National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 6 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 6 of 2010

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

I, ADRIANA PLATONA, 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 2 February 2010

ADRIANA PLATONA

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 March 2010.

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 1 mg (Alprax 1)

insert in the columns in the order indicated:

Alprazolam Tablet 1 mg Oral Alprazolam Sandoz Sandoz Pty Ltd  60 075 449 553

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

omit from the columns in the order indicated:

Alprazolam Tablet 1 mg Oral Zamhexal 1.0mg Sandoz Pty Ltd  60 075 449 553

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

insert in the columns in the order indicated:

Alprazolam Tablet 2 mg Oral Alprazolam Sandoz Sandoz Pty Ltd  60 075 449 553

[4]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 Zamhexal 2mg Sandoz Pty Ltd  60 075 449 553

[5]Schedule 1, after item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate) (Amoxycillin-DP)

insert in the columns in the order indicated:

Amoxycillin Capsule 250 mg (as trihydrate) Oral Amoxycillin-GA Genepharm Pty Ltd  68 118 734 795

[6]Schedule 1, after item dealing with Calcitriol in the form Capsule 0.25 microgram (Calcitriol-DP)

insert in the columns in the order indicated:

Calcitriol Capsule 0.25 microgram Oral Calcitriol-GA Genepharm (Australia) Limited  17 003 854 626

[7]Schedule 1, after item dealing with Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg (Atacand Plus 16/12.5)

insert in the columns in the order indicated:

Candesartan with Hydrochlorothiazide	Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg	Oral	Atacand Plus 32/12.5	AstraZeneca Pty Ltd	54 009 682 311
Candesartan with Hydrochlorothiazide	Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg	Oral	Atacand Plus 32/25	AstraZeneca Pty Ltd	54 009 682 311

[8]Schedule 1, items dealing with Captopril

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

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

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

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

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

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

[9]Schedule 1, after item dealing with Ciprofloxacin in the form Tablet 500 mg (as hydrochloride) (Ciprofloxacin-BW)

insert in the columns in the order indicated:

Ciprofloxacin Tablet 500 mg (as hydrochloride) Oral Ciprofloxacin-GA Genepharm Pty Ltd  68 118 734 795

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

insert in the columns in the order indicated:

Citalopram Tablet 20 mg (as hydrobromide) Oral Citalopram Sandoz Sandoz Pty Ltd  60 075 449 553

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

omit from the columns in the order indicated:

Citalopram Tablet 20 mg (as hydrobromide) Oral Talohexal Sandoz Pty Ltd  60 075 449 553

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

omit from the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 25 mg Oral GenRx Diclofenac Apotex Pty Ltd  52 096 916 148

1. Schedule 1, items dealing with Dicloxacillin in the form Capsule 250 mg (as sodium)

omit from the columns in the order indicated:

Dicloxacillin Capsule 250 mg (as sodium) Oral Diclocil Bristol-Myers Squibb Australia Pty Ltd  33 004 333 322

1. Schedule 1, after item dealing with Gabapentin in the form Capsule 300 mg (Gabapentin 300)

insert in the columns in the order indicated:

Gabapentin Capsule 300 mg Oral Gabapentin-GA Genepharm Pty Ltd  68 118 734 795

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

insert in the columns in the order indicated:

Gliclazide Tablet 60 mg (modified release) Oral Diamicron 60mg MR Servier Laboratories (Aust.) Pty Ltd  54 004 838 500

1. Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (Accu-Chek Go)

insert in the columns in the order indicated:

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

1. Schedule 1, items dealing with Glucose Indicator—Blood in the form Test strips, 50

omit from the columns in the order indicated:

Glucose Indicator—Blood Test strips, 50 (Glucoboy) For external use Glucoboy Diabetes Association of Australia Ltd  55 115 742 964

1. Schedule 1, item dealing with Glucose Indicator—Blood in the form Test strips, 50 (MWD Pen Sensor Strips)

omit from the columns in the order indicated:

