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:
Schedule
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).