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: Eylea
Active Ingredient: Aflibercept 40mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Bayer AG, Berlin, Germany
Regeneron Pharmaceuticals Inc, New York, United States of America
   
Product: Jardiance
Active Ingredient: Empagliflozin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Boehringer Ingelheim Ellas AE, Koropi Attiki, Greece
   
Product: Jardiance
Active Ingredient: Empagliflozin 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
Boehringer Ingelheim Ellas AE, Koropi Attiki, Greece
   
Product: Keytruda
Active Ingredient: Pembrolizumab 25mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: MSD International GmbH t/a MSD Ireland (Carlow), Carlow, Ireland


Dated this 14th day of February 2022.

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