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:*	Binocrit
Active Ingredient:	Epoetin alfa 16.8mcg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	IDT Biologika GmbH, Dessau-Rosslau, Germany

*Product:*	Binocrit
Active Ingredient:	Epoetin alfa 84mcg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	IDT Biologika GmbH, Dessau-Rosslau, Germany

*Product:*	Binocrit
Active Ingredient:	Epoetin alfa 336mcg/mL
Dosage Form:	Solution for injection
New Zealand Sponsor:	Novartis New Zealand Limited
Manufacturer:	IDT Biologika GmbH, Dessau-Rosslau, Germany

*Product:*	Varenicline Pfizer
Active Ingredient:	Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	R-Pharm Germany GmbH, Illertissen, Germany Pfizer Italia SrL, Ascoli Piceno, Italy

*Product:*	Varenicline Pfizer
Active Ingredient:	Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	R-Pharm Germany GmbH, Illertissen, Germany Pfizer Italia SrL, Ascoli Piceno, Italy

*Product:*	Varenicline Pfizer 0.5mg and 1mg tablets (Combination Product)
*Component 1:*
Active Ingredient:	Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg
Dosage Form:	Film coated tablet
*Component 2:*
Active Ingredient:	Varenicline tartrate 1.71mg equivalent to varenicline 1mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	R-Pharm Germany GmbH, Illertissen, Germany Pfizer Italia SrL, Ascoli Piceno, Italy

Dated this 25th day of May 2020.

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

Tags

Notice Number

Schedule