National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 120 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 120 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 December 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 January 2010.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1            Amendments

[1]Schedule 1, items dealing with Allopurinol in the forms Tablet 100 mg and Tablet 300 mg

omit from the column headed “Brand”: Allohexal  and substitute: Allopurinol Sandoz

[2]Schedule 1, after item dealing with Alprazolam in the form Tablet 1 mg (Alprazolam-DP)

insert in the columns in the order indicated:

Alprazolam Tablet 1 mg Oral Alprazolam-GA Genepharm Pty Ltd 68 118 734 795

[3]Schedule 1, items dealing with Alprazolam in the form Tablet 2 mg

omit from the columns in the order indicated:

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

[4]Schedule 1, after item dealing with Alprazolam in the form Tablet 500 micrograms (Alprax 0.5)

insert in the columns in the order indicated:

Alprazolam Tablet 500 micrograms Oral Alprazolam Sandoz Sandoz Pty Ltd  60 075 449 553

[5]Schedule 1, items dealing with Alprazolam in the form Tablet 500 micrograms

omit from the columns in the order indicated:

Alprazolam Tablet 500 micrograms Oral Zamhexal 0.5mg Sandoz Pty Ltd  60 075 449 553

[6]Schedule 1, item dealing with Amino acid formula with vitamins and minerals without phenylalanine

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine Oral powder 400 g (XP Analog) Oral XP Analog Nutricia Australia Pty Limited 99 076 246 752

[7]Schedule 1, item dealing with Amino acid formula without phenylalanine

omit from the columns in the order indicated:

Amino acid formula without phenylalanine Bars 42 g, 20 (Phlexy-10) Oral Phlexy-10 Nutricia Australia Pty Limited 99 076 246 752

[8]Schedule 1, item dealing with Amphotericin in the form Lozenge 10 mg

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

[9]Schedule 1, after item dealing with Cabergoline in the form Tablet 500 micrograms (Dostinex)

insert in the columns in the order indicated:

Cabergoline Tablet 500 micrograms Oral Tinexa Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, item dealing with Captopril in the form Oral solution 5 mg per mL, 95 mL (Capoten)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Captopril in the form Tablet 12.5 mg (GenRx Captopril)

insert in the columns in the order indicated:

Captopril Tablet 12.5 mg Oral Zedace Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, item dealing with Captopril in the form Tablet 25 mg (Capoten)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

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

insert in the columns in the order indicated:

Captopril Tablet 25 mg Oral Zedace Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, item dealing with Captopril in the form Tablet 50 mg (Capoten)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

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

insert in the columns in the order indicated:

Captopril Tablet 50 mg Oral Zedace Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, items dealing with Cephalexin

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

Cephalexin Capsule 250 mg (anhydrous) Oral Cephalexin Max Max Pharma Pty Ltd 93 121 857 878

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

Cephalexin Capsule 500 mg (anhydrous) Oral Cephalexin Max Max Pharma Pty Ltd 93 121 857 878

1. Schedule 1, item dealing with Cholestyramine

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, items dealing with Clomiphene

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

Clomiphene Tablet containing clomiphene citrate 50 mg Oral Clomhexal Sandoz Pty Ltd 60 075 449 553

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

Clomiphene	Tablet containing clomiphene citrate 50 mg	Oral	Fermil	Sigma Pharmaceuticals (Australia) Pty Ltd	88 004 118 594
Clomiphene	Tablet containing clomiphene citrate 50 mg	Oral	GenRx Clomiphene	Apotex Pty Ltd	52 096 916 148

1. Schedule 1, items dealing with Diazepam

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

Diazepam Tablet 2 mg Oral Ducene Roche Products Pty Ltd 70 000 132 865

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

Diazepam Tablet 5 mg Oral Ducene Roche Products Pty Ltd 70 000 132 865

1. Schedule 1, item dealing with Fludrocortisone

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

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

omit from the column headed “Form (strength, type, size, etc.)”:   Reagent strips (all instances) and substitute:  Test strips

1. Schedule 1, omit all items dealing with Glucose Indicator―Blood

and substitute: 

