Notice Type
Departmental
Notice Title

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Pro-Epanutin
Active Ingredient(s): Fosphenytoin sodium 75mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturer(s): Warner-Lambert Export Limited, Dun Laoghaire, Co. Dublin, Ireland
Product: Recormon 10000 for Reco-Pen
Active Ingredient(s): Epoetin beta 10,000IU
Dosage Form: Front compartment powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon 20000 for Reco-Pen
Active Ingredient(s): Epoetin beta 20,000IU
Dosage Form: Front compartment powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Dated this 28th day of November 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).