Commonwealth Coat of Arms of Australia

 

PB 111 of 2024

National Health (Listing of Pharmaceutical Benefits) Amendment (November 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 October 2024

 

NIKOLAI TSYGANOV
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division

Contents

1. Name

2. Commencement

3. Authority

4. Schedules

Schedule 1—Amendments

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

 

1. Name

(1) This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment (November Update) Instrument 2024.

(2) This Instrument may also be cited as PB 111 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 November 2024

1 November 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Note: This table relates only to the provisions of this instrument as originally made.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.

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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

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

[1] Schedule 1, Part 1, entries for Amiodarone in the form Tablet containing amiodarone hydrochloride 100 mg

omit from the column headed “Circumstances” (all instances): C5665  substitute (all instances): C15967

[2] Schedule 1, Part 1, entries for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

(a) omit:

Amiodarone

Tablet containing amiodarone hydrochloride 200 mg

Oral

APO-Amiodarone

TX

MP NP

C5665

 

30

5

 

30

 

 

(b) omit from the column headed “Circumstances” (all instances): C5665  substitute (all instances): C15967

[3] Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 10 mg

omit:

Amitriptyline

Tablet containing amitriptyline hydrochloride 10 mg

Oral

APO-Amitriptyline 10

TX

MP NP

 

 

50

2

 

50

 

 

[4] Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg

omit:

Amitriptyline

Tablet containing amitriptyline hydrochloride 25 mg

Oral

APO-Amitriptyline 25

TX

MP NP

 

 

50

2

 

50

 

 

[5] Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 50 mg

omit:

Amitriptyline

Tablet containing amitriptyline hydrochloride 50 mg

Oral

APO-Amitriptyline 50

TX

MP NP

 

 

50

2

 

50

 

 


[6] 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

 

30

 

 

[7] 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

MP NP

 

P14238

60

5

 

30

 

 

[8] Schedule 1, Part 1, entries for Anastrozole

substitute:

Anastrozole

Tablet 1 mg

Oral

Anastrozole GH

GQ

MP NP

C5522

P5522

30

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

Anastrozole GH

GQ

MP NP

C14895

P14895

60

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

Anastrozole Sandoz

SZ

MP NP

C5522

P5522

30

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

Anastrozole Sandoz

SZ

MP NP

C14895

P14895

60

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

ANASTROZOLE-WGR

WG

MP NP

C5522

P5522

30

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

ANASTROZOLE-WGR

WG

MP NP

C14895

P14895

60

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

APO‑Anastrozole

TX

MP NP

C5522

P5522

30

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

APO‑Anastrozole

TX

MP NP

C14895

P14895

60

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

Arianna 1

AF

MP NP

C5522

P5522

30

5

 

30

 

 

Anastrozole

Tablet 1 mg

Oral

Arianna 1

AF

MP NP

C14895

P14895

60

5

 

30

 

 

[9] Schedule 1, Part 1, entry for Apixaban in the form Tablet 2.5 mg [Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308

(b) insert in numerical order in the column headed “Circumstances”: C14301

(c) omit from the column headed “Purposes”: P14308

(d) insert in numerical order in the column headed “Purposes”: P14301

[10] Schedule 1, Part 1, entry for Apixaban in the form Tablet 5 mg [Maximum Quantity: 60; Number of Repeats: 5]

(a) insert in numerical order in the column headed “Circumstances”: C4268

(b) omit from the column headed “Circumstances”: C5083

(c) insert in numerical order in the column headed “Purposes”: P4268

(d) omit from the column headed “Purposes”: P5083

[11] Schedule 1, Part 1, entry for Apixaban in the form Tablet 5 mg [Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14302 C14308

(b) insert in numerical order in the column headed “Circumstances”: C14301 C14318

(c) omit from the column headed “Purposes”: P14302 P14308

(d) insert in numerical order in the column headed “Purposes”: P14301 P14318

[12] Schedule 1, Part 1, entry for Atenolol in the form Tablet 50 mg

omit:

Atenolol

Tablet 50 mg

Oral

APO-Atenolol

TX

MP NP

 

 

30

5

 

30

 

 

Atenolol

Tablet 50 mg

Oral

APO-Atenolol

TX

MP NP

 

P14238

60

5

 

30

 

 

[13] 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

 

30

 

 

[14] 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

 

30

 

 

[15] 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

 

30

 

 

[16] 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

 

30

 

 

[17] Schedule 1, Part 1, entries for Atropine in the form Injection containing atropine sulfate monohydrate 600 micrograms in 1 mL

omit from the column headed “Brand” (all instances): Atropine Injection (Pfizer) substitute (all instances): Atropine Injection (Bridgewest)

[18] Schedule 1, Part 1, entry for Auranofin in each of the forms: Capsule 3 mg; and Tablet 3 mg

insert in the column headed “Circumstances”: C15956

[19] Schedule 1, Part 1, entry for Avelumab

(a) omit from the column headed “Circumstances”: C8947 C10023

(b) insert in numerical order in the column headed “Circumstances”: C16053 C16085

[20] Schedule 1, Part 1, entries Azacitidine in each of the forms: Tablet 200 mg; and Tablet 300 mg

omit from the column headed “Responsible Person” (all instances): CJ  substitute (all instances): BQ

[21] Schedule 1, Part 1, fourth entry for Bimatoprost with timolol

omit from the column headed “Listed drug”: Bimatoprost with timolol`` substitute: Bimatoprost with timolol

[22] Schedule 1, Part 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)

omit:

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

BOSLEER

RW

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

60

 

D(100)

[23] Schedule 1, Part 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)

omit:

Bosentan

Tablet 125 mg (as monohydrate)

Oral

BOSLEER

RW

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

60

 

D(100)

[24] Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Injection (modified release) 8 mg in 0.16 mL pre-filled syringe; Injection (modified release) 16 mg in 0.32 mL pre-filled syringe; Injection (modified release) 24 mg in 0.48 mL pre-filled syringe; and Injection (modified release) 32 mg in 0.64 mL pre-filled syringe

omit from the column headed “Circumstances”: C15385 substitute: C16051


[25] Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Injection (modified release) 64 mg in 0.18 mL pre-filled syringe; and Injection (modified release) 96 mg in 0.27 mL pre-filled syringe

omit from the column headed “Circumstances”: C15356 substitute: C16015

[26] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 100 mg in 0.5 mL pre-filled syringe

omit from the column headed “Circumstances”: C15439 substitute: C16050

[27] Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Injection (modified release) 128 mg in 0.36 mL pre-filled syringe; and Injection (modified release) 160 mg in 0.45 mL pre-filled syringe

omit from the column headed “Circumstances”: C15356 substitute: C16015

[28] Schedule 1, Part 1, entry for Buprenorphine in the form Injection (modified release) 300 mg in 1.5 mL pre-filled syringe

omit from the column headed “Circumstances”: C15439 substitute: C16050

[29] Schedule 1, Part 1, entry for Buprenorphine in each of the forms: Tablet (sublingual) 400 micrograms (as hydrochloride); Tablet (sublingual) 2 mg (as hydrochloride); and Tablet (sublingual) 8 mg (as hydrochloride)

omit from the column headed “Circumstances”: C15355 substitute: C16009

[30] Schedule 1, Part 1, entry for Buprenorphine with naloxone in each of the forms: Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride); and Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)

omit from the column headed “Circumstances”: C15355 substitute: C16009

[31] Schedule 1, Part 1, entry for Calcitriol

(a) omit:

Calcitriol

Capsule 0.25 microgram

Oral

APO-Calcitriol

TX

MP NP

C5089 C5114 C5255 C5401 C5402

P5089 P5114 P5255 P5401 P5402

100

3

 

100

 

 

Calcitriol

Capsule 0.25 microgram

Oral

APO-Calcitriol

TX

MP NP

C14231 C14259 C14287 C14296 C14322

P14231 P14259 P14287 P14296 P14322

200

3

 

100

 

 

(b) omit:

Calcitriol

Capsule 0.25 microgram

Oral

Kosteo

RW

MP NP

C5089 C5114 C5255 C5401 C5402

P5089 P5114 P5255 P5401 P5402

100

3

 

100

 

 

Calcitriol

Capsule 0.25 microgram

Oral

Kosteo

RW

MP NP

C14231 C14259 C14287 C14296 C14322

P14231 P14259 P14287 P14296 P14322

200

3

 

100

 

 

[32] Schedule 1, Part 1, entry for Cefazolin in the form Powder for injection 1 g (as sodium)

(a) omit from the column headed “Circumstances”: C5861 C5882

(b) omit from the column headed “Circumstances”: C5891

(c) insert in numerical order in the column headed “Circumstances”: C15964 C16029 C16030

[33] Schedule 1, Part 1, entry for Cefazolin in the form Powder for injection 2 g (as sodium)

(a) omit from the column headed “Circumstances”: C5826

(b) omit from the column headed “Circumstances”: C5881 C5890

(c) insert in numerical order in the column headed “Circumstances”: C15964 C16029 C16030

[34] Schedule 1, Part 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g (as hydrochloride)

omit from the column headed “Circumstances”: C5842 substitute: C16067

[35] Schedule 1, Part 1, entry for Cefotaxime [Authorised Prescriber: MP NP]

omit from the column headed “Circumstances”: C5826 C5881 C5890  substitute: C15964 C16029 C16030

[36] Schedule 1, Part 1, entries for Ceftriaxone

substitute:

Ceftriaxone

Powder for injection 500 mg (as sodium)

Injection

Ceftriaxone‑AFT

AE

MP NP

C5855

P5855

1

0

 

1

 

 

Ceftriaxone

Powder for injection 500 mg (as sodium)

Injection

Ceftriaxone‑AFT

AE

MP NP

C15964 C16029 C16030

P15964 P16029 P16030

5

0

 

1

 

 

Ceftriaxone

Powder for injection 1 g (as sodium)

Injection

Ceftriaxone Viatris

AL

MP NP

C15964 C16029 C16030

 

5

0

 

10

 

 

Ceftriaxone

Powder for injection 2 g (as sodium)

Injection

Ceftriaxone Viatris

AL

MP NP

C15964 C16029 C16030

 

5

0

 

5

 

 

Ceftriaxone

Powder for injection 2 g (as sodium)

Injection

Ceftriaxone Viatris

AL

MP NP

C15964 C16029 C16030

 

5

0

 

10

 

 

[37] Schedule 1, Part 1, entry for Ceritinib

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

[38] Schedule 1, Part 1, after entry for Chloramphenicol

insert:

Chlormethine

Gel 160 micrograms (as hydrochloride) per g, 60 g

Application

Ledaga

JZ

MP

C16054 C16145

 

2

5

 

1

 

 

[39] Schedule 1, Part 1, entry for Chlorpromazine in each of the forms: Injection containing chlorpromazine hydrochloride 50 mg in 2 mL; Oral solution containing chlorpromazine hydrochloride 25 mg per 5 mL, 100 mL; Tablet containing chlorpromazine hydrochloride 25 mg; and Tablet containing chlorpromazine hydrochloride 100 mg

insert in the column headed “Circumstances”: C15956

[40] Schedule 1, Part 1, entry for Choriogonadotropin alfa in the form Solution for injection 250 micrograms in 0.5 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 0]

insert in the column headed “Section 100/ Prescriber Bag only”: C100

[41] Schedule 1, Part 1, after entry for Choriogonadotropin alfa in the form Solution for injection 250 micrograms in 0.5 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5]

insert:

Choriogonadotropin alfa

Solution for injection 250 micrograms in 0.5 mL pre-filled syringe (S19A)

Injection

Ovidrel (USA)

SG

MP

C14124

P14124

1

0

 

1

 

C(100)

Choriogonadotropin alfa

Solution for injection 250 micrograms in 0.5 mL pre-filled syringe (S19A)

Injection

Ovidrel (USA)

SG

MP

C14096

P14096

4

5

 

1

 

 

[42] Schedule 1, Part 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)

omit:

Ciprofloxacin

Tablet 250 mg (as hydrochloride)

Oral

APX-Ciprofloxacin

TY

MP NP

C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780

 

14

0

 

14

 

 

[43] Schedule 1, Part 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

omit:

Ciprofloxacin

Tablet 500 mg (as hydrochloride)

