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:*	Noumed Fexofenadine Hayfever and Allergy Relief
Active Ingredient:	Fexofenadine hydrochloride 180mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Noumed Pharmaceuticals Limited
Manufacturer:	Sterling Healthcare Limited, Pune, India

*Product:*	Varenicline Sandoz
*Component 1:*
Active Ingredient:	Varenicline citrate 0.955mg equivalent to varenicline 0.5mg
Dosage Form:	Film coated tablet
*Component 2:*
Active Ingredient:	Varenicline citrate 1.909mg equivalent to varenicline 1mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	AET Laboratories Private Limited, Gaddapotharam Village, India

*Product:*	Varenicline Sandoz
Active Ingredient:	Varenicline citrate 1.909mg equivalent to varenicline 1mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Sandoz New Zealand Limited
Manufacturer:	AET Laboratories Private Limited, Gaddapotharam Village, India

Dated this 5th day of August 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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