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ADEC 216th meeting resolutions, 7-8 June 2001

Australian Drug Evaluation Committee

7 June 2001

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 216th (2001/3) meeting of the Australian Drug Evaluation Committee (ADEC) (7-8 June 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.

UNOPROSTONE ISOPROPYL Rescula
Eye drops, 1.5 mg/mL
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication.

CALCIPOTRIOL Daivonex
Ointment, 50 µg/g
CSL Limited
Indication: To register a once-daily dosage regimen and to extend the indications to include

  • use in children for "the topical treatment of chronic stable plaque type psoriasis vulgaris" and
  • "In adult patients, Daivonex ointment may also be used in combination with either phototherapy, or systemic acitretin or cyclosporin".

LATANOPROST / TIMOLOL MALEATE Xalacom
Eye drops, latanoprost 50 µg/mL and timolol maleate 5 mg/mL
Pharmacia Australia Pty Limited
Variation: For the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. Xalacom should not be used to initiate therapy.

GLIMEPIRIDE Amaryl
Uncoated tablets, 3 mg
Aventis Pharma Pty Limited
Variation: New strength for use as an adjunct to diet, exercise and weight loss to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type II).

LAURETH-9 Aethoxysklerol
Sterile solution for intravenous injection, 0.5%, 1%, 2% and 3% in 2 mL ampoules
Omnicare Clinical Research
Indication: For the treatment of varicose veins (up to 6 mm in diameter) of the lower limbs by compression sclerotherapy.

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VERTEPORFIN Visudyne
Sterile powder for reconstitution for intravenous infusion, 15 mg
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Extension of indications to include the treatment of subfoveal choroidal neovascularisation due to macular diseases other than age-related macular degeneration.

DEXMEDETOMIDINE HYDROCHLORIDE Precedex
Sterile concentrate for intravenous infusion, 100 µg/ mL in 2 mL ampoules
Abbott Australasia Pty Ltd
Indication: Indicated for the sedation of initially intubated post-surgical patients during treatment in an intensive care setting. The use of Precedex by continuous infusion in these patients should not exceed 24 hours.

PAROXETINE MESILATE Arrox
Tablets, 20 mg
Synthon AU Pty Ltd
Indication: For the treatment of symptoms and prevention of relapse of major depression, obsessive compulsive disorder, panic disorder (with or without agoraphobia), and treatment of symptoms of social anxiety/social phobia.

SERTRALINE HYDROCHLORIDE Zoloft
Film-coated tablets, 50 mg, 100 mg, 200 mg
Pfizer Pty Limited
Variation: Extension of indications to include for the treatment of children and adolescents with obsessive compulsive disorder (OCD).

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INTERFERON BETA-1A Avonex
Sterile powder for reconstitution for intramuscular injection, 30 µg
CSL Limited
Variation: Extension of indications for use in patients who have experienced a single demyelinating event and are at risk of developing clinically definite multiple sclerosis based on the presence of MS-characteristic brain MRI abnormalities characteristic of MS.

FERUCARBOTRAN Resovist
Sterile solution for intravenous injection, 0.5 mmol iron/mL in vials and prefilled syringes
Schering Pty Ltd
Indication: For use as a contrast agent for hepatic magnetic resonance imaging (MRI).

MENINGOCOCCCAL OLIGOSACCHARIDE, GROUP C/DIPHTHERIA CRM197 PROTEIN Meningitec
Sterile suspension for intramuscular injection, 0.5 mL, meningococcal group C conjugated to diphtheria CRM197 protein 15 µg
Wyeth Australia Pty Limited
Indication: For the active immunisation of children from six weeks of age, adolescents and adults for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.

CASPOFUNGIN ACETATE Cancidas
Sterile powder for reconstitution for intravenous injection, 50 mg and 70 mg
Merck Sharp & Dohme (Australia) Pty Limited
Indication: For the treatment of invasive aspergillosis in patients refractory to, or intolerant of other approved therapies.

ZANAMIVIR Relenza Rotadisk
Dry powder for oral inhalation, 5 mg insufflation per blister
Glaxo Wellcome Australia Ltd
Variation: Amend the Product Information to remove from 'Precautions' statements regarding use in mild to moderate asthma and chronic obstructive pulmonary disease.

DOXORUBICIN HYDROCHLORIDE, PEGYLATED LIPOSOMAL Caelyx
Sterile concentrated suspension for intravenous injection, 2 mg/mL in 10 mL and 25 mL vials
Schering-Plough Pty Ltd
Variation: New dosage form and extension of indications to include the treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.

BASILIXIMAB Simulect
Sterile powder for reconstitution for intravenous injection, 20 mg
Novartis Pharmaceuticals Australia Pty Ltd
Variation: New paediatric dosage regimen for the prophylaxis of acute organ rejection in renal transplantation. To amend the Product Information to include data on the use of basiliximab with triple therapy immunosuppressive regimens in patients undergoing renal transplant.

FILGRASTIM Neupogen
Sterile solution for intravenous or subcutaneous injection 300 µg/mL and 400 µg/1.6 mL in vials, 300 µg/0.5 mL and 400 µg/0.5 mL in prefilled syringes
Amgen Australia Pty Ltd
Variation: Extension of indications to include use in patients with myeloid malignancy following myeloablative chemotherapy and bone marrow transplantation, with a recommended maximum dose of 5µg/kg/day.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

June 2001

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