Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is 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 Limited
Manufacturer: Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Dated this 2nd day of July 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).