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ADEC 218th meeting resolutions, 4-5 October 2001

Australian Drug Evaluation Committee

4 October 2001

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 218th (2001/5) meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 October 2001) 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.

CEFUROXIME AXETIL Zinnat
Granules for oral suspension, 125 mg/5 mL and 250 mg/5 mL
Glaxo Wellcome Australia Ltd
Variation: New dose form for the treatment of mild to moderately severe infections caused by sensitive bacteria in paediatric patients aged 3 months to 12 years: tonsillitis and pharyngitis, acute bacterial otitis media.

LAMIVUDINE 3TC
Tablets, 300 mg
Glaxo Wellcome Australia Ltd
Variation: New dosage regimen for the treatment of HIV infection in adults and adolescents aged 12 years and older, in combination with other antiretroviral therapies.

ATOVAQUONE/PROGUANIL HYDROCHLORIDE Malarone
Tablets, atovaquone 250 mg/proguanil hydrochloride 100 mg
Glaxo Wellcome Australia Ltd
Variation: Extension of indications to include prophylaxis of Plasmodium falciparum malaria in individuals weighing >40 kg

HEPATITIS A VIRUS ANTIGEN/ HEPATITIS B RECOMBINANT SURFACE ANTIGEN Twinrix Adult
Sterile solution for injection in monodose vials and pre-filled syringes, 720 Elisa units of Hepatitis A virus antigen and 20 mg of Hepatitis B surface antigen (rys) per 1 mL dose
Smithkline Beecham (Australia) Pty Ltd
Variation: New rapid vaccination schedule for active immunisation against hepatitis A and hepatitis B virus infection.

AZITHROMYCIN DIHYDRATE Zithromax
Powder for oral suspension, 200 mg per 5 mL
Pfizer Pty Limited
Variation: To revise the dose reccommendations for the treatment of acute streptococcal pharyngitis/tonsillitis in children aged 12 months and older.

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DESFERRIOXAMINE MESILATE Desferal
Sterile powder for intravenous injection, 0.5 g and 2 g per vial
Novartis Pharmaceuticals Australia Pty Limited
Variation: New dose regimen for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anaemias.

GOSERELIN ACETATE Zoladex
Implant, 3.6 mg
AstraZeneca Pty Ltd
Variation: Extension of indications to include use as adjuvant therapy in early breast cancer, in pre- and peri-menopausal women suitable for hormone manipulation.

BOTULINUM NEUROTOXIN TYPE A Botox
Sterile powder for intradermal injection, 100 Units/vial
Allergan Australia Pty Ltd
Variation: Extension of indications to include the treatment of severe primary hyperhidrosis of the axillae.

PERITONEAL DIALYSIS SOLUTION Gambrosol Trio
Sterile solution in twin bags (2 L, 2.5 L, 3 L and 5 L) and in single bags (2 L, 2.5 L and 3 L)
Gambro Pty Ltd
Variation: New combination for the treatment of patients with acute or chronic renal failure receiving peritoneal dialysis.

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DINOPROSTONECervidil
Vaginal pessary, 10 mg
F.H. Faulding and Co Ltd
Variation: New dose form and new strength for cervical ripening in patients, at or near term, who have favourable induction features and in whom there is a medical or obstetrical indication for induction of labour.

METHYLPREDNISOLONE ACEPONATE Advantan Lotion
Topical lotion, 20 g and 50 g
CSL Limited
Variation: New dose form for the topical treatment of eczema in children and adults.

ALENDRONATE SODIUM Fosamax
Tablets, 5 mg, 10 mg, 40 mg and 70 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: Revision of Product information.

RABEPRAZOLE SODIUM Pariet
Enteric-coated tablets, 10 mg and 20 mg
Janssen-Cilag Pty Ltd
Variation: Extension of indications to include use, in combination with clarithromycin and amoxycillin, for eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic gastritis, and healing of peptic ulcers in patients with H. pylori associated ulcers.

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LANSOPRAZOLE Zoton/Lanzo
Capsules, 15 mg and 30 mg
Wyeth Australia Pty Limited
Variation: Extension of indications to include relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia.

INTERFERON BETA-1a Rebif
Sterile solution for subcutaneous injection, 22 µg/0.5 mL and 44 µg/0.5 mL
Serono Australia Pty Ltd
Variation: New dosage regimen for the treatment of relapsing-remitting multiple sclerosis.

EPTIFIBATIDE ACETATE Integrilin
Sterile solution for intravenous injection, 20 mg/10 mL and 75 mg/100 mL
Schering-Plough Pty Limited
Variation:Extension of indications to include patients undergoing non-urgent percutaneous coronary intervention (PCI) with intracoronary stenting.

CELECOXIB Celebrex
Capsules, 100 mg and 200 mg
Pharmacia Australia Pty Limited
Variation: Revision of Product Information.

SILDENAFIL CITRATE Viagra
Tablets, 25 mg, 50 mg and 100 mg
Pfizer Pty Limited
Variation: Revision of Product Information.

ROFECOXIBVioxx
Tablets, 12.5 mg and 25 mg and Oral suspension, 12.5 mg/25 mL and 25 mg/25 mL
Merck Sharp & Dohme (Australia) Pty Limited
Variation: Revision of Product information.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

October 2001

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