Sandoz
Leflunomide generichealth
Lunava 10

Lercanidipine

GRP-19829

Tablet containing lercanidipine hydrochloride 20 mg

Oral

ARX-LERCANIDIPINE
LERCANIDIPINE-WGR
Lercan
Lercanidipine APOTEX
Zanidip
Zircol 20

Lercanidipine

GRP-19911

Tablet containing lercanidipine hydrochloride 10 mg

Oral

ARX-LERCANIDIPINE
LERCANIDIPINE-WGR
Lercan
Lercanidipine APOTEX
Zanidip
Zircol 10

Letrozole

GRP-19884

Tablet 2.5 mg

Oral

ARX-LETROZOLE
Femara 2.5 mg
Femolet
Gynotril
LETROZOLE-WGR
Letrozole APOTEX
Letrozole GH
Letrozole Sandoz
Pharmacor Letrozole 2.5

Levetiracetam

GRP-19643

Tablet 500 mg

Oral

APO-Levetiracetam
Keppra
Kevtam 500
LEVETIRACETAM-WGR
Levactam
Levetiracetam GH
Levetiracetam Mylan
Levetiracetam SZ
Levi 500
NOUMED LEVETIRACETAM

Levetiracetam

GRP-19648

Tablet 250 mg

Oral

APO-Levetiracetam
Keppra
Kevtam 250
LEVETIRACETAM-WGR
Levactam
Levetiracetam GH
Levetiracetam Mylan
Levetiracetam SZ
Levetiracetam Viatris
Levi 250
NOUMED LEVETIRACETAM

Levetiracetam

GRP-19680

Tablet 1 g

Oral

APO-Levetiracetam
Keppra
Kevtam 1000
LEVETIRACETAM-WGR
Levactam
Levetiracetam GH
Levetiracetam Mylan
Levetiracetam SZ
Levetiracetam Viatris
Levi 1000
NOUMED LEVETIRACETAM

Levetiracetam

GRP-20362

Oral solution 100 mg per mL, 300 mL

Oral

APO-Levetiracetam
Keppra
Kerron
Levetiracetam GH
Levetiracetam-AFT

Levodopa with carbidopa

GRP-19870

Tablet 100 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa
Kinson
SINADOPA 100/25
Sinemet 100/25

Levodopa with carbidopa

GRP-22958

Tablet 250 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa
SINADOPA 250/25
Sinemet

Levodopa with carbidopa and entacapone

GRP-24192

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Carlevent
L.C.E. Sandoz
Lecteva
Stalevo 50/12.5/200mg

Levodopa with carbidopa and entacapone

GRP-24193

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Carlevent
L.C.E. Sandoz
Lecteva
Stalevo 125/31.25/200mg

Levodopa with carbidopa and entacapone

GRP-24197

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Carlevent
L.C.E. Sandoz
Lecteva
Stalevo 150/37.5/200mg

Levodopa with carbidopa and entacapone

GRP-24198

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Carlevent
L.C.E. Sandoz
Lecteva
Stalevo 75/18.75/200mg

Levodopa with carbidopa and entacapone

GRP-24201

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Carlevent
L.C.E. Sandoz
Lecteva
Stalevo 100/25/200mg

Levodopa with carbidopa and entacapone

GRP-24203

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Carlevent
L.C.E. Sandoz
Lecteva
Stalevo 200/50/200mg

Levonorgestrel with ethinylestradiol

GRP-19824

Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets

Oral

Logynon ED
Triquilar ED

Levonorgestrel with ethinylestradiol

GRP-19827

Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets

Oral

Eleanor 150/30 ED
Evelyn 150/30 ED
Femme-Tab ED 30/150
LEVETH 150/30 ED
Lenest 30 ED
Levlen ED
Micronelle 30 ED

Levothyroxine

GRP-27400

Tablet containing 200 micrograms anhydrous levothyroxine sodium

Oral

Eltroxin
Levothox

Levothyroxine

GRP-26246

Tablet containing 200 micrograms anhydrous levothyroxine sodium

Oral

APO-Levothyroxine
Eutroxsig
LEVOXINE
Levothyroxine Lup
Levothyroxine Sandoz
Oroxine
Thyrox

Levothyroxine

GRP 27402

Tablet containing 50 micrograms anhydrous levothyroxine sodium

Oral

Eltroxin
Levothox

Levothyroxine

GRP-26247

Tablet containing 50 micrograms anhydrous levothyroxine sodium

Oral

APO-Levothyroxine
Eutroxsig
LEVOXINE
Levothyroxine Lup
Levothyroxine Sandoz
Oroxine
Thyrox

Levothyroxine

GRP-27411

Tablet containing 100 micrograms anhydrous levothyroxine sodium

Oral

Eltroxin
Levothox

Levothyroxine

GRP-26248

Tablet containing 100 micrograms anhydrous levothyroxine sodium

Oral

APO-Levothyroxine
Eutroxsig
LEVOXINE
Levothyroxine Lup
Levothyroxine Sandoz
Oroxine
Thyrox

Levothyroxine

GRP-27401

Tablet containing 75 micrograms anhydrous levothyroxine sodium

Oral

Eltroxin
Levothox

Levothyroxine

GRP-26249

Tablet containing 75 micrograms anhydrous levothyroxine sodium

Oral

APO-Levothyroxine
Eutroxsig
LEVOXINE
Levothyroxine Lup
Levothyroxine Sandoz
Oroxine
Thyrox

Lincomycin

GRP-22364

Injection 600 mg (as hydrochloride monohydrate) in 2 mL

Injection

LINCOMYCIN SXP
Lincocin

Lisinopril

GRP-19761

Tablet 20 mg

Oral

APO-Lisinopril
Fibsol 20
LISINOPRIL-WGR
Lisinopril Sandoz
Lisinopril generichealth
Zestril
Zinopril 20

Lisinopril

GRP-19764

Tablet 10 mg

Oral

APO-Lisinopril
Fibsol 10
LISINOPRIL-WGR
Lisinopril Sandoz
Zestril
Zinopril 10

Lisinopril

GRP-19823

Tablet 5 mg

Oral

APO-Lisinopril
Fibsol 5
LISINOPRIL-WGR
Lisinopril Sandoz
Zestril
Zinopril 5

Loperamide

GRP-20401

Capsule containing loperamide hydrochloride 2 mg

Oral

Gastrex
Gastro-Stop

Lurasidone

GRP-24194

Tablet containing lurasidone hydrochloride 80 mg

Oral

APO-Lurasidone
LURASIDONE SUN
LURASIDONE-WGR
Latuda
Lavione
Lurasidone Lupin
Lurasidone Sandoz
Pharmacor Lurasidone

Lurasidone

GRP-24195

Tablet containing lurasidone hydrochloride 40 mg

Oral

APO-Lurasidone
LURASIDONE SUN
LURASIDONE-WGR
Latuda
Lavione
Lurasidone Lupin
Lurasidone Sandoz
Pharmacor Lurasidone

Macrogol 3350

GRP-20122

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

APO-MACROGOL plus ELECTROLYTES
APOHEALTH Macrogol with Electrolytes
Chemists' Own Macrogol with Electrolytes
Macrovic
Molaxole
Movicol

Medroxyprogesterone

GRP-28650

Injection containing medroxyprogesterone acetate 150 mg in 1 mL

Injection

Depo-Provera

Medroxyprogesterone

GRP-28650

Injection containing medroxyprogesterone acetate 150 mg in 1 mL pre-filled syringe

Injection

Depo-Provera

Medroxyprogesterone

GRP-19676

Tablet containing medroxyprogesterone acetate 10 mg

Oral

Provera
Ralovera

Medroxyprogesterone

GRP-19872

Tablet containing medroxyprogesterone acetate 5 mg

Oral

Provera
Ralovera

Mefenamic acid

GRP-25998

Capsule 250 mg

Oral

FEMIN
Ponstan

Meloxicam

GRP-15468

Capsule 15 mg

Oral

APO-Meloxicam
MELOBIC
MELOXICAM-WGR
Meloxicam Sandoz
Mobic
Movalis 15
Moxicam

Meloxicam

GRP-15468

Tablet 15 mg

Oral

APX-Meloxicam
CIPLA MELOXICAM 15
MELOBIC
MELOXICAM-WGR
Meloxibell
Meloxicam Sandoz
Meloxicam Viatris
Mobic
Movalis 15
Moxicam 15
Pharmacor Meloxicam 15

Meloxicam

GRP-15658

Capsule 7.5 mg

Oral

APO-Meloxicam
MELOBIC
MELOXICAM-WGR
Meloxicam Sandoz
Mobic
Movalis 7.5
Moxicam

Meloxicam

GRP-15658

Tablet 7.5 mg

Oral

APX-Meloxicam
CIPLA MELOXICAM 7.5
MELOBIC
MELOXICAM-WGR
Meloxibell
Meloxicam Sandoz
Meloxicam Viatris
Mobic
Movalis 7.5
Moxicam 7.5
Pharmacor Meloxicam 7.5

Memantine

GRP- 19971

Tablet containing memantine hydrochloride 20 mg

Oral

APO-Memantine
Ebixa
Memantine generichealth

Memantine

GRP- 20090

Tablet containing memantine hydrochloride 10 mg

Oral

APO-Memantine
Ebixa
Memantine generichealth
Memanxa

Mercaptopurine

GRP-23857

Tablet containing mercaptopurine monohydrate 50 mg

Oral

MERCAPTOPURINE-LINK
Purinethol

Mesalazine

GRP-27214

Tablet 1.2 g (prolonged release)

Oral

MESALZ
Mesalazine 1.2 TAKEDA
Mezavant

Metformin

GRP-19608

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

APO-Metformin XR 1000
Diabex XR 1000
Diaformin XR 1000
METEX XR
METFORMIN-WGR XR
Pharmacor Metformin XR

Metformin

GRP-19682

Tablet containing metformin hydrochloride 850 mg

Oral

APX-Metformin
Blooms The Chemist Metformin 850 mg
Diabex 850
Diaformin 850
Diaformin Viatris
FORMET 850
Glucobete 850
METFORMIN-WGR
Metformin Sandoz

