Comirnaty

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Tozinameran / COVID-19 mRNA Vaccine (nucleoside modified)

Authorised
This medicine is authorised for use in the European Union.

Overview

Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 5 years and older.

Comirnaty contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Comirnaty does not contain the virus itself and cannot cause COVID-19.

This EPAR was last updated on 17/06/2022

Authorisation details

Product details
Name
Comirnaty
Agency product number
EMEA/H/C/005735
Active substance
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2
International non-proprietary name (INN) or common name
  • Tozinameran
  • COVID-19 mRNA Vaccine (nucleoside modified)
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
J07BX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
BioNTech Manufacturing GmbH
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
21/12/2020
Contact address

An der Goldgrube 12
55131 Mainz
Germany

Product information

04/05/2022 Comirnaty - EMEA/H/C/005735 - II/0104

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Comirnaty 10 micrograms/dose is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.
The use of this vaccine should be in accordance with official recommendations.

Comirnaty 30 micrograms/dose is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.

Assessment history

Changes since initial authorisation of medicine

Safety updates

News

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