Oral

APX-Ciprofloxacin

TY

MP NP

C5614 C5615 C5687 C5688 C5689 C5722 C5780

 

14

0

 

14

 

 

[44] Schedule 1, Part 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)

omit:

Ciprofloxacin

Tablet 750 mg (as hydrochloride)

Oral

APX-Ciprofloxacin

TY

MP NP

C5614 C5615 C5687 C5688 C5689 C5722 C5780

 

14

0

 

14

 

 

[45] Schedule 1, Part 1, after entry for Citalopram in the form Tablet 10 mg (as hydrobromide) [Brand: Celapram; Maximum Quantity: 56; Number of Repeats: 2]

insert:

Citalopram

Tablet 10 mg (as hydrobromide)

Oral

CITALOPRAM-WGR

WG

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 10 mg (as hydrobromide)

Oral

CITALOPRAM-WGR

WG

MP NP

C15666

P15666

56

2

 

28

 

 

[46] Schedule 1, Part 1, after entry for Citalopram in the form Tablet 20 mg (as hydrobromide) [Brand: Citalopram Sandoz; Maximum Quantity: 56; Number of Repeats: 2]

insert:

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

CITALOPRAM-WGR

WG

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 20 mg (as hydrobromide)

Oral

CITALOPRAM-WGR

WG

MP NP

C15666

P15666

56

2

 

28

 

 


[47] Schedule 1, Part 1, after entry for Citalopram in the form Tablet 40 mg (as hydrobromide) [Brand: Citalopram Sandoz; Maximum Quantity: 56; Number of Repeats: 2]

insert:

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

CITALOPRAM-WGR

WG

MP NP

C4755

P4755

28

5

 

28

 

 

Citalopram

Tablet 40 mg (as hydrobromide)

Oral

CITALOPRAM-WGR

WG

MP NP

C15666

P15666

56

2

 

28

 

 

[48] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Brand: ARX-Dabigatran; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[49] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Brand: Dabigatran Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[50] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Brand: PHARMACOR DABIGATRAN; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[51] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate) [Brand: Pradaxa; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[52] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 150 mg (as mesilate) [Brand: ARX-Dabigatran; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[53] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 150 mg (as mesilate) [Brand: Dabigatran Sandoz; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[54] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 150 mg (as mesilate) [Brand: PHARMACOR DABIGATRAN; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[55] Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 150 mg (as mesilate) [Brand: Pradaxa; Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14308  substitute: C14301

(b) omit from the column headed “Purposes”: P14308 substitute: P14301

[56] Schedule 1, Part 1, after entry for Dapagliflozin with metformin in the form Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride [Maximum Quantity: 56; Number of Repeats: 5]

insert:

Dapagliflozin with sitagliptin

Tablet containing 10 mg dapagliflozin (as propanediol monohydrate) with 100 mg sitagliptin (as phosphate monohydrate)

Oral

Sidapvia 10/100

AP

MP NP

C15269

P15269

28

5

 

28

 

 

Dapagliflozin with sitagliptin

Tablet containing 10 mg dapagliflozin (as propanediol monohydrate) with 100 mg sitagliptin (as phosphate monohydrate)

Oral

Sidapvia 10/100

AP

MP NP

C15270

P15270

56

5

 

28

 

 

[57] Schedule 1, Part 1, entry for Diazepam in the form Tablet 2 mg

omit:

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

 

 

[58] Schedule 1, Part 1, entry for Diazepam in the form Tablet 5 mg

omit:

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

 

 

[59] Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

omit:

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

APO-Diclofenac

TX

PDP

 

 

100

0

 

50

 

 

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

APO-Diclofenac

TX

MP NP

 

 

100

3

 

50

 

 

[60] Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

omit:

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

APO-Diclofenac

TX

PDP

 

 

50

0

 

50

 

 

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

APO-Diclofenac

TX

MP NP

 

 

50

3

 

50

 

 

[61] Schedule 1, Part 1, entry for Digoxin in each of the forms: Paediatric oral solution 50 micrograms per mL, 60 mL; Tablet 62.5 micrograms; and Tablet 250 micrograms

insert in the column headed “Circumstances” (all instances): C15956


[62] Schedule 1, Part 1, entry for Disopyramide in each of the forms: Capsule 100 mg; and Capsule 100 mg (s19A)

insert in the column headed “Circumstances”: C15956

[63] Schedule 1, Part 1, entries for Electrolyte replacement, oral in the form Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10

omit from the column headed “Responsible Person” (all instances): AF  substitute (all instances): XT

[64] Schedule 1, Part 1, entry for Entecavir in the form Tablet 0.5 mg (as monohydrate)

omit:

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

ENTECLUDE

RW

MP NP

C4993 C5036

 

60

5

 

30

 

D(100)

[65] Schedule 1, Part 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)

omit:

Entecavir

Tablet 1 mg (as monohydrate)

Oral

ENTECLUDE

RW

MP NP

C5037 C5044

 

60

5

 

30

 

D(100)

[66] Schedule 1, Part 1, entry for Entrectinib

omit from the column headed “Circumstances”: C13184 C13276 substitute: C13186 C15776

[67] Schedule 1, Part 1, entry for Eptinezumab [Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C14189  substitute: C16018

(b) omit from the column headed “Purposes”: P14189 substitute: P16018

[68] Schedule 1, Part 1, entries for Estradiol in the form Tablet 2 mg

omit from the column headed “Responsible Person” (all instances): GO  substitute (all instances): XT

[69] Schedule 1, Part 1, after entry for Estradiol in the form Tablet containing estradiol valerate 2 mg [Maximum Quantity: 112; Number of Repeats: 2]

insert:

Estradiol

Transdermal gel 500 micrograms in 0.5 g sachet, 28

Transdermal

Sandrena

OX

MP NP

 

 

1

5

 

1

 

 

Estradiol

Transdermal gel 500 micrograms in 0.5 g sachet, 28

Transdermal

Sandrena

OX

MP NP

 

P14238

2

5

 

1

 

 

[70] Schedule 1, Part 1, after entry for Estradiol in the form Transdermal patches 585 micrograms, 8 [Brand: Estradot 37.5]

insert:

Estradiol

Transdermal patches 585 micrograms, 24 (S19A)

Transdermal

Estramon 37.5 (Germany)

DZ

MP NP

 

 

1

1

 

1

 

 

[71] Schedule 1, Part 1, after entry for Estradiol in the form Transdermal patches 780 micrograms, 8

insert:

Estradiol

Transdermal patches 780 micrograms, 24 (S19A)

Transdermal

Estramon 50 (Germany)

DZ

MP NP

 

 

1

1

 

1

 

 

[72] Schedule 1, Part 1, after entry for Estradiol in the form Transdermal patches 1.17 mg, 8 [Brand: Estradot 75]

insert:

Estradiol

Transdermal patches 1.17 mg, 24 (S19A)

Transdermal

Estramon 75 (Germany)

DZ

MP NP

 

 

1

1

 

1

 

 

[73] Schedule 1, Part 1, after entry for Estradiol in the form Transdermal patches 1.56 mg, 8 [Brand: Estradot 100]

insert:

Estradiol

Transdermal patches 1.56 mg, 24 (S19A)

Transdermal

Estramon 100 (Germany)

DZ

MP NP

 

 

1

1

 

1

 

 

[74] Schedule 1, Part 1, entry for Estradiol and estradiol with dydrogesterone in each of the forms: Pack containing 14 tablets estradiol 1 mg and 14 tablets estradiol 1 mg with dydrogesterone 10 mg; and Pack containing 14 tablets estradiol 2 mg and 14 tablets estradiol 2 mg with dydrogesterone 10 mg

omit from the column headed “Responsible Person” (all instances): GO  substitute (all instances): XT

[75] Schedule 1, Part 1, entry for Exemestane [Brand: APO-Exemestane; Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14992  substitute: C14895

(b) omit from the column headed “Purposes”: P14992 substitute: P14895

[76] Schedule 1, Part 1, entry for Exemestane [Brand: Aromasin; Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14992  substitute: C14895

(b) omit from the column headed “Purposes”: P14992 substitute: P14895

[77] Schedule 1, Part 1, entry for Exemestane [Brand: Exemestane GH; Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14992  substitute: C14895

(b) omit from the column headed “Purposes”: P14992 substitute: P14895

[78] Schedule 1, Part 1, entry for Exemestane [Brand: Exemestane Sandoz; Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14992  substitute: C14895

(b) omit from the column headed “Purposes”: P14992 substitute: P14895

[79] Schedule 1, Part 1, entry for Exemestane [Brand: EXEMESTANE-WGR; Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14992  substitute: C14895

(b) omit from the column headed “Purposes”: P14992 substitute: P14895

[80] Schedule 1, Part 1, entries for Ezetimibe

substitute:

Ezetimibe

Tablet 10 mg

Oral

APO-Ezetimibe

TX

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

APO-Ezetimibe

TX

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

BTC Ezetimibe

BG

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

BTC Ezetimibe

BG

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

EZEMICHOL

RW

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

EZEMICHOL

RW

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Ezetimibe GH

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Ezetimibe GH

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Ezetimibe Sandoz

SZ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Ezetimibe Sandoz

SZ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

EZETIMIBE-WGR

WG

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

EZETIMIBE-WGR

WG

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Ezetrol

AL

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Ezetrol

AL

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Pharmacor Ezetimibe 10

CR

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Pharmacor Ezetimibe 10

CR

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Zient 10mg

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Zient 10mg

AF

MP NP

 

P14238

60

5

 

30

 

 

[81] Schedule 1, Part 1, entries for Ezetimibe and rosuvastatin

substitute:

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+10mg

AF

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+10mg

AF

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

CR

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

CR

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+20mg

AF

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+20mg

AF

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

CR

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

CR

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+40mg

AF

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+40mg

AF

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

CR

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Pharmacor Ezetimibe Rosuvastatin Composite Pack

CR

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+5mg

AF

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)

Oral

Ezalo Composite Pack 10mg+5mg

AF

MP NP

 

P14238

2

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

 

1

5

 

1

 

 

Ezetimibe and rosuvastatin

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)

Oral

Rosuzet Composite Pack

AL

MP NP

 

P14238

2

5

 

1

 

 

[82] Schedule 1, Part 1, entries for Ezetimibe with atorvastatin

substitute:

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Atozet

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Atozet

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Ezetast

XT

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Ezetast

XT

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Ezetimibe/Atorvastatin GH 10/10

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-10 mg

Oral

Ezetimibe/Atorvastatin GH 10/10

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Atozet

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Atozet

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Ezetast

XT

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Ezetast

XT

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Ezetimibe/Atorvastatin GH 10/20

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-20 mg

Oral

Ezetimibe/Atorvastatin GH 10/20

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-40 mg

Oral

Atozet

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-40 mg

Oral

Atozet

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-40 mg

Oral

Ezetast

XT

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-40 mg

Oral

Ezetast

XT

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-40 mg

Oral

Ezetimibe/Atorvastatin GH 10/40

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-40 mg

Oral

Ezetimibe/Atorvastatin GH 10/40

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-80 mg

Oral

Atozet

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-80 mg

Oral

Atozet

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-80 mg

Oral

Ezetast

XT

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-80 mg

Oral

Ezetast

XT

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-80 mg

Oral

Ezetimibe/Atorvastatin GH 10/80

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with atorvastatin

Tablet 10 mg-80 mg

Oral

Ezetimibe/Atorvastatin GH 10/80

GQ

MP NP

 

P14238

60

5

 

30

 

 

[83] Schedule 1, Part 1, entries for Ezetimibe with simvastatin

substitute:

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

APO-Ezetimibe/Simvastatin 10/10

TX

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

APO-Ezetimibe/Simvastatin 10/10

TX

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/10

WG

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/10

WG

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETORIN

RW

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EZETORIN

RW

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EzSimva GH 10/10

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

EzSimva GH 10/10

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/10

CR

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/10

CR

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Vytorin

AL

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Vytorin

AL

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Zeklen 10/10 mg

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Zeklen 10/10 mg

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Zimybe 10/10

MQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-10 mg

Oral

Zimybe 10/10

MQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

APO-Ezetimibe/Simvastatin 10/20

TX

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

APO-Ezetimibe/Simvastatin 10/20

TX

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/20

WG

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/20

WG

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETORIN

RW

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EZETORIN

RW

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EzSimva GH 10/20

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

EzSimva GH 10/20

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/20

CR

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/20

CR

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Vytorin

AL

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Vytorin

AL

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Zeklen 10/20 mg

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Zeklen 10/20 mg

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Zimybe 10/20

MQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-20 mg

Oral

Zimybe 10/20

MQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

APO-Ezetimibe/Simvastatin 10/40

TX

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

APO-Ezetimibe/Simvastatin 10/40

TX

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/40

WG

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/40

WG

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETORIN

RW

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EZETORIN

RW

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EzSimva GH 10/40

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

EzSimva GH 10/40

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/40

CR

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/40

CR

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Vytorin

AL

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Vytorin

AL

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Zeklen 10/40 mg

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Zeklen 10/40 mg

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Zimybe 10/40

MQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-40 mg

Oral

Zimybe 10/40

MQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

APO-Ezetimibe/Simvastatin 10/80

TX

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

APO-Ezetimibe/Simvastatin 10/80

TX

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETIMIBE/SIMVASTATIN SANDOZ

SZ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/80

WG

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETIMIBE/SIMVASTATIN-WGR 10/80

WG

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETORIN

RW

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EZETORIN

RW

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EzSimva GH 10/80

GQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

EzSimva GH 10/80

GQ

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/80

CR

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Pharmacor Ezetimibe Simvastatin 10/80

CR

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Vytorin

AL

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Vytorin

AL

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Zeklen 10/80 mg

AF

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Zeklen 10/80 mg

AF

MP NP

 

P14238

60

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Zimybe 10/80

MQ

MP NP

 

 

30

5

 

30

 

 

Ezetimibe with simvastatin

Tablet 10 mg-80 mg

Oral

Zimybe 10/80

MQ

MP NP

 

P14238

60

5

 

30

 

 

[84] Schedule 1, Part 1, entries for Famciclovir in the form Tablet 250 mg [Brand: Ezovir]

omit from the column headed “Responsible Person” (all instances): AF  substitute (all instances): XT

[85] Schedule 1, Part 1, entries for Famciclovir in the form Tablet 500 mg [Brand: Ezovir]

omit from the column headed “Responsible Person”: AF substitute: XT

[86] Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026

[87] Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[88] Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026

[89] Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[90] Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate)

omit from the column headed “Circumstances”: C5904 substitute: C6027

[91] Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate)

omit from the column headed “Circumstances”: C5904 substitute: C6027

[92] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 100 micrograms (as citrate) [Maximum Quantity: 20; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026

[93] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 100 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[94] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 200 micrograms (as citrate) [Maximum Quantity: 20; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026

[95] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 200 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[96] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 300 micrograms (as citrate) [Maximum Quantity: 10; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026

[97] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 300 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[98] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 400 micrograms (as citrate) [Maximum Quantity: 10; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026


[99] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 400 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[100] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 600 micrograms (as citrate) [Maximum Quantity: 10; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026

[101] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 600 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[102] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 800 micrograms (as citrate) [Maximum Quantity: 10; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5915  substitute: C6026

(b) omit from the column headed “Purposes”: P5915 substitute: P6026

[103] Schedule 1, Part 1, entry for Fentanyl in the form Tablet (sublingual) 800 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5904  substitute: C6027

(b) omit from the column headed “Purposes”: P5904 substitute: P6027

[104] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 1.28 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[105] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.063 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[106] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.1 mg [Brand: APO-Fentanyl; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[107] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.1 mg [Brand: Durogesic 12; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[108] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.1 mg [Brand: Fentanyl Sandoz; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute:C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[109] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.55 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[110] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 4.125 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000


[111] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 4.2 mg [Brand: APO-Fentanyl; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[112] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 4.2 mg [Brand: Durogesic 25; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[113] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 4.2 mg [Brand: Fentanyl Sandoz; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[114] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 5.10 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[115] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 7.65 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[116] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 8.25 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[117] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 8.4 mg [Brand: APO-Fentanyl; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[118] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 8.4 mg [Brand: Durogesic 50; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[119] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 8.4 mg [Brand: Fentanyl Sandoz; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[120] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 10.20 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[121] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 12.375 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[122] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 12.6 mg [Brand: APO-Fentanyl; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[123] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 12.6 mg [Brand: Durogesic 75; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[124] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 12.6 mg [Brand: Fentanyl Sandoz; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[125] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 16.5 mg [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[126] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 16.8 mg [Brand: APO-Fentanyl; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[127] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 16.8 mg [Brand: Durogesic 100; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[128] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 16.8 mg [Brand: Fentanyl Sandoz; Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[129] Schedule 1, Part 1, entry for Flecainide in the form Tablet containing flecainide acetate 50 mg

omit from the column headed “Circumstances” (all instances): C5550 C5584  substitute (all instances): C15965 C15966

[130] Schedule 1, Part 1, entry for Flecainide in the form Tablet containing flecainide acetate 100 mg

omit from the column headed “Circumstances” (all instances): C5550 C5584  substitute (all instances): C15965 C15966

[131] Schedule 1, Part 1, entries for Fluconazole in the form Capsule 50 mg

(a) omit from the column headed “Circumstances” (all instances): C5978

(b) omit from the column headed “Circumstances” (all instances): C6002

(c) omit from the column headed “Circumstances” (all instances): C7898

(d) insert in numerical order in the column headed “Circumstances” (all instances): C15975 C15984 C16034

[132] Schedule 1, Part 1, entry for Fluconazole in the form Capsule 50 mg [Brand: Dizole 50]

omit from the column headed “Responsible Person”: AF substitute: XT

[133] Schedule 1, Part 1, entries for Fluconazole in the form Capsule 100 mg

(a) omit from the column headed “Circumstances” (all instances): C5978

(b) omit from the column headed “Circumstances” (all instances): C6002

(c) omit from the column headed “Circumstances” (all instances): C7898

(d) insert in numerical order in the column headed “Circumstances” (all instances): C15975 C15984 C16034

[134] Schedule 1, Part 1, entry for Fluconazole in the form Capsule 100 mg [Brand: Dizole 100]

omit from the column headed “Responsible Person”: AF substitute: XT

[135] Schedule 1, Part 1, entries for Fluconazole in the form Capsule 200 mg

(a) omit from the column headed “Circumstances” (all instances): C5978

(b) omit from the column headed “Circumstances” (all instances): C6002

(c) omit from the column headed “Circumstances” (all instances): C7898

(d) insert in numerical order in the column headed “Circumstances” (all instances): C15975 C15984 C16034

[136] Schedule 1, Part 1, entry for Fluconazole in the form Capsule 200 mg [Brand: Dizole 200]

omit from the column headed “Responsible Person”: AF substitute: XT

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

insert:

Fluconazole

Capsule 200 mg

Oral

FLUCONAZOLE-WGR

WG

MP NP

C5989 C6023 C6030 C15975 C15984 C16034

 

28

5

 

28

 

 

[138] Schedule 1, Part 1, entry for Fluconazole in the form Powder for oral suspension 50 mg in 5 mL, 35 mL

(a) omit from the column headed “Circumstances”: C6006

(b) omit from the column headed “Circumstances”: C6045

(c) omit from the column headed “Circumstances”: C7934

(d) insert in numerical order in the column headed “Circumstances”: C16114 C16141 C16148

[139] Schedule 1, Part 1, entry for Flutamide

omit from the column headed “Circumstances”: C5816 substitute: C5729

[140] Schedule 1, Part 1, entry for Fremanezumab in the form Solution for injection 225 mg in 1.5 mL single dose pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C14472  substitute: C16104

(b) omit from the column headed “Purposes”: P14472 substitute: P16104

[141] Schedule 1, Part 1, entry for Fremanezumab in the form Solution for injection 225 mg in 1.5 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C14472  substitute: C16104

(b) omit from the column headed “Purposes”: P14472 substitute: P16104

[142] Schedule 1, Part 1, after entry for Fulvestrant [Brand: FULVESTRANT ACCORD]

insert:

Fulvestrant

Injection 250 mg in 5 mL pre-filled syringe

Injection

FULVESTRANT-AFT

AE

MP

C11473

 

2

5

 

2

 

 

[143] Schedule 1, Part 1, entry for Galcanezumab [Maximum Quantity: 2; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C12064  substitute: C16018

(b) omit from the column headed “Purposes”: P12064 substitute: P16018

[144] Schedule 1, Part 1, entries for Gliclazide in the form Tablet 80 mg

(a) omit:

Gliclazide

Tablet 80 mg

Oral

APO-Gliclazide

TX

MP NP

 

 

100

5

 

100

 

 

Gliclazide

Tablet 80 mg

Oral

APO-Gliclazide

TX

MP NP

 

P14238

200

5

 

100

 

 

(b) omit:

Gliclazide

Tablet 80 mg

Oral

Glyade

AF

MP NP

 

 

100

5

 

100

 

 

Gliclazide

Tablet 80 mg

Oral

Glyade

AF

MP NP

 

P14238

200

5

 

100

 

 

[145] Schedule 1, Part 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 40 g, 30 (Camino Pro Bettermilk)

insert:

Glycomacropeptide formula with amino acids and low phenylalanine

Sachets containing oral powder 12.5 g, 30 (PKU GMPro MIX-IN)

Oral

PKU GMPro MIX-IN

SB

MP NP

C4295

 

5

5

 

1

 

 

Glycomacropeptide formula with amino acids, vitamins, minerals, trace elements, carbohydrate, fat and low phenylalanine

Sachets containing oral powder 33.4 g, 30 (PKU GMPro Ultra)

Oral

PKU GMPro ULTRA

SB

MP NP

C4295

 

4

5

 

1

 

 

[146] Schedule 1, Part 1, entries for Ibuprofen in the form Tablet 400 mg

omit:

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

 

 

[147] Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate)

insert as first entries:

Imatinib

Capsule 400 mg (as mesilate)

Oral

ARX-IMATINIB

XT

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

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

30

5


 

30

 

 

[148] Schedule 1, Part 1, entry for Insulin neutral with insulin isophane in the form Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5

omit:

Insulin neutral with insulin isophane

Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5

Injection

Mixtard 30/70 Penfill 3 mL

NO

MP NP


 


 

5

1


 

1

 

 

[149] Schedule 1, Part 1, entries for Irbesartan in the form Tablet 75 mg

omit:

Irbesartan

Tablet 75 mg

Oral

Karvea

SW

MP NP


 


 

30

5

 

30

 

 

Irbesartan

Tablet 75 mg

Oral

Karvea

SW

MP NP


 

P14238

60

5

 

30

 

 

[150] Schedule 1, Part 1, entry for Isoniazid

insert in the column headed “Circumstances”: C15956

[151] Schedule 1, Part 1, entry for Itraconazole in the form Capsule 50 mg

omit from the column headed “Circumstances”: C5988 C6005 C6016 C6022 C6035 C6037 C6057 substitute: C15978 C16035 C16073 C16099 C16101 C16102 C16119

[152] Schedule 1, Part 1, entry for Itraconazole in the form Capsule 100 mg

omit:

Itraconazole

Capsule 100 mg

Oral

APO-Itraconazole

TX

MP NP

C5988 C6005 C6016 C6022 C6035 C6037 C6057

 

60

5

 

60

 

 

[153] Schedule 1, Part 1, entries for Itraconazole in the form Capsule 100 mg

omit from the column headed “Circumstances” (all instances): C5988 C6005 C6016 C6022 C6035 C6037 C6057 substitute (all instances): C15978 C16035 C16073 C16099 C16101 C16102 C16119

[154] Schedule 1, Part 1, entries for Itraconazole in the form Capsule 100 mg

omit from the column headed “Circumstances” (all instances): C5988 C6005 C6016 C6022 C6035 C6037 C6057 substitute (all instances): C15978 C16035 C16073 C16099 C16101 C16102 C16119

[155] Schedule 1, Part 1, entries for Lanreotide in the form Injection 60 mg (as acetate) in single dose pre-filled syringe

(a) omit from the column headed “Circumstances” (all instances): C7509 C7532

(b) insert in numerical order in the column headed “Circumstances” (all instances): C15955 C16024 C16055 C16057


