National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 56 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 56 of 2010

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

I, FELICITY McNEILL, 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 June 2010

FELICITY McNEILL

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 July 2010.

2              Amendment of PB 16 of 2010

Schedule 1 amends PB 16 of 2010.

Schedule 1            Amendments

[1]Schedule 1, items dealing with Aciclovir in the form Tablet 800 mg (Zovirax 800 mg)

omit from the columns in the order indicated:

Aciclovir Tablet 800 mg Oral Zovirax 800 mg GlaxoSmithKline Australia Pty Ltd 47 100 162 481

[2]Schedule 1, omit items dealing with Adrenaline in the forms I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector and
I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector

and substitute in the columns in the order indicated:

Adrenaline	I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior)	Injection	Anapen Junior	Link Medical Products Pty Ltd	73 010 971 516
Adrenaline	I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen Jr.)	Injection	EpiPen Jr.	Alphapharm Pty Ltd	93 002 359 739
Adrenaline	I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen)	Injection	Anapen	Link Medical Products Pty Ltd	73 010 971 516
Adrenaline	I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen)	Injection	EpiPen	Alphapharm Pty Ltd	93 002 359 739

[3]Schedule 1, items dealing with Atenolol in the form Tablet 50 mg

omit from the columns in the order indicated:

Atenolol Tablet 50 mg Oral GenRx Atenolol Apotex Pty Ltd  52 096 916 148

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

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

[5]Schedule 1, items dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 50 mg Oral GenRx Diclofenac Apotex Pty Ltd  52 096 916 148

[6]Schedule 1, omit items dealing with Docetaxel

and substitute in the columns in the order indicated:

Docetaxel	Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent	Injection	Taxotere	sanofi-aventis Australia Pty Ltd	31 008 558 807
Docetaxel	Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent	Injection	Taxotere	sanofi-aventis Australia Pty Ltd	31 008 558 807

[7]Schedule 1, after item dealing with Famciclovir in the form Tablet 125 mg (Famvir)

insert in the columns in the order indicated:

Famciclovir Tablet 125 mg Oral Favic 125 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

[8]Schedule 1, after item dealing with Famciclovir in the form Tablet 250 mg (Famvir)

insert in the columns in the order indicated:

Famciclovir Tablet 250 mg Oral Favic 250 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

[9]Schedule 1, after item dealing with Famciclovir in the form Tablet 500 mg (Famvir)

insert in the columns in the order indicated:

Famciclovir Tablet 500 mg Oral Favic 500 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

1. Schedule 1, items dealing with Famotidine in the form Tablet 40 mg

omit from the column headed “Brand”:         Famohexal and substitute:           Famotidine Sandoz

1. Schedule 1, item dealing with Gemfibrozil in the form Tablet 600 mg (Jezil)

omit from the columns in the order indicated:

Alphapharm Pty Ltd  93 002 359 739

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

1. Schedule 1, after items dealing with Glucose and Ketone Indicator—Urine

insert in the columns in the order indicated:

Glucose Indicator—Blood Test strips, 100 (Accu-Chek Active) For external use Accu-Chek Active Roche Diagnostics Australia Pty Limited  29 003 001 205

1. Schedule 1, items dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Glucose Indicator—Blood Test strips, 100 (SofTact) For external use SofTact Abbott Australasia Pty Ltd  95 000 180 389

1. Schedule 1, items dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Glucose Indicator—Blood Test strips, 50 (Accu-Chek Active) For external use Accu-Chek Active Roche Diagnostics Australia Pty Limited  29 003 001 205

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

insert in the columns in the order indicated:

Glucose Indicator—Blood Test strips, 50 (CareSens N) For external use CareSens N Life Bioscience Pty Ltd  13 108 135 191

1. Schedule 1, items dealing with Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

omit from the columns in the order indicated:

Indapamide Tablet containing indapamide hemihydrate 2.5 mg Oral Napamide 2.5 mg Ascent Pharmaceuticals Limited  17 003 854 626

1. Schedule 1, after item dealing with Lamotrigine in the form Tablet 100 mg (Seaze 100)

insert in the columns in the order indicated:

