Notice Type
Departmental
Notice Title

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:
Component 1:

Active Ingredient:
Dosage Form:
Component 2:
Active Ingredient:
Dosage Form:

New Zealand Sponsor:
Manufacturer:

Apo-Varenicline

Varenicline tartrate 0.855mg equivalent to varenicline 0.5mg
Film coated tablet

Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Apo-Varenicline
Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Film coated tablet
Apotex NZ Limited
Apotex Research Private Limited, Bangalore, India

Dated this 5th day of February 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).