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:*	Calquence
Active Ingredient:	Acalabrutinib maleate monohydrate 129mg equivalent to acalabrutinib 100mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	AstraZeneca Limited
Manufacturer:	AstraZeneca AB, Sodertalje, Sweden

*Product:*	Erelzi
Active Ingredient:	Etanercept 25mg
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Erelzi
Active Ingredient:	Etanercept 50mg
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Erelzi (Pre-filled auto-injector)
Active Ingredient:	Etanercept 50mg
Dosage Form:	Solution for injection
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	Novartis Pharmaceutical Manufacturing GmbH, Langkampfen, Austria

*Product:*	Jemperli
Active Ingredient:	Dostarlimab 50mg/mL
Dosage Form:	Solution for infusion
New Zealand Sponsor:	GlaxoSmithKline NZ Limited
Manufacturers:	Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Barnard Castle, United Kingdom Ajinomoto Althea Inc, California, United States of America

*Product:*	Ozempic (2mg/1.5mL)
Active Ingredient:	Semaglutide 1.34mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novo Nordisk Pharmaceuticals Limited
Manufacturers:	Novo Nordisk A/S, Copenhagen, Denmark Novo Nordisk A/S, Hillerod, Denmark

*Product:*	Ozempic (4mg/3mL)
Active Ingredient:	Semaglutide 1.34mg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novo Nordisk Pharmaceuticals Limited
Manufacturers:	Novo Nordisk A/S, Copenhagen, Denmark Novo Nordisk A/S, Hillerod, Denmark Novo Nordisk Pharmaceutical Industries, North Carolina, United States of America

Dated this 26th day of May 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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