Metformin

GRP-19880

Tablet containing metformin hydrochloride 500 mg

Oral

APX-Metformin
Blooms The Chemist Metformin 500 mg
Diabex
Diaformin
FORMET 500
Glucobete 500
METFORMIN-WGR
Metformin GH
Metformin Sandoz

Metformin

GRP-19944

Tablet containing metformin hydrochloride 1 g

Oral

APX-Metformin
Blooms The Chemist Metformin 1000 mg
Diabex 1000
Diaformin 1000
Diaformin Viatris
Formet 1000
Glucobete 1000
Metformin GH
Metformin Sandoz

Metformin

GRP-24200

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

APO-Metformin XR 500
Diabex XR 500
METFORMIN-WGR XR
Metex XR
Pharmacor Metformin XR

Methadone

GRP-27510

Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL

Oral

Aspen Methadone Syrup
Biodone Forte

Methadone

GRP-27523

Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL

Oral

Aspen Methadone Syrup
Biodone Forte

Methenamine

GRP-24551

Tablet containing methenamine hippurate 1 g

Oral

Hiprex
Uramet

Methotrexate

GRP-19736

Tablet 2.5 mg

Oral

ARX-Methotrexate
Chexate
Methoblastin

Methotrexate

GRP- 27896

Tablet 10 mg

Oral

ARX-Methotrexate
Chexate
Methoblastin

Methyldopa

GRP-19840

Tablet 250 mg (as sesquihydrate)

Oral

Aldomet
Hydopa

Methylphenidate

GRP-21745

Tablet containing methylphenidate hydrochloride 10 mg

Oral

Artige
Ritalin 10

Methylphenidate

GRP-25859

Tablet containing methylphenidate hydrochloride 27 mg (extended release)

Oral

Concerta
METHYLPHENIDATE-TEVA XR
Methylphenidate XR ARX

Methylphenidate

GRP-25885

Tablet containing methylphenidate hydrochloride 18 mg (extended release)

Oral

Concerta
METHYLPHENIDATE-TEVA XR
Methylphenidate XR ARX

Methylphenidate

GRP-25891

Tablet containing methylphenidate hydrochloride 36 mg (extended release)

Oral

Concerta
METHYLPHENIDATE-TEVA XR
Methylphenidate XR ARX

Methylphenidate

GRP-25892

Tablet containing methylphenidate hydrochloride 54 mg (extended release)

Oral

Concerta
METHYLPHENIDATE-TEVA XR
Methylphenidate XR ARX

Methylphenidate

GRP-27206

Capsule containing methylphenidate hydrochloride 40 mg (modified release)

Oral

Ritalin LA
Rubifen LA

Methylphenidate

GRP-27208

Capsule containing methylphenidate hydrochloride 60 mg (modified release)

Oral

Ritalin LA
Rubifen LA

Methylphenidate

GRP-27209

Capsule containing methylphenidate hydrochloride 30 mg (modified release)

Oral

Ritalin LA
Rubifen LA

Methylphenidate

GRP-27210

Capsule containing methylphenidate hydrochloride 10 mg (modified release)

Oral

Ritalin LA
Rubifen LA

Methylphenidate

GRP-27215

Capsule containing methylphenidate hydrochloride 20 mg (modified release)

Oral

Ritalin LA
Rubifen LA

Methylprednisolone

GRP-27888

Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g

Application

Advantan (Fatty)
Supriad Fatty Ointment
Tanilone (Fatty)

Methylprednisolone

GRP-27997

Cream containing methylprednisolone aceponate 1 mg per g, 15 g

Application

Advantan
Supriad Cream

Methylprednisolone

GRP-27999

Ointment containing methylprednisolone aceponate 1 mg per g, 15 g

Application

Advantan
Supriad Ointment

Methylprednisolone

GRP-19893

Powder for injection 1 g (as sodium succinate)

Injection

Methylpred
Solu-Medrol

Methylprednisolone

GRP-20006

Injection containing methylprednisolone acetate 40 mg in 1 mL

Injection

Depo-Medrol
Depo-Nisolone

Metoclopramide

GRP-28223

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

METOCLOPRAMIDE INJECTION BP
Metoclopramide HCI Medsurge

Metoclopramide

GRP-20027

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

APO-Metoclopramide
EMEXLON
METOCLOPRAMIDE-WGR
Maxolon
Pramin

Metoprolol

GRP-19759

Tablet containing metoprolol tartrate 50 mg

Oral

APO-Metoprolol
Betaloc
METOPROLOL-WGR
Metoprolol Sandoz
Metrol 50
Minax 50
NOUMED METOPROLOL

Metoprolol

GRP-19804

Tablet containing metoprolol tartrate 100 mg

Oral

APO-Metoprolol
Betaloc
METOPROLOL-WGR
Metoprolol Sandoz
Metrol 100
Minax 100
NOUMED METOPROLOL

Metoprolol succinate

GRP-19592

Tablet 47.5 mg (controlled release)

Oral

Metrol-XL 47.5
Minax XL
Topreloc-XL
Toprol-XL 47.5

Metoprolol succinate

GRP-19594

Tablet 190 mg (controlled release)

Oral

Metrol-XL 190
Minax XL
Topreloc-XL
Toprol-XL 190

Metoprolol succinate

GRP-19595

Tablet 95 mg (controlled release)

Oral

Metrol-XL 95
Minax XL
Topreloc-XL
Toprol-XL 95

Metoprolol succinate

GRP-19596

Tablet 23.75 mg (controlled release)

Oral

Metrol-XL 23.75
Minax XL
Topreloc-XL

Metronidazole

GRP-20212

Tablet 400 mg

Oral

Flagyl
Metrogyl 400

Minocycline

GRP-19899

Tablet 50 mg (as hydrochloride)

Oral

Akamin 50
Minomycin-50

Mirtazapine

GRP-19628

Tablet 30 mg

Oral

APX-Mirtazapine
Avanza
Axit 30
Blooms The Chemist Mirtazapine
MIRTANZA
MIRTAZAPINE-WGR
Mirtazapine Sandoz
NOUMED MIRTAZAPINE

Mirtazapine

GRP-19718

Tablet 15 mg

Oral

APX-Mirtazapine
Axit 15
Blooms The Chemist Mirtazapine
MIRTANZA
MIRTAZAPINE-WGR
Mirtazapine Sandoz

Mirtazapine

GRP-19763

Tablet 45 mg

Oral

APX-Mirtazapine
Axit 45
Blooms The Chemist Mirtazapine
MIRTANZA
MIRTAZAPINE-WGR
Mirtazapine Sandoz
NOUMED MIRTAZAPINE

Moclobemide

GRP-19630

Tablet 150 mg

Oral

Amira 150
Aurorix
Clobemix
MOCLOBEMIDE-WGR
Moclobemide Sandoz

Moclobemide

GRP-19932

Tablet 300 mg

Oral

Amira 300
Aurorix 300 mg
Clobemix
MOCLOBEMIDE-WGR
Moclobemide Sandoz

Modafinil

GRP-20604

Tablet 100 mg

Oral

APO-Modafinil
MODAFINIL-WGR
Modafin
Modafinil GH
Modafinil Mylan
Modafinil Sandoz
Modafinil Viatris
Modavigil

Mometasone

GRP-19629

Lotion containing mometasone furoate 1 mg per g, 30 mL

Application

Elocon
Novasone
Zatamil

Mometasone

GRP-19755

Ointment containing mometasone furoate 1 mg per g, 15 g

Application

Elocon
Momasone
Novasone
Zatamil

Mometasone

GRP-19924

Cream containing mometasone furoate 1 mg per g, 15 g

Application

Elocon Alcohol Free
Momasone Alcohol Free
Novasone

Montelukast

GRP-19556

Tablet, chewable, 4 mg (as sodium)

Oral

MONTELAIR 4
Montelukast APOTEX
Montelukast Lupin
Montelukast Mylan
Montelukast Sandoz 4
Montelukast Viatris

Montelukast

GRP-19572

Tablet, chewable, 5 mg (as sodium)

Oral

MONTELAIR 5
Montelukast APOTEX
Montelukast Lupin
Montelukast Mylan
Montelukast Sandoz 5
Montelukast Viatris

Morphine

GRP-20890

Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL

Injection

Morphine Juno

Morphine

GRP-20890

Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

Injection

MORPHINE SULFATE 10 mg/1 mL MEDSURGE

Morphine

GRP-19707

Tablet containing morphine sulfate pentahydrate 60 mg (controlled release)

Oral

MORPHINE MR APOTEX
MS Contin
Morphine MR Mylan

Morphine

GRP-19730

Tablet containing morphine sulfate pentahydrate 100 mg (controlled release)

Oral

MORPHINE MR APOTEX
MS Contin
Morphine MR Mylan

Morphine

GRP-19885

Tablet containing morphine sulfate pentahydrate 10 mg (controlled release)

Oral

MORPHINE MR APOTEX
MS Contin
Morphine MR Mylan

Morphine

GRP-19923

Tablet containing morphine sulfate pentahydrate 30 mg (controlled release)

Oral

MORPHINE MR APOTEX
MS Contin
Morphine MR Mylan

Morphine

GRP-28109

Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 1 mL

Oral

Ordine 2

Morphine

GRP-28109

Oral solution containing morphine sulfate 2 mg per mL in 100 mL bottle, 1 mL (S19A)

Oral

Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL)

Morphine

GRP-28109

Oral solution containing morphine sulfate 10 mg per 5 mL in 100 mL bottle, 1 mL (S19A)

Oral

Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL

Morphine

GRP-28109

Oral solution containing morphine sulfate 2 mg per mL in 500 mL bottle, 1 mL (S19A)

Oral

Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL)

Morphine

GRP-28109

Oral solution containing morphine sulfate 10 mg per 5 mL in 300 mL bottle, 1 mL (S19A)

Oral

Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL

Morphine

GRP-28497

Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL

Oral

Ordine 10

Morphine

GRP-28497

Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (RA-Morph)(S19A)

Oral

RA-Morph (NZ)

Morphine

GRP-28497

Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL (S19A)

Oral

Morphini HCl Streuli

Morphine

GRP-28763

Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL

Oral

Ordine 5

Morphine

GRP-28763

Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A)

Oral

RA-Morph (NZ)

Moxonidine

GRP-22366

Tablet 200 micrograms

Oral

APO-Moxonidine
MOXONIDINE-WGR
Moxonidine GH
Moxonidine GX
Moxonidine Viatris
Moxotens
Physiotens

