Notice Title

Consent to the Distribution of New Medicines

Publication Date
5 Feb 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go588
Title
View PDF
File Type and Size
PDF (36 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 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: Adempas
Active Ingredient: Riociguat 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer AG, Leverkusen, Germany
   
Product: Adempas
Active Ingredient: Riociguat 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer AG, Leverkusen, Germany
   
Product: Adempas
Active Ingredient: Riociguat 1.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer AG, Leverkusen, Germany
   
Product: Adempas
Active Ingredient: Riociguat 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer AG, Leverkusen, Germany
   
Product: Adempas
Active Ingredient: Riociguat 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer AG, Leverkusen, Germany
   
Product: Gadovist 1.0
Active Ingredient: Gadobutrol 604.72mg equivalent to 1mmol/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer AG, Berlin, Germany
   
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
MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland


Dated this 31st day of January 2025.

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