You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ADEC 239th meeting resolutions, 31 March - 1 April 2005

Australian Drug Evaluation Committee

31 March 2005

Published in the Commowealth of Australia Gazette, No. GN 16, 27 April 2005

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 239th (2005/2) meeting of the Australian Drug Evaluation Committee (ADEC) (31 March - 1 April 2005) 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.

NELFINAVIR MESYLATE 250mg and 50mg/g
Viracept
Tablets and Oral powder
Roche Products Pty Limited
Change in Dosage Regimen: For use in combination with other antiretroviral drugs for the treatment of HIV/AIDS in adults and adolescents. This indication is based on analyses of surrogate endpoints in studies of up to 48 weeks in adults and a study of pharmacokinetics following multiple daily doses for six weeks in infants and children.

HEPATITIS B SURFACE ANTIGEN RECOMBINANT (YEAST) 10µg/0.5mL and 20µg/mL
Engerix-B
Suspension for injection
GlaxoSmithKline Australia Pty Ltd.
Change in Dosage Regimen & New Dosage Regimen for 20µg/1mL: For active immunisation against hepatitis B virus infection.

SODIUM IODIDE [123I] 1 to 12MBq or 100 to 750MBq at calibration
Ari Sodium Iodide [123I]
Diagnostic Capsule
ANSTO Radiopharmaceuticals and Industrials (ARI)
New Chemical Entity: For diagnostic imaging of thyroid tissue.

EPLERENONE 25mg and 50mg
Inspra
Tablets
Pfizer Australia Pty Ltd.
New Chemical Entity: To reduce the risk of cardiovascular death in combination with standard medical therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction (See Clinical Trials and Dosage and Administration).

Top of page

VINORELBINE (AS TARTRATE) 20mg, 30mg, 40mg and 80mg
NAVELBINE and ONECTYL
Capsules
Pierre Fabre Medicament Australia Pty Limited
New Dose Form and Route of Administration: As first line treatment for advanced non-small cell lung cancer, as a single agent or in combination.

DOCETAXEL 20mg and 80mg
Taxotere
Concentrated Injection
Aventis Pharma Pty Limited
New Indication: The adjuvant treatment of patients with operable node-positive breast cancer, in combination with doxorubicin and cyclophosphamide.

TEMOZOLOMIDE 5mg, 20mg, 100mg and 250mg
Temodal
Capsules
Schering-Plough Pty Ltd.
New Indication: For the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.

STRONTIUM RANELATE 2g
Protos
Powder for oral suspension
Servier Laboratories (Australia) Pty. Ltd.
New Chemical Entity: Treatment of postmenopausal osteoporosis to reduce the risk of fracture.

15 April 2005

Top of page