Moxonidine

GRP-22375

Tablet 400 micrograms

Oral

APO-Moxonidine
MOXONIDINE-WGR
Moxonidine GH
Moxonidine GX
Moxonidine Viatris
Moxotens
Physiotens

Mycophenolic acid

GRP-17217

Capsule containing mycophenolate mofetil 250 mg

Oral

APO-Mycophenolate
Ceptolate
Mycophenolate Sandoz
Pharmacor Mycophenolate 250

Mycophenolic acid

GRP-20011

Tablet containing mycophenolate mofetil 500 mg

Oral

ARX-MYCOPHENOLATE
Ceptolate
MycoCept
Mycophenolate APOTEX
Mycophenolate GH
Mycophenolate Sandoz
Pharmacor Mycophenolate 500

Mycophenolic acid

GRP-26876

Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

Oral

CellCept
Pharmacor Mycophenolate

Mycophenolic acid

GRP-28115

Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid

Oral

MYCOTEX
Mycophenolic Acid ARX
Myfortic

Mycophenolic acid

GRP-28293

Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid

Oral

Mycophenolic Acid ARX
Myfortic

Naloxone

GRP-21362

Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

Injection

NALOXONE SXP
Naloxone Hydrochloride (DBL)
Naloxone Juno

Naloxone

GRP-27818

Nasal spray 1.8 mg (as hydrochloride dihydrate) in 0.1 mL single dose unit, 2

Nasal

Nyxoid

Naloxone

GRP-27818

Nasal spray 1.8 mg (as hydrochloride dihydrate) in 0.1 mL single dose unit, 2 (s19A)

Nasal

Nyxoid (UK)

Naltrexone

GRP-19914

Tablet containing naltrexone hydrochloride 50 mg

Oral

ARX-NALTREXONE
Naltrexone GH

Naproxen

GRP-20035

Tablet 1 g (sustained release)

Oral

Naprosyn SR1000
Proxen SR 1000

Naproxen

GRP-20020

Tablet containing naproxen sodium 550 mg

Oral

Anaprox 550
Crysanal

Naproxen

GRP-20009

Tablet 750 mg (sustained release)

Oral

Naprosyn SR750
Proxen SR 750

Nebivolol

GRP-22506

Tablet 1.25 mg (as hydrochloride)

Oral

APO-Nebivolol
Nebilet
Nebivolol Lupin
Nebivolol Sandoz
Nepiten

Nebivolol

GRP-22511

Tablet 5 mg (as hydrochloride)

Oral

APO-Nebivolol
Nebilet
Nebivolol Lupin
Nebivolol Sandoz
Nepiten

Nebivolol

GRP-22512

Tablet 10 mg (as hydrochloride)

Oral

APO-Nebivolol
Nebilet
Nebivolol Lupin
Nebivolol Sandoz
Nepiten

Nevirapine

GRP-19845

Tablet 200 mg

Oral

Nevirapine Alphapharm
Nevirapine Viatris

Nicorandil

GRP-19963

Tablets 20 mg, 60

Oral

APO-Nicorandil
Ikotab

Nicorandil

GRP-19964

Tablets 10 mg, 60

Oral

APO-Nicorandil
Ikotab

Nifedipine

GRP-19687

Tablet 30 mg (controlled release)

Oral

APO-Nifedipine XR
Addos XR 30

Nifedipine

GRP-19801

Tablet 60 mg (controlled release)

Oral

APO-Nifedipine XR
Addos XR 60

Niraparib

GRP-28761

Capsule 100 mg (as tosilate monohydrate)

Oral

Zejula

Niraparib

GRP-28761

Tablet 100 mg (as tosilate monohydrate)

Oral

Zejula

Nitrazepam

GRP-20002

Tablet 5 mg

Oral

Alodorm
Mogadon

Nitrofurantoin

GRP-24202

Capsule 100 mg

Oral

ARX-Nitrofurantoin
Nitrofurantoin BNM

Nitrofurantoin

GRP-25565

Capsule 50 mg

Oral

ARX-Nitrofurantoin
Nitrofurantoin BNM

Nizatidine

GRP-19651

Capsule 300 mg

Oral

Nizac
Tacidine
Tazac

Nizatidine

GRP-19784

Capsule 150 mg

Oral

Nizac
Tacidine
Tazac

Norfloxacin

GRP-19724

Tablet 400 mg

Oral

APO-Norfloxacin
Nufloxib
Roxin

Nortriptyline

GRP-21633

Tablet 25 mg (as hydrochloride)

Oral

Allegron
NortriTABS 25 mg

Nortriptyline

GRP-21641

Tablet 10 mg (as hydrochloride)

Oral

Allegron
NortriTABS 10 mg

Octreotide

GRP-17613

Injection (modified release) 10 mg (as acetate), vial and diluent syringe

Injection

Octreotide Depot
Sandostatin LAR

Octreotide

GRP-17622

Injection (modified release) 20 mg (as acetate), vial and diluent syringe

Injection

Octreotide Depot
Sandostatin LAR

Octreotide

GRP-17615

Injection (modified release) 30 mg (as acetate), vial and diluent syringe

Injection

Octreotide Depot
Sandostatin LAR

Octreotide

GRP-28766

Injection 50 micrograms (as acetate) in 1 mL (S19A)

Injection

Octreotide Acetate Omega (Canada)

Octreotide

GRP-28766

Injection 50 micrograms (as acetate) in 1 mL

Injection

Octreotide (SUN)
Octreotide GH
Sandostatin 0.05

Octreotide

GRP-28775

Injection 100 micrograms (as acetate) in 1 mL

Injection

Octreotide (SUN)
Octreotide GH
Sandostatin 0.1

Octreotide

GRP-28775

Injection 100 micrograms (as acetate) in 1 mL (S19A)

Injection

Octreotide Acetate Omega (Canada)

Octreotide

GRP-28781

Injection 500 micrograms (as acetate) in 1 mL

Injection

Octreotide (SUN)
Octreotide Acetate Omega (Canada)
Octreotide GH
Sandostatin 0.5

Olanzapine

GRP-15492

Tablet 2.5 mg

Oral

APO-OLANZAPINE
Olanzapine APOTEX
Olanzapine RBX
Olanzapine Sandoz
Ozin 2.5
PRYZEX
Zypine
Zyprexa

Olanzapine

GRP-15513

Tablet 10 mg

Oral

APO-OLANZAPINE
Olanzapine APOTEX
Olanzapine RBX
Olanzapine Sandoz
Ozin 10
PRYZEX
Zypine
Zyprexa

Olanzapine

GRP-15643

Tablet 20 mg (orally disintegrating)

Oral

APO-Olanzapine ODT
OLANZAPINE ODT-WGR
Olanzapine Sandoz ODT 20
PRYZEX ODT
Zypine ODT

Olanzapine

GRP-15643

Wafer 20 mg

Oral

Zyprexa Zydis

Olanzapine

GRP-15723

Tablet 10 mg (orally disintegrating)

Oral

APO-Olanzapine ODT
OLANZAPINE ODT-WGR
Olanzapine ODT generichealth 10
Olanzapine Sandoz ODT 10
PRYZEX ODT
Zypine ODT

Olanzapine

GRP-15723

Wafer 10 mg

Oral

Zyprexa Zydis

Olanzapine

GRP-15797

Tablet 5 mg (orally disintegrating)

Oral

APO-Olanzapine ODT
OLANZAPINE ODT-WGR
Olanzapine Sandoz ODT 5
PRYZEX ODT
Zypine ODT

Olanzapine

GRP-15797

Wafer 5 mg

Oral

Zyprexa Zydis

Olanzapine

GRP-15884

Tablet 7.5 mg

Oral

APO-OLANZAPINE
Olanzapine APOTEX
Olanzapine RBX
Olanzapine Sandoz
Ozin 7.5
PRYZEX
Zypine
Zyprexa

Olanzapine

GRP-15921

Tablet 5 mg

Oral

Olanzapine APOTEX
Olanzapine RBX
Olanzapine Sandoz
Ozin 5
PRYZEX
Zypine
Zyprexa

Olanzapine

GRP-15953

Tablet 15 mg (orally disintegrating)

Oral

APO-Olanzapine ODT
OLANZAPINE ODT-WGR
Olanzapine Sandoz ODT 15
PRYZEX ODT
Zypine ODT

Olanzapine

GRP-15953

Wafer 15 mg

Oral

Zyprexa Zydis

Olmesartan

GRP-21158

Tablet containing olmesartan medoxomil 20 mg

Oral

APO-Olmesartan
APX-Olmesartan
Blooms The Chemist Olmesartan
OLMERTAN
OLMESARTAN-WGR
Olmesartan - MYL
Olmesartan Sandoz
Olmetec
Olsetan
Pharmacor Olmesartan 20

Olmesartan

GRP-21168

Tablet containing olmesartan medoxomil 40 mg

Oral

APO-Olmesartan
APX-Olmesartan
Blooms The Chemist Olmesartan
OLMERTAN
OLMESARTAN-WGR
Olmesartan - MYL
Olmesartan Sandoz
Olmetec
Olsetan
Pharmacor Olmesartan 40

Olmesartan with amlodipine

GRP-21156

Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)

Oral

APO-OLMESARTAN/AMLODIPINE 20/5
OLMEKAR
OLMESARTAN AMLODIPINE-WGR 20/5
Olmesartan/Amlodipine - MYL 20/5
Olmesartan/Amlodipine 20/5 APOTEX
Olmesartan/Amlodipine Sandoz
Pharmacor Olmesartan Amlodipine 20/5
Sevikar 20/5

Olmesartan with amlodipine

GRP-21157

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)

Oral

OLMEKAR
OLMESARTAN AMLODIPINE-WGR 40/10
Olmesartan/Amlodipine - MYL 40/10
Olmesartan/Amlodipine 40/10 APOTEX
Olmesartan/Amlodipine Sandoz
Pharmacor Olmesartan Amlodipine 40/10
Sevikar 40/10

Olmesartan with amlodipine

GRP-21160

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)

