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:

Schedule

*Product:*	Comirnaty
Active Ingredient:	Tozinameran 0.1mg/mL
Dosage Form:	Suspension for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany Patheon Italia S.p.A, Milan, Italy BioNTech Manufacturing Marburg GmbH, Marburg, Germany Mibe GmbH Arzneimittel, Brehna, Germany Allergopharma GmbH & Co. KG, Reinbek, Germany

*Product:*	Comirnaty (3mcg/0.2mL dose)
Active Ingredient:	Tozinameran 0.1mg/mL
Dosage Form:	Concentrate for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium

*Product:*	Comirnaty (10mcg/0.2mL dose)
Active Ingredient:	Tozinameran 0.1mg/mL
Dosage Form:	Concentrate for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturer:	Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium

*Product:*	Comirnaty
Active Ingredient:	Tozinameran 0.5mg/mL
Dosage Form:	Concentrate for injection
New Zealand Sponsor:	Pfizer New Zealand Limited
Manufacturers:	Novartis Pharma Stein AG, Stein, Switzerland Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany Baxter Oncology GmbH, Halle-Kunsebeck Westfalen, Germany Patheon Italia S.p.A, Milan, Italy Polymun Scientific Immunobiologische Forschung GmbH, Klosterneuburg, Austria Siegfried Hameln GmbH, Hameln, Germany Delpharm Saint Remy, Saint Remy Sur Avre, France Catalent Anagni SRL, Anagni, Italy BioNTech Manufacturing Marburg GmbH, Marburg, Germany Mibe GmbH Arzneimittel, Brehna, Germany Allergopharma GmbH & Co. KG, Reinbek, Germany

Dated this 7th day of November 2023.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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