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: Pariet
Active Ingredient: Rabeprazole sodium 10mg equivalent to 9.42mg rabeprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Eisai Co Ltd, Hiroki, Ohaza, Misato-machi, Kodama-gun, Saitama-ken, Japan
Product: Pariet
Active Ingredient: Rabeprazole sodium 20mg equivalent to 18.85mg rabeprazole
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Eisai Co Ltd, Hiroki, Ohaza, Misato-machi, Kodama-gun, Saitama-ken, Japan
Product: Telfast
Active Ingredient: Fexofenadine hydrochloride 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Pharmaceuticals Inc, Kansas City, Missouri, United States of America
Product: Xalatan
Active Ingredient: Latanoprost 50Ág/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Automatic Liquid Packaging Inc, Woodstock, Illinois, United States of America
Fresenius Kabi AB, Uppsala, Sweden
Pharmacia NV/SA, Puurs, Belgium
Dated this 12th day of April 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).