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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Champix
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
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for one year to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other varenicline medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for one year from the date of publication of this notice.
   
Product: Champix 0.5mg and 1mg tablets (Combination Product)
Active Ingredient: Varenicline tartrate 0.85mg equivalent to varenicline 0.5mg
Dosage Form: Film coated tablet
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
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for one year to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other varenicline medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet sole tender obligations.
Note: This consent is valid for one year from the date of publication of this notice.


Dated this 29th day of April 2021.

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