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ADEC 200th meeting resolutions, 3-4 December 1998

Australian Drug Evaluation Committee

3 December 1998

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 200th (1998/6) Meeting of the Australian Drug Evaluation Committee (ADEC) (3-4 December 1998) 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 drugs 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.

REVIA Naltrexone hydrochloride tablets 50 mg
Orphan Australia Pty Ltd
Indications: For use within a comprehensive treatment program in the management of alcohol abuse and as an aid in the maintenance of previously opiate-dependent patients who have ceased the use of opioids such as heroin and morphine.

RAXAR Grepafloxacin hydrochloride sesquihydrate tablets 400 mg and 600 mg
Glaxo Wellcome Pty Ltd
Indications: For the treatment of infections caused by susceptible strains of bacteria in the following diseases:

  • Community-acquired pneumonia
  • Acute exacerbations of chronic bronchitis
  • Urethritis and cervicitis caused by chlamydia trachomatis
  • Uncomplicated gonorrhoea

ACEL-IMUNE 25 Diphtheria and tetanus toxoids, acellular pertussis vaccine
Wyeth Australia Pty Ltd
Indications: For primary immunisation of children 2 months of age up to 7 years for protection against diphtheria, tetanus and pertussis.

ENGERIX B Hepatitis B surface antigen recombinant vaccine
SmithKline Beecham (Australia) Pty Ltd
Indications: For immunisation against hepatitis B.

ZOLADEX Goserelin acetate sterile implant 3.6 mg
Zeneca Pharmaceuticals Pty Limited
Indications: Assisted reproduction and pituitary down-regulation in preparation for controlled ovarian hyperstimulation.

SOMAC/PROTAN & SOMAC-MA PACK Pantoprazole tablets 40 mg
Pharmacia & Upjohn Pty Limited
Indications: To extend the approved indications to include the eradication of Helicobacter pylori for treatment with pantoprazole and clarithromycin and amoxycillin; or clarithromycin and metronidazole; or amoxycillin and metronidazole.

MAXALT Rizatriptan benzoate tablets/wafers 5 mg or 10 mg
Merck Sharp & Dohme Pty Ltd
Indications: For the acute treatment of migraine attacks with or without aura.

ONCO TICE BCG TICE strain powder for injection, 5 X 108 CFU per ampoule
IBAH Pty Ltd
Indications: For the treatment of primary or recurrent carcinoma-in-situ of the urinary bladder; and for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder after transurethral resection.

COMBIVENT METERED AEROSOL Ipratropium bromide aerosol 21 µG/salbutamol sulfate 120 mg
Boehringer Ingelheim Pty Limited
Indications: For the treatment of bronchospasm associated with chronic obstructive pulmonary disease in patients currently established on both ipratropium bromide and salbutamol.

COMBIVENT UNIT DOSE Ipratropium bromide 0.52 mg and salbutamol sulfate 3.01 mg
Boehringer Ingelheim Pty Limited
Indications: For the treatment of bronchospasm associated with chronic obstructive pulmonary disease in patients currently established on both ipratropium bromide and salbutamol.

ZOCOR/LIPEX Simvastatin tablets 80 mg
Merck Sharp & Dohme Pty Ltd (Zocor) and Amrad Pharmaceuticals Pty Ltd (Lipex)
Indications: For the treatment of primary hypercholesterolaemia.

TIMOPTOL-XE Timolol maleate solution for eye drops
Merck Sharp & Dohme Pty Limited
Indications: For the reduction of elevated intraocular pressure in persons with ocular hypertension, chronic open-angle glaucoma, aphakia and glaucoma.

PROSCAR Finasteride tablets 5 mg
Merck Sharp & Dohme Pty Ltd
Indications: For the treatment of symptomatic benign prostatic hyperplasia with an enlarged prostate.

INTAL FORTE CFC-FREE Sodium cromoglycate inhaler
Rhone-Poulenc Rorer Pty Ltd
Indications: For the prophylactic treatment of bronchial asthma, including the prevention of exercise-induced bronchospasm.

SIMULECT Basiliximab powder for injection 20 mg
Novartis Pharmaceuticals Pty Ltd
Indications: For the prophylaxis of acute organ rejection in renal transplantation.

SIFROL Pramipexole tablets
Boehringer Ingelheim Pty Ltd
Indications: For the treatment of signs and symptoms of idiopathic Parkinson's disease in advanced states of the disease (in combination with levodopa).

The ADEC also made the following safety recommendation:

RESOLUTION NO 7553

THE AUSTRALIAN DRUG EVALUATION COMMITTEE HAS CONSIDERED THE AVAILABLE INFORMATION ON ADVERSE HEPATIC EVENTS RELATED TO THE USE OF TOLCAPONE - (TRADE NAME - TASMAR) SPONSORED BY ROCHE PRODUCTS PTY LTD. TOLCAPONE IS ASSOCIATED WITH SERIOUS, UNPREDICTABLE AND POSSIBLY FATAL HEPATIC TOXICITY. THE COMMITTEE CONSIDERED THAT THE RISK BENEFIT RATIO IS SO UNFAVOURABLE THAT TOLCAPONE SHOULD BE DEREGISTERED. IT IS NOT POSSIBLE TO RESTRICT THE INDICATIONS ADEQUATELY TO PERMIT CONTINUED SAFE USE.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

21 January 1999

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