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:
Manufacturers:

Neulastim
Pegfilgrastim 10mg/mL
Solution for injection
Amgen New Zealand Limited
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico

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

Neupogen
Filgrastim 300mcg/mL
Solution for injection
Amgen New Zealand Limited
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico

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

Neupogen
Filgrastim 600mcg/mL
Solution for injection
Amgen New Zealand Limited
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico

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

Neupogen
Filgrastim 960mcg/mL
Solution for injection
Amgen New Zealand Limited
F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Amgen Manufacturing Limited, Juncos, Puerto Rico

Dated this 7th day of July 2016.

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