Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10853/1
Trade NameDose FormStrengthIdentifier
ComirnatySuspension for injection0.1 mg/mL(grey cap, do not dilute) 30 mcg/0.3 mL dose
SponsorApplication dateRegistration situationClassification
Pfizer New Zealand Limited
P O Box 3998
AUCKLAND 1140
12/11/2021Consent given
Approval date: 15/11/2023
Labelling exemption expires 03/11/2025
Prescription
 

Composition

ComponentIngredientManufacturer
suspension for injection, New FormulationActive 
 Tozinameran 0.1 mg/mL equivalent to 30 µg/0.3mL dosePfizer 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 stepManufacturer
Finished Product TestingBioNTech 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 FormAllergopharma 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
PackingMibe 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 PackagingMibe 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 ReleasePfizer New Zealand Limited
Level 10, 11 Britomart Place
Auckland CBD
Auckland 1010

Packaging

PackageContentsShelf Life
Vial, glass, multi-dose, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey flip-off plastic cap10 dose units24 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 cap195 dose units24 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 DateApplication TypeChange(s)StatusPayment DatePriority
20/3/2024Changed Medicine NotificationContraindications, warnings and precautions - G2; Administrative fee (CMN)Pending  
7/3/2024Changed Medicine NotificationExcipient specifications/test methods - G2; Administrative fee (CMN)Initial evaluation20/3/2024 
16/2/2024Changed Medicine NotificationFinished product manufacturing process - G4; Administrative fee (CMN)Initial evaluation13/3/2024 
20/6/2023New Higher-risk Medicine ApplicationProvisional to full approval (clinical need) higher-risk NCEGranted 15/11/202323/8/2023 
12/4/2023Self-Assessable Change NotificationFinished product manufacturing process - G1 (Self assessable)Notified19/4/2023 
12/11/2021Provisional Consent (Section 23)Additional dose form - higher-risk medicine - Grade 1 or 2Granted 16/12/202124/11/2021 
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