Federal Register of Legislation - Australian Government

Primary content

PB 67 of 2011 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to provide for additions, deletions and changes to forms, brands, responsible persons, circumstances for prescribing and the maximum quantities and number of repeats that may be prescribed.
Administered by: Health
Registered 29 Sep 2011
Tabling HistoryDate
Tabled HR11-Oct-2011
Tabled Senate11-Oct-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

PB 67 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.10)1

National Health Act 1953

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

Dated 19 September 2011

 

 

 

 

 

 

 

 

 

 

 

KIM BESSELL

Acting 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 2011 (No. 10).

            (2)        This Instrument may also be cited as PB 67 of 2011.

2          Commencement

            This Instrument commences on 1 October 2011.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).



Schedule 1     Amendments

 

[1] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 5]

omit from the column headed “Circumstances”:          C370                      substitute:            C3750

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

omit:

 

 

 

Cardinorm

HX

MP NP

C1350

 

30

5

 

[3]           Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

omit:

 

 

 

Cardinorm

HX

MP NP

C1350

 

30

5

 

[4]           Schedule 1, entry for Cimetidine

substitute:

Cimetidine

Tablet 400 mg

Oral

Magicul 400

AF

MP NP

 

 

60

5

 

 

Tablet 800 mg

Oral

Magicul 800

AF

MP NP

 

 

30

5

 

[5]           Schedule 1, entry for Clodronic Acid in the form Capsule containing 400 mg sodium clodronate (as tetrahydrate)

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[6]           Schedule 1, entry for Clodronic Acid in the form Capsule containing 800 mg sodium clodronate (as tetrahydrate)

(a)        omit from the column headed “Form”:           Capsule                               substitute:             Tablet

(b)        omit from the column headed “Responsible Person”:                 SC        substitute:          BN


[7]           Schedule 1, entry for Clopidogrel with aspirin

substitute:

Clopidogrel with aspirin

Tablet 75 mg (as hydrogen sulfate)-100 mg

Oral

Clopidogrel Winthrop plus aspirin

WA

MP NP

C1722 C3219 C3246

 

30

5

 

 

 

 

CoPlavix

SW

MP NP

C1722 C3219 C3246

 

30

5

 

 

 

 

DuoCover

BQ

MP NP

C1722 C3219 C3246

 

30

5

 

[8]           Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

omit from the column headed “Responsible Person” (twice occurring):                                SC        substitute:          BN

[9]           Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[10]         Schedule 1, entry for Degarelix

(a)        omit from the column headed “Form”:           Powder for injection 80 mg (as acetate) with solvent, syringe and needles           

                substitute:          Powder for injection 80 mg (as acetate), injection set

(b)        omit from the column headed “Form”:           Powder for injection 120 mg (as acetate) with solvent, syringe and needles, 2       

                substitute:          Powder for injection 120 mg (as acetate), 2, injection set

[11]         Schedule 1, after entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent   

insert in the columns in the order indicated:

 

Powder for I.V. infusion 20 mg with solvent

Injection

Docetaxel SUN

ZF

MP

C1194 C1742 C2732 C3428

 

2

0

 

 

Powder for I.V. infusion 80 mg with solvent

Injection

Docetaxel SUN

ZF

MP

C1194 C1742 C2732 C3428

 

1

0

 


[12]         Schedule 1 entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Max Quantity 1; Number of Repeats 0]

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

 

 

 

Docetaxel Sandoz

SZ

MP

C1194 C1742 C2416 C2439 C2732 C3051 C3428

P3051

1

0

 

[13]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Max Quantity 2; Number of Repeats 0]

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

 

 

 

Docetaxel Sandoz

SZ

MP

C1194 C1742 C2416 C2439 C2732 C3051 C3428

P1194 P1742 P2416 P2439 P2732 P3428

2

0

 

[14]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL

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

 

 

 

Docetaxel Sandoz

SZ

MP

C1194 C1742 C2416 C2439 C2732 C3051 C3428

 

1

0

 

[15]         Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

omit from the column headed “Responsible Person”:                 GQ       substitute:          TA

[16]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)

omit from the column headed “Responsible Person”:                 GQ       substitute:          TA

[17]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)

omit from the column headed “Responsible Person”:                 GQ       substitute:          TA

[18]         Schedule 1, entry for Glimepiride in the form Tablet 1 mg

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

 

 

 

Glimepiride GA 1

GM

MP NP

 

 

30

5

 

[19]         Schedule 1, entry for Glimepiride in the form Tablet 2 mg

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

 

 

 

Glimepiride GA 2

GM

MP NP

 

 

30

5

 

[20]         Schedule 1, entry for Glimepiride in the form Tablet 3 mg

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

 

 

 

Glimepiride GA 3

GM

MP NP

 

 

30

5

 

[21]         Schedule 1, entry for Glimepiride in the form Tablet 4 mg

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

 

 

 

Glimepiride GA 4

GM

MP NP

 

 

30

5

 

[22]         Schedule 1, entry for Iloprost

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[23]         Schedule 1, entry for Interferon Beta-1b

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[24]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

(a)        omit from the column headed “Responsible Person”:                 GQ       substitute:          TA

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

 

 

 

Irinotecan Kabi

PK

MP

See Note 1

C3184

 

1

3

 

[25]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

(a)        omit from the column headed “Responsible Person”:                 GQ       substitute:          TA

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

 

 

 

Irinotecan Kabi

PK

MP

See Note 1

C3184

 

2

3

 

[26]         Schedule 1, entry for Levonorgestrel

omit from the column headed “Responsible Person” (twice occurring):                                SC        substitute:          BN

[27]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 125 micrograms-50 micrograms and 7 inert tablets