Oral

OLMEKAR
OLMESARTAN AMLODIPINE-WGR 40/5
Olmesartan/Amlodipine - MYL 40/5
Olmesartan/Amlodipine 40/5 APOTEX
Olmesartan/Amlodipine Sandoz
Pharmacor Olmesartan Amlodipine 40/5
Sevikar 40/5

Olmesartan with amlodipine and hydrochlorothiazide

GRP-23699

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/5/25 tablet
Olamlo HCT 40/5/25
Olmekar HCT 40/5/25
Sevikar HCT 40/5/25

Olmesartan with amlodipine and hydrochlorothiazide

GRP-23700

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/10/12.5
Olamlo HCT 40/10/12.5
Olmekar HCT 40/10/12.5
Sevikar HCT 40/10/12.5

Olmesartan with amlodipine and hydrochlorothiazide

GRP-23701

Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 20/5/12.5
Olamlo HCT 20/5/12.5
Olmekar HCT 20/5/12.5
Sevikar HCT 20/5/12.5

Olmesartan with amlodipine and hydrochlorothiazide

GRP-23703

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/5/12.5 tablet
Olamlo HCT 40/5/12.5
Olmekar HCT 40/5/12.5
Sevikar HCT 40/5/12.5

Olmesartan with amlodipine and hydrochlorothiazide

GRP-23710

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/10/25
Olamlo HCT 40/10/25
Olmekar HCT 40/10/25
Sevikar HCT 40/10/25

Olmesartan with hydrochlorothiazide

GRP-21154

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg

Oral

APO-Olmesartan/HCTZ 40/12.5
APX-Olmesartan/HCTZ
OLMERTAN COMBI 40/12.5
OLMESARTAN HCTZ-WGR 40/12.5
Olmesartan HCT - MYL 40/12.5
Olmesartan/HCT Sandoz
Olmetec Plus
Pharmacor Olmesartan HCTZ 40/12.5

Olmesartan with hydrochlorothiazide

GRP-21155

Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg

Oral

APO-Olmesartan/HCTZ 20/12.5
APX-Olmesartan/HCTZ
OLMERTAN COMBI 20/12.5
OLMESARTAN HCTZ-WGR 20/12.5
Olmesartan HCT - MYL 20/12.5
Olmesartan/HCT Sandoz
Olmetec Plus
Pharmacor Olmesartan HCTZ 20/12.5

Olmesartan with hydrochlorothiazide

GRP-21161

Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

Oral

APO-Olmesartan/HCTZ 40/25
APX-Olmesartan/HCTZ
OLMERTAN COMBI 40/25
OLMESARTAN HCTZ-WGR 40/25
Olmesartan HCT - MYL 40/25
Olmesartan/HCT Sandoz
Olmetec Plus
Pharmacor Olmesartan HCTZ 40/25

Omeprazole

GRP-14650

Capsule 20 mg

Oral

APO-Omeprazole
Maxor
Omeprazole Sandoz
Pemzo
Pharmacor Omeprazole 20
Probitor

Omeprazole

GRP-14650

Tablet 20 mg

Oral

APO-Omeprazole
Maxor EC Tabs
Ozmep

Omeprazole

GRP-14650

Tablet 20 mg (as magnesium)

Oral

Acimax Tablets
Losec Tablets
Omepral
Omeprazole Sandoz

Ondansetron

GRP-15402

Wafer 8 mg

Oral

Zofran Zydis

Ondansetron

GRP-15983

Wafer 4 mg

Oral

Zofran Zydis

Ondansetron

GRP-15983

Tablet (orally disintegrating) 4 mg

Oral

APX-Ondansetron ODT
ONDANSETRON ODT-WGR
Ondansetron Mylan ODT
Ondansetron ODT Lupin
Ondansetron ODT-DRLA
Ondansetron SZ ODT
Zotren ODT

Ondansetron

GRP-15402

Tablet (orally disintegrating) 8 mg

Oral

APX-Ondansetron ODT
ONDANSETRON ODT-WGR
Ondansetron Mylan ODT
Ondansetron ODT Lupin
Ondansetron ODT Viatris
Ondansetron ODT-DRLA
Ondansetron SZ ODT
Zotren ODT

Ondansetron

GRP-19791

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron
APX-Ondansetron
ONDANSETRON-WGR
Ondansetron Mylan Tablets
Ondansetron SZ
Ondansetron Tablets Viatris
Ondansetron-DRLA
Zofran
Zotren 4

Ondansetron

GRP-19626

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron
APX-Ondansetron
ONDANSETRON-WGR
Ondansetron Mylan Tablets
Ondansetron SZ
Ondansetron Tablets Viatris
Ondansetron-DRLA
Zofran
Zotren 8

Oxazepam

GRP-20046

Tablet 15 mg

Oral

Alepam 15
Serepax

Oxazepam

GRP-19993

Tablet 30 mg

Oral

APO-Oxazepam
Alepam 30
Murelax
OXAZEPAM-WGR
Serepax

Oxycodone

GRP-19609

Tablet containing oxycodone hydrochloride 80 mg (controlled release)

Oral

OxyContin
Oxycodone Sandoz

Oxycodone

GRP-19610

Tablet containing oxycodone hydrochloride 10 mg (controlled release)

Oral

OxyContin
Oxycodone Sandoz

Oxycodone

GRP-19617

Tablet containing oxycodone hydrochloride 40 mg (controlled release)

Oral

OxyContin
Oxycodone Sandoz

Oxycodone

GRP-19619

Tablet containing oxycodone hydrochloride 20 mg (controlled release)

Oral

OxyContin
Oxycodone Sandoz

Oxycodone

GRP-22722

Capsule containing oxycodone hydrochloride 5 mg

Oral

OxyNorm
Oxycodone BNM

Oxycodone

GRP-23065

Capsule containing oxycodone hydrochloride 20 mg

Oral

OxyNorm
Oxycodone BNM

Oxycodone

GRP- 23063

Capsule containing oxycodone hydrochloride 10 mg

Oral

OxyNorm
Oxycodone BNM

Oxycodone

GRP-22722

Tablet containing oxycodone hydrochloride 5 mg

Oral

ENDONE
Mayne Pharma Oxycodone IR
Oxycodone Viatris
Oxyndone

Palonosetron

GRP-26174

Injection 250 micrograms (as hydrochloride) in 5 mL

Injection

Aloxi
PALONOSETRON Medsurge
Palonosetron Dr.Reddy's

Pantoprazole

GRP-19833

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole
BTC Pantoprazole
NOUMED PANTOPRAZOLE
Ozpan
PANTOPRAZOLE-WGR
Panthron
Pantoprazole APOTEX
Pantoprazole Sandoz
Pantoprazole generichealth
Salpraz
Somac
Sozol

Pantoprazole

GRP-20087

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

APO-Pantoprazole
APX-PANTOPRAZOLE
BTC Pantoprazole
I-Pantoprazole
NOUMED PANTOPRAZOLE
Ozpan
PANTOPRAZOLE-WGR
Panthron
Pantoprazole APOTEX
Pantoprazole Sandoz
Pantoprazole generichealth
Salpraz
Somac
Sozol

Paracetamol

GRP-20015

Tablet 500 mg

Oral

APO-Paracetamol
Febridol
PHARMACY CARE PARACETAMOL
Panamax
Paracetamol (Sandoz)
Paracetamol Sandoz Pharma
Paralgin
Parapane
Wagner Health Paracetamol

Paracetamol

GRP-20761

Tablet 665 mg (modified release)

Oral

APOHEALTH Osteo Relief Paracetamol 665 mg
Osteomol 665 Paracetamol
Parapane OSTEO

Paroxetine

GRP-15790

Tablet 20 mg (as hydrochloride)

Oral

APO-Paroxetine
APX-Paroxetine
Aropax
Blooms The Chemist Paroxetine
Extine 20
Noumed Paroxetine
PAROXETINE-WGR
Paroxetine GH
Paroxetine Sandoz
Paxtine

Pegfilgrastim

GRP-21364

Injection 6 mg in 0.6 mL single use pre-filled syringe

Injection

Pelgraz
Ziextenzo

Perindopril

GRP-15442

Tablet containing perindopril arginine 5 mg

Oral

APO-Perindopril Arginine
APX-Perindopril Arginine
Coversyl 5mg
PREXUM 5
Perindopril Arginine Sandoz
Perindopril Arginine-WGR

Perindopril

GRP-15442

Tablet containing perindopril erbumine 4 mg

Oral

APO-Perindopril
Blooms the Chemist Perindopril
Idaprex 4
Indosyl Mono 4
PERINDOPRIL-WGR
PERISYL
Perindo

Perindopril

GRP-15525

Tablet containing perindopril arginine 10 mg

Oral

APO-Perindopril Arginine
APX-Perindopril Arginine
Coversyl 10mg
PREXUM 10
Perindopril Arginine Sandoz
Perindopril Arginine-WGR

Perindopril

GRP-15525

Tablet containing perindopril erbumine 8 mg

Oral

APO-Perindopril
Blooms the Chemist Perindopril
Idaprex 8
Indosyl Mono 8
PERINDOPRIL-WGR
PERISYL
Perindo

Perindopril

GRP-15965

Tablet containing perindopril arginine 2.5 mg

Oral

APO-Perindopril Arginine
APX-Perindopril Arginine
Coversyl 2.5mg
PREXUM 2.5
Perindopril Arginine Sandoz
Perindopril Arginine-WGR

Perindopril

GRP-15965

Tablet containing perindopril erbumine 2 mg

Oral

APO-Perindopril
Blooms the Chemist Perindopril
Idaprex 2
Indosyl Mono 2
PERINDOPRIL-WGR
PERISYL
Perindo

Perindopril with amlodipine

GRP-19627

Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besilate)

Oral

APO-Perindopril Arginine/Amlodipine 10/10
APX-Perindopril Arginine/Amlodipine 10/10
Coveram 10/10
Reaptan 10/10

Perindopril with amlodipine

GRP-19798

Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besilate)

Oral

APO-Perindopril Arginine/Amlodipine 10/5
APX-Perindopril Arginine/Amlodipine 10/5
Coveram 10/5
Reaptan 10/5

Perindopril with amlodipine

GRP-19886

Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besilate)

Oral

APO-Perindopril Arginine/Amlodipine 5/10
APX-Perindopril Arginine/Amlodipine 5/10
Coveram 5/10
Reaptan 5/10

