National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 77 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 77 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 31 July 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 September 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

[1]Schedule 1, items dealing with Amoxycillin

omit from the columns in the order indicated:

Amoxycillin Capsule 250 mg (as trihydrate) Oral Amohexal Sandoz Pty Ltd 60 075 449 553

[2]Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Curam 500/125

and substitute:

Curam Duo 500/125

[3]Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Curam 875/125

and substitute:

Curam Duo Forte 875/125

[4]Schedule 1, item dealing with Anakinra

omit from the columns in the order indicated:

Amgen Australia Pty Limited 31 051 057 428

and substitute:

PharmaLink Pty Ltd 62 116 935 758

[5]Schedule 1, item dealing with Atenolol in the form Tablet 50 mg (Atenolol-GA)

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

[6]Schedule 1, items dealing with Carboplatin

omit from 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

[7]Schedule 1, item dealing with Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) (Cefaclor-GA)

omit from the columns in the order indicated:

Genepharm Pty Ltd 68 118 734 795

and substitute:

Genepharm (Australia) Limited 17 003 854 626

[8]Schedule 1, after item dealing with Cephalexin in the form Capsule 500 mg (anhydrous) (Cephabell)

insert in the columns in the order indicated:

Cephalexin Capsule 500 mg (anhydrous) Oral Cephalexin generichealth Generic Health Pty Ltd 93 110 617 859

[9]Schedule 1, item dealing with Ciprofloxacin in the forms Tablet
500 mg (as hydrochloride) and Tablet 750 mg (as hydrochloride)

omit from the columns in the order indicated:

Genepharm Pty Ltd Genepharm Pty Ltd 68 118 734 795

and substitute:

Genepharm (Australia) Limited Genepharm (Australia) Limited 17 003 854 626

  1. Schedule 1, item dealing with Cladribine in the form Injection 10 mg in 5 mL vial

omit from the column headed “Form”:

vial

  1. Schedule 1, after items dealing with Clopidogrel

insert in the columns in the order indicated:

Clotrimazole Cream 10 mg per g, 20 g Application Clonea Alphapharm Pty Ltd 93 002 359 739

  1. Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg (Diclofenac-GA)

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

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

omit from the columns in the order indicated:

CNS Pharma Pty Ltd 76 121 515 400

and substitute:

Genepharm Pty Ltd 68 118 734 795

  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 LoxaLate Alphapharm Pty Ltd 93 002 359 739

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

omit from the columns in the order indicated:

CNS Pharma Pty Ltd 76 121 515 400

and substitute:

Genepharm Pty Ltd 68 118 734 795

  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 LoxaLate Alphapharm Pty Ltd 93 002 359 739

  1. Schedule 1, items dealing with Etanercept

omit from the columns in the order indicated:

Etanercept Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL Injection Enbrel Wyeth Australia Pty Limited 16 000 296 211

  1. Schedule 1, after item dealing with Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

insert in the columns in the order indicated:

Fludarabine Powder for I.V. injection containing fludarabine phosphate 50 mg Injection Fludarabine Actavis Generic Health Pty Ltd 93 110 617 859

  1. Schedule 1, after items dealing with Glibenclamide

insert in the columns in the order indicated:

Gliclazide Tablet 30 mg (modified release) Oral APO-Gliclazide MR Apotex Pty Ltd 52 096 916 148
Gliclazide Tablet 30 mg (modified release) Oral Chem mart Gliclazide MR Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Gliclazide in the form Tablet
    30 mg (modified release) (Oziclide MR)

insert in the columns in the order indicated:

Gliclazide Tablet 30 mg (modified release) Oral Terry White Chemists Gliclazide MR Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Glimepiride in the form Tablet 1 mg (Amaryl)

insert in the columns in the order indicated:

Glimepiride Tablet 1 mg Oral APO-Glimepiride Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Glimepiride in the form Tablet 2 mg (Amaryl)

insert in the columns in the order indicated:

Glimepiride Tablet 2 mg Oral APO-Glimepiride Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Glimepiride in the form Tablet 3 mg (Amaryl)

insert in the columns in the order indicated:

Glimepiride Tablet 3 mg Oral APO-Glimepiride Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Glimepiride in the form Tablet 4 mg (Amaryl)

insert in the columns in the order indicated:

Glimepiride Tablet 4 mg Oral APO-Glimepiride Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, after item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L (Baxter Healthcare Pty Ltd)

insert in the columns in the order indicated:

Glucose I.V. infusion 278 mmol (anhydrous) per L, 1 L Injection Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

