COVID-19 Vaccine (inactivated, adjuvanted) Valneva

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COVID-19 vaccine (inactivated, adjuvanted, adsorbed)

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

Overview

COVID-19 Vaccine (inactivated, adjuvanted) Valneva is a vaccine for protecting people aged between 18 and 50 years against coronavirus disease 2019 (COVID-19). It is used for primary vaccination.

The vaccine contains whole particles of the original strain of SARS-CoV-2 (the virus that causes COVID-19) that has been inactivated (killed) and cannot cause the disease.

This EPAR was last updated on 05/12/2022

Authorisation details

Product details
Name
COVID-19 Vaccine (inactivated, adjuvanted) Valneva
Agency product number
EMEA/H/C/006019
Active substance
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020
International non-proprietary name (INN) or common name
COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
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.

Publication details
Marketing-authorisation holder
Valneva Austria GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
24/06/2022
Contact address

Campus Vienna Biocenter 6
A-1030 Vienna
Austria

Product information

25/11/2022 COVID-19 Vaccine (inactivated, adjuvanted) Valneva - EMEA/H/C/006019 - IB/06

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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

COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. 

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

Assessment history

Safety updates

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