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ADEC 229th meeting resolutions, 7-8 August 2003

Australian Drug Evaluation Committee

7 August 2003

Published in the Commowealth of Australia Gazette, No. GN 35, 3 September 2003





The 229th (2003/4) meeting of the Australian Drug Evaluation Committee (ADEC) (7-8 August 2003) 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.

Thalidomide - Thalidomide Pharmion
Hard Capsules, 50mg
Pharmion - Pharmion Pty Ltd
New Chemical Entity: Thalidomide is indicated as maintenance therapy for prevention and suppression of cutaneous manifestations of erythema nodosum leprossum (ENL) recurrence. Treatment of multiple myeloma after failure of standard therapies.

Valcyte - Valganciclovir
Tablets, 450mg
Roche Products Pty Limited
Variation: For the treatment of prophylaxis of CMV infection and disease following solid organ transplantation in patients at risk of CMV disease. For post-transplant patients at risk of CMV disease, the recommended dose is 900mg (two 450mg tablets) once daily with food, starting within 10 days of transplantation until 100 days post transplantation.

Enfuvirtide - Fuzeon
Powder for injection. Vials, supplied with or without diluent, 90mg/mL
Roche Products Pty Limited
Variation: Enfuvirtide is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral experienced patients with treatment failure due to resistant virus.

Amphotericin B - AmBisome
Powder for injection Vials, 50mg
Gilead Sciences Pty Ltd
Variation: Ambisome is indicated for empiric treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment.

Vibrio cholera - Dukoral®
Oral suspension, 3mL Vial
Aventis Pasteur Pty Limited
New Chemical Entity: For the treatment of Cholera caused by serogroup O1 Vibrio cholerae: Active immunisation of adults and children from two years of age who will be visiting areas epidemic or endemic for cholera who are at high risk of infection.

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Adefovir dipivoxil - Hepsera™
Tablet, 10 mg
Gilead Sciences Pty Ltd
New Chemical Entity: For the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Metoprolol succinate - TOPROL-XL
Controlled release tablets, 23.75mg, 47.5mg 95mg and 190mg
AstraZeneca Pty Ltd
Variation: For the treatment of stable, chronic heart failure as an adjunct to other heart failure therapy.

Losartan potassium - Cozaar
Tablets, 25mg and 50mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: Cozaar is indicated for delaying the progression of renal disease in hypertensive type II diabetics with proteinuria, defined as macroalbuminuria.

Etoricoxib - Arcoxia
Tablets, 60mg, 90mg and 120mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: For the symptomatic treatment of rheumatoid arthritis, at a dose of 90mg daily.

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Ropivacaine HCl - Naropin 0.2%
Injection solution: ampoule and bag, 0.2% 20mg/10mL and 40mg/20mL, 0.2% 200mg/100mL and 400mg/200mL
AstraZeneca Pty Ltd
Variation: For the treatment of Continuous Peripheral Nerve Block infusion or intermittent injections for post-operative pain management.

Ropivacaine HCl - Naropin 0.5%
Injection solution: 0.5% 50mg/10mL.
AstraZeneca Pty Ltd
Variation: Intrathecal anaesthesia.

Imatinib mesylate - Glivec
Capsules, 50mg and 100mg
Novartis Pharmaceuticals Australia Pty Ltd
Variation: To include the treatment of children with chronic myeloid leukaemia.

Methylphenidate hydrochloride - Concerta
Tablets, 18mg, 36mg and 54mg
Janssen-Cilag Pty Ltd
Variation: For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6-18 years.

Botulinum Toxin - Type A - Botox
Injection, 100 U
Allergan Australia Pty Ltd
Variation: For the treatment of focal spasticity in adults.

Lamotrigine - Lamictal® and 3 new names (Bipolam®, Elmendos®, Lamapol®)
Tablets, 25mg, 50mg, 100mg and 200mg
GlaxoSmithKline Australia Pty Ltd
Variation: For the prevention of depressive episodes in patients with bipolar disorder.

Escitalopram oxalate - Lexapro
Tablets, 5, 10, 15 and 20mg
Lundbeck Australia Pty Ltd
New Chemical Entity: For the treatment of major depression.

Professor Martin Tattersall
Australian Drug Evaluation Committee
21 August 2003

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