Spikevax (previously COVID-19 Vaccine Moderna)

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elasomeran / COVID-19 mRNA vaccine (nucleoside-modified)

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

Overview

Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 6 years and older.

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

This EPAR was last updated on 22/07/2022

Authorisation details

Product details
Name
Spikevax (previously 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
  • elasomeran
  • 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
26
Date of issue of marketing authorisation valid throughout the European Union
06/01/2021
Contact address

Calle del Principe De Vergara 132 Plt 12
28002 Madrid
Spain

Product information

20/07/2022 Spikevax (previously COVID-19 Vaccine Moderna) - EMEA/H/C/005791 - IB/0072

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

Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 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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