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 Omicron XBB.1.5 (multi dose vial) |
| 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 Mibe GmbH Arzneimittel, Brehna, Germany |
| Product: | Comirnaty Omicron XBB.1.5 (single dose vial) |
| 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 |
Dated this 20th day of December 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).