Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:
Schedule
Product: Coumadin
Active Ingredient: Warfarin sodium 1mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Hamol Limited, Nottingham, Nottinghamshire, United Kingdom
Note: This consent is given subject to the following condition:
? Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.
Note: This renewed consent is valid for two years from the date of publication of this notice.
Product: Coumadin
Active Ingredient: Warfarin sodium 2mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Hamol Limited, Nottingham, Nottinghamshire, United Kingdom
Note: This consent is given subject to the following condition:
? Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.
Note: This renewed consent is valid for two years from the date of publication of this notice.
Product: Coumadin
Active Ingredient: Warfarin sodium 5mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Hamol Limited, Nottingham, Nottinghamshire, United Kingdom
Note: This consent is given subject to the following condition:
? Not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent.
Note: This renewed consent is valid for two years from the date of publication of this notice.
Dated this 16th day of October 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).