Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

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COVID-19 Vaccine (ChAdOx1-S [recombinant])

Authorised
This medicine is authorised for use in the European Union.

Overview

Vaxzevria is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus.

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.

Vaxzevria does not contain the virus itself and cannot cause COVID-19.

Detailed information about this vaccine is available in the product information, which includes the package leaflet.

This EPAR was last updated on 03/12/2021

Authorisation details

Product details
Name
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
Agency product number
EMEA/H/C/005675
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
J07BX03
Additional monitoringAdditional 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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
29/01/2021
Contact address

151 85 Sodertalje
Sweden

Product information

02/12/2021 Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - EMEA/H/C/005675 - II/0040

Contents

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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

News

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