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 (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 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 (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 |
| 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 (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 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 (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 |
| 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 |
| 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 |
| 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: | Duac Once Daily Gel |
| Active Ingredients: | Benzoyl peroxide 66.7mg/g Clindamycin phosphate 12.8mg/g |
| Dosage Form: | Topical gel |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturers: | Glaxo Operations UK Limited t/a Glaxo Wellcome Operations, Barnard Castle, United Kingdom Stiefel Laboratories (Ireland) Limited, Sligo, Ireland |
| Product: | Entyvio |
| Active Ingredient: | Vedolizumab 300mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Takeda New Zealand Limited |
| Manufacturers: | Patheon Italia S.p.A, Ferentino, Italy Takeda Pharmaceutical Company Limited, Yamaguchi, Japan |
| Product: | Humulin 30/70 |
| Active Ingredient: | Insulin, human, recombinant DNA origin 100IU |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Lilly France SAS, Fegersheim, France Eli Lilly Italia SpA, Florence, Italy |
| Product: | Humulin NPH |
| Active Ingredient: | Insulin, human, recombinant DNA origin 100IU |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Lilly France SAS, Fegersheim, France Eli Lilly Italia SpA, Florence, Italy |
| Product: | Humulin R |
| Active Ingredient: | Insulin, human, recombinant DNA origin 100IU |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Eli Lilly and Company (NZ) Limited |
| Manufacturers: | Eli Lilly and Company Inc, Indiana, United States of America Lilly France SAS, Fegersheim, France Eli Lilly Italia SpA, Florence, Italy |
| Product: | Vancomycin Viatris |
| Active Ingredient: | Vancomycin hydrochloride 512.5mg equivalent to Vancomycin 500mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Viatris Limited |
| Manufacturer: | Mylan Laboratories Limited, Bangalore, India |
| Product: | Yonsa |
| Active Ingredient: | Abiraterone acetate 125mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturer: | Mayne Pharma Inc, North Carolina, United States of America |
| Product: | Yonsa Mpred |
| Active Ingredient: | Abiraterone acetate 125mg |
| Dosage Form: | Tablet |
| Active Ingredient: | Methylprednisolone 4mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | CARSL Consulting |
| Manufacturers: | Orion Corporation, Espoo, Finland Catalent Greenville Inc, North Carolina, United States of America |
Dated this 25th day of August 2025.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).