Glucose Indicator—Blood	Test strips, 100 (Accu-Chek Performa)	For external use	Accu-Chek Performa	Roche Diagnostics Australia Pty Limited	29 003 001 205
Glucose Indicator—Blood	Test strips, 100 (FreeStyle Lite)	For external use	FreeStyle Lite	Abbott Australasia Pty Ltd	95 000 180 389
Glucose Indicator—Blood	Test strips, 100 (Optium glucose)	For external use	Optium glucose	Abbott Australasia Pty Ltd	95 000 180 389
Glucose Indicator—Blood	Test strips, 100 (Precision Plus)	For external use	Precision Plus	Abbott Australasia Pty Ltd	95 000 180 389
Glucose Indicator—Blood	Test strips, 100 (SofTact)	For external use	SofTact	Abbott Australasia Pty Ltd	95 000 180 389
Glucose Indicator—Blood	Test strips, 25 (On-Call Plus)	For external use	On-Call Plus	Prohealth Asia Pacific Pty Ltd	25 076 852 769
Glucose Indicator—Blood	Test strips, 50 (Accu-Chek Active)	For external use	Accu-Chek Active	Roche Diagnostics Australia Pty Limited	29 003 001 205
Glucose Indicator—Blood	Test strips, 50 (Accu-Chek Go)	For external use	Accu-Chek Go	Roche Diagnostics Australia Pty Limited	29 003 001 205
Glucose Indicator—Blood	Test strips, 50 (Advantage II)	For external use	Advantage II	Roche Diagnostics Australia Pty Limited	29 003 001 205
Glucose Indicator—Blood	Test strips, 50 (Betachek G5)	For external use	Betachek G5	National Diagnostic Products (Australia) Pty Limited	61 003 512 598
Glucose Indicator—Blood	Test strips, 50 (Betachek)	For external use	Betachek	National Diagnostic Products (Australia) Pty Limited	61 003 512 598
Glucose Indicator—Blood	Test strips, 50 (CareSens)	For external use	CareSens	Life Bioscience Pty Ltd	13 108 135 191
Glucose Indicator—Blood	Test strips, 50 (Freestyle Papillon)	For external use	Freestyle Papillon	Abbott Australasia Pty Ltd	95 000 180 389
Glucose Indicator—Blood	Test strips, 50 (FreeStyle)	For external use	FreeStyle	Abbott Australasia Pty Ltd	95 000 180 389
Glucose Indicator—Blood	Test strips, 50 (Glucoboy)	For external use	Glucoboy	Diabetes Association of Australia Ltd	55 115 742 964
Glucose Indicator—Blood	Test strips, 50 (Glucocard 01 Sensor)	For external use	Glucocard 01 Sensor	Medical Specialties Australia Unit Trust	75 880 043 044
Glucose Indicator—Blood	Test strips, 50 (Glucoflex-R)	For external use	Glucoflex-R	National Diagnostic Products (Australia) Pty Limited	61 003 512 598
Glucose Indicator—Blood	Test strips, 50 (GlucoOz)	For external use	GlucoOz	Medical Specialties Australia Unit Trust	75 880 043 044
Glucose Indicator—Blood	Test strips, 50 (Glucostix)	For external use	Glucostix	Bayer Australia Ltd	22 000 138 714
Glucose Indicator—Blood	Test strips, 50 (Lifeline Attest)	For external use	Lifeline Attest	Boian Surgical Pty Ltd	25 077 514 464
Glucose Indicator—Blood	Test strips, 50 (MWD Pen Sensor Strips)	For external use	MWD Pen Sensor Strips	MedWatchDog Pty Limited	46 114 482 558
Glucose Indicator—Blood	Test strips, 50 (MyGlucoHealth)	For external use	MyGlucoHealth	Entra Health Systems Pty Ltd	14 135 973 303
Glucose Indicator—Blood	Test strips, 50 (Omnitest EZ)	For external use	Omnitest EZ	B. Braun Australia Pty Ltd	56 002 945 155
Glucose Indicator—Blood	Test strips, 50 (Omnitest Plus)	For external use	Omnitest Plus	B. Braun Australia Pty Ltd	56 002 945 155
Glucose Indicator—Blood	Test strips, 50 (Optium Omega)	For external use	Optium Omega	Abbott Australasia Pty Ltd	95 000 180 389
Glucose Indicator—Blood	Test strips, 50 (SensoCard)	For external use	SensoCard	Point of Care Diagnostics Australia Pty Ltd	93 067 939 824
Glucose Indicator—Blood	Test strips, 50 (TrueTrack)	For external use	TrueTrack	Diabetes Association of Australia Ltd	55 115 742 964

Glucose Indicator—Blood Test strips, 51 (Accu-Chek Integra) For external use Accu-Chek Integra Roche Diagnostics Australia Pty Limited  29 003 001 205

1. Schedule 1, items dealing with Glucose Indicator―Urine

omit from the column headed “Form (strength, type, size, etc.)”:   Reagent strips (all instances) and substitute:   Test strips

1. Schedule 1, item dealing with Megestrol

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, item dealing with Nystatin in the forms Cream 100,000 units per g, 15 g and Oral suspension 100,000 units per mL, 24 mL (Mycostatin)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

1. Schedule 1, items dealing with Paclitaxel

omit from the columns in the order indicated:

Paclitaxel Solution concentrate for I.V. infusion 150 mg in 25 mL Injection Taxol Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

1. Schedule 1, item dealing with Pravastatin in the forms Tablet containing pravastatin sodium 10 mg (Pravachol), Tablet containing pravastatin sodium 20 mg (Pravachol), Tablet containing pravastatin sodium 40 mg (Pravachol) and Tablet containing pravastatin sodium 80 mg (Pravachol)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

1. Schedule 1, item dealing with Sotalol in the forms Tablet containing sotalol hydrochloride 160 mg (Sotacor) and Tablet containing sotalol hydrochloride 80 mg (Sotacor)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

1. Schedule 1, item dealing with Sotalol in the form Tablet containing sotalol hydrochloride 80 mg

omit from the column headed “Brand”:         Sotahexal   and substitute:           Sotalol Sandoz

1. Schedule 1, item dealing with Triamcinolone in the form Injection containing triamcinolone acetonide 10 mg in 1 mL (Kenacort-A10)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, item dealing with Triamcinolone with Neomycin, Gramicidin and Nystatin in the form Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL (Kenacomb Otic)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, item dealing with Triamcinolone with Neomycin, Gramicidin and Nystatin in the form Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL (Otocomb Otic)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066

1. Schedule 1, item dealing with Triamcinolone with Neomycin, Gramicidin and Nystatin in the form Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g (Kenacomb Otic)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, item dealing with Triamcinolone with Neomycin, Gramicidin and Nystatin in the form Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g (Otocomb Otic)

omit from the columns in the order indicated:

Bristol-Myers Squibb Australia Pty Ltd 33 004 333 322

and substitute:

Fawns and McAllan Proprietary Limited 16 004 296 066