COVID-19 Vaccine (inactivated, adjuvanted) Valneva
COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
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.
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COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Medicine overview (PDF/124.79 KB)
First published: 27/06/2022
Last updated: 01/07/2022
EMEA/H/C/006019 -
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COVID-19 Vaccine (inactivated, adjuvanted) Valneva : EPAR - Risk-management-plan (PDF/1.36 MB)
First published: 23/06/2022
Last updated: 01/07/2022
Authorisation details
Product details | |
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Name |
COVID-19 Vaccine (inactivated, adjuvanted) Valneva
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Agency product number |
EMEA/H/C/006019
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Active substance |
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020
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International non-proprietary name (INN) or common name |
COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
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Therapeutic area (MeSH) |
COVID-19 virus infection
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Anatomical therapeutic chemical (ATC) code |
J07BX03
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Additional 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 | |
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Marketing-authorisation holder |
Valneva Austria GmbH
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
24/06/2022
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Contact address |
Campus Vienna Biocenter 6 |
Product information
24/03/2023 COVID-19 Vaccine (inactivated, adjuvanted) Valneva - EMEA/H/C/006019 - II/0004
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).
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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COVID-19 vaccines - Safety update: 8 December 2022 (PDF/181.16 KB)
First published: 08/12/2022 -
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COVID-19 vaccines - Safety update: 10 November 2022 (PDF/193.65 KB)
Adopted
First published: 10/11/2022 -
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COVID-19 vaccines - Safety update: 6 October 2022 (PDF/179.91 KB)
Adopted
First published: 06/10/2022 -
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COVID-19 vaccines - Safety update: 8 September 2022 (PDF/194.49 KB)
Adopted
First published: 08/09/2022 -
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COVID-19 vaccines - Safety update: 14 July 2022 (PDF/198.21 KB)
Adopted
First published: 14/07/2022
Last updated: 03/08/2022
Rev. 1