[156] Schedule 1, Part 1, entries for Lanreotide in the form Injection 90 mg (as acetate) in single dose pre-filled syringe

(a) omit from the column headed “Circumstances” (all instances): C7509 C7532

(b) insert in numerical order in the column headed “Circumstances” (all instances): C15955 C16024 C16055 C16057

[157] Schedule 1, Part 1, entries for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe

(a) omit from the column headed “Circumstances” (all instances): C7509 C7532

(b) omit from the column headed “Circumstances” (all instances): C10075

(c) insert in numerical order in the column headed “Circumstances” (all instances): C15955 C16024 C16055 C16056 C16057 C16133

[158] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 5 mg [Brand: Revlimid]

omit from the column headed “Responsible Person” (all instances): CJ  substitute (all instances): BQ

[159] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 10 mg [Brand: Revlimid]

omit from the column headed “Responsible Person” (all instances): CJ  substitute(all instances): BQ

[160] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 15 mg [Brand: Revlimid]

omit from the column headed “Responsible Person” (all instances): CJ  substitute (all instances): BQ

[161] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 25 mg [Brand: Revlimid]

omit from the column headed “Responsible Person” (all instances): CJ  substitute (all instances): BQ

[162] Schedule 1, Part 1, entry for Letrozole [Brand: ARX-LETROZOLE; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522

[163] Schedule 1, Part 1, entry for Letrozole [Brand: ARX-LETROZOLE; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[164] Schedule 1, Part 1, entry for Letrozole [Brand: Femara 2.5 mg; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522


[165] Schedule 1, Part 1, entry for Letrozole [Brand: Femara 2.5 mg; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[166] Schedule 1, Part 1, entry for Letrozole [Brand: Femolet; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522

[167] Schedule 1, Part 1, entry for Letrozole [Brand: Femolet; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[168] Schedule 1, Part 1, entry for Letrozole [Brand: Gynotril; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522

[169] Schedule 1, Part 1, entry for Letrozole [Brand: Gynotril; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[170] Schedule 1, Part 1, entry for Letrozole [Brand: Letrozole APOTEX; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522

[171] Schedule 1, Part 1, entry for Letrozole [Brand: Letrozole APOTEX; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[172] Schedule 1, Part 1, entry for Letrozole [Brand: Letrozole GH; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522


[173] Schedule 1, Part 1, entry for Letrozole [Brand: Letrozole GH; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[174] Schedule 1, Part 1, entry for Letrozole [Brand: Letrozole Sandoz; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522

[175] Schedule 1, Part 1, entry for Letrozole [Brand: Letrozole Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[176] Schedule 1, Part 1, entry for Letrozole [Brand: LETROZOLE-WGR; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522

[177] Schedule 1, Part 1, entry for Letrozole [Brand: LETROZOLE-WGR; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[178] Schedule 1, Part 1, entry for Letrozole [Brand: Pharmacor Letrozole 2.5; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5464  substitute: C5522

(b) omit from the column headed “Purposes”: P5464 substitute: P5522

[179] Schedule 1, Part 1, entry for Letrozole [Brand: Pharmacor Letrozole 2.5; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14943  substitute: C14895

(b) omit from the column headed “Purposes”: P14943 substitute: P14895

[180] Schedule 1, Part 1, entry for Lidocaine in the form Infusion containing lidocaine hydrochloride 500 mg in 5 mL

insert in the column headed “Circumstances”: C15956


[181] Schedule 1, Part 1, entries for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: Molaxole]

omit from the column headed “Responsible Person” (all instances): GO  substitute (all instances): XT

[182] Schedule 1, Part 1, entries for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30

omit:

Macrogol 3350

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

Oral

Movicol

NE

MP NP

C4576 C4577 C4580 C4596 C4601

P4576 P4577 P4580 P4596 P4601

1

5

 

1

 

 

Macrogol 3350

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

Oral

Movicol

NE

MP NP

C6171

P6171

2

3

 

1

 

 

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

 

 

[183] Schedule 1, Part 1, entry for Methadone in the form Injection containing methadone hydrochloride 10 mg in 1 mL [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[184] Schedule 1, Part 1, entries for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL

omit from the column headed “Circumstances” (all instances): C15358  substitute (all instances): C16083

[185] Schedule 1, Part 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL [Brand: Aspen Methadone Syrup; Maximum Quantity: 840; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15358  substitute: C16083

(b) omit from the column headed “Purposes”: P15358 substitute: P16083

[186] Schedule 1, Part 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL [Brand: Biodone Forte]

omit from the column headed “Circumstances”: C15358 substitute: C16083

[187] Schedule 1, Part 1, entry for Methadone in the form Tablet containing methadone hydrochloride 10 mg [Maximum Quantity: 20; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C10745 C10747 C10751 substitute: C15994 C15996 C16000

(b) omit from the column headed “Purposes”: P10745 P10747 P10751 substitute: P15994 P15996 P16000

(c) omit from the column headed “Variations”: V10745 V10747 V10751 substitute: V15994 V15996 V16000

[188] Schedule 1, Part 1, after entry for Methotrexate in the form Tablet 10 mg [Brand: Chexate; Maximum Quantity: 50; Number of Repeats: 2]

insert:

Methotrexate

Tablet 10 mg

Oral

Methoblastin

PF

MP NP

 

 

10

5

 

10

 

 

[189] Schedule 1, Part 1, after entry for Methoxsalen [Maximum Quantity: 12; Number of Repeats: 1]

insert:

Methoxyflurane

Liquid for inhalation 999 mg per g, 3 mL (with inhaler)

Inhalation by mouth

Penthrox (Combination Pack)

DV

See Note 4

See Note 4

See Note 4

See Note 4

See Note 4

 

1

1

D(MP)

[190] Schedule 1, Part 1, entry for Methoxyflurane (after entry for Methoxy polyethylene glycol-epoetin beta in the form Injection 360 micrograms in 0.6 mL pre-filled syringe)

omit:

Methoxyflurane

Liquid for inhalation 999 mg per g, 3 mL (with inhaler)

Inhalation by mouth

Penthrox

DV

See Note 4

See Note 4

See Note 4

See Note 4

See Note 4

 

1

1

D(MP)

[191] Schedule 1, Part 1, entries for Metronidazole in the form Tablet 200 mg [Brand: Metrogyl 200]

omit from the column headed “Responsible Person” (all instances): AF  substitute (all instances): XT

[192] Schedule 1, Part 1, entries for Metronidazole in the form Tablet 400 mg [Brand: Metrogyl 400]

omit from the column headed “Responsible Person” (all instances): AF  substitute (all instances): XT

[193] Schedule 1, Part 1, after entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 20 mg [Maximum Quantity: 20; Number of Repeats: 2]

insert:

Morphine

Tablet containing morphine sulfate pentahydrate 30 mg

Oral

Anamorph

RW

MP NP PDP

C10758

P10758

10

0

 

20

 

 

Morphine

Tablet containing morphine sulfate pentahydrate 30 mg

Oral

Anamorph

RW

PDP

C10859

P10859

20

0

 

20

 

 

Morphine

Tablet containing morphine sulfate pentahydrate 30 mg

Oral

Anamorph

RW

MP NP

C10764 C10770 C10775 C10777 C10837 C10891

P10764 P10770 P10775 P10777 P10837 P10891

20

0

V10764 V10770 V10775 V10777 V10837 V10891

20

 

 

Morphine

Tablet containing morphine sulfate pentahydrate 30 mg

Oral

Anamorph

RW

MP NP

C6168

P6168

20

2

 

20

 

 

[194] Schedule 1, Part 1, entries for Naloxone

substitute:

Naloxone

Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

Injection

Naloxone Hydrochloride (DBL)

PF

MP NP PDP

 

 

5

0

 

5

 

 

Naloxone

Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

Injection

Naloxone Juno

JU

MP NP PDP

 

 

5

0

 

5

 

 

Naloxone

Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

Injection

NALOXONE SXP

XN

MP NP PDP

 

 

5

0

 

5

 

 

Naloxone

Injection containing naloxone hydrochloride 2 mg in 2 mL pre-filled syringe

Injection

Prenoxad

FF

MP NP PDP

 

 

1

0

 

1

 

 

Naloxone

Nasal spray 1.8 mg (as hydrochloride dihydrate) in 0.1 mL single dose unit, 2

Nasal

Nyxoid

MF

MP NP PDP

 

 

1

0

 

1

 

 


[195] Schedule 1, Part 1, entries for Nifedipine in the form Tablet 30 mg (controlled release)

omit:

Nifedipine

Tablet 30 mg (controlled release)

Oral

Addos XR 30

RW

MP NP

 

 

30

5

 

30

 

 

Nifedipine

Tablet 30 mg (controlled release)

Oral

Addos XR 30

RW

MP NP

 

P14238

60

5

 

30

 

 

[196] Schedule 1, Part 1, entries for Nifedipine in the form Tablet 60 mg (controlled release)

omit:

Nifedipine

Tablet 60 mg (controlled release)

Oral

Addos XR 60

RW

MP NP

 

 

30

5

 

30

 

 

Nifedipine

Tablet 60 mg (controlled release)

Oral

Addos XR 60

RW

MP NP

 

P14238

60

5

 

30

 

 

[197] Schedule 1, Part 1, entry for Olanzapine in each of the forms: Powder for injection 210 mg (as pamoate monohydrate) with diluent; Powder for injection 300 mg (as pamoate monohydrate) with diluent; and Powder for injection 405 mg (as pamoate monohydrate) with diluent

omit from the column headed “Circumstances”: C4304 substitute: C4246

[198] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 2.5 mg

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[199] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 5 mg

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[200] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 5 mg (orally disintegrating)

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[201] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 7.5 mg

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[202] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 10 mg

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[203] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 10 mg (orally disintegrating)

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[204] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 15 mg (orally disintegrating)

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[205] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 20 mg (orally disintegrating)

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246

(b) omit from the column headed “Circumstances” (all instances): C5856

[206] Schedule 1, Part 1, entry for Olanzapine in each of the forms: Wafer 5 mg; Wafer 10 mg; Wafer 15 mg; and Wafer 20 mg

(a) insert in numerical order in the column headed “Circumstances”: C4246

(b) omit from the column headed “Circumstances”: C5856

[207] Schedule 1, Part 1, entries for Ozanimod

omit from the column headed “Responsible Person” (all instances): CJ  substitute (all instances): BQ

[208] Schedule 1, Part 1, after entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate) [Brand: APO-Pantoprazole; Maximum Quantity: 60; Number of Repeats: 5]

insert:

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APX-PANTOPRAZOLE

TW

MP NP

C5444 C5512 C5529

P5444 P5512 P5529

30

5

 

30

 

 

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APX-PANTOPRAZOLE

TW

MP NP

C15574 C15575 C15633

P15574 P15575 P15633

60

5

 

30

 

 

[209] Schedule 1, Part 1, entries for Paracetamol in the form Tablet 665 mg (modified release) [Brand: Parapane OSTEO]

omit from the column headed “Responsible Person” (all instances): AF  substitute (all instances): XT

[210] Schedule 1, Part 1, entry for Penicillamine in the form Tablet 125 mg [Maximum Quantity: 100; Number of Repeats: 1]

(a) insert in the column headed “Circumstances”: C15956

(b) insert in the column headed “Purposes”: P15956

[211] Schedule 1, Part 1, entry for Penicillamine in the form Tablet 125 mg [Maximum Quantity: 200; Number of Repeats: 1]

(a) insert in the column headed “Circumstances”: C16078

(b) omit from the column headed “Purposes”: C14238 substitute: C16078

[212] Schedule 1, Part 1, entry for Penicillamine in the form Tablet 250 mg [Maximum Quantity: 100; Number of Repeats: 1]

(a) insert in the column headed “Circumstances”: C15956

(b) insert in the column headed “Purposes”: P15956

[213] Schedule 1, Part 1, entry for Penicillamine in the form Tablet 250 mg [Maximum Quantity: 200; Number of Repeats: 1]