Perindopril with amlodipine

GRP-19936

Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besilate)

Oral

APO-Perindopril Arginine/Amlodipine 5/5
APX-Perindopril Arginine/Amlodipine 5/5
Coveram 5/5
Reaptan 5/5

Perindopril with indapamide

GRP-15765

Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg

Oral

Coversyl Plus 5mg/1.25mg
Prexum Combi 5/1.25

Perindopril with indapamide

GRP-15765

Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

Oral

APO-Perindopril/Indapamide
GenRx Perindopril/ Indapamide 4/1.25
Idaprex Combi 4/1.25
Indosyl Combi 4/1.25
PERINDOPRIL/INDAPAMIDE-WGR 4/1.25
PERISYL COMBI 4/1.25
Perindo Combi 4/1.25

Perindopril with indapamide

GRP-21205

Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg

Oral

Coversyl Plus LD 2.5mg/0.625mg
PREXUM Combi LD 2.5/0.625

Pioglitazone

GRP-19790

Tablet 45 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone
Acpio 45
Actaze
Actos
Vexazone

Pioglitazone

GRP-19814

Tablet 15 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone
ARX-PIOGLITAZONE
Acpio 15
Actaze
Actos
Vexazone

Pioglitazone

GRP-19943

Tablet 30 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone
Acpio 30
Actaze
Actos
Vexazone

Pirfenidone

GRP-27890

Tablet 267 mg

Oral

Pirfenidet
Pirfenidone Ameda
Pirfenidone Dr.Reddy's
Pirfenidone Sandoz

Pirfenidone

GRP-27892

Tablet 801mg

Oral

Pirfenidet
Pirfenidone Ameda
Pirfenidone Dr.Reddy's
Pirfenidone Sandoz

Plerixafor

GRP-26646

Injection 24 mg in 1.2 mL

Injection

Mozobil
PLERIXAFOR EUGIA
Plerixafor ARX

Polyethylene glycol 400 with propylene glycol

GRP-26947

Eye drops 4 mg-3 mg per mL, 15 mL

Application to the eye

Optix
Systane

Posaconazole

GRP-24439

Tablet (modified release) 100 mg

Oral

POSACONAZOLE DR.REDDY'S
POSACONAZOLE-WGR
Pharmacor Posaconazole
Posaconazole ARX
Posaconazole Juno
Posaconazole Sandoz

Pramipexole

GRP-19734

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

APO-Pramipexole
Sifrol
Simipex 1
Simpral

Pramipexole

GRP-19836

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

APO-Pramipexole
Sifrol
Simipex 0.125
Simpral

Pramipexole

GRP-19688

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

APO-Pramipexole
Sifrol
Simipex 0.25
Simpral

Pramipexole

GRP-20529

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

APO-Pramipexole ER
SIMIPEX XR
Sifrol ER

Pramipexole

GRP-20530

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

APO-Pramipexole ER
SIMIPEX XR
Sifrol ER

Pramipexole

GRP-20531

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

APO-Pramipexole ER
SIMIPEX XR
Sifrol ER

Pramipexole

GRP-20532

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

APO-Pramipexole ER
SIMIPEX XR
Sifrol ER

Pramipexole

GRP-20533

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

APO-Pramipexole ER
SIMIPEX XR
Sifrol ER

Pramipexole

GRP-20534

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

APO-Pramipexole ER
SIMIPEX XR
Sifrol ER

Pramipexole

GRP-20535

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

APO-Pramipexole ER
SIMIPEX XR
Sifrol ER

Pravastatin

GRP-20082

Tablet containing pravastatin sodium 80 mg

Oral

APX-Pravastatin
Lipostat 80
Pravachol

Pravastatin

GRP-20142

Tablet containing pravastatin sodium 40 mg

Oral

APX-Pravastatin
Cholstat 40
Lipostat 40
PRAVASTATIN-WGR
Pravachol
Pravastatin Sandoz

Pravastatin

GRP-20150

Tablet containing pravastatin sodium 20 mg

Oral

APX-Pravastatin
Cholstat 20
Lipostat 20
PRAVASTATIN-WGR
Pravachol
Pravastatin Sandoz

Pravastatin

GRP-20171

Tablet containing pravastatin sodium 10 mg

Oral

APX-Pravastatin
Cholstat 10
Lipostat 10
PRAVASTATIN-WGR
Pravachol
Pravastatin Sandoz

Prazosin

GRP-19831

Tablet 2 mg (as hydrochloride)

Oral

APO-Prazosin
Minipress

Prazosin

GRP-19871

Tablet 5 mg (as hydrochloride)

Oral

APO-Prazosin
Minipress

Prazosin

GRP-19942

Tablet 1 mg (as hydrochloride)

Oral

APO-Prazosin
Minipress

Prednisolone

GRP-19757

Tablet 1 mg

Oral

Panafcortelone
Predsolone

Prednisolone

GRP-19768

Oral solution 5 mg (as sodium phosphate) per mL, 30 mL

Oral

PredMix
Redipred

Prednisone

GRP-19658

Tablet 1 mg

Oral

Panafcort
Predsone

Pregabalin

GRP-21628

Capsule 300 mg

Oral

APO-Pregabalin
BTC Pregabalin
Blooms The Chemist Pregabalin
Lyrica
Lyzalon
NOUMED PREGABALIN
Neuroccord
PREGABALIN-DRLA
PREGABALIN-WGR
Prebalin
Pregabalin Lupin
Pregabalin Sandoz

Pregabalin

GRP-21634

Capsule 75 mg

Oral

APO-Pregabalin
BTC Pregabalin
Lyrica
Lyzalon
NOUMED PREGABALIN
Neuroccord
PREGABALIN-DRLA
PREGABALIN-WGR
Prebalin
Pregabalin Lupin
Pregabalin Sandoz

Pregabalin

GRP-21640

Capsule 150 mg

Oral

APO-Pregabalin
BTC Pregabalin
Blooms The Chemist Pregabalin
Cipla Pregabalin
Lyrica
Lyzalon
NOUMED PREGABALIN
Neuroccord
PREGABALIN-DRLA
PREGABALIN-WGR
Prebalin
Pregabalin Lupin
Pregabalin Sandoz

Pregabalin

GRP-21642

Capsule 25 mg

Oral

APO-Pregabalin
BTC Pregabalin
Blooms The Chemist Pregabalin
Lyrica
Lyzalon
NOUMED PREGABALIN
Neuroccord
PREGABALIN-DRLA
PREGABALIN-WGR
Prebalin
Pregabalin Lupin
Pregabalin Sandoz

Prochlorperazine

GRP-28600

Tablet containing prochlorperazine maleate 5 mg (S19A)

Oral

Stemetil (Ireland)

Prochlorperazine

GRP-28600

Tablet containing prochlorperazine maleate 5 mg

Oral

APO-Prochlorperazine
PROCHLORPERAZINE-WGR
ProCalm
Prochlorperazine GH
Stemetil

Propranolol

GRP-20367

Tablet containing propranolol hydrochloride 40 mg

Oral

APO-Propranolol
Deralin 40
Inderal
PROPRANOLOL-WGR

Propranolol

GRP-20376

Tablet containing propranolol hydrochloride 10 mg

Oral

APO-Propranolol
Deralin 10
Inderal
PROPRANOLOL-WGR

Quetiapine

GRP-19663

Tablet 300 mg (as fumarate)

Oral

APX-QUETIAPINE
Blooms The Chemist Quetiapine
Kaptan
Pharmacor Quetiapine 300
Quetia 300
Quetiapine APOTEX
Quetiapine RBX
Quetiapine Sandoz Pharma
Seroquel
Syquet

Quetiapine

GRP-19709

Tablet 200 mg (as fumarate)

Oral

APX-QUETIAPINE
Blooms The Chemist Quetiapine
Kaptan
Pharmacor Quetiapine 200
Quetia 200
Quetiapine APOTEX
Quetiapine RBX
Quetiapine Sandoz Pharma
Seroquel
Syquet

Quetiapine

GRP-19767

Tablet 100 mg (as fumarate)

Oral

APX-QUETIAPINE
Blooms The Chemist Quetiapine
Kaptan
Pharmacor Quetiapine 100
Quetia 100
Quetiapine APOTEX
Quetiapine RBX
Quetiapine Sandoz Pharma
Seroquel
Syquet

Quetiapine

GRP-19935

Tablet 25 mg (as fumarate)

Oral

APX-QUETIAPINE
Blooms The Chemist Quetiapine
Kaptan
Pharmacor Quetiapine 25
Quetia 25
Quetiapine APOTEX
Quetiapine RBX
Quetiapine Sandoz Pharma
Seroquel
Syquet

Quetiapine

GRP-20702

Tablet (modified release) 200 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetia XR
Quetiapine Sandoz XR
Seroquel XR
Tevatiapine XR

Quetiapine

GRP-20713

Tablet (modified release) 300 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetia XR
Quetiapine Sandoz XR
Seroquel XR
Tevatiapine XR

Quetiapine

GRP-20726

Tablet (modified release) 400 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetia XR
Quetiapine Sandoz XR
Seroquel XR
Tevatiapine XR

Quetiapine

GRP-20779

Tablet (modified release) 50 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetia XR
Quetiapine Sandoz XR
Seroquel XR
Tevatiapine XR

Quetiapine

GRP-21163

Tablet (modified release) 150 mg (as fumarate)

Oral

APX-Quetiapine XR
Quetia XR
Quetiapine Sandoz XR
Seroquel XR
Tevatiapine XR

Quinapril

GRP-19716

Tablet 20 mg (as hydrochloride)

Oral

ACQUIN
APO-Quinapril
Accupril

Quinapril

GRP-19789

Tablet 5 mg (as hydrochloride)

Oral

ACQUIN
Accupril

Quinapril

GRP-19902

Tablet 10 mg (as hydrochloride)

Oral

ACQUIN
APO-Quinapril
Accupril

Rabeprazole

GRP-19921

Tablet containing rabeprazole sodium 10 mg (enteric coated)

Oral

APO-Rabeprazole
Parbezol
Pariet
RABEPRAZOLE-WGR
Rabeprazole Sandoz

Rabeprazole

GRP-20107

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

APO-Rabeprazole
Noumed Rabeprazole
Parbezol
Pariet
RABEPRAZOLE-WGR
Rabeprazole Mylan
Rabeprazole SUN
Rabeprazole Sandoz
Zabep

