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:
| 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 (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 (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 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 (multi doese 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 (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 |
Dated this 4th day of November 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).