(a) insert in the column headed “Circumstances”: C16078

(b) omit from the column headed “Purposes”: C14238 substitute: C16078

[214] Schedule 1, Part 1, entry for Perhexiline

omit from the column headed “Circumstances”: C5592 substitute: C16111

[215] Schedule 1, Part 1, entry for Periciazine in each of the forms: Tablet 2.5 mg; and Tablet 10 mg

insert in the column headed “Circumstances”: C15956

[216] Schedule 1, Part 1, entries for Pioglitazone in the form Tablet 15 mg (as hydrochloride)

omit:

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Acpio 15

RF

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Acpio 15

RF

MP NP

C15290

P15290

56

5

 

28

 

 

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Actaze

RW

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Actaze

RW

MP NP

C15290

P15290

56

5

 

28

 

 

[217] Schedule 1, Part 1, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)

omit:

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Acpio 30

RF

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Acpio 30

RF

MP NP

C15290

P15290

56

5

 

28

 

 

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actaze

RW

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actaze

RW

MP NP

C15290

P15290

56

5

 

28

 

 

[218] Schedule 1, Part 1, after entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride) [Brand: APOTEX-Pioglitazone; Maximum Quantity: 56; Number of Repeats: 5]

insert:

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

XT

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

XT

MP NP

C15290

P15290

56

5

 

28

 

 

[219] Schedule 1, Part 1, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)

omit:

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Acpio 45

RF

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Acpio 45

RF

MP NP

C15290

P15290

56

5

 

28

 

 

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Actaze

RW

MP NP

C15321

P15321

28

5

 

28

 

 

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Actaze

RW

MP NP

C15290

P15290

56

5

 

28

 

 

[220] Schedule 1, Part 1, entries for Pomalidomide in the form Capsule 3 mg [Brand: Pomalyst]

omit from the column headed “Responsible Person” (all instances): CJ  substitute (all instances): BQ

[221] Schedule 1, Part 1, entries for Pomalidomide in the form Capsule 4 mg [Brand: Pomalyst]

omit from the column headed “Responsible Person” (all instances): CJ  substitute (all instances): BQ

[222] Schedule 1, Part 1, entries for Posaconazole

omit from the column headed “Circumstances” (all instances): C5169 C5395 C5396  substitute (all instances): C16072 C16096 C16117

[223] Schedule 1, Part 1, entries for Quetiapine in the form Tablet 25 mg (as fumarate)

(a) insert in numerical order in the column headed “Circumstances” (all instances): C4246 C5869

(b) omit from the column headed “Circumstances” (all instances): C7893 C7916

[224] Schedule 1, Part 1, after entry for Quetiapine in the form Tablet 25 mg (as fumarate) [Brand: Quetiapine Sandoz Pharma]

insert:

Quetiapine

Tablet 25 mg (as fumarate)

Oral

QUETIAPINE-WGR

WG

MP NP

C4246 C5869 C7927

 

60

0

 

60

 

 

[225] Schedule 1, Part 1, entries for Quetiapine in the form Tablet 100 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869

[226] Schedule 1, Part 1, after entry for Quetiapine in the form Tablet 100 mg (as fumarate) [Brand: Quetiapine Sandoz Pharma]

insert:

Quetiapine

Tablet 100 mg (as fumarate)

Oral

QUETIAPINE-WGR

WG

MP NP

C4246 C5611 C5869

 

90

5

 

90

 

 

[227] Schedule 1, Part 1, entries for Quetiapine in the form Tablet 200 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869

[228] Schedule 1, Part 1, after entry for Quetiapine in the form Tablet 200 mg (as fumarate) [Brand: Quetiapine Sandoz Pharma]

insert:

Quetiapine

Tablet 200 mg (as fumarate)

Oral

QUETIAPINE-WGR

WG

MP NP

C4246 C5611 C5869

 

60

5

 

60

 

 

[229] Schedule 1, Part 1, entries for Quetiapine in the form Tablet 300 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869

[230] Schedule 1, Part 1, after entry for Quetiapine in the form Tablet 300 mg (as fumarate) [Brand: Quetiapine Sandoz Pharma]

insert:

Quetiapine

Tablet 300 mg (as fumarate)

Oral

QUETIAPINE-WGR

WG

MP NP

C4246 C5611 C5869

 

60

5

 

60

 

 

[231] Schedule 1, Part 1, entries for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869

[232] Schedule 1, Part 1, entries for Quetiapine in the form Tablet (modified release) 150 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869

[233] Schedule 1, Part 1, entries for Quetiapine in the form Tablet (modified release) 200 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869

[234] Schedule 1, Part 1, entries for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869


[235] Schedule 1, Part 1, entries for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)

(a) omit from the column headed “Circumstances” (all instances): C5639

(b) insert in numerical order in the column headed “Circumstances” (all instances): C5869

[236] Schedule 1, Part 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)

omit:

Quinapril

Tablet 10 mg (as hydrochloride)

Oral

Accupril

PF

MP NP

 

 

30

5

 

30

 

 

Quinapril

Tablet 10 mg (as hydrochloride)

Oral

ACQUIN

RF

MP NP

 

 

30

5

 

30

 

 

[237] Schedule 1, Part 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

omit:

Quinapril

Tablet 20 mg (as hydrochloride)

Oral

Accupril

PF

MP NP

 

 

30

5

 

30

 

 

Quinapril

Tablet 20 mg (as hydrochloride)

Oral

ACQUIN

RF

MP NP

 

 

30

5

 

30

 

 

[238] Schedule 1, Part 1, omit entry for Ribavirin

[239] Schedule 1, Part 1, entry for Rifampicin in the form Capsule 150 mg [Maximum Quantity: 10; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5536 C5585  substitute: C16037 C16075

(b) omit from the column headed “Purposes”: P5536 P5585 substitute: P16037 P16075

[240] Schedule 1, Part 1, entry for Rifampicin in the form Capsule 150 mg [Maximum Quantity: 100; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5552 C11018  substitute: C15973 C16043

(b) omit from the column headed “Purposes”: P5552 P11018 substitute: P15973 P16043

[241] Schedule 1, Part 1, entry for Rifampicin in the form Capsule 150 mg [Maximum Quantity: 120; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C11018  substitute: C16043

(b) omit from the column headed “Purposes”: P11018 substitute: P16043


[242] Schedule 1, Part 1, entry for Rifampicin in the form Capsule 300 mg [Maximum Quantity: 10; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5536 C5585  substitute: C16037 C16075

(b) omit from the column headed “Purposes”: P5536 P5585 substitute: P16037 P16075

[243] Schedule 1, Part 1, entry for Rifampicin in the form Capsule 300 mg [Maximum Quantity: 100; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C5552 C11018  substitute: C15973 C16043

(b) omit from the column headed “Purposes”: P5552 P11018 substitute: P15973 P16043

[244] Schedule 1, Part 1, entry for Rifampicin in the form Capsule 300 mg [Maximum Quantity: 120; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C11018  substitute: C16043

(b) omit from the column headed “Purposes”: P11018 substitute: P16043

[245] Schedule 1, Part 1, entry for Rifampicin in the form Syrup 100 mg per 5 mL, 60 mL

omit from the column headed “Circumstances”: C5536 C5585  substitute: C16037 C16075

[246] Schedule 1, Part 1, entries for Riluzole in the form Tablet 50 mg

omit:

Riluzole

Tablet 50 mg

Oral

APO-Riluzole

TX

MP NP

C5341 C8738

P5341 P8738

56

5

 

56

 

 

Riluzole

Tablet 50 mg

Oral

APO-Riluzole

TX

MP NP

C15719

P15719

112

5

 

56

 

 

[247] Schedule 1, Part 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Brand: Risperdal; Maximum Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[248] Schedule 1, Part 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Brand: Risperidone Lupin; Maximum Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[249] Schedule 1, Part 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Brand: Rixadone; Maximum Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[250] Schedule 1, Part 1, entries for Risperidone in the form Tablet 0.5 mg

substitute:

Risperidone

Tablet 0.5 mg

Oral

APO-Risperidone

TX

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

APO-Risperidone

TX

MP NP

C4246

P4246

60

5

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

NOUMED RISPERIDONE

VO

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

NOUMED RISPERIDONE

VO

MP NP

C4246

P4246

60

5

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Ozidal

RA

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Ozidal

RA

MP NP

C4246

P4246

60

5

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Rispa

RW

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Rispa

RW

MP NP

C4246

P4246

60

5

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Risperdal

JC

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

20

 

 

Risperidone

Tablet 0.5 mg

Oral

Risperdal

JC

MP NP

C4246

P4246

60

5

 

20

 

 

Risperidone

Tablet 0.5 mg

Oral

Risperidone Sandoz

SZ

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Risperidone Sandoz

SZ

MP NP

C4246

P4246

60

5

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Rispernia

ZS

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Rispernia

ZS

MP NP

C4246

P4246

60

5

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Rixadone

AF

MP NP

C6898 C10020 C10021 C16048

P6898 P10020 P10021 P16048

60

2

 

60

 

 

Risperidone

Tablet 0.5 mg

Oral

Rixadone

AF

MP NP

C4246

P4246

60

5

 

60

 

 

[251] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Brand: APO-Risperidone; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[252] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Brand: NOUMED RISPERIDONE; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[253] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Brand: Ozidal; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[254] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Brand: Rispa; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[255] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Brand: Risperdal; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

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

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[257] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Brand: Rispernia; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[258] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg [Brand: Rixadone; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6899

(b) insert in numerical order in the column headed “Circumstances”: C16048

(c) omit from the column headed “Purposes”: P6899

(d) insert in numerical order in the column headed “Purposes”: P16048

[259] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Brand: APO-Risperidone; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

[260] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Brand: NOUMED RISPERIDONE; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

[261] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Brand: Ozidal; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

[262] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Brand: Rispa; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

[263] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Brand: Risperdal; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

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

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

[265] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Brand: Rispernia; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

[266] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg [Brand: Rixadone; Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6897 C6938  substitute: C6898 C16048

(b) omit from the column headed “Purposes”: P6897 P6938 substitute: P6898 P16048

[267] Schedule 1, Part 1, entry for Rivaroxaban in the form Tablet 15 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 42; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C4260

(b) insert in numerical order in the column headed “Circumstances”: C5098

(c) omit from the column headed “Purposes”: P4260

(d) insert in numerical order in the column headed “Purposes”: P5098

[268] Schedule 1, Part 1, entry for Rivaroxaban in the form Tablet 15 mg [Brand: Xarelto; Maximum Quantity: 42; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C4260

(b) insert in numerical order in the column headed “Circumstances”: C5098

(c) omit from the column headed “Purposes”: P4260

(d) insert in numerical order in the column headed “Purposes”: P5098

[269] Schedule 1, Part 1, entry for Romosozumab

omit from the column headed “Circumstances”: C13819 C13820 substitute: C16021 C16022 C16023 C16087 C16132

[270] Schedule 1, Part 1, entry for Sevelamer in the form Tablet containing sevelamer carbonate 800 mg [Brand: ARX-SEVELAMER; Maximum Quantity: 360; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14984  substitute: C14872

(b) omit from the column headed “Purposes”: P14984 substitute: P14872

[271] Schedule 1, Part 1, entry for Sevelamer in the form Tablet containing sevelamer carbonate 800 mg [Brand: Sevelamer Apotex; Maximum Quantity: 360; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14984  substitute: C14872

(b) omit from the column headed “Purposes”: P14984 substitute: P14872


[272] Schedule 1, Part 1, entry for Sevelamer in the form Tablet containing sevelamer carbonate 800 mg [Brand: Sevelamer Lupin; Maximum Quantity: 360; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14984  substitute: C14872

(b) omit from the column headed “Purposes”: P14984 substitute: P14872

[273] Schedule 1, Part 1, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg [Brand: Renagel; Maximum Quantity: 360; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14984  substitute: C14872

(b) omit from the column headed “Purposes”: P14984 substitute: P14872

[274] Schedule 1, Part 1, entries for Sotalol in the form Tablet containing sotalol hydrochloride 80 mg

omit from the column headed “Circumstances” (all instances): C5664  substitute (all instances): C15967

[275] Schedule 1, Part 1, entries for Sotalol in the form Tablet containing sotalol hydrochloride 160 mg

omit from the column headed “Circumstances” (all instances): C5664  substitute (all instances): C15967

[276] Schedule 1, Part 1, entry for Tamoxifen [Brand: Genox 20; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6381  substitute: C5522

