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ADEC 233rd meeting resolutions, 1-2 April 2004

Australian Drug Evaluation Committee

1 April 2004

Published in the Commowealth of Australia Gazette, No. GN 17, 28 April 2004

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 233rd (2004/2) meeting of the Australian Drug Evaluation Committee (ADEC) (1-2 April 2004) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTIN COMPLEX - Dysport
Powder for Injection, 500 Units
Ipsen Pty Limited (represented by O'Shea & Associates)
New Indication: To include the treatment of blepharospasm in adults and hemifacial spasm in adults aged 18 years or older.

ESOMEPRAZOLE - Nexium
Tablet 20mg
AstraZeneca Pty Ltd
New Indication: To include the short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug (NSAID) therapy.

PAROXETINE HYDROCHLORIDE - Aropax CR & Paroxat CR
Modified Release Tablet 12.5mg & 25mg
GlaxoSmithKline Australia Pty Ltd
New Dose Form: For the treatment of major depressive disorder (MDD) and the treatment of panic disorder.

GALANTAMINE HYDROBROMIDE - Reminyl
Modified Release Capsules 8mg, 16mg, 24mg
Janssen-Cilag Pty Ltd
New Dose Form: For the treatment of mild to moderately severe dementia of the Alzheimer's type.

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DISODIUM GADOXETATE - Primovist
Solution for Injection, 181.43mg/mL
Schering Pty Ltd
New Chemical Entity: For use in adults for the enhancement of magnetic resonance imaging
(MRI) of focal lesions of the liver.

FOSAMPRENAVIR CALCIUM - Telzir
Tablet 700mg
Oral Suspension 50mg/mL
Glaxosmithkline Australia Pty Ltd
New Chemical Entity: Fosamprenavir calcium is indicated in combination with low dose ritonavir, for the treatment of Human Immunodeficiency Virus (HIV) infection in adults in combination with other antiretrovirals.

DICLOFENAC SODIUM - Voltaren
Suppositories, 12.5mg, 25mg and 50mg
Novartis Pharmaceuticals Australia Pty Ltd
New Indication: For the short term (up to three days) treatment of post-operative pain in children.

LUMIRACOXIB - Prexige
Tablets, 200mg and 400mg
Novartis Pharmaceuticals Australia Pty Ltd
New Chemical Entity: For use in:

  • the symptomatic treatment of osteoarthritis
  • the treatment of primary dysmenorrhoea in adults
  • treatment of acute pain (as a once daily dosage of 400mg for a maximum period of 5 days).

GEMCITABINE HYDROCHLORIDE - Gemzar
Powder for injection, 200mg and 1g
Eli Lilly Australia Pty. Limited
New Indication: For the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed after 6 months following platinum based therapy.

INSULIN DETEMIR - Levemir
Solution for injection, 100 U/mL
Novo Nordisk Pharmaceuticals Pty Ltd
New Chemical Entity: For the treatment of Type 1 diabetes mellitus.

KETOTIFEN HYDROGEN FUMARATE - Zaditen
Ophthalmic solution, 250µg/mL
Novartis Pharmaceuticals Pty Ltd
New Chemical Entity: For use in the symptomatic short-term treatment of seasonal allergic conjunctivitis in adults and children 3 years or older.

CARBETOCIN - Duratocin
Injection Solution, 100µg/mL
Ferring Pharmaceuticals Pty Ltd
New Chemical Entity: For the prevention of uterine atony and excessive bleeding in high risk patients following delivery of the infant by elective Caesarean section under epidural or spinal anaesthesia.

Levonorgestrel - MICROVAL
Tablets 30µg
Wyeth Australia Pty Ltd.
New Indication: the removal of the following contraindications:

  • a history of deep vein thrombophlebitis or thromboembolic disorders
  • cerebrovascular or coronary artery disease

to the Precautions section of the Product Information.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee
15 April 2004

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