National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 49 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 49 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 4 June 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 July 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

  1. Schedule 1, after items dealing with Alendronic Acid

insert in the columns in the order indicated:

Alendronic acid with colecalciferol Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol Oral Dronalen Plus Genepharm Pty Ltd 68 118 734 795

  1. Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without lysine and low in tryptophan in the form Oral powder 500 g (XLYS, LOW TRY Maxamaid)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without lysine and low in tryptophan Sachets containing oral powder 20 g, 30 (GA gel) Oral GA gel Vitaflo Australia Pty Limited 82 097 161 254

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

omit from the columns in the order indicated:

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

  1. Schedule 1, items dealing with Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

omit from the columns in the order indicated:

Amoxycillin Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL Oral Amohexal Sandoz Pty Ltd 60 075 449 553

  1. Schedule 1, omit item dealing with Anecortave

  1. Schedule 1, after item dealing with Aprepitant

insert in the columns in the order indicated:

Arginine with carbohydrate Sachets of oral powder 4 g containing 500 mg arginine, 30 (Arginine Amino Acid Supplement) Oral Arginine Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254

  1. Schedule 1, after item dealing with Atovaquone

insert in the columns in the order indicated:

Atovaquone with proguanil Tablet containing atovaquone 250 mg with proguanil hydrochloride 100 mg Oral Malarone GlaxoSmithKline Australia Pty Ltd 47 100 162 481

  1. Schedule 1, after item dealing with Bethanechol

insert in the columns in the order indicated:

Bevacizumab Solution for I.V. infusion 100 mg in
4 mL 		Injection Avastin Roche Products Pty Ltd 70 000 132 865
Bevacizumab Solution for I.V. infusion 400 mg in
16 mL 		Injection Avastin Roche Products Pty Ltd 70 000 132 865

  1. Schedule 1, items dealing with Enalapril in the form Tablet containing enalapril maleate 10 mg

omit from the columns in the order indicated:

Enalapril Tablet containing enalapril maleate
10 mg 		Oral Amprace 10 Merck Sharp & Dohme (Australia) Pty Ltd 14 000 173 508

  1. Schedule 1, items 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 Amprace 20 Merck Sharp & Dohme (Australia) Pty Ltd 14 000 173 508

  1. Schedule 1, after item dealing with Escitalopram in the form Oral solution 10 mg (as oxalate) per mL, 28 mL

insert in the columns in the order indicated:

Escitalopram Tablet 10 mg (as oxalate) Oral APO-Escitalopram Apotex Pty Ltd 52 096 916 148
Escitalopram Tablet 10 mg (as oxalate) Oral Chem mart Escitalopram Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Escitalopram Tablet 10 mg (as oxalate) Oral Terry White Chemists Escitalopram Apotex Pty Ltd 52 096 916 148
Escitalopram Tablet 20 mg (as oxalate) Oral APO-Escitalopram Apotex Pty Ltd 52 096 916 148
Escitalopram Tablet 20 mg (as oxalate) Oral Chem mart Escitalopram Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Escitalopram Tablet 20 mg (as oxalate) Oral Terry White Chemists Escitalopram Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Fluoxetine Capsule 20 mg (as hydrochloride) Oral Fluoxetine generichealth Generic Health Pty Ltd 93 110 617 859

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

insert in the columns in the order indicated:

Gemcitabine Powder for I.V. infusion 1 g (as hydrochloride) Injection Gemcite Spirit Pharmaceuticals Pty Ltd 67 109 225 747

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

insert in the columns in the order indicated:

Gemcitabine Powder for I.V. infusion 200 mg (as hydrochloride) Injection Gemcite Spirit Pharmaceuticals Pty Ltd 67 109 225 747

  1. Schedule 1, after item dealing with Insulin Lispro in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5

insert in the columns in the order indicated:

Insulin Lispro Injections (human analogue), cartridges, 100 units per mL,
3 mL, 5 		Injection Humalog Pen Eli Lilly Australia Pty Ltd 39 000 233 992

  1. Schedule 1, after item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5

insert in the columns in the order indicated:

Insulin Lispro with Insulin Lispro Protamine Suspension Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5 Injection Humalog Mix25 Pen Eli Lilly Australia Pty Ltd 39 000 233 992

  1. Schedule 1, after item dealing with Insulin Lispro with Insulin Lispro Protamine Suspension in the form Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5

insert in the columns in the order indicated:

Insulin Lispro with Insulin Lispro Protamine Suspension Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5 Injection Humalog Mix50 Pen Eli Lilly Australia Pty Ltd 39 000 233 992

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in
5 mL 		Injection Irinotecan Actavis Generic Health Pty Ltd 93 110 617 859

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

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in
2 mL 		Injection Irinotecan Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Iron Sucrose

insert in the columns in the order indicated:

Isoleucine with carbohydrate Sachets of oral powder 4 g containing 1 g isoleucine, 30 (Isoleucine 1000 Amino Acid Supplement) Oral Isoleucine 1000 Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254

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

insert in the columns in the order indicated:

Lisinopril Tablet 20 mg Oral Lisinopril-GA Ascent Pharmahealth Ltd 52 107 340 367

  1. Schedule 1, after all items dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg

insert in the columns in the order indicated:

Metformin Tablets (extended release) containing metformin hydrochloride 500 mg, 120 Oral Diabex XR Alphapharm Pty Ltd 93 002 359 739

  1. Schedule 1, after items dealing with Moxonidine

insert in the columns in the order indicated:

Mupirocin Nasal ointment 20 mg (as calcium) per g, 3 g Nasal Bactroban GlaxoSmithKline Australia Pty Ltd 47 100 162 481

  1. Schedule 1, items dealing with Nifedipine

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

Nifedipine Tablet 10 mg Oral Nypine 10 Arrow Pharmaceuticals Pty Ltd 17 003 144 170

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

Nifedipine Tablet 20 mg Oral Nypine 20 Arrow Pharmaceuticals Pty Ltd 17 003 144 170

  1. Schedule 1, items dealing with Oestradiol and Oestradiol with Norethisterone

omit from the columns in the order indicated:

Oestradiol and Oestradiol with Norethisterone Pack containing 12 tablets oestradiol
2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg 		Oral Trisequens Novo Nordisk Pharmaceuticals Pty Limited 40 002 879 996

  1. Schedule 1, items dealing with Oestradiol with Norethisterone

omit from the columns in the order indicated:

Oestradiol with Norethisterone Tablets containing
1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28 		Oral Kliovance Novo Nordisk Pharmaceuticals Pty Limited 40 002 879 996
Oestradiol with Norethisterone Tablets containing
2 mg oestradiol (as hemihydrate) with
1 mg norethisterone acetate, 28 		Oral Kliogest Novo Nordisk Pharmaceuticals Pty Limited 40 002 879 996

  1. Schedule 1, after item dealing with Oxaliplatin in the form Powder for I.V. infusion 100 mg (Oxalatin)

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 100 mg Injection Oxaliplatin Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Oxaliplatin in the form Powder for I.V. infusion 50 mg (Oxalatin)

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 50 mg Injection Oxaliplatin Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, item dealing with Oxaliplatin in the form Powder for I.V. infusion 50 mg

omit from the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 50 mg Injection Winthrop Oxaliplatin sanofi-aventis Australia Pty Ltd 31 008 558 807

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

omit from the columns in the order indicated:

Paracetamol Tablet 500 mg Oral Parahexal Sandoz Pty Ltd 60 075 449 553

  1. Schedule 1, after item dealing with Perindopril in the form Tablet containing perindopril erbumine 2 mg (Indopril 2)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine
2 mg 		Oral Ozapace Ranbaxy Australia Pty Limited 17 110 871 826