Raloxifene

GRP-19622

Tablet containing raloxifene hydrochloride 60 mg

Oral

Evista
Fixta 60
RALOVISTA
Raloxifene GH

Ramipril

GRP-15424

Capsule 5 mg

Oral

APO-Ramipril
Tryzan Caps 5

Ramipril

GRP-15424

Tablet 5 mg

Oral

APO-Ramipril
Prilace
RAMIPRIL-WGR
Ramipril Sandoz
Ramipril Viatris
Ramipril Winthrop
Tritace 5 mg
Tryzan Tabs 5

Ramipril

GRP-15431

Capsule 10 mg

Oral

APO-Ramipril
APX-Ramipril
Prilace
RAMIPRIL-WGR
Ramipril Sandoz
Ramipril Winthrop
Tritace 10 mg
Tryzan Caps 10

Ramipril

GRP-15431

Tablet 10 mg

Oral

APO-Ramipril
RAMIPRIL TABS-WGR
Ramipril Sandoz
Ramipril Viatris
Tritace
Tryzan Tabs 10

Ramipril

GRP-15640

Capsule 1.25 mg

Oral

Tryzan Caps 1.25

Ramipril

GRP-15640

Tablet 1.25 mg

Oral

Prilace
RAMIPRIL-WGR
Ramipril Sandoz
Ramipril Viatris
Ramipril Winthrop
Tritace 1.25 mg
Tryzan Tabs 1.25

Ramipril

GRP-15769

Capsule 2.5 mg

Oral

APO-Ramipril
Tryzan Caps 2.5

Ramipril

GRP-15769

Tablet 2.5 mg

Oral

APO-Ramipril
Prilace
RAMIPRIL-WGR
Ramipril Sandoz
Ramipril Viatris
Ramipril Winthrop
Tritace 2.5 mg
Tryzan Tabs 2.5

Ranibizumab

GRP-17312

Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe

Injection

Lucentis

Ranibizumab

GRP-17312

Solution for intravitreal injection 2.3 mg in 0.23 mL

Injection

Lucentis

Rasagiline

GRP-22819

Tablet 1 mg (as mesilate)

Oral

Alziras
Azilect
Pharmacor Rasagiline
RASAGILINE-WGR
Rasagiline Lupin
Rasagiline Sandoz
Rasagiline-Teva

Riluzole

GRP-19669

Tablet 50 mg

Oral

APO-Riluzole
Pharmacor Riluzole
Rilutek
Riluzole Sandoz

Risedronic acid

GRP-19671

Tablet containing risedronate sodium 150 mg

Oral

APO-Risedronate
Actonel Once-a-Month

Risedronic acid

GRP-19999

Tablet containing risedronate sodium 35 mg

Oral

APO-Risedronate
RISEDRONATE-WGR
Risedronate Sandoz
 

Risperidone

GRP-14646

Tablet 0.5 mg

Oral

APO-Risperidone
NOUMED RISPERIDONE
Ozidal
Rispa
Risperdal
Risperidone Sandoz
Rispernia
Rixadone

Risperidone

GRP-19844

Tablet 4 mg

Oral

APO-Risperidone
NOUMED RISPERIDONE
Rispa
Risperdal
Risperidone Sandoz
Rispernia
Rixadone

Risperidone

GRP-19938

Tablet 3 mg

Oral

APO-Risperidone
NOUMED RISPERIDONE
Ozidal
Rispa
Risperdal
Risperidone Sandoz
Rispernia
Rixadone

Risperidone

GRP-20017

Tablet 2 mg

Oral

APO-Risperidone
NOUMED RISPERIDONE
Ozidal
Rispa
Risperdal
Risperidone Sandoz
Rispernia
Rixadone

Risperidone

GRP-20120

Tablet 1 mg

Oral

APO-Risperidone
NOUMED RISPERIDONE
Ozidal
Rispa
Risperdal
Risperidone Sandoz
Rispernia
Rixadone

Risperidone

GRP-24014

Oral solution 1 mg per mL, 100 mL

Oral

Risperdal
Risperidone Lupin
Rixadone

Rituximab

GRP-26546

Solution for I.V. infusion 500 mg in 50 mL

Injection

Riximyo
Ruxience
Truxima

Rituximab

GRP-26547

Solution for I.V. infusion 100 mg in 10 mL

Injection

Riximyo
Ruxience
Truxima

Rizatriptan

GRP-17623

Tablet (orally disintegrating) 10 mg (as benzoate)

Oral

APO-Rizatriptan
RIXALT
RIZATRIPTAN ODT-WGR
Rizatriptan ODT APOTEX
Rizatriptan ODT GH

Rizatriptan

GRP-17623

Wafer 10 mg (as benzoate)

Oral

Maxalt
Rizatriptan Wafers-10mg

Rosuvastatin

GRP-19557

Tablet 20 mg (as calcium)

Oral

APO-ROSUVASTATIN
APX-Rosuvastatin
Blooms Rosuvastatin
Cavstat
Crestor
Crosuva 20
Pharmacor Rosuvastatin 20
ROSUVASTATIN-WGR
Rosuvastatin APOTEX
Rosuvastatin Lupin
Rosuvastatin RBX
Rosuvastatin Sandoz

Rosuvastatin

GRP-19558

Tablet 10 mg (as calcium)

Oral

APO-ROSUVASTATIN
APX-Rosuvastatin
Blooms Rosuvastatin
Cavstat
Crestor
Crosuva 10
Pharmacor Rosuvastatin 10
ROSUVASTATIN-WGR
Rosuvastatin APOTEX
Rosuvastatin Lupin
Rosuvastatin RBX
Rosuvastatin Sandoz

Rosuvastatin

GRP-19562

Tablet 40 mg (as calcium)

Oral

APO-ROSUVASTATIN
APX-Rosuvastatin
Blooms Rosuvastatin
Cavstat
Crestor
Crosuva 40
Pharmacor Rosuvastatin 40
ROSUVASTATIN-WGR
Rosuvastatin APOTEX
Rosuvastatin Lupin
Rosuvastatin RBX
Rosuvastatin Sandoz

Rosuvastatin

GRP-19569

Tablet 5 mg (as calcium)

Oral

APO-ROSUVASTATIN
APX-Rosuvastatin
Blooms Rosuvastatin
Cavstat
Crestor
Crosuva 5
Pharmacor Rosuvastatin 5
ROSUVASTATIN-WGR
Rosuvastatin APOTEX
Rosuvastatin Lupin
Rosuvastatin RBX
Rosuvastatin Sandoz

Roxithromycin

GRP-20052

Tablet 150 mg

Oral

APO-Roxithromycin
APX-Roxithromycin
ROXITHROMYCIN-WGR
Roxar 150
Roxithromycin Sandoz

Roxithromycin

GRP-20144

Tablet 300 mg

Oral

APO-Roxithromycin
APX-Roxithromycin
ROXITHROMYCIN-WGR
Roxar 300
Roxithromycin Sandoz

Salbutamol

GRP-21361

Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20

Inhalation

Ventolin Nebules

Salbutamol

GRP-21361

Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

Inhalation

Salbutamol Cipla

Salbutamol

GRP-21535

Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20

Inhalation

Ventolin Nebules

Salbutamol

GRP-21535

Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 (S19A)

Inhalation

pms-SALBUTAMOL

Salbutamol

GRP-21535

Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30

Inhalation

Salbutamol Cipla

Salbutamol

GRP-24211

Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

Inhalation by mouth

Asmol CFC-Free with dose counter
Ventolin CFC-Free with dose counter
Zempreon CFC-Free with dose counter

Sertraline

GRP-24879

Tablet 50 mg (as hydrochloride)

Oral

APO-Sertraline
Blooms The Chemist Sertraline
Eleva 50
NOUMED SERTRALINE
SERTRALINE-WGR
Sertra 50
Sertraline Sandoz
Sertraline generichealth
Setrona
Zoloft

Sertraline

GRP-24880

Tablet 100 mg (as hydrochloride)

Oral

APO-Sertraline
Blooms The Chemist Sertraline
Eleva 100
NOUMED SERTRALINE
SERTRALINE-WGR
Sertra 100
Sertraline Sandoz
Sertraline generichealth
Setrona
Zoloft

Sevelamer

GRP-23578

Tablet containing sevelamer carbonate 800 mg

Oral

ARX-SEVELAMER
Sevelamer Apotex
Sevelamer Lupin

Sevelamer

GRP-23578

Tablet containing sevelamer hydrochloride 800 mg

Oral

Renagel

Sildenafil

GRP-20013

Tablet 20 mg (as citrate)

Oral

Revatio
SILDATIO PHT
Sildenafil PHT APOTEX
Sildenafil Sandoz PHT 20

Simvastatin

GRP-20109

Tablet 80 mg

Oral

APO-Simvastatin
Simvar 80
Simvastatin Sandoz
Zimstat

Simvastatin

GRP-20174

Tablet 20 mg

Oral

APO-Simvastatin
Lipex 20
NOUMED SIMVASTATIN
Simvar 20
Simvastatin Sandoz
Zimstat
Zocor

Simvastatin

GRP-20182

Tablet 40 mg

Oral

APO-Simvastatin
Lipex 40
NOUMED SIMVASTATIN
Simvar 40
Simvastatin Sandoz
Zimstat
Zocor

Simvastatin

GRP-20328

Tablet 10 mg

Oral

APO-Simvastatin
NOUMED SIMVASTATIN
Simvar 10
Simvastatin Sandoz
Zimstat

Simvastatin

GRP-20357

Tablet 5 mg

Oral

Simvastatin Sandoz
Zimstat

Sitagliptin

GRP-26493

Tablet 50 mg

Oral

Januvia
Sitagliptin Lupin
Sitagliptin Mylan
Sitagliptin SUN
Sitagliptin Sandoz Pharma
Sitaglo
Xelevia

Sitagliptin

GRP-26495

Tablet 25 mg

Oral

Januvia
Sitagliptin Lupin
Sitagliptin Mylan
Sitagliptin SUN
Sitagliptin Sandoz Pharma
Sitaglo
Xelevia

