Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine 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 renewed consent is valid for two years from 16 February 2014.
Dated this 5th day of December 2013.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).