  1. Schedule 1, after item dealing with Perindopril in the form Tablet containing perindopril erbumine 4 mg (Indopril 4)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine
4 mg 		Oral Ozapace Ranbaxy Australia Pty Limited 17 110 871 826

  1. Schedule 1, after item dealing with Perindopril in the form Tablet containing perindopril erbumine 8 mg (Indopril 8)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine
8 mg 		Oral Ozapace Ranbaxy Australia Pty Limited 17 110 871 826

  1. Schedule 1, after item dealing with Riluzole

insert in the columns in the order indicated:

Risedronic Acid Tablet containing risedronate sodium 150 mg Oral Actonel Once-a-Month sanofi-aventis Australia Pty Ltd 31 008 558 807

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

insert in the columns in the order indicated:

Risperidone Tablet 0.5 mg Oral Ozidal Ranbaxy Australia Pty Limited 17 110 871 826

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

insert in the columns in the order indicated:

Risperidone Tablet 1 mg Oral Ozidal Ranbaxy Australia Pty Limited 17 110 871 826

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

insert in the columns in the order indicated:

Risperidone Tablet 2 mg Oral Ozidal Ranbaxy Australia Pty Limited 17 110 871 826

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

insert in the columns in the order indicated:

Risperidone Tablet 3 mg Oral Ozidal Ranbaxy Australia Pty Limited 17 110 871 826

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

insert in the columns in the order indicated:

Risperidone Tablet 4 mg Oral Ozidal Ranbaxy Australia Pty Limited 17 110 871 826

  1. Schedule 1, after item dealing with Tramadol in the form Tablet (extended release) containing tramadol hydrochloride 300 mg

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 100 mg Oral APO-Tramadol SR Apotex Pty Ltd 52 096 916 148
Tramadol Tablet (sustained release) containing tramadol hydrochloride 100 mg Oral Chem mart Tramadol SR Apotex Pty Ltd 52 096 916 148
Tramadol Tablet (sustained release) containing tramadol hydrochloride 100 mg Oral Terry White Chemists Tramadol SR Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg
    (Zydol SR 100)

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 150 mg Oral APO-Tramadol SR Apotex Pty Ltd 52 096 916 148
Tramadol Tablet (sustained release) containing tramadol hydrochloride 150 mg Oral Chem mart Tramadol SR Apotex Pty Ltd 52 096 916 148
Tramadol Tablet (sustained release) containing tramadol hydrochloride 150 mg Oral Terry White Chemists Tramadol SR Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg
    (Zydol SR 150)

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 200 mg Oral APO-Tramadol SR Apotex Pty Ltd 52 096 916 148
Tramadol Tablet (sustained release) containing tramadol hydrochloride 200 mg Oral Chem mart Tramadol SR Apotex Pty Ltd 52 096 916 148
Tramadol Tablet (sustained release) containing tramadol hydrochloride 200 mg Oral Terry White Chemists Tramadol SR Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Trandolapril in the form Capsule
    1 mg (Tranalpha)

insert in the columns in the order indicated:

Trandolapril Capsule 1 mg Oral Trandolapril generichealth Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Trandolapril in the form Capsule
    2 mg (Tranalpha)

insert in the columns in the order indicated:

Trandolapril Capsule 2 mg Oral Trandolapril generichealth Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Trandolapril in the form Capsule
    4 mg (Tranalpha)

insert in the columns in the order indicated:

Trandolapril Capsule 4 mg Oral Trandolapril generichealth Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Trandolapril in the form Capsule
    500 micrograms (Tranalpha)

insert in the columns in the order indicated:

Trandolapril Capsule
500 micrograms 		Oral Trandolapril generichealth Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after item dealing with Valaciclovir

insert in the columns in the order indicated:

Valine with carbohydrate Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000 Amino Acid Supplement) Oral Valine 1000 Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254
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