National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 41 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 41 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 1 May 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 June 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

1. Schedule 1, after item dealing with Amoxycillin in the form
   Capsule 250 mg (as trihydrate) (Amoxycillin Ranbaxy)

insert in the columns in the order indicated:

Amoxycillin Capsule 250 mg (as trihydrate) Oral Amoxycillin Sandoz Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, item dealing with Azathioprine in the form Tablet 25 mg (Imuran)

omit from the columns in the order indicated:

GlaxoSmithKline Australia Pty Ltd 47 100 162 481

and substitute:

Aspen Pharmacare Australia Pty Limited 51 096 236 985

1. Schedule 1, item dealing with Azathioprine in the form Tablet 50 mg (Imuran)

omit from the columns in the order indicated:

GlaxoSmithKline Australia Pty Ltd 47 100 162 481

and substitute:

Aspen Pharmacare Australia Pty Limited 51 096 236 985

1. Schedule 1, item dealing with Citalopram in the form Tablet 20 mg (as hydrobromide)

omit from the columns in the order indicated:

Citalopram Tablet 20 mg (as hydrobromide) Oral Citalopram Winthrop sanofi-aventis Australia Pty Ltd 31 008 558 807

1. Schedule 1, omit item dealing with Efalizumab

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

omit from the columns in the order indicated:

Enalapril Tablet containing enalapril maleate
20 mg Oral Enalapril Winthrop sanofi-aventis Australia Pty Ltd 31 008 558 807

1. Schedule 1, after item dealing with Escitalopram in the form Tablet
   10 mg (as oxalate) (Esipram)

insert in the columns in the order indicated:

Escitalopram Tablet 10 mg (as oxalate) Oral Esitalo Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, after item dealing with Escitalopram in the form Tablet
   20 mg (as oxalate) (Esipram)

insert in the columns in the order indicated:

Escitalopram Tablet 20 mg (as oxalate) Oral Esitalo Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, item dealing with Fosinopril in the form Tablet containing fosinopril sodium 10 mg

omit from the columns in the order indicated:

Fosinopril Tablet containing fosinopril sodium
10 mg Oral Fosinopril Winthrop sanofi-aventis Australia Pty Ltd 31 008 558 807

1. Schedule 1, item dealing with Fosinopril in the form Tablet containing fosinopril sodium 20 mg

omit from the columns in the order indicated:

Fosinopril Tablet containing fosinopril sodium
20 mg Oral Fosinopril Winthrop sanofi-aventis Australia Pty Ltd 31 008 558 807

1. Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg

omit from the columns in the order indicated:

Fosinopril Tablet containing fosinopril sodium
10 mg with hydrochlorothiazide 12.5 mg Oral Fosinopril/HCT Winthrop
10mg/12.5mg sanofi-aventis Australia Pty Ltd 31 008 558 807

1. Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg

omit from the columns in the order indicated:

Fosinopril Tablet containing fosinopril sodium
20 mg with hydrochlorothiazide 12.5 mg Oral Fosinapril/HCT Winthrop 20mg/12.5mg sanofi-aventis Australia Pty Ltd 31 008 558 807

1. Schedule 1, omit item dealing with Glucose Indicator—Blood in the form Electrode strips, 50 (GlucoCare Super Sensor)

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in
5 mL Injection Omegapharm Irinotecan Omegapharm Pty Ltd 86 128 078 151

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in
2 mL Injection Omegapharm Irinotecan Omegapharm Pty Ltd 86 128 078 151

1. Schedule 1, item dealing with Isotretinoin in the form Capsule 20 mg

(a) omit from the columns in the order indicated:

Isotretinoin Capsule 20 mg Oral Chem mart Isotretinoin Apotex Pty Ltd 52 096 916 148

(b) omit from the columns in the order indicated:

Isotretinoin Capsule 20 mg Oral Terry White Chemists Isotretinoin Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Lisinopril Tablet 10 mg Oral Lisinopril Ranbaxy Ranbaxy Australia Pty Limited 17 110 871 826

