Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Diane-35 ED
Active Ingredients: Cyproterone acetate 2mg
Ethinylestradiol 0.035mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer AG, Berlin, Germany
Bayer Weimar GmbH und Co KG, Weimar, Germany
   
Product: Esmeron
Active Ingredient: Rocuronium bromide 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: NV Organon, Oss, Netherlands
Siegfried Hameln GmbH, Hameln, Germany
   
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 8th day of May 2020.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).