Comirnaty

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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 12 years and older.

Comirnaty contains a molecule called messenger RNA (mRNA) 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 03/06/2021

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
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
8
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

28/05/2021 Comirnaty - EMEA/H/C/005735 - II/0030

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunization against COVID-19 disease

Assessment history

Safety updates

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