Gazette.govt.nzPursuant 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).