Notice Title

Consent to the Distribution of New Medicines

Publication Date
16 Oct 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go5802
Title
View PDF
File Type and Size
PDF (22 KB)

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 are set out in the Schedule hereto:

Schedule

Product: Alyftrek 10/50/125
Active Ingredients: Deutivacaftor 125mg
Tezacaftor 50mg
Vanzacaftor calcium 10.6mg equivalent to vanzacaftor 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Pharmaceuticals Inc, Ohio, United States of America
   
Product: Alyftrek 4/20/50
Active Ingredients: Deutivacaftor 50mg
Tezacaftor 20mg
Vanzacaftor calcium 4.24mg equivalent to vanzacaftor 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon Pharmaceuticals Inc, Ohio, United States of America
   
Product: Posaconazole Devatis
Active Ingredient: Posaconazole 100mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey


Dated this 10th day of October 2025.

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