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: Coumadin
Active Ingredient: Warfarin sodium 1mg
Dosage Form: Tablet
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: The Boots Company Plc., Beeston, Nottingham, United Kingdom
This consent is given subject to the following condition:
? Not to be marketed as substitutable for any other warfarin product as if the 2 products were bioequivalent.
Note: This consent is valid for 2 years from 31 October 2001.
Product: Coumadin
Active Ingredient: Warfarin sodium 2mg
Dosage Form: Tablet
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: The Boots Company Plc., Beeston, Nottingham, United Kingdom
This consent is given subject to the following condition:
? Not to be marketed as substitutable for any other warfarin product as if the 2 products were bioequivalent.
Note: This consent is valid for 2 years from 31 October 2001.
Product: Coumadin
Active Ingredient: Warfarin sodium 5mg
Dosage Form: Tablet
New Zealand Sponsor: Boots Healthcare New Zealand Limited
Manufacturer: The Boots Company Plc., Beeston, Nottingham, United Kingdom
This consent is given subject to the following condition:
? Not to be marketed as substitutable for any other warfarin product as if the 2 products were bioequivalent.
Note: This consent is valid for 2 years from 31 October 2001.
Dated this 6th 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).