Sitagliptin

GRP-26496

Tablet 100 mg

Oral

Januvia
Sitagliptin Lupin
Sitagliptin Mylan
Sitagliptin SUN
Sitagliptin Sandoz Pharma
Sitaglo
Xelevia

Sitagliptin with metformin

GRP-26448

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

Janumet
SITAGLIPTIN/METFORMIN 50/850 SUN
Sitagliptin/Metformin Mylan 50/850
Sitagliptin/Metformin Sandoz
Velmetia

Sitagliptin with metformin

GRP-26451

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

Janumet
SITAGLIPTIN/METFORMIN 50/500 SUN
Sitagliptin/Metformin Mylan 50/500
Sitagliptin/Metformin Sandoz
Velmetia

Sitagliptin with metformin

GRP-26455

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet
SITAGLIPTIN/METFORMIN 50/1000 SUN
Sitagliptin/Metformin Mylan 50/1000
Sitagliptin/Metformin Sandoz
Velmetia

Sitagliptin with metformin

GRP-28124

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR
Sitagliptin/Metformin Sandoz XR

Sitagliptin with metformin

GRP-28131

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR
Sitagliptin/Metformin Sandoz XR

Sotalol

GRP-19704

Tablet containing sotalol hydrochloride 160 mg

Oral

APX-Sotalol
Cardol
SOTALOL-WGR
Solavert
Sotacor
Sotalol Sandoz

Sotalol

GRP-19874

Tablet containing sotalol hydrochloride 80 mg

Oral

APX-Sotalol
Cardol
SOTALOL-WGR
Solavert
Sotacor
Sotalol Sandoz

Spironolactone

GRP-19653

Tablet 100 mg

Oral

Aldactone
Spiractin 100
Spironolactone Viatris 100

Spironolactone

GRP-19873

Tablet 25 mg

Oral

Aldactone
Spiractin 25
Spironolactone Viatris 25

Sulfasalazine

GRP-20249

Tablet 500 mg (enteric coated)

Oral

Pyralin EN
Salazopyrin-EN

Sumatriptan

GRP-15928

Tablet 50 mg (as succinate)

Oral

APO-Sumatriptan
IMIGRAN MIGRAINE
Imigran
Iptam
Pharmacor Sumatriptan 50
SUMATRIPTAN-WGR
Sumagraine Migraine Relief
Sumatran
Sumatriptan Sandoz
Sumatriptan generichealth

Sumatriptan

GRP-15928

Tablet (fast disintegrating) 50 mg (as succinate)

Oral

Imigran FDT

Sunitinib

GRP-25556

Capsule 37.5 mg

Oral

ARX-Sunitinib
Sunitinib MSN
Sunitinib Sandoz
Sutent

Sunitinib

GRP-25554

Capsule 25 mg

Oral

ARX-Sunitinib
Sunitinib MSN
Sunitinib Sandoz
Sutent

Sunitinib

GRP-25561

Capsule 12.5 mg

Oral

Sunitinib MSN
Sunitinib Sandoz
Sutent

Sunitinib

GRP-25553

Capsule 50 mg

Oral

ARX-Sunitinib
Sunitinib MSN
Sunitinib Sandoz
Sutent

Tacrolimus

GRP-19985

Capsule 1 mg

Oral

Pacrolim
Pharmacor Tacrolimus 1
Prograf
Tacrograf
Tacrolimus Sandoz

Tacrolimus

GRP-20056

Capsule 5 mg

Oral

Pharmacor Tacrolimus 5
Prograf
Tacrograf
Tacrolimus Sandoz

Tacrolimus

GRP-20053 

 

Capsule 0.5 mg

Oral

Pacrolim
Pharmacor Tacrolimus 0.5
Prograf
Tacrograf
Tacrolimus Sandoz

Tacrolimus

GRP-20887

Capsule 5 mg (once daily prolonged release)

Oral

ADVAGRAF XL
Tacrolimus XR Sandoz

Tacrolimus

GRP-20891

Capsule 1 mg (once daily prolonged release)

Oral

ADVAGRAF XL
Tacrolimus XR Sandoz

Tacrolimus

GRP- 20892

Capsule 0.5 mg (once daily prolonged release)

Oral

ADVAGRAF XL
Tacrolimus XR Sandoz

Tacrolimus

GRP-28602

Capsule 3 mg (once daily prolonged release)

Oral

ADVAGRAF XL
Tacrolimus XR Sandoz

Tadalafil

GRP-24271

Tablet 20 mg

Oral

Adcirca
TADALIS 20
Tadalca

Tamoxifen

GRP-15405

Tablet 20 mg (as citrate)

Oral

GenRx Tamoxifen
Genox 20
Nolvadex-D
Tamosin
Tamoxifen Sandoz

Telmisartan

GRP-19601

Tablet 80 mg

Oral

APO-Telmisartan
Micardis
Mizart
NOUMED TELMISARTAN
Pharmacor Telmisartan 80
TELMISARTAN-WGR
Telmisartan Sandoz
Teltartan

Telmisartan

GRP-19604

Tablet 40 mg

Oral

APO-Telmisartan
Micardis
Mizart
NOUMED TELMISARTAN
Pharmacor Telmisartan 40
TELMISARTAN-WGR
Telmisartan Sandoz
Teltartan

Telmisartan with amlodipine

GRP-19587

Tablet 40 mg-5 mg (as besilate)

Oral

Pritor/Amlodipine
Twynsta

Telmisartan with amlodipine

GRP-19588

Tablet 40 mg-10 mg (as besilate)

Oral

Pritor/Amlodipine
Twynsta

Telmisartan with amlodipine

GRP-19589

Tablet 80 mg-10 mg (as besilate)

Oral

Pritor/Amlodipine
Twynsta

Telmisartan with amlodipine

GRP-19590

Tablet 80 mg-5 mg (as besilate)

Oral

Pritor/Amlodipine
Twynsta

Telmisartan with hydrochlorothiazide

GRP-19555

Tablet 40 mg-12.5 mg

Oral

APO-Telmisartan HCTZ 40/12.5
Micardis Plus 40/12.5 mg
Mizart HCT 40/12.5 mg
TELMISARTAN HCTZ-WGR 40/12.5
Telmisartan/HCT Sandoz
Teltartan HCT 40/12.5

Telmisartan with hydrochlorothiazide

GRP-19561

Tablet 80 mg-12.5 mg

Oral

APO-Telmisartan HCTZ 80/12.5
Micardis Plus 80/12.5 mg
Mizart HCT 80/12.5 mg
TELMISARTAN HCTZ-WGR 80/12.5
Telmisartan/HCT Sandoz
Teltartan HCT 80/12.5

Telmisartan with hydrochlorothiazide

GRP-19571

Tablet 80 mg-25 mg

Oral

APO-Telmisartan HCTZ 80/25
Micardis Plus 80/25 mg
Mizart HCT 80/25 mg
TELMISARTAN HCTZ-WGR 80/25
Telmisartan/HCT Sandoz
Teltartan HCT 80/25

Temazepam

GRP-19980

Tablet 10 mg

Oral

APO-Temazepam
Normison
TEMAZEPAM-WGR
Temaze
Temtabs

Temozolomide

GRP-19803

Capsule 250 mg

Oral

APO-Temozolomide
Temizole 250
Temozolomide Juno

Temozolomide

GRP-19977

Capsule 20 mg

Oral

APO-Temozolomide
Temizole 20
Temozolomide Juno

Temozolomide

GRP-19997

Capsule 5 mg

Oral

APO-Temozolomide
Temizole 5
Temozolomide Juno

Temozolomide

GRP-20004

Capsule 180 mg

Oral

APO-Temozolomide
Temozolomide Juno

Temozolomide

GRP-20068

Capsule 140 mg

Oral

APO-Temozolomide
Temizole 140
Temodal
Temozolomide Juno

Temozolomide

GRP-20268

Capsule 100 mg

Oral

APO-Temozolomide
Temizole 100
Temodal
Temozolomide Juno

Tenecteplase

GRP-26656

Powder for injection 50 mg with solvent

Injection

Metalyse

Tenecteplase

GRP-26656

Powder for injection 50 mg with solvent (s19A)

Injection

TNKase (Canada)
TNKase (Canada) Medsurge Healthcare Pty Ltd

Tenofovir

GRP-21636

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

TENOFOVIR ARX
Tenofovir APOTEX
Tenofovir Sandoz
Viread

Tenofovir

GRP-21636

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Mylan
Tenofovir Disoproxil Viatris

Tenofovir

GRP-21636

Tablet containing tenofovir disoproxil phosphate 291 mg

Oral

Tenofovir GH

Tenofovir with emtricitabine

GRP- 21638

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

CIPLA TENOFOVIR + EMTRICITABINE 300/200
TENOFOVIR/EMTRICITABINE 300/200 ARX
Tenofovir/Emtricitabine 300/200 APOTEX

Tenofovir with emtricitabine

GRP-21638

Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg

Oral

Tenofovir Disoproxil Emtricitabine Viatris 300/200

Tenofovir with emtricitabine

GRP-21638

Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg

Oral

Tenofovir EMT GH

Tenofovir with emtricitabine

GRP- 21638

Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine Sandoz 301/200

Terbinafine

GRP-20256

Tablet 250 mg (as hydrochloride)

Oral

APO-Terbinafine
Lamisil (Novartis Pharmaceuticals Australia Pty Limited)
NOUMED TERBINAFINE
TERBINAFINE-WGR
Tamsil
Terbinafine Sandoz
Terbinafine-DRLA
Tinasil

Teriflunomide

GRP-23068

Tablet 14 mg

Oral

APO-TERIFLUNOMIDE
Pharmacor Teriflunomide
TERIFLAGIO
Teriflunomide Dr.Reddy's
Teriflunomide GH
Teriflunomide Sandoz
Terimide

Teriparatide

GRP-25564

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen

Injection

Teriparatide Lupin
Terrosa

Testosterone

GRP-28648

I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL

Injection

Gonadron
REJUNON 1000
Reandron 1000
Testosterone ADVZ 1000

Tetrabenazine

GRP-26950

Tablet 25 mg

Oral

Tetrabenazine SUN
iNova Pharmaceuticals (Australia) Pty Ltd

Timolol

GRP-28880

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Timoptol XE

Timolol

GRP-28880

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL (S19A)