(b) omit from the column headed “Purposes”: P6381 substitute: P5522

[277] Schedule 1, Part 1, entry for Tamoxifen [Brand: GenRx Tamoxifen; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6381  substitute: C5522

(b)  omit from the column headed “Purposes”: P6381 substitute: P5522

[278] Schedule 1, Part 1, entry for Tamoxifen [Brand: Nolvadex-D; Maximum Quantity: 60; Number of Repeats: 5]

(a) insert in numerical order in the column headed “Circumstances”: C5522

(b) omit from the column headed “Circumstances”: C6449

(c) insert in numerical order in the column headed “Purposes”: P5522

(d)  omit from the column headed “Purposes”: P6449

[279] Schedule 1, Part 1, entry for Tamoxifen [Brand: Tamosin; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6381  substitute: C5522

(b) omit from the column headed “Purposes”: P6381 substitute: P5522

[280] Schedule 1, Part 1, entry for Tamoxifen [Brand: Tamoxifen Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6381  substitute: C5522

(b) omit from the column headed “Purposes”: P6381 substitute: P5522

[281] Schedule 1, Part 1, entry for Thalidomide in each of the forms: Capsule 50 mg; and Capsule 100 mg

omit from the column headed “Responsible Person”: CJ substitute: BQ

[282] Schedule 1, Part 1, after entry for Timolol in the form Eye drops 5 mg (as maleate) per mL, 5 mL

insert:

Timolol

Eye drops 5 mg (as maleate) per mL, 5 mL (S19A)

Application to the eye

Timolol (Brown & Burk, UK)

LM

MP AO

 

 

1

5

 

1

 

 

[283] Schedule 1, Part 1, entries for Tirofiban

omit from the column headed “Circumstances” (all instances): C5691 C5782 C5809  substitute (all instances): C16063 C16123 C16147

[284] Schedule 1, Part 1, entries for Valaciclovir in the form Tablet 500 mg (as hydrochloride)

omit:

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

Valaciclovir generichealth

GQ

MP NP

C5940 C5961

P5940 P5961

30

5

 

30

 

 

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

Valaciclovir generichealth

GQ

MP NP

C5962 C5968

P5962 P5968

42

0

 

42

 

 

[285] Schedule 1, Part 1, entries for Voriconazole

substitute:

Voriconazole

Powder for oral suspension 40 mg per mL, 70 mL

Oral

Vfend

PF

MP NP

C15979 C15981 C16042 C16094 C16115


 

1

0


 

1

 

 

Voriconazole

Tablet 50 mg

Oral

Voriconazole Sandoz

SZ

MP NP

C16115

P16115

56

0

 

56

 

 

Voriconazole

Tablet 50 mg

Oral

Voriconazole Sandoz

SZ

MP NP

C15979 C15981 C16042 C16094

P15979 P15981 P16042 P16094

56

2

 

56

 

 

Voriconazole

Tablet 50 mg

Oral

Vttack

AF

MP NP

C16115

P16115

56

0

 

56

 

 

Voriconazole

Tablet 50 mg

Oral

Vttack

AF

MP NP

C15979 C15981 C16042 C16094

P15979 P15981 P16042 P16094

56

2

 

56

 

 

Voriconazole

Tablet 50 mg

Oral

Vzole

RW

MP NP

C16115

P16115

56

0

 

56

 

 

Voriconazole

Tablet 50 mg

Oral

Vzole

RW

MP NP

C15979 C15981 C16042 C16094

P15979 P15981 P16042 P16094

56

2

 

56

 

 

Voriconazole

Tablet 200 mg

Oral

Voriconazole Sandoz

SZ

MP NP

C16115

P16115

56

0

 

56

 

 

Voriconazole

Tablet 200 mg

Oral

Voriconazole Sandoz

SZ

MP NP

C15979 C15981 C16042 C16094

P15979 P15981 P16042 P16094

56

2

 

56

 

 

Voriconazole

Tablet 200 mg

Oral

Vttack

AF

MP NP

C16115

P16115

56

0

 

56

 

 

Voriconazole

Tablet 200 mg

Oral

Vttack

AF

MP NP

C15979 C15981 C16042 C16094

P15979 P15981 P16042 P16094

56

2

 

56

 

 

Voriconazole

Tablet 200 mg

Oral

Vzole

RW

MP NP

C16115

P16115

56

0

 

56

 

 

Voriconazole

Tablet 200 mg

Oral

Vzole

RW

MP NP

C15979 C15981 C16042 C16094

P15979 P15981 P16042 P16094

56

2

 

56

 

 

[286] Schedule 1, Part 1, entry for Zolmitriptan [Brand: Zomig]

omit from the column headed “Responsible Person”: AP substitute: AS

[287] Schedule 1, Part 1, entry for Zuclopenthixol decanoate

insert in the column headed “Circumstances”: C15956

[288] Schedule 1, Part 2, omit entry for Carbomer 974

[289] Schedule 1, Part 2, omit entry for Hypromellose with dextran

[290] Schedule 1, Part 2, omit entry for Mepolizumab

[291] Schedule 1, Part 2, omit entry for Risankizumab

[292] Schedule 3,

omit:

CJ

Celgene Pty Limited

42 118 998 771

[293] Schedule 4, Part 1, entry for Circumstances Code “C4246”

insert in alphabetical order in the column headed “Listed Drug”: Olanzapine

[294] Schedule 4, Part 1, omit entry for Circumstances Code “C4260”

[295] Schedule 4, Part 1, entry for Circumstances Code “C4268”

insert in alphabetical order in the column headed “Listed Drug”: Apixaban

[296] Schedule 4, Part 1, entry for Circumstances Code “C4295”

(a) insert in alphabetical order in the column headed “Listed Drug”: Glycomacropeptide formula with amino acids and low phenylalanine

(b) insert in alphabetical order in the column headed “Listed Drug”: Glycomacropeptide formula with amino acids, vitamins, minerals, trace elements, carbohydrate, fat and low phenylalanine

[297] Schedule 4, Part 1, omit entry for Circumstances Code “C4304”

[298] Schedule 4, Part 1, omit entry for Circumstances Code “C4683”

[299] Schedule 4, Part 1, omit entry for Circumstances Code “C4685”

[300] Schedule 4, Part 1, omit entry for Circumstances Code “C5083”

[301] Schedule 4, Part 1, entry for Circumstances Code “C5098”

insert in alphabetical order in the column headed “Listed Drug”: Rivaroxaban

[302] Schedule 4, Part 1, omit entry for Circumstances Code “C5169”

[303] Schedule 4, Part 1, omit entry for Circumstances Code “C5395”

[304] Schedule 4, Part 1, omit entry for Circumstances Code “C5396”

[305] Schedule 4, Part 1, omit entry for Circumstances Code “C5464”


[306] Schedule 4, Part 1, entry for Circumstances Code “C5522”

(a) insert in alphabetical order in the column headed “Listed Drug”: Anastrozole

(b) insert in alphabetical order in the column headed “Listed Drug”: Letrozole

(c) insert in alphabetical order in the column headed “Listed Drug”: Tamoxifen

[307] Schedule 4, Part 1, omit entry for Circumstances Code “C5536”

[308] Schedule 4, Part 1, omit entry for Circumstances Code “C5550”

[309] Schedule 4, Part 1, omit entry for Circumstances Code “C5552”

[310] Schedule 4, Part 1, omit entry for Circumstances Code “C5584”

[311] Schedule 4, Part 1, omit entry for Circumstances Code “C5585”

[312] Schedule 4, Part 1, omit entry for Circumstances Code “C5592”

[313] Schedule 4, Part 1, omit entry for Circumstances Code “C5624”

[314] Schedule 4, Part 1, omit entry for Circumstances Code “C5639”

[315] Schedule 4, Part 1, omit entry for Circumstances Code “C5664”

[316] Schedule 4, Part 1, omit entry for Circumstances Code “C5665”

[317] Schedule 4, Part 1, omit entry for Circumstances Code “C5691”

[318] Schedule 4, Part 1, omit entry for Circumstances Code “C5692”

[319] Schedule 4, Part 1, omit entry for Circumstances Code “C5725”

[320] Schedule 4, Part 1, entry for Circumstances Code “C5729”

insert in alphabetical order in the column headed “Listed Drug”: Flutamide

[321] Schedule 4, Part 1, omit entry for Circumstances Code “C5734”

[322] Schedule 4, Part 1, omit entry for Circumstances Code “C5748”

[323] Schedule 4, Part 1, omit entry for Circumstances Code “C5782”

[324] Schedule 4, Part 1, omit entry for Circumstances Code “C5809”

[325] Schedule 4, Part 1, omit entry for Circumstances Code “C5813”

[326] Schedule 4, Part 1, omit entry for Circumstances Code “C5814”

[327] Schedule 4, Part 1, omit entry for Circumstances Code “C5816”

[328] Schedule 4, Part 1, omit entry for Circumstances Code “C5826”

[329] Schedule 4, Part 1, omit entry for Circumstances Code “C5830”

[330] Schedule 4, Part 1, omit entry for Circumstances Code “C5842”

[331] Schedule 4, Part 1, omit entry for Circumstances Code “C5856”

[332] Schedule 4, Part 1, omit entry for Circumstances Code “C5861”

[333] Schedule 4, Part 1, omit entry for Circumstances Code “C5862”

[334] Schedule 4, Part 1, omit entry for Circumstances Code “C5868”

[335] Schedule 4, Part 1, entry for Circumstances Code “C5869”

insert in alphabetical order in the column headed “Listed Drug”: Quetiapine

[336] Schedule 4, Part 1, omit entry for Circumstances Code “C5881”

[337] Schedule 4, Part 1, omit entry for Circumstances Code “C5882”

[338] Schedule 4, Part 1, omit entry for Circumstances Code “C5890”

[339] Schedule 4, Part 1, omit entry for Circumstances Code “C5891”

[340] Schedule 4, Part 1, omit entry for Circumstances Code “C5903”

[341] Schedule 4, Part 1, omit entry for Circumstances Code “C5904”

[342] Schedule 4, Part 1, omit entry for Circumstances Code “C5915”

[343] Schedule 4, Part 1, omit entry for Circumstances Code “C5957”

[344] Schedule 4, Part 1, omit entry for Circumstances Code “C5978”

[345] Schedule 4, Part 1, omit entry for Circumstances Code “C5988”

[346] Schedule 4, Part 1, omit entry for Circumstances Code “C6002”

[347] Schedule 4, Part 1, omit entry for Circumstances Code “C6005”

[348] Schedule 4, Part 1, omit entry for Circumstances Code “C6006”

[349] Schedule 4, Part 1, omit entry for Circumstances Code “C6016”

[350] Schedule 4, Part 1, omit entry for Circumstances Code “C6022”

[351] Schedule 4, Part 1, omit entry for Circumstances Code “C6035”

[352] Schedule 4, Part 1, omit entry for Circumstances Code “C6037”

[353] Schedule 4, Part 1, omit entry for Circumstances Code “C6045”

[354] Schedule 4, Part 1, omit entry for Circumstances Code “C6057”

[355] Schedule 4, Part 1, omit entry for Circumstances Code “C6381”

[356] Schedule 4, Part 1, omit entry for Circumstances Code “C6449”

[357] Schedule 4, Part 1, omit entry for Circumstances Code “C6897”

[358] Schedule 4, Part 1, omit entry for Circumstances Code “C6899”

[359] Schedule 4, Part 1, omit entry for Circumstances Code “C6938”

[360] Schedule 4, Part 1, omit entry for Circumstances Code “C7509”

[361] Schedule 4, Part 1, omit entry for Circumstances Code “C7532”

[362] Schedule 4, Part 1, omit entry for Circumstances Code “C7893”

[363] Schedule 4, Part 1, omit entry for Circumstances Code “C7898”

[364] Schedule 4, Part 1, omit entry for Circumstances Code “C7916”

[365] Schedule 4, Part 1, omit entry for Circumstances Code “C7934”

[366] Schedule 4, Part 1, omit entry for Circumstances Code “C7957”

[367] Schedule 4, Part 1, omit entry for Circumstances Code “C7958”

[368] Schedule 4, Part 1, omit entry for Circumstances Code “C7966”

[369] Schedule 4, Part 1, omit entry for Circumstances Code “C7990”

