National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 108 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 108 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 12 November 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 December 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 Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Sachets containing oral powder 29 g, 30 (Mapleflex)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid Oral liquid 125 mL, 36 (MSUD Anamix Junior LQ) Oral MSUD Anamix Junior LQ Nutricia Australia Pty Limited 99 076 246 752

[2]Schedule 1, after item dealing with Arsenic

insert in the columns in the order indicated:

Artemether with lumefantrine Tablet 20 mg-120 mg Oral Riamet Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

[3]Schedule 1, item dealing with Cabergoline in the form Tablet 500 micrograms

omit from the columns in the order indicated:

Cabergoline Tablet 500 micrograms Oral Tinexa Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

[4]Schedule 1, items dealing with Calcipotriol

omit from the columns in the order indicated:

Calcipotriol Ointment 50 micrograms per g, 30 g Application Daivonex CSL Biotherapies Pty Ltd 66 120 398 067

[5]Schedule 1, after items dealing with Calcipotriol

insert in the columns in the order indicated:

Calcipotriol with betamethasone Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g Application Daivobet CSL Biotherapies Pty Ltd 66 120 398 067

[6]Schedule 1, after item dealing with Calcium in the form Tablet 250 mg (as citrate)

insert in the columns in the order indicated:

Calcium Tablet 600 mg (as carbonate) Oral Calci-Tab 600 AFT Pharmaceuticals Pty Ltd 29 105 636 413

[7]Schedule 1, items dealing with Cimetidine

omit from the columns in the order indicated:

Cimetidine Tablet 200 mg Oral Tagamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481

[8]Schedule 1, after items dealing with Clopidogrel

insert in the columns in the order indicated:

Clopidogrel with aspirin	Tablet 75 mg (as hydrogen sulfate)-100 mg	Oral	CoPlavix	sanofi-aventis Australia Pty Ltd	31 008 558 807
Clopidogrel with aspirin	Tablet 75 mg (as hydrogen sulfate)-100 mg	Oral	DuoCover	Bristol-Myers Squibb Australia Pty Ltd	33 004 333 322

[9]Schedule 1, after item dealing with Diclofenac in the form Suppository containing diclofenac sodium 100 mg

insert in the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 25 mg Oral APO-Diclofenac Apotex Pty Ltd 52 096 916 148

1. Schedule 1, item dealing with Fluconazole in the forms Capsule 100 mg and Capsule 200 mg

omit from the column headed “Brand”: Fluconazole Hexal  and substitute: Fluconazole Sandoz

1. Schedule 1, after items dealing with Glucose

insert in the columns in the order indicated:

Glucose I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL Injection Glucose 5% Freeflex Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

1. Schedule 1, after item dealing with Glucose Indicator—Blood in the form Reagent strips, 50 (Glucostix)

insert in the columns in the order indicated:

Glucose Indicator—Blood Reagent strips, 50 (Lifeline Attest) For external use Lifeline Attest Boian Surgical Pty Ltd 25 077 514 464

1. Schedule 1, after item dealing with Hydroxychloroquine

insert in the columns in the order indicated:

Hydroxyethyl starch 130/0.4 I.V. infusion 30 g per 500 mL, 500 mL Injection Voluven 6% Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate
100 mg in 5 mL Injection Irinotecan Alphapharm Alphapharm Pty Ltd 93 002 359 739

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL Injection Irinotecan Alphapharm Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, after item dealing with Ofloxacin

insert in the columns in the order indicated:

Olanzapine	Powder for injection 210 mg (as pamoate monohydrate) with diluent	Injection	Zyprexa Relprevv	Eli Lilly Australia Pty Ltd	39 000 233 992
Olanzapine	Powder for injection 300 mg (as pamoate monohydrate) with diluent	Injection	Zyprexa Relprevv	Eli Lilly Australia Pty Ltd	39 000 233 992

1. Schedule 1, items dealing with Paliperidone

omit from the columns in the order indicated:

Paliperidone Tablet 12 mg (prolonged release) Oral Invega Janssen-Cilag Pty Ltd  47 000 129 975

1. Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg

omit from the column headed “Brand”:  Chem mart Chemadol  and substitute: Chem mart Paracetamol

1. Schedule 1, items dealing with Paroxetine

omit from the columns in the order indicated:

