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 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
Manufacturer:	GlaxoSmithKline LLC, North Carolina, United States of America

*Product:*	Sunitinib
Active Ingredient:	Sunitinib 12.5mg
Dosage Form:	Capsule
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

*Product:*	Sunitinib
Active Ingredient:	Sunitinib 25mg
Dosage Form:	Capsule
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

*Product:*	Sunitinib
Active Ingredient:	Sunitinib 37.5mg
Dosage Form:	Capsule
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

*Product:*	Sunitinib
Active Ingredient:	Sunitinib 50mg
Dosage Form:	Capsule
New Zealand Sponsor:	Teva Pharma (New Zealand) Limited
Manufacturer:	Teva Pharmaceutical Industries Limited, Kfar Saba, Israel

*Product:*	Teriflunomide Dr.Reddy’s
Active Ingredient:	Teriflunomide 14mg
Dosage Form:	Tablet
New Zealand Sponsor:	Dr Reddy’s New Zealand Limited
Manufacturer:	MSN Laboratories Private Limited, Nandigama, India

Dated this 15th day of November 2021.

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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