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 medicines set out in the Schedule hereto:
Schedule
Product: Viramune
Active Ingredient: Nevirapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharmaceuticals Inc, Danbury, Connecticut, United States of America
Boehringer Ingelheim Roxane Inc, Columbus, Ohio, United States of America
Note: This consent is valid for two years from 4 December 2005.
Product: HyperHep B
Active Ingredient: Hepatitis B immunoglobulin, human 220IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Talecris Biotherapeutics, Inc., Clayton, North Carolina, United States of America
Note: This consent is valid for two years from 13 December 2005.
Product: Fabrazyme
Active Ingredient: Agalsidase beta - rch 35mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Genzyme Corporation, Allston, Massachusetts, United States of America
Note: This consent is valid for two years from 24 January 2006.
Dated this 1st day of December 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).