National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 126 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 126 of 2008

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 DECEMBER    2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 January 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

1. Schedule 1, omit item dealing with Aminoglutethimide

1. Schedule 1, items dealing with Amiodarone

omit from the columns in the order indicated:

Amiodarone Tablet containing amiodarone hydrochloride 100 mg Oral GenRx Amiodarone Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate) (Amoxil)

insert in  the columns in the order indicated:

Amoxycillin Capsule 500 mg (as trihydrate) Oral Amoxycillin Sandoz Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, items dealing with Amoxycillin with Clavulanic Acid

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

Amoxycillin with Clavulanic Acid Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75mL Oral Clavulin GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Amoxycillin with Clavulanic Acid Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with
57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL Oral Clavulin Duo 400 GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Amoxycillin with Clavulanic Acid Tablet containing
500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral Clavulin Duo GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Amoxycillin with Clavulanic Acid Tablet containing
875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral Clavulin Duo Forte GlaxoSmithKline Australia Pty Ltd 47 100 162 481

1. Schedule 1, items dealing with Bupropion

omit from the columns in the order indicated:

Bupropion Tablet containing bupropion hydrochloride 150 mg (sustained release) Oral Bupropion-RL GlaxoSmithKline Australia Pty Ltd 47 100 162 481

1. Schedule 1, items dealing with Captopril

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

Captopril Tablet 12.5 mg Oral Chem mart Captopril Apotex Pty Ltd 52 096 916 148

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

Captopril Tablet 12.5 mg Oral Terry White Chemists Captopril Apotex Pty Ltd 52 096 916 148

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

Captopril Tablet 25 mg Oral Chem mart Captopril Apotex Pty Ltd 52 096 916 148

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

Captopril Tablet 25 mg Oral Terry White Chemists Captopril Apotex Pty Ltd 52 096 916 148

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

Captopril Tablet 50 mg Oral Chem mart Captopril Apotex Pty Ltd 52 096 916 148

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

Captopril Tablet 50 mg Oral Terry White Chemists Captopril Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Carboplatin in the form Solution for I.V. injection 150 mg in 15 mL (Pfizer Australia Pty Ltd)

insert in the columns in the order indicated:

Carboplatin Solution for I.V. injection 450 mg in
45 mL Injection Baxter Carboplatin Baxter Healthcare Pty Ltd 43 000 392 781

1. Schedule 1, after item dealing with Clarithromycin in the form Powder for oral liquid 250 mg per 5 mL, 50 mL

insert in the columns in the order indicated:

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

1. Schedule 1, item dealing with Cyproheptadine

omit from the columns in the order indicated:

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

and substitute:

Aspen Pharmacare Australia Pty Limited 51 096 236 985

1. Schedule 1, after items dealing with Fosinopril

insert in the columns in the order indicated:

Fosinopril with Hydrochlorothiazide Tablet containing fosinopril sodium
10 mg with hydrochlorothiazide 12.5 mg Oral APO-Fosinopril HCTZ 10/12.5 Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Fosinopril with Hydrochlorothiazide	Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg	Oral	APO-Fosinopril HCTZ 20/12.5	Apotex Pty Ltd	52 096 916 148
Fosinopril with Hydrochlorothiazide	Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg	Oral	Fosetic 20/12.5	Spirit Pharmaceuticals Pty Ltd	67 109 225 747

1. Schedule 1, after item dealing with Glucose Indicator─Blood in the form Electrode strips, 50 (Advantage II)

insert in the columns in the order indicated:

Glucose Indicator─Blood Electrode strips, 50 (FreeStyle) For external use FreeStyle Abbott Australasia Pty Ltd 95 000 180 389

1. Schedule 1, after items dealing with Hypromellose with Dextran

insert in the columns in the order indicated:

Ibandronic acid Tablet 50 mg (as ibandronate sodium monohydrate) Oral Bondronat Hospira Pty Limited 13 107 058 328

1. Schedule 1, items dealing with Indomethacin

omit from the columns in the order indicated (twice occurring):

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

and substitute:

Aspen Pharmacare Australia Pty Limited 51 096 236 985

1. Schedule 1, items dealing with Ipratropium

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

Ipratropium Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation Chem mart Ipratropium Apotex Pty Ltd 52 096 916 148

