National Health Act 1953 - Amendment determination under section 84af - responsible persons (No. PB 88 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 88 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 3 September 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 October 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 Alprazolam in the form Tablet 2 mg (Alprazolam-DP)

insert in the columns in the order indicated:

Alprazolam Tablet 2 mg Oral Alprazolam-GA Genepharm Pty Ltd  68 118 734 795

[2]Schedule 1, items dealing with Amino acid formula with vitamins and minerals without phenylalanine

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

Amino acid formula with vitamins and minerals without phenylalanine Oral liquid 125 mL, 30 (Lophlex LQ) Oral Lophlex LQ Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins and minerals without phenylalanine Oral liquid 125 mL, 30 (PKU Lophlex LQ 20) Oral PKU Lophlex LQ 20 Nutricia Australia Pty Limited  99 076 246 752

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

Amino acid formula with vitamins and minerals without phenylalanine Oral liquid 62.5 mL, 60 (Lophlex LQ 10) Oral Lophlex LQ 10 Nutricia Australia Pty Limited  99 076 246 752

and substitute:

Amino acid formula with vitamins and minerals without phenylalanine Oral liquid 62.5 mL, 60 (PKU Lophlex LQ 10) Oral PKU Lophlex LQ 10 Nutricia Australia Pty Limited  99 076 246 752

[3]Schedule 1, items dealing with Amino acid formula without phenylalanine

omit from the columns in the order indicated:

Amino acid formula without phenylalanine Oral powder 250 g (PK AID II) Oral PK AID II Nutricia Australia Pty Limited  99 076 246 752

[4]Schedule 1, after item dealing with Amisulpride in the form Tablet 400 mg (Solian 400)

insert in the columns in the order indicated:

Amisulpride Tablet 400 mg Oral Sulprix Alphapharm Pty Ltd  93 002 359 739

[5]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) (Moxiclav Duo 500/125)

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

[6]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) (Moxiclav Duo Forte 875/125)

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

[7]Schedule 1, item dealing with Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL (Aclor 125)

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

[8]Schedule 1, item dealing with Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL (Aclor 250)

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

[9]Schedule 1, items dealing with Cephalexin

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

Cephalexin Capsule 250 mg (anhydrous) Oral Sporahexal Sandoz Pty Ltd  60 075 449 553

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

Cephalexin Capsule 500 mg (anhydrous) Oral Sporahexal Sandoz Pty Ltd  60 075 449 553

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

insert in the columns in the order indicated:

Citalopram Tablet 20 mg (as hydrobromide) Oral Citalopram generichealth Generic Health Pty Ltd  93 110 617 859

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

1. Schedule 1, items dealing with Diclofenac

omit from the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 25 mg Oral Dinac Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg (Clonac 50)

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

1. Schedule 1, after item dealing with Fusidic Acid

insert in the columns in the order indicated:

Gabapentin Capsule 100 mg Oral APO-Gabapentin Apotex Pty Ltd  52 096 916 148

1. Schedule 1, items dealing with Gabapentin

omit from the columns in the order indicated:

Gabapentin Capsule 300 mg Oral Pendine 300 Alphapharm Pty Ltd  93 002 359 739

1. Schedule 1, items dealing with Gliclazide

omit from the columns in the order indicated:

Gliclazide Tablet 80 mg Oral Diamicron Servier Laboratories (Aust.) Pty Ltd  54 004 838 500

1. Schedule 1, item dealing with Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL (Genlac)

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

1. Schedule 1, items dealing with Naloxone

omit from the columns in the order indicated:

Naloxone Injection containing naloxone hydrochloride 800 micrograms in
2 mL disposable injection set Injection Naloxone Min-I-Jet CSL Biotherapies Pty Ltd  66 120 398 067

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

insert in the columns in the order indicated:

Omeprazole Tablet 20 mg Oral Ozmep Spirit Pharmaceuticals Pty Ltd  67 109 225 747

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

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 100 mg Injection Oxaliplatin Alphapharm Alphapharm Pty Ltd  93 002 359 739

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

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 50 mg Injection Oxaliplatin Alphapharm Alphapharm Pty Ltd  93 002 359 739

1. Schedule 1, item dealing with Simvastatin in the form Tablet 10 mg (Simvar 10)

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

1. Schedule 1, after item dealing with Simvastatin in the form Tablet 10 mg (Simvastatin-DP)

insert in the columns in the order indicated:

Simvastatin Tablet 10 mg Oral Simvastatin-GA 10 Genepharm (Australia) Limited  17 003 854 626

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

1. Schedule 1, after item dealing with Topiramate in the form Capsule 50 mg

insert in the columns in the order indicated:

Topiramate	Tablet 100 mg	Oral	APO-Topiramate	Apotex Pty Ltd	52 096 916 148
Topiramate	Tablet 100 mg	Oral	Tamate	Alphapharm Pty Ltd	93 002 359 739

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

insert in the columns in the order indicated:

Topiramate	Tablet 100 mg	Oral	Topiramate Sandoz	Sandoz Pty Ltd	60 075 449 553
Topiramate	Tablet 200 mg	Oral	APO-Topiramate	Apotex Pty Ltd	52 096 916 148
Topiramate	Tablet 200 mg	Oral	Tamate	Alphapharm Pty Ltd	93 002 359 739

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

insert in the columns in the order indicated:

Topiramate	Tablet 200 mg	Oral	Topiramate Sandoz	Sandoz Pty Ltd	60 075 449 553
Topiramate	Tablet 25 mg	Oral	APO-Topiramate	Apotex Pty Ltd	52 096 916 148
Topiramate	Tablet 25 mg	Oral	Tamate	Alphapharm Pty Ltd	93 002 359 739

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

insert in the columns in the order indicated:

Topiramate	Tablet 25 mg	Oral	Topiramate Sandoz	Sandoz Pty Ltd	60 075 449 553
Topiramate	Tablet 50 mg	Oral	APO-Topiramate	Apotex Pty Ltd	52 096 916 148
Topiramate	Tablet 50 mg	Oral	Tamate	Alphapharm Pty Ltd	93 002 359 739

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

insert in the columns in the order indicated:

Topiramate Tablet 50 mg Oral Topiramate Sandoz Sandoz Pty Ltd  60 075 449 553

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

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

omit from the columns in the order indicated:

Arrow Pharmaceuticals Pty Ltd  17 003 144 170

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594