Notice Type
Departmental
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:

Schedule

Product: Egoderm
Active Ingredients: Ichthammol 1%w/w Zinc oxide 15%w/w
Dosage Form: Topical ointment
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ego Pharmaceuticals Pty Limited, Melbourne, Australia
   
Product: Glypressin
Active Ingredient: Terlipressin acetate 1mg equivalent to terlipressin 0.85mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Zentiva AS (Czech Republic), Prague, Czech Republic
Ferring Pharmaceuticals China (Co) Limited, Zhongshan City, China
   
Product: Keytruda
Active Ingredient: Pembrolizumab 25mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: MSD International GmbH (Singapore Branch), Singapore City, Singapore
MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland
   
Product: Tagrisso
Active Ingredient: Osimertinib mesilate 47.7mg equivalent to osimertinib 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
   
Product: Tagrisso
Active Ingredient: Osimertinib mesilate 95.4mg equivalent to osimertinib 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden


Dated this 16th day of April 2024.

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