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[28]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[29]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[30]         Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g [Max Quantity 2; Number of Repeats 0]

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

 

 

 

your pharmacy Clear Laxative

TW

MP NP

C1263 C1613 C2693 C2823 C3642 C3643

P3643

2

0

 

[31]         Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g [Max Quantity 2; Number of Repeats 3]

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

 

 

 

your pharmacy Clear Laxative

TW

MP NP

C1263 C1613 C2693 C2823 C3642 C3643

P3642

2

3

 

[32]         Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g [Max Quantity 1; Number of Repeats 5]

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

 

 

 

your pharmacy Clear Laxative

TW

MP NP

C1263 C1613 C2693 C2823 C3642 C3643

P1263 P1613 P2693 P2823

1

5

 


[33]         Schedule 1, entry for Metronidazole in the form I.V. infusion 500 mg in 100 mL

(a)        omit:

 

 

 

Metronidazole Sandoz

SZ

PDP

C1448

 

5

0

 

(b)        omit:

 

 

 

Metronidazole Sandoz

SZ

MP NP

C1300 C1448

 

5

1

 

[34]         Schedule 1, entry for Norethisterone in the form Tablet 5 mg

omit from the column headed “Responsible Person”:                 SC        substitute:          BN

[35]         Schedule 1, entry for Oestradiol

omit from the column headed “Responsible Person” (all instances):                      SC        substitute:          BN

[36]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL

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

 

 

 

Oxaliplatin SUN

ZF

MP

See Note 1

C2717 C3449 C3450

 

1

2

 

[37]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg

omit from the column headed “Responsible Person”:                 GQ       substitute:          TA

[38]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

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

 

 

 

Oxaliplatin SUN

ZF

MP

See Note 1

C2717 C3449 C3450

 

1

2

 

[39]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg

omit from the column headed “Responsible Person”:                 GQ       substitute:          TA


[40]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL

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

 

 

 

Oxaliplatin SUN

ZF

MP

See Note 1

C2717 C3449 C3450

 

1

2

 

[41]         Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL

omit from the column headed “Responsible Person”:                 GQ       substitute:          TA

[42]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Cholvastin

RA

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit: 

 

 

 

Vastoran

RA

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[43]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Cholvastin

RA

MP

C1540 C3047

P3047

30

11

 

(b)        omit: 

 

 

 

Vastoran

RA

MP

C1540 C3047

P3047

30

11

 


[44]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Cholvastin

RA

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit: 

 

 

 

Vastoran

RA

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[45]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Cholvastin

RA

MP

C1540 C3047

P3047

30

11

 

(b)        omit: 

 

 

 

Vastoran

RA

MP

C1540 C3047

P3047

30

11

 

[46]         Schedule 1, entry for Ranibizumab

omit from the column headed “Circumstances”:

C3788

insert in numerical order:

C3859

[47]         Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b

(a)        omit: 

 

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent

Injection/oral

Pegatron

MK

MP
See Note 1

C3053 C3055 C3413 C3414

 

2

5

D

 

(b)        omit:

 

Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

Injection/oral

Pegatron

MK

MP
See Note 1

C3053 C3055 C3413 C3414

 

2

5

D

            (c)        omit:

 

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent

Injection/oral

Pegatron

MK

MP
See Note 1

C3053 C3055 C3413 C3414

 

2

5

D

(d)        omit:

 

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent

Injection/oral

Pegatron

MK

MP
See Note 1

C3053 C3055 C3413 C3414

 

2

5

D

(e)        omit:

 

Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Injection/oral

Pegatron

MK

MP
See Note 1

C3053 C3055 C3413 C3414

 

2

5

D

[48]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg

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

 

 

 

Risedronate-GA

GM

MP NP

C2645 C2646 C3070

 

4

5

 

[49]         Schedule 1, entry for Testosterone

omit from the column headed “Responsible Person”(all instances):                       SC        substitute:          BN

[50]         Schedule 1, after entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)

insert in the columns in the order indicated:

 

Solution for inhalation 300 mg in 5 mL

Inhalation

Tobi

NV

MP

C3842

 

56

2

 


[51]         Schedule 1, entry for Verteporfin

omit from the column headed “Circumstances”:

C3793  C3794

insert in numerical order:

C3860  C3861

[52]         Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL

omit: 

 

 

 

Vinorelbine Kabi

PK

MP

See Note 1

C1194 C1741

 

16

2

 

 

 

 

Vinorelbine Link

FU

MP

See Note 1

C1194 C1741

 

16

2

 

[53]         Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

(a)        omit: 

 

 

 

Vinorelbine Link

FU

MP
See Note 1

C1194 C1741

 

4

2

 

[54]         Schedule 3

omit:

FU

Fresenius Kabi Australia Pty Limited

39 109 383 593

[55]         Schedule 3

omit:

SC

Bayer Australia Ltd

22 000 138 714

[56]         Schedule 3, details relevant to code ZF

omit:       Sun Pharmaceutical Industries Pty Ltd                substitute:             Sun Pharmaceutical Industries (Australia) Pty Ltd


[57]         Schedule 4, Part 1, entry for Ranibizumab [Circumstances Code C3788]

omit from the column headed “Circumstances”:          C3788               substitute:          C3859

[58]         Schedule 4, Part 1, entry for Tobramycin

insert after existing text in the columns in the order indicated:

 

 

C3842

 

Management of a proven Pseudomonas aeruginosa infection in a patient with cystic fibrosis

Compliance with Authority Required procedures - Streamlined Authority Code 3842

[59]         Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C3793]

omit from the column headed “Circumstances”:          C3793               substitute:          C3860

[60]         Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C3794]

omit from the column headed “Circumstances”:          C3794               substitute:          C3861

 

 

 

 

 

 

 

 

 

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.