Comirnaty

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tozinameran / riltozinameran and tozinameran / famtozinameran and 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 from the age of 6 months. Comirnaty contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.

Comirnaty is also available as two adapted vaccines:

  • Comirnaty Original/Omicron BA.1 contains tozinameran and riltozinameran, another mRNA molecule with instructions for producing a protein from the Omicron BA.1 subvariant of SARS-CoV-2.
  • Comirnaty Original/Omicron BA.4-5 contains tozinameran and famtozinameran, another mRNA molecule with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2.

The adapted vaccines are only used in people who have received at least a primary vaccination course against COVID-19.

Comirnaty and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.

This EPAR was last updated on 25/11/2022

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
  • riltozinameran and tozinameran
  • famtozinameran and 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.

Publication details
Marketing-authorisation holder
BioNTech Manufacturing GmbH
Revision
34
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

10/11/2022 Comirnaty - EMEA/H/C/005735 - X/0147

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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 concentrate for dispersion for injection is indicated for active immunisation to prevent 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.

Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.

Comirnaty 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.

Comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent 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.

Comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent 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.

Comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 6 months to 4 years. The use of this vaccine should be in accordance with official recommendations.

Assessment history

Changes since initial authorisation of medicine

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