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ADEC 199th meeting resolutions, 1-2 October 1998

Australian Drug Evaluation Committee

1 October 1998

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 199th (1998/5) Meeting of the Australian Drug Evaluation Committee (ADEC) (1-2 October 1998) resolved to advise the Parliamentary Secretary to the Minister for Health and Family Services, and the Secretary, Department of Health and Family Services, 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.

VALACICLOVIR Valtrex/Valavir tablets 250 mg
GlaxoWellcome Australia Ltd
Indications: For the prevention of recurrent genital herpes in immunocompetent patients at doses 250 mg twice daily or 500 mg once daily for patients with a history of fewer than ten recurrences each year when not taking suppressive therapy and at a dose of 1000 mg once daily for patients with frequent (10 or more) recurrences.

TOPOTECAN Hycamtin powder for injection 4 mg
SmithKline Beecham (Australia) Pty Ltd
Indications: As a single agent therapy for the treatment of small cell lung cancer patients after failure of first line chemotherapy, at a dosage of 1.5 mg/m2/day for 5 days every 21 days.

ATOVAQUONE Wellvone oral suspension 750 mg/5ml
GlaxoWellcome Australia Ltd
Indications: For the treatment of mild to moderate Pneumocystis Carinii pneumonia in adults patients with AIDS who are intolerant of trimethoprim/sulphamethoxazole therapy.

DESONIDE Desowen 0.5% ointment, cream and lotion
Galderma Australia Pty Ltd
Indications: For the relief of inflammatory and pruritic manifestations of corticosteroid sensitive dermatoses, in adults and children aged 2 years and older.

COMBINED DIPHTHERIA/TETANUS/ACELLULAR PERTUSSIS & H INFLUENZAE VACCINE Infanrix-Hib
SmithKline Beecham (Australia) Pty Ltd
Indications: For use as a booster dose at 18 months in children who have had a primary course of immunisation with PRP-Tetanus or PRP-Haemophilus b containing vaccine.

ACELLULAR PERTUSSIS VACCINE Parix
SmithKline Beecham (Australia) Pty Ltd
Indications: For active primary immunisation in children and infants from 2 months of age who have been vaccinated previously against diphtheria and tetanus but not pertussis.

AMOXYCILLIN 400 MG/CLAVULANIC ACID 57 MG PER 5ML Augmentin
Junior Forte
SmithKline Beecham (Australia) Pty Ltd
Indications: For the treatment of:

  • upper respiratory tract infections including sinusitis and otitis media
  • lower respiratory tract infections including acute exacerbations of chronic bronchitis, and community-acquired pneumonia
  • urinary tract infections (complicated and uncomplicated)
  • skin and skin structure infections

ALPROSTADIL Muse single use urethral delivery system 125 mg, 250 mg, 500 mg or 1000 mg
Astra Pharmaceuticals Pty Ltd
Indications: For the treatment of erectile dysfunction.

INDAPAMIDE Natrilix SR modified release tablets 1.5 mg
Servier Laboratories (Australia) Pty Ltd
Indications: For the treatment of mild to moderate hypertension.

GADOBUTROL Gadovist solution for injection 0.5 mmol/mL and 1 mmol/mL
Schering Pty Limited
Indications: For contrast enhancement in cranial and spinal magnetic resonance imaging.

INFLUENZA VACCINE Fluarix injection 45 mg
SmithKline Beecham (Australia) Pty Ltd
Indications: For prophylaxis against influenza in adults and children older than one year of age.

COMBINED MEASLES, MUMPS, RUBELLA VACCINE (LIVE) Priorix
SmithKline Beecham (Australia) Pty Ltd
Indications: For active immunisation against measles, mumps and rubella infections.

DIPYRIDAMOLE Persantin SR capsules 200 mg
Boehringer Ingelheim Pty Limited
Indications: For the secondary prevention of ischaemic stroke and transient ischaemic attacks in conjunction with low-dose aspirin.

DICLOFENAC POTASSIUM Voltaren Rapid tablets 25 mg and 50 mg
Novartis Pharmaceuticals Australia Pty Limited
Indications: For the treatment of acute migraine attacks (with or without aura).

ETHINYLOESTRADIOL 20 m;g/LEVONORGESTREL 100 mg Microlevlen/Microlevlen ED tablets, Microgynon 20/Microgynon 20ED tablets
Schering Pty Limited
Indications: For the prevention of pregnancy.

14C-UREA TEST FOR H PLYORI PYtest capsules/Breath Test
Tri-Med Distributors Pty Ltd
Indications: For use in the detection of gastric urease as an aid in the diagnosis of Helicobacter pylori infection in the human stomach.

EPTACOG ALPHA ACTIVATED (RECOMBINANT FACTOR VIIa) NovoSeven single single use vials activated lyophilised power 60 KIU (1.2 mg), 120 KIU (2.4 mg) and 240 KIU (4.8 mg)
Novo Nordisk Pharmaceuticals Pty Ltd
Indications: For the control of bleeding and surgery prophylaxis in patients with inhibitors to coagulation factors VIII and IX.

RANITIDINE BISMUTH CITRATE Pylorid tablets 400 mg
GlaxoWellcome Australia Ltd
Indications: To include three new treatment regimens

  • pylorid 400 mg bd, clarithromycin 500 mg bd and amoxycillin 1000 mg bd
  • pylorid 400 mg bd, clarithromycin 500 mg bd and metronidazole 400 mg bd
  • pylorid 400 mg bd, clarithromycin 250 mg bd and metronidazole 400 mg bd

for eradication of Helicobacter pylori which involve administration of pylorid in combination with two other agents for seven days.

HUMAN COAGULATION FACTOR IX MonoFix VF concentrate 500 IU per vial
CSL Limited
Indications: For the treatment of Haemorrhages for use in minor surgery and as prophylaxis in patients with haemophilia B.

CLOPIDOGREL HYDROGEN SULFATE Plavix tablets 75 mg and Iscover tablets 75 mg
Sanofi Winthrop Pty Ltd and Bristol-Myers Squibb Australia Pty Ltd
Indications: For the prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

NADROPARIN CALCIUM Fraxiparine Forte injection 19,000 IU/ml
Sanofi Winthrop Pty Ltd
Indications: For the treatment of deep vein thrombosis, given once daily for 10 days with the dose being adjusted for body weight.

ENOXAPARIN SODIUM Clexane injection 20 mg/0.2 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1.0 mL and ampoules 100 mg/1.0mL
Rhône-Poulenc Rorer Australia Pty Ltd
Indications: As a subcutaneous single daily injection of 1.5 mg/kg for the treatment of deep vein thrombosis.

TAZAROTENE Zorac 0.5%, 0.1% Topical Gel
Allergan Australia Pty Ltd
Indications: For the topical treatment of plaque psoriasis and for the topical treatment of acne vulgaris.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

29 October 1998

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