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.

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

Nuvaxovid is also available as an adapted vaccine, Nuvaxovid XBB.1.5, which contains a version of the protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2.

This EPAR was last updated on 08/11/2023

Authorisation details

Product details
Name
Nuvaxovid
Agency product number
EMEA/H/C/005808
Active substance
  • SARS CoV-2 (Original) recombinant spike protein
  • SARS-CoV-2 (Omicron XBB.1.5) 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
J07BN04
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
Novavax CZ, a.s.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
20/12/2021
Contact address

Bohumil 138
Jevany, 28163
Czechia

Product information

31/10/2023 Nuvaxovid - EMEA/H/C/005808 - II/0058/G

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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

Covid-19 vaccines

Therapeutic indication

Nuvaxovid 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.

Nuvaxovid XBB.1.5 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.

Assessment history

Safety updates

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