PB 108 of 2012

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No. 9)1

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 11th December 2012

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

 


1 Name of Instrument

 (1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 9).

 (2) This Instrument may also be cited as PB 108 of 2012.

2 Commencement

This Instrument commences on 1 January 2013.

3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

 Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

 

Schedule 1 Amendments

 

[1]                Schedule 1, entry for Betamethasone

omit:

 

Ointment 500 micrograms (as valerate) per g, 15 g

Application

Betnovate 1/2

QA

MP NP

C1422

 

1

1

1

 

 

 

 

 

Cortival 1/2

FM

MP NP

C1422

 

1

1

1

 

 

[2]                Schedule 1, entry for Bicalutamide

omit from the column headed “Responsible Person” for the brand “Cosudex”: SZ substitute: AP

[3]                Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

omit from the column headed “Circumstances” for the brands “APO-Clopidogrel”, Clopidogrel Winthrop”, “Iscover” and “Plavix”:

 

C3146

C3879

insert in numerical order:

 

C4165

C4166

[4]                Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

insert in numerical order in the column headed “Circumstances” for the brand “Clovix 75”:

 

C4165

C4166

[5]                Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Max Quantity 56; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Famciclovir generichealth 500

GQ

MP NP

C3626 C3627 C3628 C3629

P3626 P3627 P3628 P3629

56

5

56

 

 

[6]                Schedule 1, entry for Felodipine in each of the forms: Tablet 2.5 mg (extended release); Tablet 5 mg (extended release); and
Tablet 10 mg (extended release)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Fendex ER

AF

MP NP

 

 

30

5

30

 

 

[7]                Schedule 1, entry for Fentanyl in the form Transdermal patch 2.063 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Dutran 12

GM

MP NP

C1062

 

5

0

5

 

 

[8]                Schedule 1, entry for Fentanyl in the form Transdermal patch 4.125 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Dutran 25

GM

MP NP

C1062

 

5

0

5

 

 

[9]                Schedule 1, entry for Fentanyl in the form Transdermal patch 8.25 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Dutran 50

GM

MP NP

C1062

 

5

0

5

 

 

[10]            Schedule 1, entry for Fentanyl in the form Transdermal patch 12.375 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Dutran 75

GM

MP NP

C1062

 

5

0

5

 

 

[11]            Schedule 1, entry for Fentanyl in the form Transdermal patch 16.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Dutran 100

GM

MP NP

C1062

 

5

0

5

 

 

[12]            Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

omit from the column headed “Brand”: Auscap substitute: Auscap Aspen

[13]            Schedule 1, entry for Lamotrigine in the form Tablet 25 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Lamotrigine Aspen 25

AS

MP NP

C1426

 

56

5

56

 

 

[14]            Schedule 1, entry for Lamotrigine in the form Tablet 100 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Lamotrigine Aspen 100

AS

MP NP

C1426

 

56

5

56

 

 

[15]            Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g

(a) omit:

 

 

 

your pharmacy Clear Laxative

OY

MP NP

C1263 C1613 C2693 C2823 C3642 C3643

P3643

2

0

1

 

 

(b) omit:

 

 

 

your pharmacy Clear Laxative

OY

MP NP

C1263 C1613 C2693 C2823 C3642 C3643

P3642

2

3

1

 

 

(c) omit:

 

 

 

your pharmacy Clear Laxative

OY

MP NP

C1263 C1613 C2693 C2823 C3642 C3643

P1263 P1613 P2693 P2823

1

5

1

 

 

[16]            Schedule 1, entry for Mirtazapine in each of the forms: Tablet 15 mg (orally disintegrating); Tablet 30 mg (orally disintegrating);
and Tablet 45 mg (orally disintegrating)

omit from the column headed “Brand”: Mirtazapine Pfizer substitute: Mirtazapine Dispersible Pfizer

[17]            Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 250 mg

(a) omit:

 

 

 

Cellplant

WQ

MP

C1765 C1766

 

300

3

100

 

 

(b) omit:

 

 

 

Cellplant

WQ

MP
See Note 1

C1650 C1651 C3355 C3356

 

600

5

100

 

C(100)

[18]            Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 500 mg

(a) omit:

 

 

 

Cellplant

WQ

MP

C1765 C1766

 

150

3

50

 

 

(b) omit:

 

 

 

Cellplant

WQ

MP
See Note 1

C1650 C1651 C3355 C3356

 

300

5

50

 

C(100)

[19]            Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 2]

(a) omit from the column headed “Responsible Person” for the brand “Panto”: NZ substitute: TK

(b) omit from the column headed “Responsible Person” for the brand “Pantoloc”: NH substitute: TE

[20]            Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 5]

(a) omit from the column headed “Responsible Person” for the brand “Panto”: NZ substitute: TK

(b) omit from the column headed “Responsible Person” for the brand “Pantoloc”: NH substitute: TE

[21]            Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

(a) omit from the column headed “Responsible Person” for the brand “Panto”: NZ substitute: TK

(b) omit from the column headed “Responsible Person” for the brand “Pantoloc”: NH substitute: TE

[22]            Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

(a) omit from the column headed “Brand”: Parzole 10 substitute: Parzol 10

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Razit 10

DO

MP NP

C1337 C1533

 

28

5

28

 

 

[23]            Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Max Quantity 30; Number of Repeats 2]

(a) omit from the column headed “Brand”: Parzole 20 substitute: Parzol 20

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Razit 20

DO

MP NP

C1177 C1337 C1533

P1177

30

2

30

 

