Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand
of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Actilyse
Active Ingredient: Alteplase 10mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Actilyse
Active Ingredient: Alteplase 20mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Actilyse
Active Ingredient: Alteplase 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Mabthera
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, California, United States of America
Product: Telfast
Active Ingredient: Fexofenadine hydrochloride 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: sanofi-aventis us llc, Missouri, United States of America
Dated this 28th day of July 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).