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:*	Dovato 50/300
Active Ingredients:	Dolutegravir sodium 52.6mg equivalent to dolutegravir 50mg Lamivudine 300mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	GlaxoSmithKline NZ Limited
Manufacturers:	Glaxo Wellcome SA, Burgos, Spain GlaxoSmithKline LLC, North Carolina, United States of America

*Product:*	Fluad
Active Ingredients:	Influenza virus A (H1N1) haemagglutinin 15mcg Influenza virus A (H3N2) haemagglutinin 15mcg Influenza virus B (Victoria) haemagglutinin 15mcg
Dosage Form:	Suspension for injection
New Zealand Sponsor:	Seqirus (NZ) Limited
Manufacturers:	Seqirus Vaccines Limited., Liverpool, United Kingdom Seqirus Inc., North Carolina, United States of America

*Product:*	Galvumet
Active Ingredients:	Metformin hydrochloride 850mg Vildagliptin 50mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey Novartis Pharma Produktions GmbH, Wehr, Germany Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

*Product:*	Galvumet
Active Ingredients:	Metformin hydrochloride 1000mg Vildagliptin 50mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey Novartis Pharma Produktions GmbH, Wehr, Germany Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

*Product:*	Galvus
Active Ingredient:	Vildagliptin 50mg
Dosage Form:	Tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Siegfried Barbera SL, Barcelona, Spain Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia

*Product:*	Nicorette QuickMist (Cool Berry flavour)
Active Ingredient:	Nicotine 13.6mg/mL
Dosage Form:	Oral spray
New Zealand Sponsor:	JNTL Consumer Health (New Zealand) Limited
Manufacturer:	McNeil AB, Helsingborg, Sweden

*Product:*	Nicorette QuickMist (Freshmint)
Active Ingredient:	Nicotine 13.6mg/mL
Dosage Form:	Oral spray
New Zealand Sponsor:	JNTL Consumer Health (New Zealand) Limited
Manufacturer:	McNeil AB, Helsingborg, Sweden

*Product:*	Sublocade
Active Ingredient:	Buprenorphine 100mg
Dosage Form:	Depot injection
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Albany Molecular Research Inc (AMRI), Massachusetts, United States of America

*Product:*	Sublocade
Active Ingredient:	Buprenorphine 300mg
Dosage Form:	Depot injection
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Albany Molecular Research Inc (AMRI), Massachusetts, United States of America

Dated this 28th day of October 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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