Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new 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: Baraclude
Active Ingredient: Entecavir monohydrate 0.05mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Product: Baraclude
Active Ingredient: Entecavir monohydrate 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Product: Baraclude
Active Ingredient: Entecavir monohydrate 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Bristol-Myers Squibb Company, Mt Vernon, Indiana, United States of America
Dated this 13th day of March 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).