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 224th meeting resolutions, 3-4 October 2002

Australian Drug Evaluation Committee

3 October 2002

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 224th (2002/5) meeting of the Australian Drug Evaluation Committee (ADEC) (3-4 October 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.

DARBEPOETIN ALFA Aranesp
Solution for injection, 10-500 µg pre-filled syringes, 15-100 µg vials
Amgen Australia Pty Ltd
Variation: Extension of indications to include the prevention and treatment of anaemia in patients with non-myeloid malignancies where anaemia is anticipated to develop or develops as a result of concomitantly administered chemotherapy. Aranesp is indicated to decrease the need for red blood cell transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months.

MONTELUKAST SODIUM Singulair
Granule formulation, 4 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: New dosage form for the prophylaxis and treatment of chronic asthma in adults and children aged two years and over.

ICODEXTRAN Extraneal 7.5 % Peritoneal dialysis solution
Peritoneal dialysis solution 1.5, 2.0, 2.5 and 3 L bags
Baxter Healthcare Pty Limited
Indication: For use as an alternative osmotic agent in dialysis solutions for the long dwell exchange in patients treated with peritoneal dialysis.

RISEDRONATE SODIUM Actonel
Tablets, 35 mg
Aventis Pharma Pty Limited
Variation: Once weekly dosage regimen of 35 mg for the treatment of osteoporosis including post-menopausal osteoporosis, glucocorticoid-induced osteoporosis and preservation of bone mineral density in patients on long-term corticosteroid therapy.

CYPROTERONE ACETATE/ ETHINYLOESTRADIOL Estelle-35 ED
Tablets, 2 mg cyproterone acetate / 35 µg ethinyloestradiol
Douglas Pharmaceuticals Australia Ltd
Indication: As a generic equivalent to Diane-35 tablets.

Top of page

CHORIOGONADOTROPIN ALFA Ovidrel
Vial containing 250 µg choriogonadotropin alfa, plus diluent vial with water
Serono Australia Pty Ltd
Indication: For the treatment of:

  • Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovidrel is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth.
  • Anovulatory or oligo-ovulatory women: Ovidrel is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.

BOSENTAN Tracleer
Tablets, 62.5 mg and 125 mg
Actelion Pharmaceuticals Australia Pty Ltd
Indication: For the treatment of primary pulmonary hypertension or pulmonary hypertension associated with scleroderma, in adults with WHO Class III or IV symptoms.

DUTASTERIDE Avolve
Capsules, 500 µg
GlaxoSmithKline Australia Pty Ltd
Indication: For the treatment of patients with symptomatic benign prostatic hypertrophy (BPH) with an enlarged prostate.

Top of page

FENTANYL CITRATE Actiq
Oral mucosal lozenge/ applicator 200, 400, 600, 800, 1200, 1600 µg
Orphan Australia Pty Ltd
Variation: A new dosage form for the management of breakthrough cancer pain in patients who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.

GADOBUTROL Gadovist
Solution for injection, 1.0 M
Schering Pty Limited
Variation: An extension of indications to include use in contrast enhancement in magnetic resonance angiography (CE-MRA).

ARCITUMOMAB CEA-Scan
Kit for the preparation of 99MTc-arcitumomab, 1.25 mg powder for injection per vial
Australian Radioisotopes (ANSTO)
Indication: Indicated only in patients with histologically proven carcinoma of the colon or rectum for imaging of recurrence and/or metastases.

EFAVIRENZ Stocrin
Oral solution, 30 mg/ mL
Merck Sharp & Dohme (Australia) Pty Limited
Variation: A new dosage form for use in combination with other antiviral agents for the treatment of HIV-1 infection in adults and children.

Top of page

TELITHROMYCIN Ketek
Tablets, 400 mg
Aventis Pharma Pty Limited
Indication: For the treatment in patients 18 years and older of community acquired pneumonia and for the treatment of acute exacerbations of chronic bronchitis, where there is demonstrated resistance to penicillins and/or macrolides in the pathogen-causing infection, or treatment failure after use of a first-line agent.

AZITHROMYCIN DIHYDRATE Zithromax IV
Powder for injection, 500 mg
Pfizer Pty Limited
Variation: Extension of indications to include the treatment of community acquired pneumonia (CAP) caused by susceptible organisms in patients who require initial intravenous therapy.

CIPROFLAXIN Ciproxin & Ciprobay, Ciproxin IV
Tablets, 250, 500 750 mg; and Injection, 100 mg/ 50 mL, 200 mg/ 100 mL
Variation: Extension of indications to include the treatment of inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

REMIFENTANIL HYDROCHLORIDE Ultiva
Powder for injection, 1, 2 or 5 mg
GlaxoSmithKline Australia Pty Ltd
Variation: Extension of indications to include for the provision of analgesia and sedation in mechanically ventilated intensive care patients.

PHYENYTOIN Dilantin Paediatric Suspension
Paediatric suspension, 30 mg/ 5 mL
Pfizer Pty Limited
Variation: A new formulation for the treatment of grand mal and psychomotor seizures.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

October 2002

Top of page