Notice Type
Notice Title

Consent to the Distribution of New Medicines

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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:


Product: Cotellic
Active Ingredient: Cobimetinib hemifumarate 22.2mg equivalent to cobimetinib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Excella GmbH & Co KG, Feucht, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Martindale Pharma® Acetylcysteine 200mg/mL Injection
Active Ingredient: Acetylcysteine 20%w/v
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Max Health Limited
Manufacturers: Demo SA Pharmaceutical Industry, Athens, Greece
Panpharma GmbH, Trittau, Germany

Dated this 21st day of October 2022.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).