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The marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva has been withdrawn at the request of the marketing authorisation holder.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

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COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Risk-management-plan

Product information

COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Product information

български (BG) (1.39 MB - PDF)
español (ES) (1.1 MB - PDF)
čeština (CS) (1.19 MB - PDF)
dansk (DA) (1.01 MB - PDF)
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eesti keel (ET) (974.37 KB - PDF)
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polski (PL) (1.27 MB - PDF)
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română (RO) (1.3 MB - PDF)
slovenčina (SK) (1.21 MB - PDF)
slovenščina (SL) (1.18 MB - PDF)
Suomi (FI) (1.03 MB - PDF)
svenska (SV) (982.29 KB - PDF)

Latest procedure affecting product information: II/0004

12/10/2023

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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

български (BG) (144.11 KB - PDF)
español (ES) (121.79 KB - PDF)
čeština (CS) (126.11 KB - PDF)
dansk (DA) (119.05 KB - PDF)
Deutsch (DE) (123.25 KB - PDF)
eesti keel (ET) (116.88 KB - PDF)
ελληνικά (EL) (134.61 KB - PDF)
français (FR) (124.6 KB - PDF)
hrvatski (HR) (122.34 KB - PDF)
íslenska (IS) (131.46 KB - PDF)
italiano (IT) (120.11 KB - PDF)
latviešu valoda (LV) (123.85 KB - PDF)
lietuvių kalba (LT) (123.75 KB - PDF)
magyar (HU) (121.79 KB - PDF)
Malti (MT) (134.68 KB - PDF)
Nederlands (NL) (120.28 KB - PDF)
norsk (NO) (129.29 KB - PDF)
polski (PL) (137.11 KB - PDF)
português (PT) (124.04 KB - PDF)
română (RO) (123.01 KB - PDF)
slovenčina (SK) (125.73 KB - PDF)
slovenščina (SL) (124.15 KB - PDF)
Suomi (FI) (114.96 KB - PDF)
svenska (SV) (117.48 KB - PDF)

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

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.

Authorisation details

EMA product number
EMEA/H/C/006019
Marketing authorisation holder
Valneva Austria GmbH

Campus Vienna Biocenter 6
A-1030 Vienna
Austria

Opinion adopted
23/06/2022
Marketing authorisation issued
24/06/2022
Withdrawal of marketing authorisation
12/10/2023
Revision
6

Assessment history

COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Procedural steps taken and scientific information after authorisation

COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Public assessment report

CHMP summary of positive opinion for COVID-19 Vaccine (inactivated, adjuvanted) Valneva

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

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