National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 130 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 130 of 2009

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

I, ROGER BUSCH, 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 21 December 2009

ROGER BUSCH

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 February 2010.

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 phenylalanine in the form Sachets containing oral powder 29 g, 30 (Minaphlex)

omit from the columns in the order indicated:

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

and substitute:

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

[2]Schedule 1, items dealing with Baclofen

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

Baclofen Tablet 10 mg Oral Baclo Genepharm Pty Ltd 68 118 734 795

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

Baclofen Tablet 25 mg Oral Baclo Genepharm Pty Ltd 68 118 734 795

[3]Schedule 1, omit item dealing with Bifonazole

[4]Schedule 1, items dealing with Calcium

omit from the columns in the order indicated:

Calcium Tablet 250 mg (as citrate) Oral Citracal Bayer Australia Ltd 22 000 138 714

[5]Schedule 1, items dealing with Captopril in the form Tablet 12.5 mg

omit from the columns in the order indicated:

Captopril Tablet 12.5 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd 68 118 734 795

[6]Schedule 1, item dealing with Captopril in the form Tablet 25 mg (Captohexal)

omit from the column headed “Brand”: Captohexal         and substitute: Captopril Sandoz

[7]Schedule 1, after item dealing with Carmustine

insert in the columns in the order indicated:

Carvedilol Tablet 12.5 mg Oral Carvedilol generichealth Generic Health Pty Ltd 93 110 617 859

[8]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 generichealth Generic Health Pty Ltd 93 110 617 859

[9]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 generichealth Generic Health Pty Ltd 93 110 617 859

1. Schedule 1, after item dealing with Cephalexin in the form Capsule 250 mg (anhydrous) (Cephabell)

insert in the columns in the order indicated:

Cephalexin Capsule 250 mg (anhydrous) Oral Cephalexin generichealth Generic Health Pty Ltd 93 110 617 859

1. Schedule 1, items dealing with Ciprofloxacin

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

Ciprofloxacin Tablet 500 mg (as hydrochloride) Oral Proquin Genepharm Pty Ltd 68 118 734 795

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

Ciprofloxacin Tablet 750 mg (as hydrochloride) Oral Proquin Genepharm Pty Ltd 68 118 734 795

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

insert in the columns in the order indicated:

Citalopram Tablet 40 mg (as hydrobromide) Oral APO-Citalopram Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Citalopram in the form Tablet 40 mg (as hydrobromide) (Celapram)

insert in the columns in the order indicated:

Citalopram Tablet 40 mg (as hydrobromide) Oral Citalopram Sandoz Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, items dealing with Citalopram in the form Tablet 40 mg (as hydrobromide)

omit from the columns in the order indicated:

Citalopram Tablet 40 mg (as hydrobromide) Oral Talohexal Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, after item dealing with Diazepam in the form Tablet 5 mg (Diazepam-DP)

insert in the columns in the order indicated:

Diazepam Tablet 5 mg Oral Diazepam-GA Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Diclofenac

omit from the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 50 mg Oral Dinac Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Essential amino acids formula with minerals and vitamin C

omit from the columns in the order indicated:

Essential amino acids formula with minerals and vitamin C Oral powder 200 g (Dialamine) Oral Dialamine Nutricia Australia Pty Limited 99 076 246 752

1. Schedule 1, item dealing with Fluconazole in the form Capsule 50 mg (Fluconazole Hexal)

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

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

insert in the columns in the order indicated:

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

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

insert in the columns in the order indicated:

Gemcitabine Powder for I.V. infusion 1 g (as hydrochloride) Injection Gemcitabine Ebewe InterPharma Pty Ltd 19 099 877 899

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

insert in the columns in the order indicated:

Gemcitabine Powder for I.V. infusion 200 mg (as hydrochloride) Injection Gemcitabine Ebewe InterPharma Pty Ltd 19 099 877 899

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

insert in the columns in the order indicated:

Glucose Indicator—Blood Test strips, 50 (Bionime Rightest) For external use Bionime Rightest CS Pharma Australia Pty Ltd 15 104 365 460

1. Schedule 1, omit item dealing with Hydrochlorothiazide with Amiloride

and substitute:

Hydrochlorothiazide with Amiloride Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg Oral Moduretic Aspen Pharmacare Australia Pty Limited  51 096 236 985

1. Schedule 1, after item dealing with Hydromorphone in the form Tablet (modified release) containing hydromorphone hydrochloride 32 mg

insert in the columns in the order indicated:

Hydromorphone Tablet (modified release) containing hydromorphone hydrochloride 4 mg Oral Jurnista Janssen-Cilag Pty Ltd 47 000 129 975

1. Schedule 1, omit all items dealing with Influenza Vaccine

and substitute in the columns in the order indicated:

Influenza Vaccine	Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe	Injection	Fluvax Junior	CSL Biotherapies Pty Ltd	66 120 398 067
Influenza Vaccine	Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe	Injection	Vaxigrip Junior	Sanofi Pasteur Pty Ltd	79 085 258 797
Influenza Vaccine	Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 15 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 15 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe	Injection	Fluvax	CSL Biotherapies Pty Ltd	66 120 398 067
Influenza Vaccine	Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 15 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 15 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe	Injection	Influvac	Solvay Biosciences Pty Ltd	41 007 401 201
Influenza Vaccine	Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/California/7/2009 (H1N1)-like strain 15 micrograms haemagglutinin; A/Perth/16/2009 (H3N2)-like strain 15 micrograms haemagglutinin; B/Brisbane/60/2008-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe	Injection	Vaxigrip	Sanofi Pasteur Pty Ltd	79 085 258 797

1. Schedule 1, omit item dealing with Insect Allergen Extract—Honey Bee Venom

and substitute:

Insect Allergen Extract—Honey Bee Venom Injection set containing 550 micrograms Injection Albey Bee Venom Helex-A Pty. Ltd.  89 070 826 176

1. Schedule 1, omit item dealing with Insect Allergen Extract—Paper Wasp Venom

and substitute:

Insect Allergen Extract—Paper Wasp Venom Injection set containing 550 micrograms Injection Albey Paper Wasp Venom Helex-A Pty. Ltd.  89 070 826 176

1. Schedule 1, omit item dealing with Insect Allergen Extract—Yellow Jacket Venom

and substitute:

Insect Allergen Extract—Yellow Jacket Venom Injection set containing 550 micrograms Injection Albey Yellow Jacket Venom Helex-A Pty. Ltd.  89 070 826 176

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 Apoven 250 Genepharm Pty Ltd 68 118 734 795

(b) 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 Apoven 500 Genepharm Pty Ltd 68 118 734 795

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL Injection Irinotecan Ebewe InterPharma Pty Ltd 19 099 877 899

1. Schedule 1, after item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL (Camptosar)

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL Injection Irinotecan Ebewe InterPharma Pty Ltd 19 099 877 899

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL Injection Irinotecan Ebewe InterPharma Pty Ltd 19 099 877 899

1. Schedule 1, after item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
   (Hospira Pty Limited)

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL Injection Irinotecan Ebewe InterPharma Pty Ltd 19 099 877 899

1. Schedule 1, items dealing with Metformin

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

Metformin Tablet containing metformin hydrochloride 500 mg Oral Glucomet 500 mg Genepharm Pty Ltd 68 118 734 795

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

Metformin Tablet containing metformin hydrochloride 850 mg Oral Glucomet 850 mg Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Metoprolol

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

Metoprolol Tablet containing metoprolol tartrate 100 mg Oral Metolol Genepharm Pty Ltd 68 118 734 795

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

Metoprolol Tablet containing metoprolol tartrate 50 mg Oral Metolol Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Mitozantrone in the form Injection 10 mg (as hydrochloride) in 5 mL

omit from the columns in the order indicated:

Mitozantrone Injection 10 mg (as hydrochloride) in 5 mL Injection Mitozantrone Ebewe InterPharma Pty Ltd 19 099 877 899

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

insert in the columns in the order indicated:

Naltrexone Tablet containing naltrexone hydrochloride 50 mg Oral Naltrexone QP Max Pharma Pty Ltd 93 121 857 878

1. Schedule 1, items dealing with Nifedipine

omit from the columns in the order indicated:

Nifedipine Tablet 20 mg Oral Nyefax 20 mg Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Pravastatin

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

Pravastatin Tablet containing pravastatin sodium 10 mg Oral Pravastatin-DP Genepharm Pty Ltd 68 118 734 795

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

Pravastatin Tablet containing pravastatin sodium 20 mg Oral Pravastatin-DP Genepharm Pty Ltd 68 118 734 795

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

Pravastatin Tablet containing pravastatin sodium 40 mg Oral Pravastatin-DP Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Ranitidine in the form Tablet 300 mg (as hydrochloride)

omit from the columns in the order indicated:

Ranitidine Tablet 300 mg (as hydrochloride) Oral Ranoxyl Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, item dealing with Selegiline in the form Tablet containing selegiline hydrochloride 5 mg (Eldepryl)

omit from the columns in the order indicated:

Genepharm Pty Ltd 68 118 734 795

and substitute:

Aspen Pharmacare Australia Pty Limited 51 096 236 985

1. Schedule 1, omit items dealing with Silver Sulfadiazine with Chlorhexidine

1. Schedule 1, item dealing with Sotalol in the form Tablet containing sotalol hydrochloride 160 mg

omit from the columns in the order indicated:

Sotalol Tablet containing sotalol hydrochloride 160 mg Oral Sotab Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, item dealing with Tamoxifen in the form Tablet 10 mg (as citrate)

omit from the columns in the order indicated:

Tamoxifen Tablet 10 mg (as citrate) Oral Tamoxen 10 mg Genepharm Pty Ltd 68 118 734 795