Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Cancidas
Active Ingredient(s): Caspofungin acetate 57.8mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Vial + transfer set, powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Cancidas
Active Ingredient(s): Caspofungin acetate 60.6mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Cancidas
Active Ingredient(s): 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(s): Merck & Co Inc, West Point, Pennsylvania, United States of America
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 26th day of April 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).