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: 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: Pradaxa
Active Ingredient: Dabigatran etexilate 86.48mg equivalent to Dabigatran 75mg
Dosage Form: Capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product: Pradaxa
Active Ingredient: Dabigatran etexilate 126.83mg equivalent to Dabigatran 110mg
Dosage Form: Capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Product: Pradaxa
Active Ingredient: Dabigatran etexilate 172.95mg equivalent to Dabigatran 150mg
Dosage Form: Capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Dated this 10th day of July 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).