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: Zelboraf
Active Ingredient: Vemurafenib 800mg equivalent to vemurafenib base 240mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Roche SpA, Milan, Italy
Note: This consent is valid to 16 February 2014.
Dated this 6th day of December 2012.
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).