 

(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Rabeprazole

TD

MP NP

C1177 C1337 C1533

P1177

30

2

30

 

 

[24]            Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Max Quantity 30; Number of Repeats 5]

(a) omit from the column headed “Brand”: Parzole 20 substitute: Parzol 20

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Razit 20

DO

MP NP

C1177 C1337 C1533

P1337 P1533

30

5

30

 

 

(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

STADA Rabeprazole

TD

MP NP

C1177 C1337 C1533

P1337 P1533

30

5

30

 

 

[25]            Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]

(a) omit:

 

 

 

Resdone 0.5

CR

MP NP

C1589 C2061 C3083

P2061 P3083

60

2

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 0.5

CR

MP NP

C1589 C2061 C3083

P2061 P3083

60

2

60

 

 

[26]            Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]

(a) omit:

 

 

 

Resdone 0.5

CR

MP NP

C1589 C2061 C3083

P1589

60

5

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 0.5

CR

MP NP

C1589 C2061 C3083

P1589

60

5

60

 

 

[27]            Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]

(a) omit:

 

 

 

Resdone 1

CR

MP NP

C1589 C2061 C2272 C3083

P2061 P3083

60

2

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 1

CR

MP NP

C1589 C2061 C2272 C3083

P2061 P3083

60

2

60

 

 

[28]            Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]

(a) omit:

 

 

 

Resdone 1

CR

MP NP

C1589 C2061 C2272 C3083

P1589 P2272

60

5

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 1

CR

MP NP

C1589 C2061 C2272 C3083

P1589 P2272

60

5

60

 

 

[29]            Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]

(a) omit:

 

 

 

Resdone 2

CR

MP NP

C1589 C2272 C3083

P3083

60

2

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 2

CR

MP NP

C1589 C2272 C3083

P3083

60

2

60

 

 

[30]            Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]

(a) omit:

 

 

 

Resdone 2

CR

MP NP

C1589 C2272 C3083

P1589 P2272

60

5

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 2

CR

MP NP

C1589 C2272 C3083

P1589 P2272

60

5

60

 

 

[31]            Schedule 1, entry for Risperidone in the form Tablet 3 mg

(a) omit:

 

 

 

Resdone 3

CR

MP NP

C1589 C2272

 

60

5

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 3

CR

MP NP

C1589 C2272

 

60

5

60

 

 

[32]            Schedule 1, entry for Risperidone in the form Tablet 4 mg

(a) omit:

 

 

 

Resdone 4

CR

MP NP

C1589 C2272

 

60

5

60

 

 

(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Rispericor 4

CR

MP NP

C1589 C2272

 

60

5

60

 

 

[33]            Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

(a) omit:

 

 

 

Terbix 250

MI

MP NP

C2191 C2865 C3244

P2865 P3244

42

0

42

 

 

(b) omit:

 

 

 

Terbix 250

MI

MP NP

C2191 C2865 C3244

P2191

42

1

42

 

 

[34]            Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

(a) omit:

 

 

 

GenRx Tramadol

GX

MP NP

C1497 C1615

P1497

20

0

20

 

 

 

 

 

 

 

PDP

C1497 C1615

 

20

0

20

 

 

(b) omit:

 

 

 

GenRx Tramadol

GX

MP NP

C1497 C1615

P1615

20

2

20

 

 

[35]            Schedule 1, entry for Tramadol

(a) omit:

 

Tablet (extended release) containing tramadol hydrochloride 100 mg

Oral

Durotram XR

IA

MP NP

C1537

 

10

0

10

 

 

(b) omit:

 

Tablet (extended release) containing tramadol hydrochloride 200 mg

Oral

Durotram XR

IA

MP NP

C1537

 

10

0

10

 

 

(c) omit:

 

Tablet (extended release) containing tramadol hydrochloride 300 mg

Oral

Durotram XR

IA

MP NP

C1537

 

10

0

10

 

 

[36]            Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

omit from the column headed “Brand”: STADA Venlafaxine SR substitute: STADA Venlafaxine-SR

[37]            Schedule 3

omit:

NH

Nycomed Healthcare Pty Limited

 55 140 659 374

[38]            Schedule 3, details relevant to Responsible person code NQ

omit:  Nycomed Pty Ltd  substitute: Takeda Pharmaceuticals Australia Pty Ltd

[39]            Schedule 3

omit:

NZ

Nycomed Services Pty Limited

 15 140 661 123

[40]            Schedule 3, after details relevant to Responsible person code TD

insert:

TE

Takeda Pharmaceuticals Australia Pty Ltd

 71 095 610 870

TK

Takeda Pharmaceuticals Australia Pty Ltd

 71 095 610 870

[41]            Schedule 4, Part 1, entry for Clopidogrel

(a) omit:

 

C3146

 

 

Treatment in combination with aspirin following cardiac stent insertion

Compliance with Authority Required procedures - Streamlined Authority Code 3146

 

C3879

 

 

Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin

Compliance with
Authority Required procedures – Streamlined Authority
Code 3879

(b) insert in numerical order following existing text:

 

C4165

 

 

Cardiac stent insertion

The treatment must be in combination with aspirin;

The treatment must follow insertion of a cardiac stent

Compliance with Authority Required procedures - Streamlined Authority Code 4165

 

C4166

 

 

Acute coronary syndrome (myocardial infarction or unstable angina)

The treatment must be in combination with aspirin

 

Compliance with Authority Required procedures - Streamlined Authority Code 4166

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 

See http://www.frli.gov.au.