COVID-19 Vaccine (inactivated, adjuvanted) Valneva

RSS
Withdrawn

This medicine's authorisation has been withdrawn

COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
MedicineHumanWithdrawn
  • Rolling review
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 12 October 2023, the European Commission withdrew the marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva (SARS-CoV-2 virus, strain Wuhan hCoV-19/Italy/INMI1- isl/2020, inactivated) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Valneva Austria GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

COVID-19 Vaccine (inactivated, adjuvanted) Valneva was granted marketing authorisation in the EU on 24 June 2022 for active immunisation against coronavirus disease 2019 (COVID-19). The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for COVID-19 Vaccine (inactivated, adjuvanted) Valneva is updated to indicate that the marketing authorisation is no longer valid.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Medicine overview

English (EN) (276.06 KB - PDF)

First published: Last updated:
View

български (BG) (412.12 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

español (ES) (296.05 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

čeština (CS) (353.49 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

dansk (DA) (280.97 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

Deutsch (DE) (314.28 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

eesti keel (ET) (273.24 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

ελληνικά (EL) (416.76 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

français (FR) (301.09 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

hrvatski (HR) (340.66 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

italiano (IT) (285.18 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

latviešu valoda (LV) (359.53 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

lietuvių kalba (LT) (343.51 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

magyar (HU) (327.46 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

Malti (MT) (397.24 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

Nederlands (NL) (302.98 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

polski (PL) (353.81 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

português (PT) (293.01 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

română (RO) (360.97 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

slovenčina (SK) (371.58 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

slovenščina (SL) (329.43 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

Suomi (FI) (277.49 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

svenska (SV) (281.18 KB - PDF)

First published: 27/06/2023Last updated: 01/12/2023
View

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

English (EN) (1.36 MB - PDF)

First published: Last updated:
View

Product information

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

English (EN) (1.03 MB - PDF)

First published: Last updated:
View

български (BG) (1.39 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

español (ES) (1.1 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

čeština (CS) (1.19 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

dansk (DA) (1.01 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

Deutsch (DE) (1.08 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

eesti keel (ET) (974.37 KB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

ελληνικά (EL) (1.46 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

français (FR) (1.04 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

hrvatski (HR) (1.15 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

italiano (IT) (1.09 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

latviešu valoda (LV) (1.27 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

lietuvių kalba (LT) (1.23 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

magyar (HU) (1.2 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

Nederlands (NL) (1.08 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

norsk (NO) (991.74 KB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

polski (PL) (1.27 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

português (PT) (1.02 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

română (RO) (1.3 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

slovenčina (SK) (1.21 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

slovenščina (SL) (1.18 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

Suomi (FI) (1.03 MB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View

svenska (SV) (982.29 KB - PDF)

First published: 23/06/2022Last updated: 01/12/2023
View
Latest procedure affecting product information: II/0004
12/10/2023
icon globe

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

English (EN) (86.74 KB - PDF)

First published: Last updated:
View

български (BG) (144.11 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

español (ES) (121.79 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

čeština (CS) (126.11 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

dansk (DA) (119.05 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

Deutsch (DE) (123.25 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

eesti keel (ET) (116.88 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

ελληνικά (EL) (134.61 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

français (FR) (124.6 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

hrvatski (HR) (122.34 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

íslenska (IS) (131.46 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

italiano (IT) (120.11 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

latviešu valoda (LV) (123.85 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

lietuvių kalba (LT) (123.75 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

magyar (HU) (121.79 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

Malti (MT) (134.68 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

Nederlands (NL) (120.28 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

norsk (NO) (129.29 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

polski (PL) (137.11 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

português (PT) (124.04 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

română (RO) (123.01 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

slovenčina (SK) (125.73 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

slovenščina (SL) (124.15 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

Suomi (FI) (114.96 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

svenska (SV) (117.48 KB - PDF)

First published: 01/07/2022Last updated: 01/12/2023
View

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 3
Landstrasse
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

English (EN) (329.01 KB - PDF)

First published: Last updated:
View

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

AdoptedReference Number: EMA/627695/2022

English (EN) (8.35 MB - PDF)

First published: Last updated:
View

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

AdoptedReference Number: EMEA/H/C/006019

English (EN) (267.38 KB - PDF)

First published: Last updated:
View

Safety updates

COVID-19 vaccines - Safety update: 14 July 2022

AdoptedReference Number: Rev. 1

English (EN) (263.34 KB - PDF)

First published: Last updated:
View

COVID-19 vaccines - Safety update: 8 September 2022

Adopted

English (EN) (257.73 KB - PDF)

First published: Last updated:
View

COVID-19 vaccines - Safety update: 6 October 2022

Adopted

English (EN) (237.46 KB - PDF)

First published: Last updated:
View

COVID-19 vaccines - Safety update: 8 December 2022

Reference Number: Rev. 2

English (EN) (239.73 KB - PDF)

First published: Last updated:
View

COVID-19 vaccines - Safety update: 10 November 2022

Adopted

English (EN) (254.94 KB - PDF)

First published: Last updated:
View

COVID-19 Vaccine (inactivated, adjuvanted) Valneva: Periodic safety update report assessment 28 February 2022 to 27 August 2022

English (EN) (2.43 MB - PDF)

First published: Last updated:
View

COVID-19 Vaccine (inactivated, adjuvanted) Valneva : Periodic safety update report assessment 28 August 2022 to 27 February 2023

English (EN) (1.73 MB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page

Back to top