[370] Schedule 4, Part 1, omit entry for Circumstances Code “C7996”

[371] Schedule 4, Part 1, omit entry for Circumstances Code “C8662”

[372] Schedule 4, Part 1, omit entry for Circumstances Code “C8692”

[373] Schedule 4, Part 1, omit entry for Circumstances Code “C8947”

[374] Schedule 4, Part 1, omit entry for Circumstances Code “C10023”

[375] Schedule 4, Part 1, entry for Circumstances Code “C10075”

omit from the column headed “Listed Drug”: Lanreotide

[376] Schedule 4, Part 1, omit entry for Circumstances Code “C10745”

[377] Schedule 4, Part 1, omit entry for Circumstances Code “C10747”

[378] Schedule 4, Part 1, omit entry for Circumstances Code “C10751”

[379] Schedule 4, Part 1, omit entry for Circumstances Code “C11018”

[380] Schedule 4, Part 1, omit entry for Circumstances Code “C12004”

[381] Schedule 4, Part 1, omit entry for Circumstances Code “C12064”

[382] Schedule 4, Part 1, omit entry for Circumstances Code “C13819”

[383] Schedule 4, Part 1, omit entry for Circumstances Code “C13820”

[384] Schedule 4, Part 1, omit entry for Circumstances Code “C14189”

[385] Schedule 4, Part 1, entry for Circumstances Code “C14238”

(a) insert in alphabetical order in the column headed “Listed Drug”: Ezetimibe

(b) insert in alphabetical order in the column headed “Listed Drug”: Ezetimibe and rosuvastatin

(c) insert in alphabetical order in the column headed “Listed Drug”: Ezetimibe with atorvastatin

(d) insert in alphabetical order in the column headed “Listed Drug”: Ezetimibe with simvastatin

(e) omit from the column headed “Listed Drug”: Penicillamine

[386] Schedule 4, Part 1, omit entry for Circumstances Code “C14249”

[387] Schedule 4, Part 1, omit entry for Circumstances Code “C14269”

[388] Schedule 4, Part 1, omit entry for Circumstances Code “C14283”

[389] Schedule 4, Part 1, omit entry for Circumstances Code “C14284”

[390] Schedule 4, Part 1, entry for Circumstances Code “C14301”

(a) insert in alphabetical order in the column headed “Listed Drug”: Apixaban

(b) insert in alphabetical order in the column headed “Listed Drug”: Dabigatran etexilate

[391] Schedule 4, Part 1, omit entry for Circumstances Code “C14302”

[392] Schedule 4, Part 1, omit entry for Circumstances Code “C14308”

[393] Schedule 4, Part 1, omit entry for Circumstances Code “C14310”

[394] Schedule 4, Part 1, entry for Circumstances Code “C14318”

insert in alphabetical order in the column headed “Listed Drug”: Apixaban

[395] Schedule 4, Part 1, omit entry for Circumstances Code “C14348”

[396] Schedule 4, Part 1, omit entry for Circumstances Code “C14350”

[397] Schedule 4, Part 1, omit entry for Circumstances Code “C14472”

[398] Schedule 4, Part 1, entry for Circumstances Code “C14872”

insert in alphabetical order in the column headed “Listed Drug”: Sevelamer

[399] Schedule 4, Part 1, entry for Circumstances Code “C14895”

(a) insert in alphabetical order in the column headed “Listed Drug”: Anastrozole

(b) insert in alphabetical order in the column headed “Listed Drug”: Exemestane

(c) insert in alphabetical order in the column headed “Listed Drug”: Letrozole

[400] Schedule 4, Part 1, omit entry for Circumstances Code “C14943”

[401] Schedule 4, Part 1, omit entry for Circumstances Code “C14984”

[402] Schedule 4, Part 1, omit entry for Circumstances Code “C14992”

[403] Schedule 4, Part 1, entry for Circumstances Code “C15269”

insert in alphabetical order in the column headed “Listed Drug”: Dapagliflozin with sitagliptin

[404] Schedule 4, Part 1, entry for Circumstances Code “C15270”

insert in alphabetical order in the column headed “Listed Drug”: Dapagliflozin with sitagliptin

[405] Schedule 4, Part 1, omit entry for Circumstances Code “C15355”

[406] Schedule 4, Part 1, omit entry for Circumstances Code “C15356”

[407] Schedule 4, Part 1, omit entry for Circumstances Code “C15358”

[408] Schedule 4, Part 1, omit entry for Circumstances Code “C15385”

[409] Schedule 4, Part 1, omit entry for Circumstances Code “C15439”

[410] Schedule 4, Part 1, after entry for Circumstances Code “C15952”

insert:

C15955

P15955

CN15955

Lanreotide

Functional carcinoid tumour

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be causing intractable symptoms; AND

Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND

Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 15955

C15956

P15956

CN15956

Auranofin

Chlorpromazine

Digoxin

Disopyramide

Isoniazid

Lidocaine

Penicillamine

Periciazine

Zuclopenthixol decanoate

For prescribing by certain health practitioners

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C15964

P15964

CN15964

Cefazolin

Cefotaxime

Ceftriaxone

Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C15965

P15965

CN15965

Flecainide

Serious supra-ventricular cardiac arrhythmias

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C15966

P15966

CN15966

Flecainide

Serious ventricular cardiac arrhythmias

The treatment must be initiated in a hospital; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C15967

P15967

CN15967

Amiodarone

Sotalol

Severe cardiac arrhythmias

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C15973

P15973

CN15973

Rifampicin

Leprosy

Patient must be an adult;

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C15975

P15975

CN15975

Fluconazole

Cryptococcal meningitis

The treatment must be maintenance therapy; AND

Patient must be immunosuppressed; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 15975

C15978

P15978

CN15978

Itraconazole

Systemic sporotrichosis

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 15978

C15979

P15979

CN15979

Voriconazole

Serious Candida infections

Treatment and maintenance therapy

The condition must be caused by species not susceptible to fluconazole; or

The condition must be resistant to fluconazole; or

Patient must be unable to tolerate fluconazole; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C15981

P15981

CN15981

Voriconazole

Serious invasive mycosis infections

Treatment and maintenance therapy

The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C15984

P15984

CN15984

Fluconazole

Cryptococcal meningitis

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 15984

C15994

P15994

CN15994

Fentanyl

Methadone

Chronic severe disabling pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must not be opioid naive; AND

Patient must have cancer pain; or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 15994

C15996

P15996

CN15996

Fentanyl

Methadone

Chronic severe disabling pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must not be opioid naive; AND

Patient must have cancer pain; or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 15996

C16000

P16000

CN16000

Fentanyl

Methadone

Chronic severe disabling pain

Continuing PBS treatment after 1 June 2020

Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16000

C16009

P16009

CN16009

Buprenorphine

Buprenorphine with naloxone

Opioid dependence

The treatment must be within a framework of medical, social and psychological treatment.

The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16009

C16015

P16015

CN16015

Buprenorphine

Opioid dependence

Must be treated by a health care professional; AND

The treatment must be within a framework of medical, social and psychological treatment; AND

Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone.

The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16015

C16018

P16018

CN16018

Eptinezumab

Galcanezumab

Chronic migraine

Initial treatment

Must be treated by a neurologist; or

Must be treated by a general practitioner in consultation with a neurologist; AND

Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND

Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND

Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND

Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug;

Patient must be at least 18 years of age.

Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.

Patient must have the number of migraine days per month documented in their medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 16018

C16021

P16021

CN16021

Romosozumab

Severe established osteoporosis

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 November 2024; AND

Patient must not have received PBS-subsidised treatment with any of the following prior to initiating non-PBS-subsidised treatment with this drug for this condition: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab; AND

Patient must be at very high risk of fracture; AND

Patient must have had a Bone Mineral Density (BMD) T-score of -2.5 or less prior to starting non-PBS-subsidised treatment with this drug for this condition; AND

Patient must have had a symptomatic fracture due to minimal trauma prior to starting non-PBS-subsidised treatment with this drug for this condition; AND

Patient must have had at least 1 hip or symptomatic vertebral fracture in the 24 months prior to starting non-PBS-subsidised treatment with this drug for this condition; or

Patient must have had at least 2 fractures including 1 symptomatic new fracture in the 24 months prior to starting non-PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND

Must be treated by a consultant physician.

Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.

Compliance with Authority Required procedures

C16022

P16022

CN16022

Romosozumab

Severe established osteoporosis

Continuing treatment - First-line therapy

Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND

Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.

Compliance with Authority Required procedures

C16023

P16023

CN16023

Romosozumab

Severe established osteoporosis

Continuing treatment - Second-line therapy

Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND

The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND

Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.

Compliance with Authority Required procedures

C16024

P16024

CN16024

Lanreotide

Acromegaly

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND

The condition must be active; AND

Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND

The treatment must be after failure of other therapy including dopamine agonists; or

The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or

The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND

The treatment must cease if IGF1 is not lower after 3 months of treatment; AND

The treatment must not be given concomitantly with PBS-subsidised pegvisomant.

In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 16024

C16029

P16029

CN16029

Cefazolin

Cefotaxime

Ceftriaxone

Septicaemia, proven

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C16030

P16030

CN16030

Cefazolin

Cefotaxime

Ceftriaxone

Septicaemia, suspected

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C16034

P16034

CN16034

Fluconazole

Fungal infection

The condition must be serious or life-threatening; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16034

C16035

P16035

CN16035

Itraconazole

Systemic histoplasmosis

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16035

C16037

P16037

CN16037

Rifampicin

Haemophilus influenzae type B

The treatment must be for prophylaxis; AND

Patient must be in contact with people who have the disease; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C16042

P16042

CN16042

Voriconazole

Definite or probable invasive aspergillosis

Treatment and maintenance therapy

Patient must be immunocompromised; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C16043

P16043

CN16043

Rifampicin

Mycobacterium ulcerans infection (Buruli ulcer)

The treatment must be used in combination with another antibiotic for the treatment of Buruli ulcer; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C16048

P16048

CN16048

Risperidone

Severe behavioural disturbances

Continuing treatment

Patient must have autism spectrum disorder; AND

Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND

The treatment must be under the supervision of a paediatrician or psychiatrist; AND

The treatment must be in combination with non-pharmacological measures;

Patient must be at least 18 years of age.

Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.

The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.

Compliance with Authority Required procedures - Streamlined Authority Code 16048

C16050

P16050

CN16050

Buprenorphine

Opioid dependence

Must be treated by a health care professional; AND

The treatment must be within a framework of medical, social and psychological treatment; AND

Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.

The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16050

C16051

P16051

CN16051

Buprenorphine

Opioid dependence

Must be treated by a health care professional; AND

The treatment must be within a framework of medical, social and psychological treatment.

The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16051

C16053

P16053

CN16053

Avelumab

Stage IV (metastatic) Merkel Cell Carcinoma

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction. or

The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 16053

C16054

P16054

CN16054

Chlormethine

Mycosis fungoides cutaneous T-cell lymphoma

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND

Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND

The treatment must be approved for 1 unit if the condition is no more than 10% of the patient's body surface area to provide 4 weeks of treatment per script. or

The treatment must be approved for 2 units if the condition is no more than 25% of the patient's body surface area to provide 4 weeks of treatment per script.

Compliance with Authority Required procedures

C16055

P16055

CN16055

Lanreotide

Acromegaly

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be active; AND

Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND

The treatment must be after failure of other therapy including dopamine agonists; or

The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or

The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND

The treatment must cease if IGF1 is not lower after 3 months of treatment; AND

The treatment must not be given concomitantly with PBS-subsidised pegvisomant.

In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 16055

C16056

P16056

CN16056

Lanreotide

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition;

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 16056

C16057

P16057

CN16057

Lanreotide

Functional carcinoid tumour

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND

The condition must be causing intractable symptoms; AND

Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND

Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 16057

C16063

P16063

CN16063

Tirofiban

Non-Q-wave myocardial infarction

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16063

C16067

P16067

CN16067

Cefepime

Febrile neutropenia

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C16072

P16072

CN16072

Posaconazole

Invasive aspergillosis

Patient must be unable to tolerate alternative therapy; or

Patient must have disease refractory to alternative therapy; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C16073

P16073

CN16073

Itraconazole

Oropharyngeal candidiasis

Patient must be immunosuppressed; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16073

C16075

P16075

CN16075

Rifampicin

Meningococcal disease

The treatment must be for prophylaxis; AND

Patient must be a carrier of the disease; or

Patient must be in close contact with people who have the disease; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C16078

P16078

CN16078

Penicillamine

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 health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

 

C16083

P16083

CN16083

Methadone

Opioid dependence

The treatment must be within a framework of medical, social and psychological treatment.

