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: Pradaxa
Active Ingredient: Dabigatran etexilate 86.48mg equivalent to 75mg free base
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 110mg free base
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 20th day of December 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).