National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 88 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 88 of 2008

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

I, DIANA MCDONELL, Acting 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 1st AUGUST 2008

DIANA MCDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 September 2008.

2              Amendment of PB 76 of 2008

Schedule 1 amends PB 76 of 2008.

Schedule 1        Amendments

[1]            Schedule 1, after item dealing with Alendronic Acid in the form Tablet 70 mg (as alendronate sodium) (Alendrobell 70 mg)

insert in the columns in the order indicated:

Alendronic Acid Tablet 70 mg (as alendronate sodium) Oral Alendronate Sandoz Sandoz Pty Ltd 60 075 449 553

[2]            Schedule 1,  item dealing with Alendronic Acid with Colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

omit from the column headed “Brand”:

Fosamax Plus 70mg/140ug

and substitute:

Fosamax Plus 70mg/140mcg

[3]            Schedule 1, after item dealing with Bicalutamide in the form Tablet  
50 mg (APO-Bicalutamide)

insert in the columns in the order indicated:

Bicalutamide Tablet 50 mg Oral Bicalutamide Ranbaxy Ranbaxy Australia Pty Ltd 17 110 871 826

[4]            Schedule 1, after item dealing with Cephalexin in the form Capsule 250 mg (anhydrous) (Cephalexin Max)

insert in the columns in the order indicated:

Cephalexin Capsule 250 mg (anhydrous) Oral Cephatrust 250 Meditech Int. Pty Ltd 17 069 879 465

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

insert in the columns in the order indicated:

Cephalexin Capsule 500 mg (anhydrous) Oral Cephatrust 500 Meditech Int. Pty Ltd 17 069 879 465

[6]            Schedule 1, after items dealing with Cladribine

insert in the columns in the order indicated:

Clarithromycin Powder for oral liquid 250 mg per
5 mL, 50 mL Oral Klacid Abbott Australasia Pty Ltd 95 000 180 389

[7]            Schedule 1, items dealing with Diazepam in the form Tablet 2 mg

omit from the columns in the order indicated:

Diazepam Tablet 2 mg Oral Ranzepam Ranbaxy Australia Pty Limited 17 110 871 826

[8]            Schedule 1, omit item dealing with Dipivefrine

[9]            Schedule 1, items dealing with Electrolyte Replacement, Oral

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

Electrolyte Replacement, Oral Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 Oral Chem mart Oral Rehydration Salts Symbion Pharmacy Services Pty Ltd 25 000 875 034

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

Electrolyte Replacement, Oral Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 Oral Terry White Chemists Oral Rehydration Salts Symbion Pharmacy Services Pty Ltd 25 000 875 034

[10]   Schedule 1, after items dealing with Glucose and Ketone Indicator—Urine

insert in the columns in the order indicated:

Glucose Indicator —Blood Electrode strips, 25 (On-Call Plus) For external use On-Call Plus Prohealth Asia Pacific Pty Ltd 25 076 852 769

[11]          Schedule 1, items dealing with Glucose Indicator—Blood

omit from the column headed “Form”:

Reagent strips, 50 (Accu-Chek Integra)

and substitute:

Reagent strips, 51 (Accu-Chek Integra)

[12]          Schedule 1, after item dealing with Lisinopril in the form Tablet 10 mg

(Lisinopril Winthrop)

insert in the columns in the order indicated:

Lisinopril Tablet 10 mg Oral Lisinotrust 10 Meditech Int. Pty Ltd 17 069 879 465

[13]          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 Lisinotrust 20 Meditech Int. Pty Ltd 17 069 879 465

[14]          Schedule 1, after item dealing with Lisinopril in the form Tablet 5 mg

(Lisinopril Winthrop)

insert in the columns in the order indicated:

Lisinopril Tablet 5 mg Oral Lisinotrust 5 Meditech Int. Pty Ltd 17 069 879 465

[15]          Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg (Metformin 500)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 500 mg Oral Metformin generichealth Generic Health Pty Ltd 93 110 617 859

[16]          Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg (Metformin 850)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 850 mg Oral Metformin generichealth Generic Health Pty Ltd 93 110 617 859

[17]          Schedule 1, after item dealing with Omeprazole in the form Tablet
20 mg (Meprazol)

insert in the columns in the order indicated:

Omeprazole Tablet 20 mg Oral Omeprazole Ranbaxy Ranbaxy Australia Pty Ltd 17 110 871 826

[18]          Schedule 1, after item dealing with Paracetamol in the form Tablet
500 mg (Parmol)

insert in the columns in the order indicated:

Paracetamol Tablet 500 mg Oral Pharmacy Choice Paracetamol Symbion Pharmacy Services Pty Ltd 25 000 875 034

[19]          Schedule 1, after item dealing with Quinapril in the form Tablet 5 mg (as hydrochloride) (Quinapril generichealth)

insert in the columns in the order indicated:

Quinapril Tablet 5 mg (as hydrochloride) Oral Quinapril Sandoz Sandoz Pty Ltd 60 075 449 553

[20]          Schedule 1, after item dealing with Raltitrexed

insert in the columns in the order indicated:

Ramipril Capsule 1.25 mg Oral Pharmacor Ramipril 1.25 Pharmacor Pty Limited 58 121 020 835

[21]          Schedule 1, after item dealing with Ramipril in the form Capsule 10 mg (GenRx Ramipril)

insert in the columns in the order indicated:

Ramipril Capsule 10 mg Oral Pharmacor Ramipril 10 Pharmacor Pty Limited 58 121 020 835

[22]          Schedule 1, after item dealing with Ramipril in the form Capsule 10 mg (Tryzan Caps 10)

insert in the columns in the order indicated:

Ramipril Capsule 2.5 mg Oral Pharmacor Ramipril 2.5 Pharmacor Pty Limited 58 121 020 835

[23]          Schedule 1, after item dealing with Ramipril in the form Capsule        2.5 mg (Tryzan Caps 2.5)

insert in the columns in the order indicated:

Ramipril Capsule 5  mg Oral Pharmacor Ramipril 5 Pharmacor Pty Limited 58 121 020 835

[24]          Schedule 1, after item dealing with Ramipril in the form Tablet 1.25 mg (Tryzan Tabs 1.25)

insert in the columns in the order indicated:

Ramipril Tablet 10 mg Oral Ramipril Sandoz Sandoz Pty Ltd 60 075 449 553

[25]          Schedule 1, after item dealing with Sertraline in the form Tablet
100 mg (as hydrochloride) (Sertraline-DP)

insert in the columns in the order indicated:

Sertraline Tablet 100 mg (as hydrochloride) Oral Sertratrust 100 Meditech Int. Pty Ltd 17 069 879 465

[26]          Schedule 1, after item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride) (Sertraline-DP)

insert in the columns in the order indicated:

Sertraline Tablet 50 mg (as hydrochloride) Oral Sertratrust 50 Meditech Int. Pty Ltd 17 069 879 465

[27]          Schedule 1, after item dealing with Simvastatin in the form Tablet      10 mg (Simvasyn)

insert in the columns in the order indicated:

Simvastatin Tablet 10 mg Oral Simvatrust 10 Meditech Int. Pty Ltd 17 069 879 465

[28]          Schedule 1, after item dealing with Simvastatin in the form Tablet       20 mg (Simvasyn)

insert in the columns in the order indicated:

Simvastatin Tablet 20 mg Oral Simvatrust 20 Meditech Int. Pty Ltd 17 069 879 465

[29]          Schedule 1, after item dealing with Simvastatin in the form Tablet      40 mg (Simvasyn)

insert in the columns in the order indicated:

Simvastatin Tablet 40 mg Oral Simvatrust 40 Meditech Int. Pty Ltd 17 069 879 465

[30]          Schedule 1, after item dealing with Simvastatin in the form Tablet       80 mg (Simvasyn)

insert in the columns in the order indicated:

Simvastatin Tablet 80 mg Oral Simvatrust 80 Meditech Int. Pty Ltd 17 069 879 465

[31]          Schedule 1, items dealing with Tramadol

omit from the columns in the order indicated:

Tramadol Injection containing tramadol hydrochloride 100 mg in 2 mL Injection Tramahexal Sandoz Pty Ltd 60 075 449 553

[32]          Schedule 1, after items dealing with Tramadol

insert in the columns in the order indicated:

Trandolapril Capsule 1 mg Oral APO-Trandolapril Apotex Pty Ltd 52 096 916 148

[33]             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-DP	Genepharm Pty Ltd	68 118 734 795
Trandolapril	Capsule 2 mg	Oral	APO-Trandolapril	Apotex Pty Ltd	52 096 916 148

[34]          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-DP	Genepharm Pty Ltd	68 118 734 795
Trandolapril	Capsule 4 mg	Oral	APO-Trandolapril	Apotex Pty Ltd	52 096 916 148

[35]          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-DP	Genepharm Pty Ltd	68 118 734 795
Trandolapril	Capsule 500 micrograms	Oral	APO-Trandolapril	Apotex Pty Ltd	52 096 916 148

[36]          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-DP Genepharm Pty Ltd 68 118 734 795