Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
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File ref: TT50-10853/1 |
Trade Name | Dose Form | Strength | Identifier |
Comirnaty | Suspension for injection | 0.1 mg/mL | (grey cap, do not dilute) 30 mcg/0.3 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 |
suspension for injection, New Formulation | Active | |
Tozinameran 0.1 mg/mL equivalent to 30 µg/0.3mL dose | 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 | ||
((4-Hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) | ||
1,2-Distearoyl-sn-glycero-3-phosphocholine | ||
Azane;2-(2-methoxyethoxy)-N,N-di(tetradecyl)acetamide | ||
Cholesterol | ||
Sucrose | ||
Trometamol | ||
Trometamol hydrochloride | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | BioNTech Innovative Manufacturing Services GmbH Vollmersbachstrasse 66 Idar-Oberstein 55743 GERMANY |
BioNTech Manufacturing GmbH An der Goldgrube 12 Mainz 55131 GERMANY | |
BioNTech Manufacturing Marburg GmbH Emil-von-Behring-Strasse 76 Marburg 35041 GERMANY | |
Eurofins Pharma Quality Control 16 rue Clement Ader Sainte Croix en Plaine 68127 FRANCE | |
Eurofins Pharma Quality Control 9 Avenue de Laponie ZI de Courtaboeuf Les Ulis 91940 FRANCE | |
Mibe GmbH Arzneimittel Munchener Strasse 15 Brehna 06796 GERMANY | |
Patheon Italia S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin Dublin 22 IRELAND | |
Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM | |
Sanofi-Aventis Deutschland GmbH Industriepark Hochst Bruningstrasse 50 Frankfurt am Main 65926 GERMANY | |
Wyeth Biopharma, Division of Wyeth Pharmaceuticals LLC One Burtt Road Andover Massachussetts 01810 UNITED STATES OF AMERICA | |
Manufacture of Final Dose Form | Allergopharma GmbH & Co. KG Hermann-Koerner-Strasse 52 Reinbek 21465 GERMANY |
BioNTech Manufacturing Marburg GmbH Emil-von-Behring-Strasse 76 Marburg 35041 GERMANY | |
Mibe GmbH Arzneimittel Munchener Strasse 15 Brehna 06796 GERMANY | |
Patheon Italia S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM | |
Sanofi-Aventis Deutschland GmbH Industriepark Hochst Bruningstrasse 50 Frankfurt am Main 65926 GERMANY | |
Packing | Mibe GmbH Arzneimittel Munchener Strasse 15 Brehna 06796 GERMANY |
Patheon Italia S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM | |
Sanofi-Aventis Deutschland GmbH Industriepark Hochst Bruningstrasse 50 Frankfurt am Main 65926 GERMANY | |
Secondary Packaging | Mibe GmbH Arzneimittel Munchener Strasse 15 Brehna 06796 GERMANY |
Patheon Italia S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands B-2870 BELGIUM | |
Sanofi-Aventis Deutschland GmbH Industriepark Hochst Bruningstrasse 50 Frankfurt am Main 65926 GERMANY | |
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, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey 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 opened stored at or below 30°C |
Vial, glass, multi-dose, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey 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 opened stored at or below 30°C |
Indications
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 12 years of age and older.
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) | Pending | ||
7/3/2024 | Changed Medicine Notification | Excipient specifications/test methods - G2; Administrative fee (CMN) | Initial evaluation | 20/3/2024 | |
16/2/2024 | Changed Medicine Notification | Finished product manufacturing process - G4; Administrative fee (CMN) | Initial evaluation | 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 | |
12/4/2023 | Self-Assessable Change Notification | Finished product manufacturing process - G1 (Self assessable) | Notified | 19/4/2023 | |
12/11/2021 | Provisional Consent (Section 23) | Additional dose form - higher-risk medicine - Grade 1 or 2 | Granted 16/12/2021 | 24/11/2021 |