Application to the eye

Timoptol XE 0.50% (South Africa)

Tiotropium

GRP-23704

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

Inhalation by mouth

Braltus

Tiotropium

GRP-23704

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

Inhalation by mouth

Spiriva

Tiotropium

GRP-23704

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)

Inhalation by mouth

Tiotropium Lupin

Tirofiban

GRP-19593

Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL

Injection

Aggrastat
Tirofiban Juno

Tobramycin

GRP-20899

Solution for inhalation 300 mg in 5 mL

Inhalation

TOBRAMYCIN SUN
Tobi
Tobramycin WKT

Topiramate

GRP-19668

Tablet 200 mg

Oral

APO-Topiramate
Epiramax 200
RBX Topiramate
TOPIRAMATE-WGR
Tamate
Topiramate Sandoz

Topiramate

GRP-19765

Tablet 50 mg

Oral

APO-Topiramate
Epiramax 50
RBX Topiramate
TOPIRAMATE-WGR
Tamate
Topiramate Sandoz

Topiramate

GRP-19766

Tablet 100 mg

Oral

APO-Topiramate
Epiramax 100
RBX Topiramate
TOPIRAMATE-WGR
Tamate
Topiramate Sandoz

Topiramate

GRP-19896

Tablet 25 mg

Oral

APO-Topiramate
Epiramax 25
RBX Topiramate
TOPIRAMATE-WGR
Tamate
Topiramate Sandoz

Tramadol

GRP-20129

Injection containing tramadol hydrochloride 100 mg in 2 mL

Injection

Tramadol AN
Tramadol Sandoz
Tramal 100

Tramadol

GRP-19670

Tablet (sustained release) containing tramadol hydrochloride 100 mg

Oral

APO-Tramadol SR
TRAMADOL-WGR SR
Tramadol SR generichealth
Tramadol Sandoz SR
Tramal SR 100
Tramedo SR
Zydol SR 100

Tramadol

GRP-19805

Tablet (sustained release) containing tramadol hydrochloride 200 mg

Oral

APO-Tramadol SR
TRAMADOL-WGR SR
Tramadol SR generichealth
Tramadol Sandoz SR
Tramal SR 200
Tramedo SR
Zydol SR 200

Tramadol

GRP-19815

Tablet (sustained release) containing tramadol hydrochloride 150 mg

Oral

APO-Tramadol SR
TRAMADOL-WGR SR
Tramadol SR generichealth
Tramadol Sandoz SR
Tramal SR 150
Tramedo SR
Zydol SR 150

Tramadol

GRP-20030

Capsule containing tramadol hydrochloride 50 mg

Oral

APO-Tramadol
TRAMADOL-WGR
Tramadol Sandoz
Tramal
Tramedo
Zydol

Trandolapril

GRP-19654

Capsule 2 mg

Oral

Dolapril 2
Gopten
Tranalpha

Trandolapril

GRP-19735

Capsule 500 micrograms

Oral

Dolapril 0.5
Gopten
Tranalpha

Trandolapril

GRP-19830

Capsule 1 mg

Oral

Dolapril 1
Gopten
Tranalpha

Trandolapril

GRP-19912

Capsule 4 mg

Oral

Dolapril 4
Gopten
Tranalpha

Tranexamic acid

GRP-21497

Tablet 500 mg

Oral

APO-Tranexamic Acid
Cyklokapron
Tranexamic Acid Lupin

Triamcinolone

GRP-19701

Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g

Application

Aristocort 0.02%
Tricortone

Triamcinolone

GRP-19745

Cream containing triamcinolone acetonide 200 micrograms per g, 100 g

Application

Aristocort 0.02%
Tricortone

Triamcinolone with neomycin, gramicidin and nystatin

GRP-19681

Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g

Application to the ear

Kenacomb Otic
Otocomb Otic

Triamcinolone with neomycin, gramicidin and nystatin

GRP-19728

Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per mL, 7.5 mL

Application to the ear

Kenacomb Otic
Otocomb Otic

Trientine

GRP-28298

Capsule containing trientine dihydrochloride 250 mg (equivalent to 166.7 mg trientine)

Oral

Trientine Dr. Reddy's
Trientine Waymade

Trimethoprim

GRP-20308

Tablet 300 mg

Oral

Alprim
TRIMETHOPRIM-WGR
Trimethoprim Viatris
Triprim

Trimethoprim with sulfamethoxazole

GRP-20094

Tablet 160 mg-800 mg

Oral

Bactrim DS
Resprim Forte
Septrin Forte

Ursodeoxycholic acid

GRP-19961

Capsule 250 mg

Oral

APO-Ursodeoxycholic acid
Ursodox GH
Ursofalk
Ursosan

Valaciclovir

GRP-19634

Tablet 500 mg (as hydrochloride)

Oral

APX-Valaciclovir
Shilova 500
VALACICLOVIR-WGR
Vaclovir
Valaciclovir APOTEX
Valaciclovir RBX
Valaciclovir SZ
Valaciclovir Sandoz
Valaciclovir generichealth
Valacor 500
Valtrex
Zelitrex

Valganciclovir

GRP-21630

Tablet 450 mg (as hydrochloride)

Oral

Valganciclovir Sandoz
Valganciclovir Viatris

Valproic acid

GRP-19751

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

APO-Sodium Valproate
Epilim EC
Sodium Valproate Sandoz
Valprease 200
Valpro EC 200
Valproate Winthrop EC 200

Valproic acid

GRP-19922

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

APO-Sodium Valproate
Epilim EC
Sodium Valproate Sandoz
Valprease 500
Valpro EC 500
Valproate Winthrop EC 500

Valsartan

GRP-19598

Tablet 40 mg

Oral

Dilart
Diovan

Valsartan

GRP-19599

Tablet 160 mg

Oral

Dilart
Diovan

Valsartan

GRP-19600

Tablet 320 mg

Oral

Dilart
Diovan

Valsartan

GRP-19602

Tablet 80 mg

Oral

Dilart
Diovan

Valsartan with hydrochlorothiazide

GRP-19612

Tablet 160 mg-12.5 mg

Oral

Co-Diovan 160/12.5
Dilart HCT 160/12.5

Valsartan with hydrochlorothiazide

GRP-19614

Tablet 320 mg-12.5 mg

Oral

Co-Diovan 320/12.5
Dilart HCT 320/12.5

Valsartan with hydrochlorothiazide

GRP-19615

Tablet 320 mg-25 mg

Oral

Co-Diovan 320/25
Dilart HCT 320/25

Valsartan with hydrochlorothiazide

GRP-19965

Tablet 80 mg-12.5 mg

Oral

Co-Diovan 80/12.5
Dilart HCT 80/12.5

Valsartan with hydrochlorothiazide

GRP-19966

Tablet 160 mg-25 mg

Oral

Co-Diovan 160/25
Dilart HCT 160/25

Vancomycin

GRP-26946

Capsule 125 mg (125,000 I.U.) (as hydrochloride)

Oral

Vancocin
Vancomycin BNM 125mg

Vancomycin

GRP-26952

Capsule 250 mg (250,000 I.U.) (as hydrochloride)

Oral

Vancocin
Vancomycin BNM 250mg

Varenicline

GRP-26245

Tablet 1 mg (as tartrate)

Oral

Champix
PHARMACOR VARENICLINE
VARENAPIX
Varenicline Viatris

Varenicline

GRP-27996

Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack

Oral

Champix
PHARMACOR VARENICLINE
VARENAPIX

Venlafaxine

GRP-19721

Capsule (modified release) 37.5 mg (as hydrochloride)

Oral

Efexor-XR
Elaxine SR 37.5
VENLAFAXINE XR-WGR

Venlafaxine

GRP-19796

Capsule (modified release) 150 mg (as hydrochloride)

Oral

APO-Venlafaxine XR
Efexor-XR
Elaxine SR 150
Enlafax-XR
Sandoz Venlafaxine XR
VENLAFAXINE XR-WGR
Venlafaxine generichealth XR

Venlafaxine

GRP-19797

Capsule (modified release) 75 mg (as hydrochloride)

Oral

APO-Venlafaxine XR
Efexor-XR
Elaxine SR 75
Enlafax-XR
Sandoz Venlafaxine XR
VENLAFAXINE XR-WGR
Venlafaxine generichealth XR

Verapamil

GRP-19760

Tablet containing verapamil hydrochloride 180 mg (sustained release)

Oral

Cordilox 180 SR
Isoptin 180 SR

Verapamil

GRP-19780

Tablet containing verapamil hydrochloride 240 mg (sustained release)

Oral

Cordilox SR
Isoptin SR

Verapamil

GRP-19898

Tablet containing verapamil hydrochloride 80 mg

Oral

Anpec 80
Isoptin

Vinorelbine

GRP-27399

Capsule 30 mg (as tartrate)

Oral

Navelbine
Velabine

Vinorelbine

GRP-27405

Capsule 20 mg (as tartrate)

Oral

Navelbine
Velabine

Voriconazole

GRP-20447

Tablet 200 mg

Oral

Voriconazole Sandoz
Vttack
Vzole

Voriconazole

GRP-20450

Tablet 50 mg

Oral

Voriconazole Sandoz
Vttack
Vzole

Ziprasidone

GRP-19574

Capsule 20 mg (as hydrochloride)

Oral

ZIPROX
Zeldox
Ziprasidone GH

Ziprasidone

GRP-19575

Capsule 40 mg (as hydrochloride)

Oral

ZIPROX
Zeldox
Ziprasidone GH

Ziprasidone

GRP-19576

Capsule 80 mg (as hydrochloride)

Oral

ZIPROX
Zeldox
Ziprasidone GH

Ziprasidone

GRP-19577

Capsule 60 mg (as hydrochloride)

Oral

ZIPROX
Zeldox
Ziprasidone GH

Zoledronic acid

GRP-17612

Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

Injection

Aclasta
Osteovan
Zoledasta
Zoledronate-RDY 5
Zoledronic Acid SUN

Zoledronic acid

GRP-17614

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

APO-Zoledronic Acid
DEZTRON
Zoledronate-DRLA 4
Zoledronic Acid Accord
Zometa

Zolmitriptan

GRP-19573

Tablet 2.5 mg

Oral

APO-Zolmitriptan
Zoltrip
Zomig