Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Tafinlar
Active Ingredient: Dabrafenib mesilate 59.25mg equivalent to Dabrafenib 50mg
Dosage Form: Capsule
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline (Canada) Inc, Ontario, Canada
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Product: Tafinlar
Active Ingredient: Dabrafenib mesilate 88.88mg equivalent to Dabrafenib 75mg
Dosage Form: Capsule
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline (Canada) Inc, Ontario, Canada
Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Hertfordshire, United Kingdom
Dated this 13th day of June 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).