Notice Title

Consent to the distribution of changed medicines - aropax

Consent to the Distribution of Changed Medicines Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto: Schedule Product: Aropax Active Ingredient(s): Paroxetine hydrochloride 24.9mg equiv to 20mg Paroxetine Dosage Form: Film coated tablet New Zealand Sponsor: SmithKline Beecham (NZ) Limited Manufacturer(s): Les Laboratories Beecham, Mayenne, France SmithKline Beecham Pharmaceuticals Limited, Magpie Wood, Manor Royal, Crawley, Sussex, England Product: Foradil Active Ingredient(s): Eformoterol fumarate 12µg Dosage Form: Powder filled inhalation capsule New Zealand Sponsor: Novartis New Zealand Limited Manufacturer(s): Novartis Pharma Stein AG/SA, Stein, Switzerland Novartis Pharmaceuticals UK Limited, Horsham, West Sussex, United Kingdom Product: Fosamax Active Ingredient(s): Alendronate sodium 13.05mg equivalent to 10mg Alendronic acid Dosage Form: Tablet New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited Manufacturer(s): Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico Merck Sharp & Dohme SpA., Pavia, Italy Product: Fosamax Active Ingredient(s): Alendronate sodium 6.53mg equivalent to 5mg alendronic acid Dosage Form: Tablet New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited Manufacturer(s): Merck Sharp & Dohme SpA., Pavia, Italy Product: Ultravist 240 Active Ingredient(s): Iopromide 498.72mg/mL equivalent to 240mg iodine Dosage Form: Solution for injection New Zealand Sponsor: Schering (NZ) Limited Manufacturer(s): Schering AG, Wedding Plant, Berlin, Germany Dated this 6th day of December 2000. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).