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).