Lamotrigine Tablet 200 mg Oral APO- Lamotrigine Apotex Pty Ltd  52 096 916 148

1. Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg

omit from the columns in the order indicated:

Lisinopril Tablet 20 mg Oral Lisinopril Hexal Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, items dealing with Medroxyprogesterone

omit from the columns in the order indicated:

Medroxyprogesterone Injection containing medroxyprogesterone acetate 50 mg in 1 mL Injection Depo-Provera Pfizer Australia Pty Ltd  50 008 422 348

1. Schedule 1, item dealing with Mesalazine

omit from the columns in the order indicated:

Mesalazine Suppositories 1 g, 28 Rectal Pentasa Ferring Pharmaceuticals Pty Limited 87 003 037 170

and substitute:

Mesalazine Suppository 1 g Rectal Pentasa Ferring Pharmaceuticals Pty Limited 87 003 037 170

1. Schedule 1, items dealing with Metformin

omit from 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
Metformin	Tablets (extended release) containing metformin hydrochloride 500 mg, 120	Oral	Diaformin XR	Alphapharm Pty Ltd	93 002 359 739
Metformin	Tablets (extended release) containing metformin hydrochloride 500 mg, 120	Oral	Metex XR	Sigma Pharmaceuticals (Australia) Pty Ltd	88 004 118 594

1. Schedule 1, items dealing with Moclobemide in the form Tablet 300 mg

omit from the column headed “Brand”:         Mohexal     and substitute:        Moclobemide Sandoz

1. Schedule 1, item dealing with Oestradiol

omit from the columns in the order indicated:

Oestradiol Transdermal patches 4 mg, 8 Transdermal Estraderm 50 Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

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

omit from the columns in the order indicated:

Oestradiol and Oestradiol with Norethisterone Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg Transdermal Estracombi Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

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

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 50 mg Injection Oxaliplatin Link Fresenius Kabi Australia Pty Ltd 39 109 383 593

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

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 100 mg in 16.7 mL Injection Plaxel Willow Pharmaceuticals Pty Ltd  80 118 534 704

1. Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL (Paclitaxel Ebewe)

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 150 mg in 25 mL Injection Plaxel Willow Pharmaceuticals Pty Ltd  80 118 534 704

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

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 30 mg in 5 mL Injection Plaxel Willow Pharmaceuticals Pty Ltd  80 118 534 704

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

insert in the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 300 mg in 50 mL Injection Plaxel Willow Pharmaceuticals Pty Ltd  80 118 534 704

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

omit from the columns in the order indicated:

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

1. Schedule 1, items dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg

omit from the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 20 mg Oral Liprachol Sandoz Pty Ltd  60 075 449 553

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

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 20 mg Oral Pravastatin Sandoz Sandoz Pty Ltd  60 075 449 553

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

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

Tamoxifen Tablet 20 mg (as citrate) Oral Chem mart Tamoxifen Apotex Pty Ltd  52 096 916 148

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

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

1. Schedule 1, after item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride) (Terbinafine-DP)

insert in the columns in the order indicated:

Terbinafine Tablet 250 mg (as hydrochloride) Oral Terbinafine-GA Ascent Pharma Pty Ltd 68 118 734 795

1. Schedule 1, item dealing with Tiludronic Acid

omit from the columns in the order indicated:

Hospira Pty Limited  13 107 058 328

and substitute:

sanofi-aventis Australia Pty Ltd  31 008 558 807

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

insert in the columns in the order indicated:

Topiramate Tablet 100 mg Oral Topiramate-GA Ascent Pharma Pty Ltd  68 118 734 795

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

insert in the columns in the order indicated:

Topiramate Tablet 200 mg Oral Topiramate-GA Ascent Pharma Pty Ltd  68 118 734 795

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

insert in the columns in the order indicated:

Topiramate Tablet 25 mg Oral Topiramate-GA Ascent Pharma Pty Ltd  68 118 734 795

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

insert in the columns in the order indicated:

Topiramate Tablet 50 mg Oral Topiramate-GA Ascent Pharma Pty Ltd  68 118 734 795