National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 98 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 98 of 2009

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

I, LINDA JACKSON, 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 2 October 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 November 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1            Amendments

[1]Schedule 1, item 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 liquid 130 mL, 30 (MSUD Express Cooler) Oral MSUD Express Cooler Vitaflo Australia Pty Limited  82 097 161 254

and substitute:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine Oral liquid 130 mL, 30 (MSUD Cooler) Oral MSUD Cooler Vitaflo Australia Pty Limited  82 097 161 254

[2]Schedule 1, after item dealing with Carmustine

insert in  the columns in the order indicated:

Carvedilol Tablet 12.5 mg Oral Carvedilol Sandoz Sandoz Pty Ltd  60 075 449 553

[3]Schedule 1, after item dealing with Carvedilol in the form Tablet 12.5 mg (Vedilol 12.5)

insert in  the columns in the order indicated:

Carvedilol Tablet 25 mg Oral Carvedilol Sandoz Sandoz Pty Ltd  60 075 449 553

[4]Schedule 1, after item dealing with Carvedilol in the form Tablet 3.125 mg (Vedilol 3.125)

insert in  the columns in the order indicated:

Carvedilol Tablet 6.25 mg Oral Carvedilol Sandoz Sandoz Pty Ltd  60 075 449 553

[5]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-GA Genepharm (Australia) Limited  17 003 854 626

[6]Schedule 1, items dealing with Etanercept

omit from the column headed “Form”:

Injection 50 mg in 1 mL single use injection pen, 4

and substitute:

Injection 50 mg in 1 mL single use auto-injector, 4

[7]Schedule 1, after item dealing with Ezetimibe

insert in the columns in the order indicated:

Ezetimibe with Simvastatin	Tablet 10 mg-10 mg	Oral	Vytorin	Merck Sharp & Dohme (Australia) Pty Ltd	14 000 173 508
Ezetimibe with Simvastatin	Tablet 10 mg-20 mg	Oral	Vytorin	Merck Sharp & Dohme (Australia) Pty Ltd	14 000 173 508

[8]Schedule 1, item dealing with Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg (Fludara)

omit from the columns in the order indicated:

Bayer Australia Ltd  22 000 138 714

and substitute:

Genzyme Australasia Pty Ltd  24 083 420 526

[9]Schedule 1, item dealing with Fludarabine in the form Tablet containing fludarabine phosphate 10 mg (Fludara)

omit from the columns in the order indicated:

Bayer Australia Ltd  22 000 138 714

and substitute:

Genzyme Australasia Pty Ltd  24 083 420 526

1. Schedule 1, after item dealing with Frusemide in the form Injection 20 mg in 2 mL (Frusehexal)

insert in the columns in the order indicated:

Frusemide Injection 20 mg in 2 mL Injection Frusemide-Claris AFT Pharmaceuticals Pty Ltd  29 105 636 413

1. Schedule 1, after item dealing with Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride) (DBL Gemcitabine for Injection)

insert in the columns in the order indicated:

Gemcitabine Powder for I.V. infusion 1 g (as hydrochloride) Injection Gemcitabine Actavis Generic Health Pty Ltd  93 110 617 859

1. Schedule 1, after item dealing with Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride) (DBL Gemcitabine for Injection)

insert in the columns in the order iindicated:

Gemcitabine Powder for I.V. infusion 200 mg (as hydrochloride) Injection Gemcitabine Actavis Generic Health Pty Ltd  93 110 617 859

1. Schedule 1, item dealing with Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g (Cortef)

omit from the columns in the order indicated:

DermaTech Pty Ltd  14 003 982 161

and substitute:

Valeant Pharmaceuticals Australasia Pty Limited  64 001 083 352

1. Schedule 1, items dealing with Lansoprazole

omit from the columns in the order indicated:

Lansoprazole	Capsule 30 mg	Oral	Zoton	Wyeth Australia Pty Limited	16 000 296 211
Lansoprazole	Sachet containing granules for oral suspension, 30 mg per sachet	Oral	Zoton	Wyeth Australia Pty Limited	16 000 296 211

1. Schedule 1, item dealing with Naltrexone in the form Tablet containing naltrexone hydrochloride 50 mg (Naltrexone QP)

omit from the columns in the order indicated:

Naltrexone QP Max Pharma Pty Ltd  93 121 857 878

and substitute:

Naltrexone generichealth Generic Health Pty Ltd  93 110 617 859

1. Schedule 1, after item dealing with Risperidone in the form Tablet 0.5 mg (Ozidal)

insert in the columns in the order indicated:

Risperidone Tablet 0.5 mg Oral Resdone 0.5 Pharmacor Pty Limited  58 121 020 835

1. Schedule 1, after item dealing with Risperidone in the form Tablet 1 mg (Ozidal)

insert in the columns in the order indicated:

Risperidone Tablet 1 mg Oral Resdone 1 Pharmacor Pty Limited  58 121 020 835

1. Schedule 1, after item dealing with Risperidone in the form Tablet 2 mg (Ozidal)

insert in the columns in the order indicated:

Risperidone Tablet 2 mg Oral Resdone 2 Pharmacor Pty Limited  58 121 020 835

1. Schedule 1, after item dealing with Risperidone in the form Tablet 3 mg (Ozidal)

insert in the columns in the order indicated:

Risperidone Tablet 3 mg Oral Resdone 3 Pharmacor Pty Limited  58 121 020 835

1. Schedule 1, after item dealing with Risperidone in the form Tablet 4 mg (Ozidal)

insert in the columns in the order indicated:

Risperidone Tablet 4 mg Oral Resdone 4 Pharmacor Pty Limited  58 121 020 835

1. Schedule 1, items dealing with Terbutaline

omit from the columns in the order indicated:

Terbutaline Nebuliser solution containing terbutaline sulfate 5 mg in 2 mL single dose units, 30 Inhalation Bricanyl Respules AstraZeneca Pty Ltd  54 009 682 311

1. Schedule 1, after item dealing with Tobramycin in the form Eye ointment 3 mg per g, 3.5 g

insert in the columns in the order indicated:

Tobramycin Injection 500 mg (as sulfate) in 5 mL (without preservative) Injection Tobra-Day Virgo Unit Trust  77 695 661 635

1. Schedule 1, after item dealing with Valsartan with hydrochlorothiazide in the form Tablet 160 mg-25 mg

insert in the columns in the order indicated:

Valsartan with hydrochlorothiazide	Tablet 320 mg-12.5 mg	Oral	Co-Diovan 320/12.5	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Valsartan with hydrochlorothiazide	Tablet 320 mg-25 mg	Oral	Co-Diovan 320/25	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160