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

Ipratropium Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation GenRx Ipratropium Apotex Pty Ltd 52 096 916 148

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

Ipratropium Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation Terry White Chemists Ipratropium Apotex Pty Ltd 52 096 916 148

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

Ipratropium Nebuliser solution containing ipratropium bromide
500 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation Chem mart Ipratropium Apotex Pty Ltd 52 096 916 148

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

Ipratropium Nebuliser solution containing ipratropium bromide
500 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation GenRx Ipratropium Apotex Pty Ltd 52 096 916 148

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

Ipratropium Nebuliser solution containing ipratropium bromide
500 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation Terry White Chemists Ipratropium Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Ipratropium in the form Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 (Apoven 250)

insert in the columns in the order indicated:

Ipratropium Nebuliser solution containing ipratropium bromide
250 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation APO-Ipratropium Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Ipratropium in the form Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 (Apoven 500)

insert in the columns in the order indicated:

Ipratropium Nebuliser solution containing ipratropium bromide
500 micrograms (anhydrous) in 1 mL single dose units, 30 Inhalation APO-Ipratropium Apotex Pty Ltd 52 096 916 148

1. Schedule 1, item dealing with Isotretinoin

omit from the columns in the order indicated:

Isotretinoin Capsule 10 mg Oral GenRx Isotretinoin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, items dealing with Lamotrigine

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

Lamotrigine Tablet 100 mg Oral Elmendos GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Lamotrigine Tablet 100 mg Oral Lamitrin Sandoz Pty Ltd 60 075 449 553

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

Lamotrigine Tablet 200 mg Oral Elmendos GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Lamotrigine Tablet 200 mg Oral Lamitrin Sandoz Pty Ltd 60 075 449 553

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

Lamotrigine Tablet 25 mg Oral Elmendos GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Lamotrigine Tablet 25 mg Oral Lamitrin Sandoz Pty Ltd 60 075 449 553

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

Lamotrigine Tablet 5 mg Oral Elmendos GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Lamotrigine Tablet 5 mg Oral Lamitrin Sandoz Pty Ltd 60 075 449 553

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

Lamotrigine Tablet 50 mg Oral Elmendos GlaxoSmithKline Australia Pty Ltd 47 100 162 481

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

Lamotrigine Tablet 50 mg Oral Lamitrin Sandoz Pty Ltd 60 075 449 553

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

omit from the column headed “Form”:

Tablet containing metformin hydrochloride 500 mg (extended release)

and substitute:

Tablet (extended release) containing metformin hydrochloride 500 mg

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

insert in the columns in the order indicated:

Metformin Tablet (extended release) containing metformin hydrochloride 500 mg Oral Metex XR Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, item dealing with Methyldopa in the form Tablet 250 mg (Aldomet)

omit from the columns in the order indicated:

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

and substitute:

Aspen Pharmacare Australia Pty Limited 51 096 236 985

1. Schedule 1, after item dealing with Mirtazapine in the form Tablet
   30 mg (orally disintegrating)

insert in the columns in the order indicated:

Mirtazapine Tablet 45 mg Oral APO-Mirtazapine Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Mirtazapine in the form Tablet
   45 mg (Avanza)

insert in the columns in the order indicated:

Mirtazapine Tablet 45 mg Oral Chem mart Mirtazapine Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Mirtazapine in the form Tablet
   45 mg (Mirtazon)

insert in the columns in the order indicated:

Mirtazapine Tablet 45 mg Oral Terry White Chemists Mirtazapine Apotex Pty Ltd 52 096 916 148

1. Schedule 1, items dealing with Nifedipine

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

Nifedipine Tablet 20 mg Oral Chem mart Nifedipine Apotex Pty Ltd 52 096 916 148

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

Nifedipine Tablet 20 mg Oral Terry White Chemists Nifedipine Apotex Pty Ltd 52 096 916 148

1. Schedule 1, item dealing with Paclitaxel in the forms Solution concentrate for I.V. infusion 30 mg in 5 mL vial, Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial, Solution concentrate for I.V. infusion 150 mg in 25 mL vial and Solution concentrate for I.V. infusion 300 mg in 50 mL vial

omit from the column headed “Form”:

vial

1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Anzatax)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 100 mg in 16.7 mL Injection Baxter Paclitaxel Baxter Healthcare Pty Ltd 43 000 392 781

