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ADEC 225th meeting resolutions, 5-6 December 2002

Australian Drug Evaluation Committee

5 December 2002

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 225th (2002/6) meeting of the Australian Drug Evaluation Committee (ADEC) (5-6 December 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.

SIMVASTATIN Zocor [Lipex]
Tablets, 5,10, 20, 40 and 80mg
Merck Sharp and Dohme Pty Limited
Variation: Extension of indication to include: Zocor [Lipex] is indicated in patients at high risk of CHD (with or without hypercholesterolaemia) including diabetes mellitus, in order to reduce the risk of cardiovascular death, major cardiovascular events and hospitalisation due to angina pectoris. These effects do not replace the need to control known causes of cardiovascular mortality or morbidity such as hypertension, diabetes and smoking.

VALSARTAN Diovan
Tablets, 40, 80 and 160mg
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Registration of a new 40mg tablet strength and extension of indication to include: for treatment of heart failure (NYHA class II-IV) in patients receiving usual therapy (eg diuretics, digitalis but not β-blockers) who are intolerant of ACE inhibitors."

HYDROMORPHONE HCl Palladone
Controlled release capsules, 12, 16, 24 and 32mg
Mundipharma Pty Limited
NCE: Register the new chemical entity Palladone capsules containing hydromorphone hydrochloride 12, 16, 24 and 32mg, in an extended release formulation, for "the management of opioid responsive chronic pain of moderate to severe intensity in patients who have been titrated to a daily dose of 12mg or more of immediate release hydromorphone or other equivalent opioid."

DEFERRIPRONE Ferriprox
Tablets, 500mg
Orphan Australia Pty Ltd
Variation: Register Ferriprox for the treatment of iron overload in patients with thalassaemia major unable to take desferrioxamine therapy.

MYCOPHENOLATE SODIUM Myfortic
Enteric coated oral tablet, 360mg
Novartis Pharmaceuticals Australia Pty Ltd
NCE: Register Myfortic enteric-coated tablets, containing mycophenolate sodium, 360mg, for the prophylaxis of organ rejection in adult patients receiving allogeneic renal transplants.

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DESMOPRESSIN ACETATE minirin
Tablets, 0.1 and 0.2mg
Ferring Pharmaceuticals Pty Ltd
Variation: register Minirin tablets containing 0.1mg or 0.2mg of desmopressin acetate for the treatment of cranial diabetes insipidus and treatment of primary nocturnal enuresis, in patients from 6 years of age, with normal ability to concentrate urine, who are refractory to an enuresis alarm, or in whom an enuresis alarm is contraindicated or inappropriate.

LUTROPIN ALFA (rch) Luveris 75 IU
Powder for injection containing 75IU of r-hLH
Indication: register Luveris powder for injection for the stimulation of follicular development in women with severe luteinising hormone (LH) and follicular stimulating hormone (FSH) deficiency. [Severe luteinising hormone deficiency is defined by a LH level less than 1.2IU/L]. The starting dose recommended is 37.5IU.

LATANOPROST Xalatan Eye Drops
Latanoprost Opthalmic Solution 50µg/mL or 2.5mL
Pharmacia Australia Pty Ltd
Variation: to extend the registered indications of Xalatan Eye Drops to include: "Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension."

OLANZAPINE Zyprexa IM
Powder for injection vials and combination pack with pre-filled syringe, 10mg
Eli Lilly Australia Pty Ltd
Variation: to extend the registered indications of Zyprexa IM to include "the rapid control of agitation and disturbed behaviours in patients with dementia, when other therapies are not appropriate."

VARICELLA VIRUS VACCINE LIVE (OKA/MERCK) Varivax [Refrigerated]
Lyophilised powder for injection, minimum potency 1350 plaque forming units (PFU) per 0.5mL
Merck Sharp and Dohme (Australia) Pty Limited
Variation: to register the reformulation and the increased potency release limits for Varicella virus vaccine live (Oka/Merck) - VARIVAX [Refrigerated] as indicated for vaccination against varicella in healthy individuals 12 months of age to 12 years of age. Two 0.5 ml doses are recommended for adolescents and adults 13 years of age and older.

ATOVAQUONE/PROGUANIL Malarone paediatric™
Tablets, atovaquone 62.5mg / proquanil hydrochloride 25mg
GlaxoSmithKline Australia Pty Ltd
Variation: extend the registered indications of Malarone Paediatric tablets to include prophylaxis of Plasmodium falciparum malaria in children greater than or equal to 11 kg.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

18 December 2002

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