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

*Product:*	Mekinist
Active Ingredient:	Trametinib dimethyl sulfoxide 0.5635mg equivalent to trametinib 0.5mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Pharma Stein AG, Stein, Switzerland GlaxoSmithKline Manufacturing SpA, Parma, Italy

*Product:*	Mekinist
Active Ingredient:	Trametinib dimethyl sulfoxide 2.254mg equivalent to trametinib 2mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Pharma Stein AG, Stein, Switzerland GlaxoSmithKline Manufacturing SpA, Parma, Italy

*Product:*	Tafinlar
Active Ingredient:	Dabrafenib mesilate 59.25mg equivalent to dabrafenib 50mg
Dosage Form:	Capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Siegfried Barbera SL, Barcelona, Spain Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

*Product:*	Tafinlar
Active Ingredient:	Dabrafenib mesilate 88.88mg equivalent to dabrafenib 75mg
Dosage Form:	Capsule
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Siegfried Barbera SL, Barcelona, Spain Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

Dated this 8th day of December 2025.

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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