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:*	Alecensa
Active Ingredient:	Alectinib hydrochloride 161.33mg equivalent to alectinib 150mg
Dosage Form:	Capsule
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	Excella GmbH & Co KG, Feucht, 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 City, Singapore MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland

*Product:*	Nubeqa
Active Ingredient:	Darolutamide 300mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Bayer New Zealand Limited
Manufacturers:	Orion Corporation, Espoo, Finland Orion Corporation, Turku, Finland

*Product:*	Vabysmo
Active Ingredient:	Faricimab 120mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Roche Products (NZ) Limited
Manufacturer:	F Hoffmann-La Roche AG, Kaiseraugst, Switzerland

Dated this 5th day of August 2024.

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

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