  1. Schedule 1, item dealing with Lamotrigine in the forms Tablet 100 mg, Tablet 200 mg, Tablet 25 mg and Tablet 50 mg (Lamotrigine-GA)

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

  1. Schedule 1, after item dealing with Lansoprazole in the form Sachet containing granules for oral suspension, 30 mg per sachet

insert in the columns in the order indicated:

Lansoprazole Tablet 30 mg (orally disintegrating) Oral Zoton FasTabs Wyeth Australia Pty Limited 16 000 296 211

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

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

  1. Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g (Metformin-GA)

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

  1. Schedule 1, item dealing with Metformin in the forms Tablet containing metformin hydrochloride 500 mg and Tablet containing metformin hydrochloride 850 mg

omit from the columns in the order indicated:

Genepharm Pty Ltd Genepharm Pty Ltd 68 118 734 795

and substitute:

Genepharm (Australia) Limited Genepharm (Australia) Limited 17 003 854 626

  1. Schedule 1, after item dealing with Metformin in the form Tablets (extended release) containing metformin hydrochloride 500 mg, 120 (Diabex XR)

insert in the columns in the order indicated:

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 Paclitaxel

(a) omit from 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

(b) omit from 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

(c) omit from 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, item dealing with Paroxetine in the form Tablet 20 mg (as hydrochloride) (Paroxetine-GA)

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

  1. Schedule 1, after item dealing with Polygeline

insert in the columns in the order indicated:

Poly-l-lactic acid Powder for injection
150 mg 		Injection Sculptra sanofi-aventis Australia Pty Ltd 31 008 558 807

  1. Schedule 1, after items dealing with Pramipexole

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 10 mg Oral APO-Pravastatin Apotex Pty Ltd 52 096 916 148

  1. Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg (Pravastatin-GA 10)

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

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

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

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

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

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

omit from the columns in the order indicated:

Ascent Pharmahealth Ltd 52 107 340 367

and substitute:

Genepharm (Australia) Limited 17 003 854 626

  1. Schedule 1, after item dealing with Roxithromycin in the form Tablet 150 mg (Roximycin)

insert in the columns in the order indicated:

Roxithromycin Tablet 150 mg Oral Roxithromycin-GA Genepharm Pty Ltd 68 118 734 795

  1. Schedule 1, after item dealing with Roxithromycin in the form Tablet 300 mg (Roximycin)

insert in the columns in the order indicated:

Roxithromycin Tablet 300 mg Oral Roxithromycin-GA Genepharm Pty Ltd 68 118 734 795

  1. Schedule 1, after item dealing with Sevelamer

insert in the columns in the order indicated:

Silver sulfadiazine Cream 10 mg per g, 50 g Application Flamazine Smith & Nephew Pty Limited 68 000 087 507

  1. Schedule 1, items dealing with Simvastatin

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

Simvastatin Tablet 10 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd 68 118 734 795

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

Simvastatin Tablet 20 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd 68 118 734 795

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

Simvastatin Tablet 40 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd 68 118 734 795

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

Simvastatin Tablet 80 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd 68 118 734 795

  1. Schedule 1, after item dealing with Sodium Acid Phosphate

insert in the columns in the order indicated:

Sodium bicarbonate Capsule 840 mg Oral Sodibic Aspen Pharmacare Australia Pty Limited 51 096 236 985

  1. Schedule 1, after item dealing with Sodium Chloride in the form
    I.V. infusion 154 mmol per L, 1 L (Baxter Healthcare Pty Ltd)

insert in the columns in the order indicated:

Sodium Chloride I.V. infusion 154 mmol per L, 1 L Injection Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

  1. Schedule 1, after item dealing with Sodium Lactate Compound in the form I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L (Baxter Healthcare Pty Ltd)

insert in the columns in the order indicated:

Sodium Lactate Compound I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride),    2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L Injection Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited 39 109 383 593

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

insert in the columns in the order indicated:

Tramadol Capsule containing tramadol hydrochloride
50 mg 		Oral Lodam 50 Spirit Pharmaceuticals Pty Ltd 67 109 225 747

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

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 100 mg Oral Lodam SR 100 Spirit Pharmaceuticals Pty Ltd 67 109 225 747

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

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 150 mg Oral Lodam SR 150 Spirit Pharmaceuticals Pty Ltd 67 109 225 747

  1. Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg
    (Chem mart Tramadol SR)

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 200 mg Oral Lodam SR 200 Spirit Pharmaceuticals Pty Ltd 67 109 225 747
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