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

1. Schedule 1, after item dealing with Pneumococcal Vaccine - Polyvalent

insert in the columns in the order indicated:

Polyethylene glycol 400	Eye drops 2.5 mg per mL, 15 mL	Application to the eye	Blink Intensive Tears	AMO Australia Pty Limited	95 099 963 194
Polyethylene glycol 400	Eye drops 2.5 mg per mL, single dose units 0.4 mL, 20	Application to the eye	Blink Intensive Tears	AMO Australia Pty Limited	95 099 963 194

1. Schedule 1, after items dealing with Pramipexole

insert in the columns in the order indicated:

Prasugrel	Tablet 10 mg (as hydrochloride)	Oral	Effient	Eli Lilly Australia Pty Ltd	39 000 233 992
Prasugrel	Tablet 5 mg (as hydrochloride)	Oral	Effient	Eli Lilly Australia Pty Ltd	39 000 233 992

1. Schedule 1, after item dealing with Quinapril in the form Tablet 20 mg (as hydrochloride) (Quinapril-DP)

insert in the columns in the order indicated:

Quinapril Tablet 20 mg (as hydrochloride) Oral Quinapril-GA Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Quinine

omit from the columns in the order indicated:

Quinine Tablet containing quinine sulfate 300 mg Oral Quinsul Aspen Pharmacare Australia Pty Limited  51 096 236 985

1. Schedule 1, items dealing with Sertraline in the form Tablet 100 mg (as hydrochloride)

omit from the columns in the order indicated:

Sertraline Tablet 100 mg (as hydrochloride) Oral Sertraline Winthrop sanofi-aventis Australia Pty Ltd  31 008 558 807

1. Schedule 1, item dealing with Sertraline in the form Tablet 100 mg (as hydrochloride) (Xydep 100)

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

and substitute:

Pfizer Australia Pty Ltd 50 008 422 348

1. Schedule 1, item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride) (Xydep 50)

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

and substitute:

Pfizer Australia Pty Ltd 50 008 422 348

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

insert in the columns in the order indicated:

Simvastatin Tablet 20 mg Oral Simvastatin-GA 20 Genepharm (Australia) Limited 17 003 854 626

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

insert in the columns in the order indicated:

Simvastatin Tablet 40 mg Oral Simvastatin-GA 40 Genepharm (Australia) Limited 17 003 854 626

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

insert in the columns in the order indicated:

Simvastatin Tablet 80 mg Oral Simvastatin-GA 80 Genepharm (Australia) Limited 17 003 854 626

1. Schedule 1, after item dealing with Sodium Chloride in the form I.V. infusion 38.5 mmol per 250 mL, 250 mL

insert in the columns in the order indicated:

Sodium Chloride I.V. infusion 38.5 mmol per 250 mL, 250 mL Injection Sodium Chloride 0.9% Freeflex Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

1. Schedule 1, omit item dealing with Tamarindus indica seed polysaccharide

1. Schedule 1, after item dealing with Topiramate in the form Tablet 100 mg (APO-Topiramate)

insert in the columns in the order indicated:

Topiramate Tablet 100 mg Oral Epiramax 100 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Topiramate in the form Tablet 200 mg (APO-Topiramate)

insert in the columns in the order indicated:

Topiramate Tablet 200 mg Oral Epiramax 200 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Topiramate in the form Tablet 25 mg (APO-Topiramate)

insert in the columns in the order indicated:

Topiramate Tablet 25 mg Oral Epiramax 25 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Topiramate in the form Tablet 50 mg (APO-Topiramate)

insert in the columns in the order indicated:

Topiramate Tablet 50 mg Oral Epiramax 50 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Tramadol in the form Capsule containing tramadol hydrochloride 50 mg (Zydol)

insert in the columns in the order indicated:

Tramadol Injection containing tramadol hydrochloride 100 mg in 2 mL Injection Tramahexal Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, after item dealing with Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 200 mg (Sodium Valproate Sandoz)

insert in the columns in the order indicated:

Valproic Acid Tablet (enteric coated) containing sodium valproate 200 mg Oral Valprease 200 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 500 mg (Sodium Valproate Sandoz)

insert in the columns in the order indicated:

Valproic Acid Tablet (enteric coated) containing sodium valproate 500 mg Oral Valprease 500 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594