Gazette.govt.nzPursuant 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:
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| 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:
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| 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).