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:*	Darzalex SC
Active Ingredient:	Daratumumab 120mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Janssen-Cilag (New Zealand) Limited
Manufacturer:	Cilag AG, Schaffhausen, Switzerland

*Product:*	ENHERTU
Active Ingredient:	Trastuzumab deruxtecan 100mg
Dosage Form:	Powder for infusion concentrate
New Zealand Sponsor:	AstraZeneca Limited
Manufacturer:	Baxter Deutschland GmbH, Halle-Kunsebeck, Germany

*Product:*	Imfinzi
Active Ingredient:	Durvalumab 120mg
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AstraZeneca AB, Sodertalje, Sweden Catalent Indiana LLC, Indiana, United States of America
Note:	Applications were received 27 February 2024, 20 August 2024, and 13 December 2024

*Product:*	Imfinzi
Active Ingredient:	Durvalumab 500mg
Dosage Form:	Concentrate for infusion
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany AstraZeneca AB, Sodertalje, Sweden Catalent Indiana LLC, Indiana, United States of America
Note:	Applications were received 27 February 2024, 20 August 2024, and 13 December 2024

*Product:*	Lynparza
Active Ingredient:	Olaparib 100mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	AstraZeneca AB, Sodertalje, Sweden AbbVie Limited, Barceloneta, Puerto Rico AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany

*Product:*	Lynparza
Active Ingredient:	Olaparib 150mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	AstraZeneca Limited
Manufacturers:	AstraZeneca AB, Sodertalje, Sweden AbbVie Limited, Barceloneta, Puerto Rico AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany

*Product:*	Tasigna
Active Ingredient:	Nilotinib hydrochloride monohydrate 165.45mg equivalent to nilotinib anhydrous free base 150mg
Dosage Form:	Capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Pharma Stein AG, Stein, Switzerland Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

*Product:*	Tasigna
Active Ingredient:	Nilotinib hydrochloride monohydrate 220.6mg equivalent to nilotinib anhydrous free base 200mg
Dosage Form:	Capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

Dated this 21st day of July 2025.

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

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