Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:
Schedule
Product: RiaSTAP
Active Ingredient: Fibrinogen 900mg - 1300mg
Dosage Form: Powder for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturers: CSL Behring GmbH, Marburg, Germany
Note: This consent is valid to 5 December 2013.
Dated this 8th day of September 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).