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:*	Alcaine
Active Ingredient:	Proxymetacaine hydrochloride 5mg/mL
Dosage Form:	Eye drops, solution
New Zealand Sponsor:	Alcon Laboratories (New Zealand) Limited
Manufacturers:	Alcon Couvreur NV, Puurs, Belgium Alcon Research LLC, Texas, United States of America

*Product:*	Entresto 24/26
Active Ingredient:	Sacubitril/valsartan 50mg equivalent to sacubitril 24.3mg and valsartan 25.7mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Farma SpA, Torre Annunziata, Italy Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore

*Product:*	Entresto 49/51
Active Ingredient:	Sacubitril/valsartan 100g equivalent to sacubitril 48.6mg and valsartan 51.4mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Farma SpA, Torre Annunziata, Italy Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore

*Product:*	Entresto 97/103
Active Ingredient:	Sacubitril/valsartan 200mg equivalent to sacubitril 97.2mg and valsartan 102.8mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturers:	Novartis Farma SpA, Torre Annunziata, Italy Novartis Saglik ve Gida Urunleri Sanayi ve Ticaret AS, Istanbul, Turkey Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore

*Product:*	Tenofovir Disoproxil Emtricitabine Efavirenz Viatris
Active Ingredients:	Efavirenz 600mg Emtricitabine 200mg Tenofovir disoproxil maleate 300mg equivalent to 245mg Tenofovir disoproxil
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Laboratories Limited, Pithampur, India

*Product:*	Tenofovir Disoproxil Emtricitabine Viatris
Active Ingredient:	Emtricitabine 200mg Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Viatris Limited
Manufacturer:	Mylan Laboratories Limited, Pithampur, India

*Product:*	Trajenta
Active Ingredient:	Linagliptin 5mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Boehringer Ingelheim (NZ) Limited
Manufacturers:	Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany West-Ward Columbus Inc., Ohio, United States of America

Dated this 25th day of November 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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