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The marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva has been withdrawn at the request of the marketing authorisation holder.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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magyar (HU) (327.46 KB - PDF)
Malti (MT) (397.24 KB - PDF)
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polski (PL) (353.81 KB - PDF)
português (PT) (293.01 KB - PDF)
română (RO) (360.97 KB - PDF)
slovenčina (SK) (371.58 KB - PDF)
slovenščina (SL) (329.43 KB - PDF)
Suomi (FI) (277.49 KB - PDF)
svenska (SV) (281.18 KB - PDF)
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Risk-management-plan
English (EN) (1.36 MB - PDF)
Product information
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Product information
English (EN) (1.03 MB - PDF)
български (BG) (1.39 MB - PDF)
español (ES) (1.1 MB - PDF)
čeština (CS) (1.19 MB - PDF)
dansk (DA) (1.01 MB - PDF)
Deutsch (DE) (1.08 MB - PDF)
eesti keel (ET) (974.37 KB - PDF)
ελληνικά (EL) (1.46 MB - PDF)
français (FR) (1.04 MB - PDF)
hrvatski (HR) (1.15 MB - PDF)
italiano (IT) (1.09 MB - PDF)
latviešu valoda (LV) (1.27 MB - PDF)
lietuvių kalba (LT) (1.23 MB - PDF)
magyar (HU) (1.2 MB - PDF)
Nederlands (NL) (1.08 MB - PDF)
norsk (NO) (991.74 KB - PDF)
polski (PL) (1.27 MB - PDF)
português (PT) (1.02 MB - PDF)
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
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)
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
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.
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
English (EN) (329.01 KB - PDF)
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Public assessment report
English (EN) (8.35 MB - PDF)
CHMP summary of positive opinion for COVID-19 Vaccine (inactivated, adjuvanted) Valneva
English (EN) (267.38 KB - PDF)
Safety updates
COVID-19 vaccines - Safety update: 8 December 2022
English (EN) (231.07 KB - PDF)
COVID-19 vaccines - Safety update: 10 November 2022
English (EN) (244.31 KB - PDF)
COVID-19 vaccines - Safety update: 6 October 2022
English (EN) (230.7 KB - PDF)
COVID-19 vaccines - Safety update: 8 September 2022
English (EN) (246.95 KB - PDF)
COVID-19 vaccines - Safety update: 14 July 2022
English (EN) (255.05 KB - PDF)
COVID-19 Vaccine (inactivated, adjuvanted) Valneva: Periodic safety update report assessment 28 February 2022 to 27 August 2022
English (EN) (2.43 MB - PDF)
COVID-19 Vaccine (inactivated, adjuvanted) Valneva : Periodic safety update report assessment 28 August 2022 to 27 February 2023
English (EN) (1.73 MB - PDF)
News on COVID-19 Vaccine (inactivated, adjuvanted) Valneva
More information on COVID-19 Vaccine (inactivated, adjuvanted) Valneva
Public statement on COVID-19 Vaccine (inactivated, adjuvanted) Valneva
English (EN) (117.94 KB - PDF)