National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 36 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 36 of 2010

Amendment determination under section 84AF of the National Health Act 1953

I, FELICITY McNEILL, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under section 84AF of the National Health Act 1953.

Dated 1 April 2010

FELICITY McNEILL

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 May 2010.

2              Amendment of PB 16 of 2010

Schedule 1 amends PB 16 of 2010.

Schedule 1            Amendments

[1]Schedule 1, after item dealing with Alprazolam in the form Tablet 250 micrograms (Alprax 0.25)

insert in the columns in the order indicated:

Alprazolam Tablet 250 micrograms Oral Alprazolam Sandoz Sandoz Pty Ltd  60 075 449 553

[2]Schedule 1, items dealing with Alprazolam in the form Tablet 250 micrograms

omit from the columns in the order indicated:

Alprazolam Tablet 250 micrograms Oral Zamhexal 0.25mg Sandoz Pty Ltd  60 075 449 553

[3]Schedule 1, items dealing with Amino acid formula with vitamins and minerals without lysine and low in tryptophan

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without lysine and low in tryptophan Oral powder 400 g (XLYS, LOW TRY Analog) Oral XLYS, LOW TRY Analog Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins and minerals without lysine and low in tryptophan Oral powder 400 g (GA1 Anamix infant) Oral GA1 Anamix infant Nutricia Australia Pty Limited  99 076 246 752

[4]Schedule 1, items dealing with Amino acid formula with vitamins and minerals without methionine

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without methionine Oral powder 400 g (XMET Analog) Oral XMET Analog Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins and minerals without methionine Oral powder 400 g (HCU Anamix infant) Oral HCU Anamix infant Nutricia Australia Pty Limited  99 076 246 752

[5]Schedule 1, items dealing with Amino acid formula with vitamins and minerals without methionine, threonine and valine and
low in isoleucine

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine Oral powder 400 g (XMTVI Analog) Oral XMTVI Analog Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine Oral powder 400 g (MMA/PA Anamix infant) Oral MMA/PA Anamix infant Nutricia Australia Pty Limited  99 076 246 752

[6]Schedule 1, items dealing with Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine Oral powder 400 g (XPhen, Tyr Analog) Oral XPhen, Tyr Analog Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine Oral powder 400 g (TYR Anamix infant) Oral TYR Anamix infant Nutricia Australia Pty Limited  99 076 246 752

[7]Schedule 1, items dealing with Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine Oral powder 400 g (MSUD Analog) Oral MSUD Analog Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine Oral powder 400 g (MSUD Anamix infant) Oral MSUD Anamix infant Nutricia Australia Pty Limited  99 076 246 752

[8]Schedule 1, item dealing with Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine

omit from the columns in the order indicated:

Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine Oral powder 400 g (XP Analog LCP) Oral XP Analog LCP Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine Oral powder 400 g (PKU Anamix infant) Oral PKU Anamix infant Nutricia Australia Pty Limited  99 076 246 752

[9]Schedule 1, after item dealing with Amino acid formula without phenylalanine, tyrosine and methionine

insert in the columns in the order indicated:

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids Oral powder 400 g (EleCare LCP) Oral EleCare LCP Abbott Australasia Pty Ltd  95 000 180 389

1. Schedule 1, after item dealing with Carmellose with glycerin

insert in the columns in the order indicated:

Carmellose with glycerin Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30 Application to the eye Optive Allergan Australia Pty Limited  85 000 612 831

1. Schedule 1, after item dealing with Ciprofloxacin in the form Tablet 750 mg (as hydrochloride) (Ciprofloxacin 750)

insert in the columns in the order indicated:

Ciprofloxacin Tablet 750 mg (as hydrochloride) Oral Ciprofloxacin Sandoz Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, items dealing with Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)

omit from the columns in the order indicated:

Ciprofloxacin Tablet 750 mg (as hydrochloride) Oral Profloxin Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, after items dealing with Clonidine

insert in the columns in the order indicated:

Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	APO-Clopidogrel	Apotex Pty Ltd	52 096 916 148
Clopidogrel	Tablet 75 mg (as hydrogen sulfate)	Oral	Chem mart Clopidogrel	Apotex Pty Ltd	52 096 916 148

1. Schedule 1, after item dealing with Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) (Plavix)

insert in the columns in the order indicated:

Clopidogrel Tablet 75 mg (as hydrogen sulfate) Oral Terry White Chemists Clopidogrel Apotex Pty Ltd  52 096 916 148

1. Schedule 1, after items dealing with Dapsone

insert in the columns in the order indicated:

Dasatinib Tablet 100 mg Oral Sprycel Bristol-Myers Squibb Australia Pty Ltd  33 004 333 322

1. Schedule 1, items dealing with Diazepam in the form Tablet 5 mg

omit from the columns in the order indicated:

Diazepam Tablet 5 mg Oral Diazepam-DP Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg (Clonac 25)

insert in the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 25 mg Oral Diclofenac Sandoz Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, items dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

omit from the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 25 mg Oral Diclohexal Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, after item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg (Clonac 50)

insert in the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 50 mg Oral Diclofenac Sandoz Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, items dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 50 mg Oral Diclohexal Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, after items dealing with Fluconazole

insert in the columns in the order indicated:

Fludarabine Powder for I.V. injection containing fludarabine phosphate 50 mg Injection Farine Willow Pharmaceuticals Pty Ltd  80 118 534 704

1. Schedule 1, items dealing with Fluoxetine in the form Capsule 20 mg (as hydrochloride)

omit from the columns in the order indicated:

Fluoxetine Capsule 20 mg (as hydrochloride) Oral Fluoxetine-DP Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, item dealing with Imipramine in the form Tablet containing imipramine hydrochloride 10 mg (Tolerade 10)

omit from the columns in the order indicated:

