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: Hycamtin
Active Ingredient(s): Topotecan hydrochloride 4.49mg/dose equivalent to 4mg topotecan
Dosage Form: Powder for infusion
NZ Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer(s): SmithKline Beecham Pharmaceuticals, Anti-infective manufacturing operations, Conshohocken, Pennsylvania, United States of America
Dated this 24th day of February 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).