Notice Type
Notice Title

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:


Product: Ronapreve
Component 1:  
Active Ingredient: Imdevimab 120mg/mL
Dosage Form: Solution for injection
Component 2:  
Active Ingredient: Casirivimab 120mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Genentech Inc, Oregon, United States of America
Catalent Indiana LLC, Indiana, United States of America

Dated this 21st day of December 2021.

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