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 210th meeting resolutions, 8-9 June 2000

Australian Drug Evaluation Committee

8 June 2000

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 210th (2000/3) meeting of the Australian Drug Evaluation Committee (ADEC) (8-9 June 2000) resolved to advise the Parliamentary Secretary to the Minister for Health and Aged Care and the Secretary, Department of Health and Aged Care 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.

TAXOL Paclitaxel
Solution for injection, 6 mg/mL in single-dose vials of 30 mg, 100 mg, 150 mg and 300 mg
Bristol Myers Squibb Australia Pty Ltd
Variation: To extend the indications to include the treatment of node-positive breast cancer sequentially to doxorubicin and cyclophosphamide.

TYPHIM VI Purified capsular polysaccharide
Sterile solution for intramuscular injection, 25 mg per 0.5 mL
CSL Limited
Variation: To extend the patient population to include children aged two years and older.

MAXIPIME Cefepime hydrochloride
Sterile powder for parenteral injection, 500 mg
Bristol-Myers Squibb Australia Pty Ltd
Variation: To extend the indications to include surgical prophylaxis in patients undergoing intra-abdominal surgery.

KLIOVANCE Oestradiol hemihydrate and norethisterone acetate
Tablets, 1 mg oestradiol hemihydrate and 0.5 mg norethisterone acetate
Novo Nordisk Pharmaceuticals Pty Ltd
Variation: To extend the indications to include the prevention of post-menopausal bone mineral density loss.

GENOTROPIN MINIQUICK Somatropin (recombinant human growth hormone)
Sterile two-compartment syringe containing, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg or 2 mg Somatropin powder
Pharmacia & Upjohn Pty Limited
Variation: To include a new formulation and presentation for the currently registered indications.

ZYBAN Bupropion hydrochloride
Sustained release tablets, 150 mg
Glaxo Wellcome Australia Ltd
Indication: For short-term adjunctive therapy for the treatment of nicotine dependence in those who are committed to quitting smoking.

Top of page

PROHANCE Gadoteridol
Sterile solution for intravenous injection, 279.3 mg/mL in 5 mL, 10 mL, 15 mL and 20 mL vials and 5 mL, 10 mL, 15 mL and 17 mL syringes
Bracco Pty Ltd
Indication: For use in adults and children aged from two years for enhancement of magnetic resonance imaging (MRI) of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity, and in whole body imaging.

LEVOVIST Galactose/Palmitic acid
Sterile microcrystalline suspension for intravesical administration, containing 999 mg galactose and 1 mg per gram palmitic acid in 2.5 g/20 mL and 4 g/20 mL vials
Schering Pty Limited
Variation: To extend indications to include diagnosis of vesicoureteral reflux (VUR) in children by contrast enhanced voiding urosonography.

TAMIFLU Oseltamivir phosphate
Capsules, 75 mg
Roche Products Pty Limited
Indication: For the treatment of infections due to influenza A and B viruses in adults and children aged twelve years and older.

BOOSTRIX Diphtheria/tetanus/acellular pertussis vaccine
Sterile liquid suspension for intramuscular injection, 2.5 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 8 µg of pertussis toxoid, 8 µg of filamentous haemagglutin and 8 µg of 69 kDa outer membrane protein per 0.5 mL dose
Smithkline Beecham (Australia) Pty Ltd
Variation: A new formulation for booster vaccination against diphtheria, tetanus and pertussis of individuals aged ten years and older.

Top of page

TRAMAL SR Tramadol hydrochloride
Tablets, 100 mg, 150 mg and 200 mg
CSL Limited
Variation: A new strength and new dose form for the relief of moderate to severe pain.

VISUDYNE Verteporfin
Sterile powder for intravenous infusion, 15 mg per vial
CIBA Vision Australia
Indication: For the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularisation.

ZOCOR Simvastatin
Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: Amend the Product Information to include information on the effect of simvastatin on Fredrickson Type IV hyperlipidaemia (hypertriglyceridaemia) and Type III hyperlipidaemia (dysbetalipoproteinaemia).

LIPEX Simvastatin
Tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg
Amrad Pharmaceuticals Pty Ltd
Variation: Amend the Product Information to include information on the effect of simvastatin on Fredrickson Type IV hyperlipidaemia (hypertriglyceridaemia) and Type III hyperlipidaemia (dysbetalipoproteinaemia).

Top of page

HERCEPTIN Trastuzumab
Sterile powder for injection, 150 mg in single dose vials
Roche Products Pty Limited
Indication: For the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2, as a single agent for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease, or in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease.

GLIADEL IMPLANTS Carmustine
Intracerebral implants, 7.7 mg per implant
Rhone-Poulenc Rorer Australia Pty Ltd
Variation: New dose form for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme (GBM) for whom surgical resection is indicated.

BENEFIX Factor IX, recombinant
Sterile powder for intravenous injection, 250 IU, 500 IU and 1000 IU per vial plus diluent
Wyeth Australia Pty Ltd
Indication: For the control and prevention of haemorrhagic episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

MIACALCIC Salcatonin
Nasal spray, 200 IU (40 µg) per actuation
Novartis Pharmaceuticals Australia Pty Ltd
Variation: A new route of administration and new dose form for the treatment of post-menopausal osteoporosis.

CETROTIDE Cetrorelix acetate
Sterile powder for subcutaneous injection, 0.25 mg 1 and 3 mg/vial
Asta Medica Australasia Pty Limited
Indication: For the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation followed by oocyte pick-up and assisted reproductive techniques.

FEMTRAN Oestradiol
Transdermal patches, 25 µg or 75 µg per day for one week
3M Pharmaceutical Pty Ltd
Variation: New strengths for the signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced.

CLIMARA Oestradiol
Transdermal patches, 25 µg or 75 µg per day for one week
Schering Pty Ltd
Variation: New strengths for the signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced.

AZOPT Brinzolamide
Eye drops, 1% in 5 mL and 10 mL drop-tainer dispensers
Alcon Laboratories (Australia) Pty Ltd
Indication: For the treatment of elevated intraocular pressure resulting from ocular hypertension or open-angle glaucoma.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

22 June 2000

Top of page