Overview
The marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva has been withdrawn at the request of the marketing authorisation holder.
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Medicine overview
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Risk-management-plan
Product information
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Product information
Latest procedure affecting product information: II/0004
12/10/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - All authorised presentations
Product details
- Name of medicine
- COVID-19 Vaccine (inactivated, adjuvanted) Valneva
- Active substance
- COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
- 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
Pharmacotherapeutic group
VaccinesTherapeutic 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
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Procedural steps taken and scientific information after authorisation
Safety updates
COVID-19 vaccines - Safety update: 8 December 2022
COVID-19 Vaccine (inactivated, adjuvanted) Valneva: Periodic safety update report assessment 28 February 2022 to 27 August 2022
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : Periodic safety update report assessment 28 August 2022 to 27 February 2023
COVID-19 vaccines - Safety update: 10 November 2022
COVID-19 vaccines - Safety update: 6 October 2022
COVID-19 vaccines - Safety update: 8 September 2022
COVID-19 vaccines - Safety update: 14 July 2022