Nuvaxovid

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COVID-19 Vaccine (recombinant, adjuvanted)

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

Overview

Nuvaxovid is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 12 years and older.

Nuvaxovid contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein of the virus that causes COVID-19), which has been produced in the laboratory.

This EPAR was last updated on 01/08/2022

Authorisation details

Product details
Name
Nuvaxovid
Agency product number
EMEA/H/C/005808
Active substance
SARS-CoV-2 recombinant spike protein
International non-proprietary name (INN) or common name
COVID-19 Vaccine (recombinant, adjuvanted)
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
Novavax CZ, a.s.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
20/12/2021
Contact address

Bohumil 138
Jevany, 28163
Czechia

Product information

01/07/2022 Nuvaxovid - EMEA/H/C/005808 - II/0009

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

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

Assessment history

Safety updates

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