MedWatchDog Pty Limited  46 114 482 558

and substitute:

Skyline Productions Pty Limited  22 135 408 374

1. Schedule 1, omit items dealing with Influenza Vaccine

1. 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 Lisinopril-GA Genepharm (Australia) Limited  17 003 854 626

1. Schedule 1, after item dealing with Memantine in the form Tablet containing memantine hydrochloride 10 mg

insert in the columns in the order indicated:

Memantine Tablet  containing memantine hydrochloride 20 mg Oral Ebixa Lundbeck Australia Pty Ltd  86 070 094 290

1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg (Metformin Ranbaxy)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 500 mg Oral Metformin-GA Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after items dealing with Methyldopa

insert in the columns in the order indicated:

Methylnaltrexone Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL Injection Relistor Wyeth Australia Pty Limited  16 000 296 211

1. Schedule 1, after item dealing with Naratriptan

insert in the columns in the order indicated:

Nebivolol	Tablet 1.25 mg (as hydrochloride)	Oral	Nebilet	CSL Biotherapies Pty Ltd	66 120 398 067
Nebivolol	Tablet 1.25 mg (as hydrochloride), 28	Oral	Nebilet	CSL Biotherapies Pty Ltd	66 120 398 067
Nebivolol	Tablet 10 mg (as hydrochloride)	Oral	Nebilet	CSL Biotherapies Pty Ltd	66 120 398 067
Nebivolol	Tablet 5 mg (as hydrochloride)	Oral	Nebilet	CSL Biotherapies Pty Ltd	66 120 398 067

1. Schedule 1, after item dealing with Olanzapine in the form Powder for injection 300 mg (as pamoate monohydrate) with diluent

insert in the columns in the order indicated:

Olanzapine Powder for injection 405 mg (as pamoate monohydrate) with diluent Injection Zyprexa Relprevv Eli Lilly Australia Pty Ltd  39 000 233 992

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

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 100 mg Injection Oxaliplatin Link Pharmatel Fresenius Kabi Pty Limited  39 109 383 593

1. Schedule 1, after item dealing with Paracetamol in the form Tablet 500 mg (Febridol)

insert in the columns in the order indicated:

Paracetamol Tablet 500 mg Oral Generic Health Pty Ltd Generic Health Pty Ltd  93 110 617 859

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

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 80 mg Oral Pravastatin Sandoz Sandoz Pty Ltd  60 075 449 553

1. Schedule 1, items dealing with Quinapril in the form Tablet 20 mg (as hydrochloride)

omit from the columns in the order indicated:

Quinapril Tablet 20 mg (as hydrochloride) Oral Quinapril-DP Genepharm Pty Ltd  68 118 734 795

1. Schedule 1, after items dealing with Rivastigmine

insert in the columns in the order indicated:

Rizatriptan Wafer 10 mg (as benzoate) Oral Maxalt Merck Sharp & Dohme (Australia) Pty Ltd  14 000 173 508

1. Schedule 1, item dealing with Sodium Chloride in the form Injection 9 mg per mL, 10 mL

omit from the column headed “Manner of administration”:         Injection       and substitute:         Injection/solvent for injectables

1. Schedule 1, items dealing with Sotalol in the form Tablet containing sotalol hydrochloride 160 mg

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

1. Schedule 1, after items dealing with Triglycerides — medium chain, formula

insert in the columns in the order indicated:

Triglycerides, long chain with glucose polymer	Oral liquid 1 L, 6 (ProZero)	Oral	ProZero	Vitaflo Australia Pty Limited	82 097 161 254
Triglycerides, long chain with glucose polymer	Oral liquid 250 mL, 18 (ProZero)	Oral	ProZero	Vitaflo Australia Pty Limited	82 097 161 254

1. Schedule 1, after item dealing with Ursodeoxycholic Acid

insert in the columns in the order indicated:

Ustekinumab Injection 45 mg in 0.5 mL Injection Stelara Janssen-Cilag Pty Ltd  47 000 129 975