National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 22 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 22 of 2009

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

I, DIANA MACDONELL, Acting 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           3rd March                       2009

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 April 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

1. Schedule 1, items dealing with Aluminium Hydroxide with Magnesium Hydroxide

omit from the columns in the order indicated:

Aluminium Hydroxide with Magnesium Hydroxide Tablet 200 mg-200 mg Oral Mylanta P Johnson & Johnson Pacific Pty Limited 73 001 121 446

1. Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 125 mL, 30 (Lophlex LQ)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine Oral liquid 125 mL, 36 (PKU Anamix Junior LQ) Oral PKU Anamix Junior LQ Nutricia Australia Pty Limited 99 076 246 752

1. Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 250 mL (Easiphen)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine Oral liquid 62.5 mL, 60 (Lophlex LQ 10) Oral Lophlex LQ 10 Nutricia Australia Pty Limited 99 076 246 752

1. Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine in the form Oral powder 500 g
   (XP Maxamum)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine Sachets containing oral powder 18.2 g, 60 (add-ins) Oral add-ins Nutricia Australia Pty Limited 99 076 246 752

1. Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Sachets containing oral powder 25 g, 30 (TYR Express)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine Sachets containing oral powder 29 g, 30 (TYR Anamix Junior) Oral TYR Anamix Junior Nutricia Australia Pty Limited 99 076 246 752

1. Schedule 1, omit item dealing with Amino acid formula without phenylalanine, and vitamins with minerals

1. Schedule 1, after items dealing with Carbohydrate, fat, vitamins, minerals and trace elements

insert in the columns in the order indicated:

Carbomer	Eye gel 2 mg per g, single dose units 0.6 mL, 30	Application to the eye	Viscotears	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Carbomer	Eye gel 2 mg per g, 10 g	Application to the eye	GelTears	Bausch & Lomb (Australia) Pty Ltd	34 000 650 251
Carbomer	Eye gel 2 mg per g, 10 g	Application to the eye	PAA	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Carbomer	Eye gel 2 mg per g, 10 g	Application to the eye	Viscotears	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160

1. Schedule 1, omit items dealing with Carbomer 980

1. Schedule 1, items dealing with Clarithromycin

omit from the columns in the order indicated:

Clarithromycin Tablet 250 mg Oral APO-Clarithromycin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Desmopressin in the form Tablet containing desmopressin acetate 200 micrograms

insert in the columns in the order indicated:

Desmopressin Wafer 120 micrograms (as acetate) Sublingual Minirin Melt Ferring Pharmaceuticals Pty Limited 87 003 037 170

1. Schedule 1, after item dealing with Enalapril in the form Tablet containing enalapril maleate 10 mg (Enalabell)

insert in the columns in the order indicated:

Enalapril Tablet containing enalapril maleate
10 mg Oral Enalapril generichealth Generic Health Pty Ltd 93 110 617 859

1. Schedule 1, after item dealing with Enalapril in the form Tablet containing enalapril maleate 20 mg (Enalabell)

insert in the columns in the order indicated:

Enalapril Tablet containing enalapril maleate
20 mg Oral Enalapril generichealth Generic Health Pty Ltd 93 110 617 859

1. Schedule 1, after item dealing with Enalapril in the form Tablet containing enalapril maleate 5 mg (Enalabell)

insert in the columns in the order indicated:

Enalapril Tablet containing enalapril maleate 5 mg Oral Enalapril generichealth Generic Health Pty Ltd 93 110 617 859

1. Schedule 1, after item dealing with Fluvastatin in the form Tablet (prolonged release) 80 mg (as sodium)

insert in the columns in the order indicated:

Fluvoxamine Tablet containing fluvoxamine maleate 100 mg Oral APO-Fluvoxamine Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Fluvoxamine in the form Tablet containing fluvoxamine maleate 100 mg (Voxam)

insert in the columns in the order indicated:

Fluvoxamine Tablet containing fluvoxamine maleate 50 mg Oral APO-Fluvoxamine Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Gemcitabine	Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL	Injection	Gemcitabine Ebewe	InterPharma Pty Ltd	19 099 877 899
Gemcitabine	Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL	Injection	Gemcitabine Ebewe	InterPharma Pty Ltd	19 099 877 899

1. Schedule 1, after item dealing with Gliclazide in the form Tablet 30 mg (modified release) (Diamicron MR)

insert in the columns in the order indicated:

Gliclazide Tablet 30 mg (modified release) Oral Glyade MR Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, item dealing with Interferon Beta-1b

omit from the columns in the order indicated:

Injection set comprising 1 vial powder for injection 8,000,000 I.U.
(250 micrograms) and solvent

and substitute:

Injection set including 1 vial powder for injection 8,000,000 I.U. (250 micrograms) and solvent

1. Schedule 1, after item dealing with Liothyronine

insert in the columns in the order indicated:

Lisinopril Tablet 10 mg Oral APO-Lisinopril Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g (Glucohexal)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 1 g Oral Metformin-GA Ascent Pharmahealth Ltd 52 107 340 367

1. Schedule 1, after item dealing with Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg (Diabex XR)

insert in the columns in the order indicated:

Metformin Tablet (extended release) containing metformin hydrochloride 500 mg Oral Diaformin XR Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, items dealing with Methylphenidate

omit from the columns in the order indicated:

Methylphenidate Tablet containing methylphenidate hydrochloride 10 mg Oral Attenta Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, after item dealing with Omeprazole in the form Tablet
   10 mg (as magnesium)

insert in the columns in the order indicated:

Omeprazole Tablet 20 mg Oral APO-Omeprazole Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release) (OxyContin)

insert in the columns in the order indicated:

Oxycodone Tablet containing oxycodone hydrochloride 15 mg (controlled release) Oral OxyContin Mundipharma Pty Limited 87 081 322 509

1. Schedule 1, after item dealing with Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release) (OxyContin)

insert in the columns in the order indicated:

Oxycodone Tablet containing oxycodone hydrochloride 30 mg (controlled release) Oral OxyContin Mundipharma Pty Limited 87 081 322 509

1. Schedule 1, item dealing with Ranibizumab

omit from the columns in the order indicated:

Solution for intravitreal injection
3 mg in 0.3 mL

and substitute:

Solution for intravitreal injection 2.3 mg in 0.23 mL

1. Schedule 1, after item dealing with Zolmitriptan

insert in the columns in the order indicated:

Zonisamide	Capsule 100 mg	Oral	Zonegran	Eisai Australia Pty Ltd	73 117 970 993
Zonisamide	Capsule 25 mg	Oral	Zonegran	Eisai Australia Pty Ltd	73 117 970 993
Zonisamide	Capsule 50 mg	Oral	Zonegran	Eisai Australia Pty Ltd	73 117 970 993