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:
| Product: | Comirnaty JN.1 (single dose vial) |
| Active Ingredient: | Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty JN.1 (multi dose vial) |
| Active Ingredient: | Bretovameran 0.033mg/mL equivalent to 10mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty JN.1 |
| Active Ingredient: | Bretovameran 0.033mg/mL equivalent to 3mcg/0.3mL dose |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty JN.1 (single dose vial) |
| Active Ingredient: | Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium BioNTech Manufacturing Marburg GmbH, Marburg, Germany |
| Product: | Comirnaty JN.1 (multi dose vial) |
| Active Ingredient: | Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium BioNTech Manufacturing Marburg GmbH, Marburg, Germany Mibe GmbH Arzneimittel, Brehna, Germany |
| Product: | Comirnaty JN.1 (multi dose vial) |
| Active Ingredient: | Bretovameran 0.1mg/mL equivalent to 3mcg/0.2mL dose |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
| Product: | Comirnaty JN.1 (multi dose vial) |
| Active Ingredient: | Bretovameran 0.1mg/mL equivalent to 10mcg/0.2mL dose |
| Dosage Form: | Concentrate for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium BioNTech Manufacturing Marburg GmbH, Marburg, Germany |
| Product: | Comirnaty JN.1 (pre-filled syringe, glass) |
| Active Ingredient: | Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium BioNTech Manufacturing Marburg GmbH, Marburg, Germany |
| Product: | Comirnaty JN.1 (pre-filled syringe, plastic) |
| Active Ingredient: | Bretovameran 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium BioNTech Manufacturing Marburg GmbH, Marburg, Germany |
| Product: | Comirnaty Omicron XBB.1.5 (pre-filled syringe, glass) |
| Active Ingredient: | Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium BioNTech Manufacturing Marburg GmbH, Marburg, Germany |
| Product: | Comirnaty Omicron XBB.1.5 (pre-filled syringe, plastic) |
| Active Ingredient: | Raxtozinameran 0.1mg/mL equivalent to 30mcg/0.3mL dose |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium BioNTech Manufacturing Marburg GmbH, Marburg, Germany |
| Product: | Oseltamivir Viatris |
| Active Ingredient: | Oseltamivir phosphate 98.53mg equivalent to oseltamivir 75mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Chhatrapati Sambhajinagar, India |
| Product: | Pharmacor Varenicline (0.5mg and 1mg) |
| Component 1: | |
| Active Ingredient: | Varenicline tartrate 0.855mg equivalent to varenicline free base 0.50mg |
| Dosage Form: | Film coated tablet |
| Component 2: | |
| Active Ingredient: | Varenicline tartrate 1.71mg equivalent to varenicline free base 1mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Nalagarh, India |
| Product: | Pharmacor Varenicline |
| Active Ingredient: | Varenicline tartrate 0.855mg equivalent to varenicline free base 0.50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Nalagarh, India |
| Product: | Pharmacor Varenicline |
| Active Ingredient: | Varenicline tartrate 1.71mg equivalent to varenicline free base 1mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pharmacor Limited |
| Manufacturer: | Alkem Laboratories Limited, Nalagarh, India |
Dated this 1st day of November 2024.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).