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ADEC 236th meeting resolutions, 7-8 October 2004

Australian Drug Evaluation Committee

7 August 2004

Published in the Commonwealth of Australia Gazette No. GN 45, 10 November 2004

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 236th(2004/5) meeting of the Australian Drug Evaluation Committee (ADEC) (7-8 October 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.

OXALIPLATIN 50mg and 100 mg
Eloxatin
Powder for Injection
Sanofi-Synthelabo Australia Pty Limited
New Indication: Adjuvant treatment, in combination with 5-fluorouracil and folinic acid, of stage III (Duke;s C) colon cancer after complete resection of primary tumour.

CARMUSTINE 7.7mg
Gliadel
Intracerebral implant
Orphan Australia Pty Ltd
New Indication: The treatment of newly-diagnosed high-grade malignant glioma patients, as an adjunct to surgery and radiation.

TESTOSTERONE 1% w/w
Testogel, Androgel
Gel
Schering Pty Limited
New Chemical Entity: For testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

MIRTAZAPINE 30mg
AVANZA, AVANZA SOLTAB And MIRTAZON
Film-coated Tablets
British Pharmaceutical (a trading name of Organon Australia)
New Indication: Relapse prevention of major depression.

RABEPRAZOLE SODIUM 10mg, 20mg
Pariet
Tablets
Janssen-Cilag Pty Ltd
New Indication: Symptomatic treatment of gastro-oesophageal reflux disease.

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EMTRICITABINE 200mg
Emtriva
Capsule
Gilead Sciences Pty Ltd
New Chemical Entity: For the treatment of HIV-1 infected adults, in combination with other antiretrovirals agents. Evidence to support this claim is based on surrogate endpoints (plasma HIV RNA and CD4 count) in naïve populations and in antiretroviral experienced individuals with virological suppression.

HEPATITIS A VACCINE, INACTIVATED 25 Units/0.5mL
VAQTA
Suspension for injection
Merck Sharp & Dohme (Australia) Pty Ltd
Change in Patient Group: To include active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 12 months of age and older.

FLUMAZENIL 0.5mg/0.5mL
Anexate
Solution for Injection
Roche Products Pty Limited
Change in Patient Group: To include children greater than one year of age.

PRAVASTATIN 40mg and ASPIRIN 81mg
Pravigard
Tablets
Bristol-Myers Squibb Australia Pty Ltd
New fixed combination: For the prevention of cardiovascular events including coronary heart disease (CHD) death, recurrent myocardial infarction (MI) or ischaemic stroke in patients who have had a myocardial infarction or who have unstable angina pectoris. Pravigard is not indicated for the treatment of hypercholesterolaemia in patients without a history of cardiovascular disease.

TOLTERODINE TARTRATE 1mg and 2mg
Detrusitol
Tablets
Pfizer Australia Pty Ltd
New Chemical Entity: For the treatment of patients with overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms.

EZETIMIBE 10mg and SIMVASTATIN 10mg, 20mg, 40mg or 80mg
Vytorin
Merck Sharp & Dohme (Australia) Pty Limited
Tablets
New fixed combination: Indicated for the following:

  • Primary hypercholesterolaemia: Vytorin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia. Treatment should not be initiated with Vytorin
  • Homozygous Familial Hypercholesterolaemia (HoFH): Vytorin is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg, LDL apheresis). Treatment should not be initiated with Vytorin

27 October 2004

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