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

insert in the columns in the order indicated:

Lisinopril Tablet 20 mg Oral Lisinopril Ranbaxy Ranbaxy Australia Pty Limited 17 110 871 826

1. Schedule 1, after item dealing with Lisinopril in the form Tablet 5 mg (Lisinopril Hexal)

insert in the columns in the order indicated:

Lisinopril Tablet 5 mg Oral Lisinopril Ranbaxy Ranbaxy Australia Pty Limited 17 110 871 826

1. Schedule 1, item dealing with Metoprolol succinate

omit from the columns in the order indicated:

Metoprolol succinate Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release) Oral Toprol-XL Titration Pack AstraZeneca Pty Ltd 54 009 682 311

1. Schedule 1, omit items dealing with Oestrogens — Conjugated

1. Schedule 1, omit items dealing with Oestrogens — Conjugated with Medroxyprogesterone

1. Schedule 1, after item dealing with Pancrelipase

insert in the columns in the order indicated:

Pantoprazole Sachet containing granules 40 mg (as sodium sesquihydrate) Oral Somac Nycomed Pty Ltd 71 095 610 870

1. Schedule 1, items dealing with Phenoxymethylpenicillin

(a) omit from the columns in the order indicated:

Phenoxymethylpenicillin Capsule 250 mg phenoxymethylpenicillin (as potassium) Oral Penhexal VK Sandoz Pty Ltd 60 075 449 553

(b) omit from the columns in the order indicated:

Phenoxymethylpenicillin Capsule 500 mg phenoxymethylpenicillin (as potassium) Oral Penhexal VK Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg (Terry White Chemists Pravastatin)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
20 mg Oral APO-Pravastatin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg (Vastoran)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
40 mg Oral APO-Pravastatin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, item dealing with Propylthiouracil

omit from the column headed “Brand”:

Virgo Unit Trust

and substitute:

PTU

1. Schedule 1, after item dealing with Rosuvastatin in the form Tablet
   5 mg (as calcium)

insert in the columns in the order indicated:

Roxithromycin Tablet 150 mg Oral APO-Roxithromycin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Roxithromycin in the form Tablet 150 mg (Biaxsig)

insert in the columns in the order indicated:

Roxithromycin Tablet 150 mg Oral Chem mart Roxithromycin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Roxithromycin in the form Tablet 150 mg (Rulide)

insert in the columns in the order indicated:

Roxithromycin	Tablet 150 mg	Oral	Terry White Chemists Roxithromycin	Apotex Pty Ltd	52 096 916 148
Roxithromycin	Tablet 300 mg	Oral	APO- Roxithromycin	Apotex Pty Ltd	52 096 916 148

1. Schedule 1, after item dealing with Roxithromycin in the form Tablet 300 mg (Biaxsig)

insert in the columns in the order indicated:

Roxithromycin Tablet 300 mg Oral Chem mart Roxithromycin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Roxithromycin in the form Tablet 300 mg (Rulide)

insert in the columns in the order indicated:

Roxithromycin Tablet 300 mg Oral Terry White Chemists Roxithromycin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Terbinafine in the form Tablet
   250 mg (as hydrochloride) (Lamisil (Novartis Pharmaceuticals Australia Pty Limited))

insert in the columns in the order indicated:

Terbinafine Tablet 250 mg (as hydrochloride) Oral Sebifin 250 Ranbaxy Australia Pty Limited 17 110 871 826

1. Schedule 1, item dealing with Tirofiban

omit from the columns in the order indicated:

Merck Sharp and Dohme (Australia) Pty Ltd 14 000 173 508

and substitute:

Aspen Pharmacare Australia Pty Limited 51 096 236 985

1. Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL

omit from the column headed “Brand”:

Vinorelbine 10 Link

and substitute:

Vinorelbine Link

1. Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

omit from the column headed “Brand”:

Vinorelbine 50 Link

and substitute:

Vinorelbine Link