Aspen Pharmacare Australia Pty Limited  51 096 236 985

and substitute:

PMIP Pty Ltd   11 463  31 1 7

1. Schedule 1, item dealing with Imipramine in the form Tablet containing imipramine hydrochloride 25 mg (Tolerade 25)

omit from the columns in the order indicated:

Aspen Pharmacare Australia Pty Limited  51 096 236 985

and substitute:

PMIP Pty Ltd   11 463  31 1 7

1. Schedule 1, after item dealing with Interferon Beta-1a in the form Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent

insert in the columns in the order indicated:

Interferon Beta-1a Solution for injection 132 micrograms in 1.5 mL multidose cartridge Injection Rebif 44 Merck Serono Australia Pty Ltd  72 006 900 830

1. Schedule 1, after item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Omegapharm Irinotecan)

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL Injection Tecan Willow Pharmaceuticals Pty Ltd  80 118 534 704

1. Schedule 1, after item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Omegapharm Irinotecan)

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL Injection Tecan Willow Pharmaceuticals Pty Ltd  80 118 534 704

1. Schedule 1, after items dealing with Labetalol

insert in the columns in the order indicated:

Lacosamide	Tablet 100 mg	Oral	Vimpat	UCB Australia Proprietary Limited	48 005 799 208
Lacosamide	Tablet 150 mg	Oral	Vimpat	UCB Australia Proprietary Limited	48 005 799 208
Lacosamide	Tablet 200 mg	Oral	Vimpat	UCB Australia Proprietary Limited	48 005 799 208
Lacosamide	Tablet 50 mg	Oral	Vimpat	UCB Australia Proprietary Limited	48 005 799 208
Lacosamide	Tablets 100 mg, 14	Oral	Vimpat	UCB Australia Proprietary Limited	48 005 799 208
Lacosamide	Tablets 150 mg, 14	Oral	Vimpat	UCB Australia Proprietary Limited	48 005 799 208

1. Schedule 1, after item dealing with Lansoprazole in the form Capsule 15 mg (Zoton)

insert in the columns in the order indicated:

Lansoprazole	Capsule 30 mg	Oral	APO-Lansoprazole	Apotex Pty Ltd	52 096 916 148
Lansoprazole	Capsule 30 mg	Oral	Lanzopran	Ranbaxy Australia Pty Limited	17 110 871 826

1. Schedule 1, after item dealing with Levodopa with Carbidopa and Entacapone in the form Tablet 100 mg-25 mg-200 mg

insert in the columns in the order indicated:

Levodopa with Carbidopa and Entacapone Tablet 125 mg-31.25 mg-200 mg Oral Stalevo 125/31.25/200mg Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

1. Schedule 1, after item dealing with Levodopa with Carbidopa and Entacapone in the form Tablet 50 mg-12.5 mg-200 mg

insert in the columns in the order indicated:

Levodopa with Carbidopa and Entacapone Tablet 75 mg-18.75 mg-200 mg Oral Stalevo 75/18.75/200mg Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg (Metformin Ranbaxy)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 850 mg Oral Metformin-GA Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoprazole Sandoz)

insert in the columns in the order indicated:

Pantoprazole Tablet (enteric coated) 20 mg (as sodium sesquihydrate) Oral Pantoprazole-GA Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Pantoprazole Sandoz)

insert in the columns in the order indicated:

Pantoprazole Tablet (enteric coated) 40 mg (as sodium sesquihydrate) Oral Pantoprazole-GA Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after items dealing with Paroxetine

insert in the columns in the order indicated:

Paroxetine Tablet 20 mg (as mesilate) Oral Pharmacor Paroxo 20 Meditech Int. Pty Ltd  17 069 879 465

1. Schedule 1, after item dealing with Perindopril in the form Tablet containing perindopril erbumine 2 mg (Perindopril-DP)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine 2 mg Oral Perindopril-GA Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after item dealing with Perindopril in the form Tablet containing perindopril erbumine 4 mg (Perindopril-DP)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine 4 mg Oral Perindopril-GA Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after item dealing with Perindopril in the form Tablet containing perindopril erbumine 8 mg (Perindopril-DP)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine 8 mg Oral Perindopril-GA Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, items dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg

omit from the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 40 mg Oral Liprachol Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg (Pravastatin generichealth)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 40 mg Oral Pravastatin Sandoz Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, after item dealing with Simvastatin in the form Tablet 10 mg (Lipex 10)

insert in the columns in the order indicated:

Simvastatin Tablet 10 mg Oral Pharmacor Simvastatin 10 Meditech Int. Pty Ltd  17 069 879 465

1. Schedule 1, after item dealing with Simvastatin in the form Tablet 20 mg (Lipex 20)

insert in the columns in the order indicated:

Simvastatin Tablet 20 mg Oral Pharmacor Simvastatin 20 Meditech Int. Pty Ltd  17 069 879 465

1. Schedule 1, after item dealing with Simvastatin in the form Tablet 40 mg (Lipex 40)

insert in the columns in the order indicated:

Simvastatin Tablet 40 mg Oral Pharmacor Simvastatin 40 Meditech Int. Pty Ltd  17 069 879 465

1. Schedule 1, after item dealing with Simvastatin in the form Tablet 80 mg (Lipex 80)

insert in the columns in the order indicated:

Simvastatin Tablet 80 mg Oral Pharmacor Simvastatin 80 Meditech Int. Pty Ltd  17 069 879 465

1. Schedule 1, after item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride) (Terbinafine-DP)

insert in the columns in the order indicated:

Terbinafine Tablet 250 mg (as hydrochloride) Oral Terbix 250 Meditech Int. Pty Ltd  17 069 879 465