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: Tykerb
Active Ingredient: Lapatinib ditosilate 405mg equivalent to Lapatinib 250mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline New Zealand Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom
Note: This renewal consent is valid for two years from 23 August 2009.
Dated this 29th day of June 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).