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: Caelyx
Active Ingredient: Doxorubicin hydrochloride 2mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Schering-Plough Pty Ltd
Manufacturer: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 57.8mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 60.6mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 83.9mg equivalent to 70mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Dated this 9th day of October 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).