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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Movapo
Apomorphine hydrochloride hemihydrate 10mg/mL
Solution for injection
CARSL Consulting
Hemofarm AD, Vrsac, Serbia

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Tamiflu
Oseltamivir phosphate 39.4mg equivalent to oseltamivir 30mg
Capsule
Roche Products (NZ) Limited
F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
DSM Pharmaceuticals Inc, North Carolina, United States of America

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

Tamiflu
Oseltamivir phosphate 39.4mg/g equivalent to oseltamivir 6mg/mL
when reconstituted with 55mL of water
Powder for oral suspension
Roche Products (NZ) Limited
Rottendorf Pharma GmbH, Ennigerloh, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Tamiflu
Oseltamivir phosphate 59.1mg equivalent to oseltamivir 45mg
Capsule
Roche Products (NZ) Limited
F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
DSM Pharmaceuticals Inc, North Carolina, United States of America

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Tamiflu
Oseltamivir phosphate 98.5mg equivalent to oseltamivir 75mg
Capsule
Roche Products (NZ) Limited
Cenexi SAS, Fontenay-sous-Bois, France
Catalent Germany Schorndorf GmbH, Schorndorf, Germany
Roche SpA, Milan, Italy

Dated this 18th day of March 2016.

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