National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 33 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 33 of 2009

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

I, DIANA MACDONELL, 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 2nd April 2009

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 May 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 Amoxycillin in the form Capsule 250 mg (as trihydrate) (Amoxil)

insert in the columns in the order indicated:

Amoxycillin Capsule 250 mg (as trihydrate) Oral Amoxycillin Ranbaxy Ranbaxy Australia Pty Limited 17 110 871 826

1. Schedule 1, after item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate) (Amoxil)

insert in the columns in the order indicated:

Amoxycillin Capsule 500 mg (as trihydrate) Oral Amoxycillin Ranbaxy Ranbaxy Australia Pty Limited 17 110 871 826

1. Schedule 1, items dealing with Etoposide

(a) omit from the column headed “Form”:

Powder for I.V. infusion containing etoposide phosphate 1.136 g

and substitute:

Powder for I.V. infusion 1 g (as phosphate)

(b) omit from the column headed “Form”:

Powder for I.V. infusion containing etoposide phosphate 113.6 mg

and substitute:

Powder for I.V. infusion 100 mg (as phosphate)

1. Schedule 1, after item dealing with Fluconazole in the form Capsule 100 mg (Ozole)

insert in the columns in the order indicated:

Fluconazole Capsule 200 mg Oral APO-Fluconazole Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Gelatin - Succinylated

insert in the columns in the order indicated:

Gemcitabine Powder for I.V. infusion 1 g (as hydrochloride) Injection DBL Gemcitabine for Injection Hospira Pty Limited 13 107 058 328

1. Schedule 1, after item dealing with Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride) (Gemzar)

insert in the columns in the order indicated:

Gemcitabine	Powder for I.V. infusion 2 g (as hydrochloride)	Injection	DBL Gemcitabine for Injection	Hospira Pty Limited	13 107 058 328
Gemcitabine	Powder for I.V. infusion 200 mg (as hydrochloride)	Injection	DBL Gemcitabine for Injection	Hospira Pty Limited	13 107 058 328

1. Schedule 1, after item dealing with Hydromorphone in the form Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL

insert in the columns in the order indicated:

Hydromorphone	Tablet (modified release) containing hydromorphone hydrochloride 16 mg	Oral	Jurnista	Janssen-Cilag Pty Ltd	47 000 129 975
Hydromorphone	Tablet (modified release) containing hydromorphone hydrochloride 32 mg	Oral	Jurnista	Janssen-Cilag Pty Ltd	47 000 129 975
Hydromorphone	Tablet (modified release) containing hydromorphone hydrochloride 64 mg	Oral	Jurnista	Janssen-Cilag Pty Ltd	47 000 129 975
Hydromorphone	Tablet (modified release) containing hydromorphone hydrochloride 8 mg	Oral	Jurnista	Janssen-Cilag Pty Ltd	47 000 129 975

1. Schedule 1, item dealing with Imipramine in the form Tablet containing imipramine hydrochloride 10 mg (Tofranil 10)

omit from the columns in the order indicated:

Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

1. Schedule 1, item dealing with Imipramine in the form Tablet containing imipramine hydrochloride 25 mg (Tofranil 25)

omit from the columns in the order indicated:

Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

1. Schedule 1, after item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Sandoz)

insert in the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL Injection Camptosar Pfizer Australia Pty Ltd 50 008 422 348

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

insert in the columns in the order indicated:

Lamotrigine Tablet 100 mg Oral Lamotrust 100 Meditech Int. Pty Ltd 17 069 879 465

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

insert in the columns in the order indicated:

Lamotrigine Tablet 200 mg Oral Lamotrust 200 Meditech Int. Pty Ltd 17 069 879 465

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

insert in the columns in the order indicated:

Lamotrigine Tablet 25 mg Oral Lamotrust 25 Meditech Int. Pty Ltd 17 069 879 465

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

insert in the columns in the order indicated:

Lamotrigine Tablet 50 mg Oral Lamotrust 50 Meditech Int. Pty Ltd 17 069 879 465

1. Schedule 1, after items dealing with Lansoprazole

insert in the columns in the order indicated:

Lanthanum	Tablet, chewable, 1000 mg (as carbonate hydrate)	Oral	Fosrenol	Shire Australia Pty Limited	29 128 941 819
Lanthanum	Tablet, chewable, 500 mg (as carbonate hydrate)	Oral	Fosrenol	Shire Australia Pty Limited	29 128 941 819
Lanthanum	Tablet, chewable, 750 mg (as carbonate hydrate)	Oral	Fosrenol	Shire Australia Pty Limited	29 128 941 819

1. Schedule 1, after item dealing with Ondansetron in the form Syrup
   4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

insert in the columns in the order indicated:

Ondansetron Tablet 4 mg (as hydrochloride dihydrate) Oral APO-Ondansetron Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Ondansetron in the form Tablet
   4 mg (as hydrochloride dihydrate) (Zofran)

insert in the columns in the order indicated:

Ondansetron Tablet 8 mg (as hydrochloride dihydrate) Oral APO-Ondansetron Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after items dealing with Paclitaxel

insert in the columns in the order indicated:

Paclitaxel, nanoparticle albumin-bound Powder for I.V. injection containing 100 mg paclitaxel Injection Abraxane Specialised Therapeutics Australia Pty Ltd 73 124 031 241

1. Schedule 1, after item dealing with Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity

insert in the columns in the order indicated:

Pancreatic Extract Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity Oral Creon 40,000 Solvay Biosciences Pty Ltd 41 007 401 201

1. Schedule 1, items dealing with Piroxicam

omit from the columns in the order indicated:

Piroxicam Dispersible tablet
10 mg Oral Feldene-D Pfizer Australia Pty Ltd 50 008 422 348

1. Schedule 1, after items dealing with Silver Sulfadiazine with Chlorhexidine

insert in the columns in the order indicated:

Simvastatin Tablet 10 mg Oral APO-Simvastatin Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Simvastatin Tablet 20 mg Oral APO-Simvastatin Apotex Pty Ltd 52 096 916 148

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

insert in the columns in the order indicated:

Simvastatin Tablet 40 mg Oral APO-Simvastatin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Simvastatin in the form Tablet
   5 mg (Zocor)

insert in the columns in the order indicated:

Simvastatin Tablet 80 mg Oral APO-Simvastatin Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Sodium Lactate Compound

insert in the columns in the order indicated:

Sodium Lactate Compound I.V. infusion containing approximately
65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride),
0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL Injection B. Braun Australia Pty Ltd B. Braun Australia Pty Ltd 56 002 945 155

1. Schedule 1, after items dealing with Sumatriptan

insert in the columns in the order indicated:

Sunitinib	Capsule 12.5 mg (as malate)	Oral	Sutent	Pfizer Australia Pty Ltd	50 008 422 348
Sunitinib	Capsule 25 mg (as malate)	Oral	Sutent	Pfizer Australia Pty Ltd	50 008 422 348
Sunitinib	Capsule 50 mg (as malate)	Oral	Sutent	Pfizer Australia Pty Ltd	50 008 422 348

1. Schedule 1, after items dealing with Terbutaline

insert in the columns in the order indicated:

Teriparatide Injection 250 micrograms per mL,
3 mL in multi-dose pre-filled pen Injection Forteo Eli Lilly Australia Pty Ltd 39 000 233 992

1. Schedule 1, omit items dealing with Zonisamide