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 set out in the Schedule hereto:
Schedule
| Product: | Comirnaty Omicron XBB.1.5 (single dose vial) |
| Active Ingredient: | Raxtozinameran 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 Omicron XBB.1.5 (multi dose vial) |
| Active Ingredient: | Raxtozinameran 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 Omicron XBB.1.5 |
| Active Ingredient: | Raxtozinameran 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 Omicron XBB.1.5 |
| Active Ingredient: | Raxtozinameran 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 Omicron XBB.1.5 |
| Active Ingredient: | Raxtozinameran 0.1mg/mL equivalent to 3mcg/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 |
Dated this 12th day of April 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on the 11th day of September 2013).