Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10853/1a |
| Trade Name | Dose Form | Strength | Identifier |
| Comirnaty | Concentrate for injection | 0.1 mg/mL | (orange cap, must dilute) 10 mcg/0.2 mL dose |
| Sponsor | Application date | Registration situation | Classification |
| Pfizer New Zealand Limited P O Box 3998 AUCKLAND 1140 | 12/11/2021 | Consent given Approval date: 15/11/2023 Labelling exemption expires 03/11/2025 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for injection, New Formulation | Active | |
| Tozinameran 0.1 mg/mL equivalent to 10 µg/0.2mL dose after dilution | Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin Dublin 22 IRELAND | |
| BioNTech Manufacturing Marburg GmbH Emil-von-Behring-Strasse 76 Marburg 35041 GERMANY | ||
| Wyeth Biopharma, Division of Wyeth Pharmaceuticals LLC One Burtt Road Andover Massachussetts 01810 UNITED STATES OF AMERICA | ||
| Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 Laupheim 88471 GERMANY | ||
| BioNTech Manufacturing GmbH An der Goldgrube 12 Mainz 55131 GERMANY | ||
| Excipient | ||
| 1,2-Distearoyl-sn-glycero-3-phosphocholine | ||
| ALC-0159 | ||
| ALC-0315 | ||
| Cholesterol | ||
| Sucrose | ||
| Trometamol | ||
| Trometamol hydrochloride | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin Dublin 22 IRELAND |
| Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM | |
| Wyeth Biopharma, Division of Wyeth Pharmaceuticals LLC One Burtt Road Andover Massachussetts 01810 UNITED STATES OF AMERICA | |
| Manufacture of Final Dose Form | Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM |
| Packing | Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM |
| Secondary Packaging | Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM |
| NZ Site of Product Release | Pfizer New Zealand Limited Level 10, 11 Britomart Place Auckland CBD Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, multi-dose, (1.3 mL fill), closed with rubber stopper, aluminium overseal and orange flip-off plastic cap | 10 dose units | 24 months from date of manufacture stored in the freezer at -90°C to -60°C protect from light 24 hours unopened stored at or below 30°C. Applies to thawed vials. Do not refreeze. 10 weeks unopened stored at 2° to 8°C (Refrigerate, do not freeze). Applies to thawed vials within the 24 month shelf-life. Do not refreeze. 12 hours diluted stored at or below 30°C |
| Vial, glass, multi-dose, (1.3 mL fill), closed with rubber stopper, aluminium overseal and orange flip-off plastic cap | 195 dose units | 24 months from date of manufacture stored in the freezer at -90°C to -60°C protect from light 24 hours unopened stored at or below 30°C. Applies to thawed vials. Do not refreeze. 10 weeks unopened stored at 2° to 8°C (Refrigerate, do not freeze). Applies to thawed vials within the 24 month shelf-life. Do not refreeze. 12 hours diluted stored at or below 30°C |
Indications
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in children aged 5 to 11 years.
The use of this vaccine should be in accordance with official recommendations.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 20/3/2024 | Changed Medicine Notification | Contraindications, warnings and precautions - G2; Administrative fee (CMN) | Initial evaluation | 3/4/2024 | |
| 7/3/2024 | Changed Medicine Notification | Excipient specifications/test methods - G2; Administrative fee (CMN) | Information requested 12/4/2024 | 20/3/2024 | |
| 16/2/2024 | Changed Medicine Notification | Finished product manufacturing process - G4; Administrative fee (CMN) | Information requested 19/4/2024 | 13/3/2024 | |
| 20/6/2023 | New Higher-risk Medicine Application | Provisional to full approval (clinical need) higher-risk NCE | Granted 15/11/2023 | 23/8/2023 | |
| 12/11/2021 | Provisional Consent (Section 23) | Additional dose form - higher-risk medicine - Grade 1 or 2 | Granted 16/12/2021 | 24/11/2021 |