1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL (Anzatax)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 30 mg in 5 mL Injection Baxter Paclitaxel Baxter Healthcare Pty Ltd 43 000 392 781

1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL (Anzatax)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 300 mg in 50 mL Injection Baxter Paclitaxel Baxter Healthcare Pty Ltd 43 000 392 781

1. Schedule 1, items dealing with Paracetamol

omit from the columns in the order indicated:

Paracetamol Tablet 500 mg Oral Tylenol Johnson & Johnson Pacific Pty Limited 73 001 121 446

1. Schedule 1, omit items dealing with Piperazine Oestrone

1. Schedule 1, items dealing with Piroxicam

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

Piroxicam Dispersible tablet
10 mg Oral GenRx Piroxicam Dispersible Apotex Pty Ltd 52 096 916 148

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

Piroxicam Dispersible tablet
20 mg Oral Chem mart Piroxicam Dispersible Apotex Pty Ltd 52 096 916 148

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

Piroxicam Dispersible tablet
20 mg Oral GenRx Piroxicam Dispersible Apotex Pty Ltd 52 096 916 148

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

Piroxicam Dispersible tablet
20 mg Oral Terry White Chemists Piroxicam Dispersible Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after items dealing with Polyvinyl Alcohol

insert in the columns in the order indicated:

Posaconazole Oral suspension 40 mg per mL, 105 mL Oral Noxafil Schering-Plough Pty Limited 57 000 235 245

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

insert in the columns in the order indicated:

Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	APO-Pravastatin	Apotex Pty Ltd	52 096 916 148
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Chem mart Pravastatin	Apotex Pty Ltd	52 096 916 148

1. Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg (Pravastatin-GA 80)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
80 mg Oral Terry White Chemists Pravastatin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, items dealing with Salbutamol

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

Salbutamol Nebuliser solution
2.5 mg (as sulfate) in 2.5 mL single dose units, 30 Inhalation Chem mart Salbutamol Apotex Pty Ltd 52 096 916 148

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

Salbutamol Nebuliser solution
2.5 mg (as sulfate) in 2.5 mL single dose units, 30 Inhalation Terry White Chemists Salbutamol Apotex Pty Ltd 52 096 916 148

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

Salbutamol Nebuliser solution
5 mg (as sulfate) in
2.5 mL single dose units, 30 Inhalation Chem mart Salbutamol Apotex Pty Ltd 52 096 916 148

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

Salbutamol Nebuliser solution
5 mg (as sulfate) in
2.5 mL single dose units, 30 Inhalation Terry White Chemists Salbutamol Apotex Pty Ltd 52 096 916 148

1. Schedule 1, items dealing with Sumatriptan

omit from the columns in the order indicated:

Sumatriptan Tablet 50 mg (as succinate) Oral Suvalan 50 GlaxoSmithKline Australia Pty Ltd 47 100 162 481

1. Schedule 1, items dealing with Tamoxifen

omit from the columns in the order indicated:

Tamoxifen Tablet 10 mg (as citrate) Oral Nolvadex AstraZeneca Pty Ltd 54 009 682 311

1. Schedule 1, after item dealing with Temozolomide in the form Capsule 100 mg

insert in the columns in the order indicated:

Temozolomide Capsule 140 mg Oral Temodal Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, items dealing with Trimethoprim with Sulfamethoxazole

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

Trimethoprim with Sulfamethoxazole Tablet 160 mg-800 mg Oral Chem mart Trimethoprim with Sulfamethoxazole DS Apotex Pty Ltd 52 096 916 148

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

Trimethoprim with Sulfamethoxazole Tablet 160 mg-800 mg Oral GenRx Trimethoprim with SulfamethoxazoleDS Apotex Pty Ltd 52 096 916 148

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

Trimethoprim with Sulfamethoxazole Tablet 160 mg-800 mg Oral Terry White Chemists Trimethoprim with SulfamethoxazoleDS Apotex Pty Ltd 52 096 916 148