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ADEC 222nd meeting resolutions, 6-7 June 2002

Australian Drug Evaluation Committee

6 June 2002

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 222nd (2002/3) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 June 2002) 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.

INACTIVATED INFLUENZA VACCINE (SURFACE ANTIGEN) Fluad
Sterile suspension for injection, 15 µg each of inactivated influenza surface antigens conjugated with MF59C.1 adjuvant pre-filled single dose syringe.
Delpharm Consultants Pty Limited
Indication: For active immunisation against influenza in the elderly (>= 65 years of age), especially for those with an increased risk of associated complications (ie. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

ARTEMETHER and LUMEFANTRINE Riamet
Scored tablets, 20 mg and 120 mg
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For treatment of acute, uncomplicated malaria due to Plasmodium falciparum in patients aged at least 12 years and weighing at least 35 kg.

VORICONAZOLE Vfend
Film-coated tablets, 50 mg and 200 mg and sterile powder for injection, 200 mg/vial
Pfizer Pty Ltd
Indication: For the treatment of the following fungal infections:

  • invasive aspergillosis;
  • serious candida infections;
  • serious fungal infections caused by scedosporium spp and fusarium spp.;
  • serious fungal infections in patients intolerant of, or refractory to, other therapy;
  • prevention of breakthrough fungal infections in high-risk febrile neutropenic patients.

INTERFERON β 1A (RCH) Rebif
Sterile solution for injection, 22 µg/0.5 mL and 44 µg/0.5 mL pre-filled syringes
Serono Australia Pty Ltd
Variation: Extension of indications to include the treatment of ambulatory patients with multiple sclerosis who have experienced two or more relapses within the last 2 years. Rebif therapy should not be initiated in secondary progressive MS patients who no longer experience relapses.

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ALPROSTADIL Caverject Impulse / Alproject DC
Sterile powder for injection, 10 µg (Caverject Impulse 10, Alproject DC 10) and 20 µg (Caverject Impulse 20, Alproject DC 20) with dilutent. Pre-filled disposable dual chamber syringe.
Pharmacia Australia Pty Ltd
Variation: New dosage form and new formulation indicated for the treatment of erectile dysfunction. Intracavernosal alprostadil may be a useful adjunct to other diagnostic tests in the investigation of erectile dysfunction.

FLUVASTATIN SODIUM Lescol XL
Extended release tablets, 80 mg
Novartis Pharmaceuticals Australia Pty Ltd
Variation: New dosage form and formulation as an adjunct to diet for the treatment of hypercholesterolaemia.

CLOPIDOGREL HYDROGEN SULFATE Plavix and Iscover
Film-coated tablets, 75 mg
Bristol-Myers Squibb Australia Pty Ltd (for 'Iscover') and Sanfoi-Synthelabo Australia Pty Ltd (for 'Plavix')
Variation: Extension of indications to include the treatment of acute coronary syndrome (unstable angina or non- ST elevation myocardial infarction) in combination with aspirin in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia).

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VERTEPORFIN Visudyne
Sterile powder for intravenous infusion (prior to illumination of target tissue) 15 mg
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Extension of indications to include the treatment of patients with predominantly classic or occult subfoveal choroidal neovascularisation due to age-related macular degeneration (AMD), or with subfoveal choroidal neovascularisation caused by other macular diseases.

ALFUZOSIN HYDROCHLORIDE Xatral / Xatral SR
Tablets, 2.5 mg immediate release (IR) tablets, 5 mg and 10 mg slow release (SR) tablets
Sanofi-Snythelabo Australia Pty Ltd
Variation: A new slow release formulation for the treatment of the functional symptoms of benign prostatic hyperplasia.

TELMISARTAN and HYDROCHLOROTHIAZIDE Micardis Plus and Pritor Plus
Tablets, 40 mg/ 12.5 mg and 80 mg/ 12.5 mg
Boehringer Ingelheim Pty Ltd
Indication: New fixed combination for treatment of mild to moderate hypertension. Treatment should not be initiated with this fixed dose combination.

IRBESARTAN Avapro and Karvea
Tablets, 75 mg, 150 mg and 300 mg
Bristol-Myers Squibb Australia Pty Ltd (Avapro) and Sanofi-Synthelabo Australia Pty Ltd (Karvea)
Variation: Extension of indications to include delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria or urinary protein in excess of 900 mg per 24 hours. The maintenance dose for this indication should be 300 mg daily. The Product Information should specify that, in addition to the use of irbesartan, blood pressure control is essential and this may require the addition of other agents.

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ZOLEDRONIC ACID Zometa
Sterile powder for solution, intravenous infusion, 4 mg vials
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Extension of indication to include the treatment of patients with multiple myeloma and patients with bone metastases from breast and prostate cancer, in conjunction with standard antineoplastic therapy.

RASBURICASE Fasturtec
Sterile powder for injection, 1.5 mg vials and ampoules
Sanofi-Synthelabo Australia Pty Ltd
Indication: For the treatment and prophylaxis of acute hyperuricaemia, in patients with haematological malignancy at risk of rapid tumour lysis.

PROGESTERONE Crinone
8 % gel, 90 mg per application
Serono Australia Pty Ltd
Variation: A new dosage form indicated for in vitro fertilisation (IVF) and assisted reproductive technology (ART) where luteal phase support is indicated.

OESTRADIOL HEMIHYDRATE Aerodiol
Nasal spray solution in a glass bottle with a metering pump and a nasal applicator, 150 µg
Servier Laboratories (Australia) Pty Ltd
Variation: New route of administration and new dosage form for the treatment of oestrogen deficiency symptoms related to natural or artificial menopause.

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MULTIVITAMINS Cernevit IV
Multivitamin supplement injection present as lyophilised powder with water for reconstitution and subsequent intravenous infusion, 5 mL vials and ampoules
Baxter Healthcare Pty Ltd
Indication: Indicated in adults and children over 11 years requiring multi-vitamin supplementation to correct or prevent vitamin deficiencies by parenteral administration because oral administration in contraindicated, impossible or insufficient. This product does not contain vitamin K1 which may be given separately, if required.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

24 June 2002

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GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 222nd (2002/3) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 June 2002) 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.

BIMATOPROST Lumigan Eye Drops
Eye drops, 0.30 mg/mL
Allergan Australia Pty Ltd
Indication: For the reduction of elevated intraocular pressure or open angle glaucoma as first line therapy or monotherapy or as adjunctive therapy. The dose recommended is one drop once daily.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

9 July 2002

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GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 222nd (2002/3) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 June 2002) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicine should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. This recommendation for approval may be subject to specific conditions.

PERINDOPRIL ERBUMINE 2mg and INDAPAMIDE HEMIHYDRATE 0.625mg Predonium Tablets
Servier Laboratories (Australia) Pty Ltd
A new lower strength fixed-dose combination for the treatment of mild to moderate hypertension. Treatment should not be initiated with this fixed-dose combination.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

8 August 2002

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