COVID-19 Vaccine Moderna

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COVID-19 mRNA Vaccine (nucleoside modified)

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

Overview

COVID-19 Vaccine Moderna is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older.

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

This EPAR was last updated on 17/06/2021

Authorisation details

Product details
Name
COVID-19 Vaccine Moderna
Agency product number
EMEA/H/C/005791
Active substance
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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
J07BX03
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
Moderna Biotech Spain, S.L.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
06/01/2021
Contact address

Calle Monte Esquinza 30
28010 Madrid
Spain

Product information

11/06/2021 COVID-19 Vaccine Moderna - EMEA/H/C/005791 - II/0018/G

Contents

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Pharmacotherapeutic group

Vaccines

Therapeutic indication

COVID-19 Vaccine Moderna is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Assessment history

Safety updates

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