Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Aerius
Active Ingredient: Desloratadine 0.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Pty Limited, Baulkham Hills, New South Wales, Australia
Product: Arixtra
Active Ingredient: Fondaparinux sodium 5mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer: Sanofi Winthrop Industrie, Notre Dame de Bondeville, France
Product: Claramax
Active Ingredient: Desloratadine 0.5mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer: Schering-Plough Pty Limited, Baulkham Hills, New South Wales, Australia
Product: Clean & Clear Continuous Control Daily Cleanser
Active Ingredient: Benzoyl peroxide 5%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Johnson & Johnson Pacific New Zealand
Manufacturer: CCL Custom Manufacturing, Etobicoke, Ontario, Canada
Product: Rescula
Active Ingredient: Unoprostone isopropyl 1.5mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Ciba Vision Canada Inc - Sterile Manufacturing, Mississauga, Ontario, Canada
Product: Viaderm KC
Active Ingredients: Gramicidin 0.25mg/g
Neomycin sulphate 2.5mg/g
Nystatin 100,000U/g
Triamcinolone acetonide 1mg/g
Dosage Form: Topical cream
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Taro Pharmaceuticals Inc., Bramelea, Ontario, Canada
Product: Viaderm KC
Active Ingredients: Gramicidin 0.25mg/g
Neomycin sulphate 2.5mg/g
Nystatin 100,000U/g
Triamcinolone acetonide 1mg/g
Dosage Form: Topical ointment
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Taro Pharmaceuticals Inc., Bramelea, Ontario, Canada
Product: Xyzal
Active Ingredient: Levocetirizine dihydrochloride 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturers: UCB Farchim SA, Chemin de Croix-Blanche, Bulle, Switzerland
UCB S.A., Chemin du Foriest, Braine-l'Alleud, Brussels, Belgium
Dated this 10th day of May 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).