The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16083

C16085

P16085

CN16085

Avelumab

Stage IV (metastatic) Merkel Cell Carcinoma

Continuing treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

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 exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction. or

The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 16085

C16087

P16087

CN16087

Romosozumab

Severe established osteoporosis

Initial treatment - Second-line therapy

Patient must be at very high risk of fracture; AND

Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND

Patient must have had 2 or more fractures due to minimal trauma; AND

Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND

Patient must not have received treatment with PBS-subsidised teriparatide; or

Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND

Must be treated by a consultant physician.

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated.

If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated.

Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.

Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.

Compliance with Authority Required procedures

C16094

P16094

CN16094

Voriconazole

Serious fungal infections

Treatment and maintenance therapy

The condition must be caused by Scedosporium species; or

The condition must be caused by Fusarium species; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C16096

P16096

CN16096

Posaconazole

Fungal infection

The condition must be fusariosis; or

The condition must be zygomycosis; or

The condition must be coccidioidomycosis; or

The condition must be chromoblastomycosis; or

The condition must be mycetoma; AND

Patient must be unable to tolerate alternative therapy; or

Patient must have disease refractory to alternative therapy; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C16099

P16099

CN16099

Itraconazole

Disseminated pulmonary histoplasmosis infection

Treatment and maintenance therapy

Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16099

C16101

P16101

CN16101

Itraconazole

Chronic pulmonary histoplasmosis infection

Treatment and maintenance therapy

Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16101

C16102

P16102

CN16102

Itraconazole

Oesophageal candidiasis

Patient must be immunosuppressed; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16102

C16104

P16104

CN16104

Fremanezumab

Treatment-resistant migraine

Initial treatment

Must be treated by a neurologist; or

Must be treated by a general practitioner in consultation with a neurologist; AND

Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND

Patient must have experienced at least 8 migraine headache days per month, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND

Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND

Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug;

Patient must be at least 18 years of age.

Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.

Patient must have the number of migraine headache days per month documented in their medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 16104

C16111

P16111

CN16111

Perhexiline

Angina

The condition must not be responding to other therapy; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16111

C16114

P16114

CN16114

Fluconazole

Fungal infection

The condition must be serious or life-threatening; AND

Patient must be unable to take a solid dose form of fluconazole; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16114

C16115

P16115

CN16115

Voriconazole

Prophylaxis of invasive fungal infections including both yeasts and moulds

Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre) for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or

Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or, extensive chronic GVHD, whilst receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; or

Patient must be undergoing allogeneic haematopoietic stem cell transplant using either bone marrow from an unrelated donor or umbilical cord blood (related or unrelated), and, be considered to be at high risk of developing an invasive fungal infection during the neutropenic phase prior to engraftment; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures

C16117

P16117

CN16117

Posaconazole

Prophylaxis of invasive fungal infections including both yeasts and moulds

Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre), for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or

Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or extensive chronic GVHD, and receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Treatment of neutropenia should continue until recovery of the neutrophil count to at least 500 cells per cubic millimetre.

Patients who have had a previous invasive fungal infection should have secondary prophylaxis during subsequent episodes of neutropenia.

No more than 6 months therapy per episode will be PBS-subsidised

Compliance with Authority Required procedures

C16119

P16119

CN16119

Itraconazole

Systemic aspergillosis

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16119

C16123

P16123

CN16123

Tirofiban

High risk of unstable angina

Patient must have new transient or persistent ST-T ischaemic changes; AND

Patient must have pain lasting longer than 20 minutes; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16123

C16132

P16132

CN16132

Romosozumab

Severe established osteoporosis

Initial treatment - First-line therapy

Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab; AND

Patient must be at very high risk of fracture; AND

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND

Patient must have had a symptomatic fracture due to minimal trauma; AND

Patient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; or

Patient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND

Must be treated by a consultant physician.

Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.

A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.

Compliance with Authority Required procedures

C16133

P16133

CN16133

Lanreotide

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition;

Patient must be at least 18 years of age.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 16133

C16141

P16141

CN16141

Fluconazole

Cryptococcal meningitis

Patient must be unable to take a solid dose form of fluconazole; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16141

C16145

P16145

CN16145

Chlormethine

Mycosis fungoides cutaneous T-cell lymphoma

Initial treatment

The condition must be any of: (i) Stage IA, (ii) IIA, (iii) IB mycosis fungoides cutaneous T-cell lymphoma; AND

The condition must have been confirmed through a diagnostic lesion biopsy from an Approved Pathology Authority; AND

The condition must cover either of which: (i) no more than 10% of the patient's body surface area, (ii) no more than 25% of the patient's body surface area; AND

Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND

The treatment must be approved for 1 unit if the condition is no more than 10% of the patient's body surface area to provide 4 weeks of treatment per script; or

The treatment must be approved for 2 units if the condition is no more than 25% of the patient's body surface area to provide 4 weeks of treatment per script;

Patient must be at least 18 years of age.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C16147

P16147

CN16147

Tirofiban

High risk of unstable angina

Patient must have new transient or persistent ST-T ischaemic changes; AND

Patient must have repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16147

C16148

P16148

CN16148

Fluconazole

Cryptococcal meningitis

The treatment must be maintenance therapy; AND

Patient must be immunosuppressed; AND

Patient must be unable to take a solid dose form of fluconazole; AND

Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.

Compliance with Authority Required procedures - Streamlined Authority Code 16148

[411] Schedule 4, Part 2, omit entry for Variation Code "V10745"

[412] Schedule 4, Part 2, omit entry for Variation Code "V10747"

[413] Schedule 4, Part 2, omit entry for Variation Code "V10751"

[414] Schedule 4, Part 2, after entry for Variation Code "V15457"

insert:

V15457

Nivolumab

An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.

[415] Schedule 4, Part 2, omit second entry for Variation Code "V15818"

[416] Schedule 4, Part 2, after entry for Variation Code "V15832"

insert:

V15994

Fentanyl

Methadone

Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment: (i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or (ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or (iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.

Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).

V15996

Fentanyl

Methadone

Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.

Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).

V16000

Fentanyl

Methadone

Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment: (i) is less than 12 months; or (ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or (iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or (iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.

Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).

[417] Schedule 5, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

omit from the column headed "Brand": APO-Amiodarone

[418] Schedule 5, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg

omit from the column headed "Brand": APO-Amitriptyline 25

[419] Schedule 5, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 10 mg

omit from the column headed "Brand": APO-Amitriptyline 10

[420] Schedule 5, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 50 mg

omit from the column headed "Brand": APO-Amitriptyline 50

[421] Schedule 5, entry for Atenolol

omit from the column headed "Brand": APO-Atenolol

[422] Schedule 5, entry for Bosentan in each of the forms: Tablet 125 mg (as monohydrate); and Tablet 62.5 mg (as monohydrate)

omit from the column headed "Brand": BOSLEER

[423] Schedule 5, entry for Calcitriol

(a) omit from the column headed "Brand": APO-Calcitriol

(b) omit from the column headed "Brand": Kosteo

[424] Schedule 5, after entry for Celecoxib in the form Capsule 200 mg [GRP-19623]

insert:

Choriogonadotropin alfa

GRP-29227

Solution for injection 250 micrograms in 0.5 mL pre-filled pen

Injection

Ovidrel

Choriogonadotropin alfa

GRP-29227

Solution for injection 250 micrograms in 0.5 mL pre-filled syringe (S19A)

Injection

Ovidrel (USA)

[425] Schedule 5, entry for Ciprofloxacin in each of the forms: Tablet 750 mg (as hydrochloride); Tablet 500 mg (as hydrochloride); and Tablet 250 mg (as hydrochloride)

omit from the column headed "Brand": APX-Ciprofloxacin

[426] Schedule 5, entry for Citalopram in each of the forms: Tablet 40 mg (as hydrobromide); Tablet 20 mg (as hydrobromide); and Tablet 10 mg (as hydrobromide)

insert in alphabetical order in the column headed "Brand": CITALOPRAM-WGR

[427] Schedule 5, entry for Diazepam in each of the forms: Tablet 5 mg; and Tablet 2 mg

omit from the column headed "Brand": APO-Diazepam

[428] Schedule 5, entry for Diclofenac in each of the forms: Tablet (enteric coated) containing diclofenac sodium 50 mg; and Tablet (enteric coated) containing diclofenac sodium 25 mg

omit from the column headed "Brand": APO-Diclofenac

[429] Schedule 5, entry for Entecavir in each of the forms: Tablet 0.5 mg (as monohydrate); and Tablet 1 mg (as monohydrate)

omit from the column headed "Brand": ENTECLUDE

[430] Schedule 5, entry for Fluconazole in the form Capsule 200 mg

insert in alphabetical order in the column headed "Brand": FLUCONAZOLE-WGR

[431] Schedule 5, entry for Fulvestrant

insert in alphabetical order in the column headed "Brand": FULVESTRANT-AFT

[432] Schedule 5, entry for Gliclazide in the form Tablet 80 mg

(a) omit from the column headed "Brand": APO-Gliclazide

(b) omit from the column headed "Brand": Glyade


[433] Schedule 5, entry for Ibuprofen

omit from the column headed "Brand": MEDICHOICE Ibuprofen 400 mg

[434] Schedule 5, entry for Imatinib in the form Capsule 400 mg (as mesilate)

insert in alphabetical order in the column headed "Brand": ARX-IMATINIB

[435] Schedule 5, entry for Irbesartan in the form Tablet 75 mg

omit from the column headed "Brand": Karvea

[436] Schedule 5, entry for Itraconazole

omit from the column headed "Brand": APO-Itraconazole

[437] Schedule 5, entry for Macrogol 3350

omit from the column headed "Brand": Movicol

[438] Schedule 5, entries for Naloxone

omit:

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)

[439] Schedule 5, omit entries Nifedipine

[440] Schedule 5, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

insert in alphabetical order in the column headed "Brand": APX-PANTOPRAZOLE

[441] Schedule 5, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)

(a) omit from the column headed "Brand": Acpio 45

(b) omit from the column headed "Brand": Actaze

[442] Schedule 5, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)

(a) omit from the column headed "Brand": Acpio 15

(b) omit from the column headed "Brand": Actaze


[443] Schedule 5, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)

(a) omit from the column headed "Brand": Acpio 30

(b) omit from the column headed "Brand": Actaze

(c) insert in alphabetical order in the column headed "Brand": ARX-PIOGLITAZONE

[444] Schedule 5, entry for Quetiapine in each of the forms: Tablet 300 mg (as fumarate); Tablet 200 mg (as fumarate); Tablet 100 mg (as fumarate); and Tablet 25 mg (as fumarate)

insert in alphabetical order in the column headed "Brand": QUETIAPINE-WGR

[445] Schedule 5, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

omit:

Quinapril

GRP-19716

Tablet 20 mg (as hydrochloride)

Oral

Accupril
ACQUIN
APO-Quinapril

[446] Schedule 5, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)

omit:

Quinapril

GRP-19902

Tablet 10 mg (as hydrochloride)

Oral

Accupril
ACQUIN
APO-Quinapril

[447] Schedule 5, entry for Riluzole

omit from the column headed "Brand": APO-Riluzole

[448] Schedule 5, entries for Timolol

substitute:

Timolol

GRP-29229

Eye drops 5 mg (as maleate) per mL, 5 mL

Application to the eye

Timoptol

Timolol

GRP-29229

Eye drops 5 mg (as maleate) per mL, 5 mL (S19A)

Application to the eye

Timolol (Brown & Burk, UK)

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)

Timolol

GRP-28880

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL - (Timoptol-LA) (S19A)

Application to the eye

Timoptol-LA 0.5 % (Santen Oy, Finland)

[449] Schedule 5, entry for Valaciclovir

omit from the column headed "Brand": Valaciclovir generichealth