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:

Xyntha
Moroctocog alfa 250IU equivalent to 23mcg
Powder for injection
Pfizer New Zealand Limited
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Xyntha
Moroctocog alfa 500IU equivalent to 45mcg
Powder for injection
Pfizer New Zealand Limited
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Xyntha
Moroctocog alfa 1000IU equivalent to 90mcg
Powder for injection
Pfizer New Zealand Limited
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Xyntha
Moroctocog alfa 2000IU equivalent to 180mcg
Powder for injection
Pfizer New Zealand Limited
Wyeth Farma SA, Madrid, Spain
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

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

Xyntha
Moroctocog alfa 3000IU
Powder for injection
Pfizer New Zealand Limited
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany

Dated this 26th day of November 2015.

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