Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

Rolling review
Application under evaluation
CHMP opinion
European Commission decision

Overview

The marketing authorisation for Vaxzevria (SRD) has been withdrawn at the request of the marketing-authorisation holder.

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Medicine overview

Reference Number: EMA/609262/2021

English (EN) (314.66 KB - PDF)

First published: 18/02/2021Last updated: 07/05/2024

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Other languages (22)

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Risk-management-plan

English (EN) (3.02 MB - PDF)

First published: 18/02/2021Last updated: 07/05/2024

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Product information

Vaxzevria : EPAR - Product information

English (EN) (709.52 KB - PDF)

First published: 18/02/2021Last updated: 07/05/2024

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Other languages (24)

Latest procedure affecting product information: II/0096

07/03/2024

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).

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - All authorised presentation

English (EN) (57.61 KB - PDF)

First published: 18/02/2021Last updated: 07/05/2024

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Product details

Name of medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
Active substance: ChAdOx1-SARS-COV-2
International non-proprietary name (INN) or common name: COVID-19 Vaccine (ChAdOx1-S [recombinant])
Therapeutic area (MeSH): COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code: J07BN02

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.

Authorisation details

EMA product number: EMEA/H/C/005675
Marketing authorisation holder: AstraZeneca AB
151 85 Sodertalje
Sweden
Opinion adopted: 29/01/2021
Marketing authorisation issued: 29/01/2021
Withdrawal of marketing authorisation: 27/03/2024
Revision: 32

Assessment history

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (1.13 MB - PDF)

First published: 23/03/2021Last updated: 07/05/2024

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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202212 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/317895/2023

English (EN) (713.83 KB - PDF)

First published: 21/09/2023Last updated: 07/05/2024

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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202206: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/38839/2023

English (EN) (701.32 KB - PDF)

First published: 20/03/2023Last updated: 07/05/2024

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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-R-0079 : EPAR - Assessment report - Renewal

AdoptedReference Number: EMA/865685/2022

English (EN) (1.3 MB - PDF)

First published: 17/11/2022Last updated: 07/05/2024

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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202112 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/666408/2022

English (EN) (722.66 KB - PDF)

First published: 12/08/2022Last updated: 07/05/2024

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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-II-0052 : EPAR - Assessment report - Variation

AdoptedReference Number: EMA/351687/2022

English (EN) (10.41 MB - PDF)

First published: 04/08/2022Last updated: 07/05/2024

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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-R-0037 : EPAR - Assessment report - Renewal

AdoptedReference Number: EMA/622071/2021

English (EN) (1.41 MB - PDF)

First published: 18/11/2021Last updated: 07/05/2024

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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Public assessment report

AdoptedReference Number: EMA/94907/2021

English (EN) (9.96 MB - PDF)

First published: 18/02/2021Last updated: 07/05/2024

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CHMP summary of positive opinion for COVID-19 Vaccine AstraZeneca

AdoptedReference Number: EMA/57617/2021

English (EN) (269.64 KB - PDF)

First published: 29/01/2021Last updated: 07/05/2024

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Safety updates

Vaxzevria: Periodic safety update report assessment 29 December 2022 to 28 December 2023

English (EN) (15.79 MB - PDF)

First published: 22/08/2024

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COVID-19 vaccines - Safety update: 14 July 2022

AdoptedReference Number: Rev. 1

English (EN) (263.34 KB - PDF)

First published: 14/07/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 8 September 2022

Adopted

English (EN) (257.73 KB - PDF)

First published: 08/09/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 17 March 2022

Adopted

English (EN) (237.65 KB - PDF)

First published: 17/03/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 6 October 2022

Adopted

English (EN) (237.46 KB - PDF)

First published: 06/10/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 8 December 2022

Reference Number: Rev. 2

English (EN) (239.73 KB - PDF)

First published: 08/12/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 10 November 2022

Adopted

English (EN) (254.94 KB - PDF)

First published: 10/11/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 12 May 2022

Adopted

English (EN) (214.22 KB - PDF)

First published: 12/05/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 13 April 2022

Adopted

English (EN) (228.5 KB - PDF)

First published: 13/04/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 17 February 2022

Adopted

English (EN) (226.15 KB - PDF)

First published: 17/02/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 17 June 2022

Adopted

English (EN) (249.16 KB - PDF)

First published: 17/06/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 20 January 2022

Adopted

English (EN) (251.15 KB - PDF)

First published: 20/01/2022Last updated: 09/08/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 8 September 2021

Adopted

English (EN) (492.14 KB - PDF)

First published: 08/09/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 9 December 2021

Adopted

English (EN) (301.05 KB - PDF)

First published: 09/12/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 11 August 2021

Adopted

English (EN) (280.1 KB - PDF)

First published: 11/08/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 11 November 2021

Adopted

English (EN) (333.55 KB - PDF)

First published: 11/11/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 April 2021

Adopted

English (EN) (340.14 KB - PDF)

First published: 16/04/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 14 July 2021

Adopted

English (EN) (347.15 KB - PDF)

First published: 14/07/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 18 June 2021

Adopted

English (EN) (489.91 KB - PDF)

First published: 18/06/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 21 May 2021

Adopted

English (EN) (264.25 KB - PDF)

First published: 21/05/2021Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 29 March 2021

Adopted

English (EN) (413.69 KB - PDF)

First published: 30/03/2021Last updated: 07/05/2024

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Vaxzevria: Periodic safety update report assessment 29 December 2021 to 28 June 2022

English (EN) (39.56 MB - PDF)

First published: 18/12/2023Last updated: 07/05/2024

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Vaxzevria: Periodic safety update report assessment 29 June 2022 to 28 December 2022

English (EN) (15.04 MB - PDF)

First published: 21/12/2023Last updated: 07/05/2024

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 6 October 2021

Adopted

English (EN) (115.75 KB - PDF)

First published: 06/10/2021

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COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 11 May 2021

Adopted

English (EN) (87.31 KB - PDF)

First published: 12/05/2021

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News on Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

This page was last updated on 22/08/2024

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

Withdrawn

Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

Authorisation details

Assessment history

Changes since initial authorisation of medicine

Initial marketing authorisation documents

Safety updates

News on Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

Signal assessment reports

Related information on Vaxzevria

External links

More information on Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

More information on Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

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