Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
COVID-19 Vaccine (ChAdOx1-S [recombinant])
Overview
Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older.
Vaxzevria is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19.
Vaxzevria does not contain the virus itself and cannot cause COVID-19.
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Medicine overview (PDF/165.94 KB)
First published: 18/02/2021
Last updated: 30/11/2022
EMA/609262/2021 -
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Risk-management-plan (PDF/872.62 KB)
First published: 18/02/2021
Last updated: 16/08/2023
Authorisation details
Product details | |
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Name |
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
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Agency product number |
EMEA/H/C/005675
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Active substance |
ChAdOx1-SARS-COV-2
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International non-proprietary name (INN) or common name |
COVID-19 Vaccine (ChAdOx1-S [recombinant])
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Therapeutic area (MeSH) |
COVID-19 virus infection
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Anatomical therapeutic chemical (ATC) code |
J07BN02
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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 |
AstraZeneca AB
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Revision |
30
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Date of issue of marketing authorisation valid throughout the European Union |
29/01/2021
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Contact address |
151 85 Sodertalje |
Product information
15/09/2023 Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - EMEA/H/C/005675 - PSUSA/00010912/202212
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
Vaxzevria is indicated for active immunisation to prevent COVID 19 caused by SARS CoV 2, in individuals 18 years of age and older.
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/720.9 KB) (updated)
First published: 08/12/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 10 November 2022 (PDF/726.69 KB) (updated)
Adopted
First published: 10/11/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 6 October 2022 (PDF/716.78 KB) (updated)
Adopted
First published: 06/10/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 8 September 2022 (PDF/729.47 KB) (updated)
Adopted
First published: 08/09/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 14 July 2022 (PDF/731.54 KB) (updated)
Adopted
First published: 14/07/2022
Last updated: 01/12/2023
Rev. 1 -
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COVID-19 vaccines - Safety update: 17 June 2022 (PDF/235.43 KB)
Adopted
First published: 17/06/2022 -
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COVID-19 vaccines - Safety update: 12 May 2022 (PDF/203.03 KB)
Adopted
First published: 12/05/2022 -
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COVID-19 vaccines - Safety update: 13 April 2022 (PDF/214.65 KB)
Adopted
First published: 13/04/2022 -
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COVID-19 vaccines - Safety update: 17 March 2022 (PDF/221.74 KB)
Adopted
First published: 17/03/2022 -
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COVID-19 vaccines - Safety update: 17 February 2022 (PDF/212.51 KB)
Adopted
First published: 17/02/2022 -
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COVID-19 vaccines - Safety update: 20 January 2022 (PDF/234.12 KB)
Adopted
First published: 20/01/2022 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 9 December 2021 (PDF/171.7 KB)
Adopted
First published: 09/12/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 11 November 2021 (PDF/99.26 KB)
Adopted
First published: 11/11/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 6 October 2021 (PDF/115.75 KB)
Adopted
First published: 06/10/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 8 September 2021 (PDF/156.83 KB)
Adopted
First published: 08/09/2021
Last updated: 14/09/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 11 August 2021 (PDF/90.13 KB)
Adopted
First published: 11/08/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 July 2021 (PDF/99.8 KB)
Adopted
First published: 14/07/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 18 June 2021 (PDF/193.35 KB)
Adopted
First published: 18/06/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 21 May 2021 (PDF/85.78 KB)
Adopted
First published: 21/05/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 11 May 2021 (PDF/87.31 KB)
Adopted
First published: 12/05/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021 (PDF/101.03 KB)
Adopted
First published: 16/04/2021 -
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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 29 March 2021 (PDF/185.91 KB)
Adopted
First published: 30/03/2021
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 202214/10/2022
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20/05/2022
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24/01/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 202129/01/2021
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29/01/2021
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12/01/2021
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30/12/2020
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01/10/2020