COVID-19 Vaccine AstraZeneca
COVID-19 Vaccine (ChAdOx1-S [recombinant])
Table of contents
Overview
COVID-19 Vaccine AstraZeneca 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.
COVID-19 Vaccine AstraZeneca 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.
COVID-19 Vaccine AstraZeneca 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.
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COVID-19 Vaccine AstraZeneca : EPAR - Medicine overview (PDF/132.54 KB) (new)
First published: 18/02/2021
EMA/60496/2021 -
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COVID-19 Vaccine AstraZeneca : EPAR - Risk-management-plan (PDF/847.95 KB) (new)
First published: 18/02/2021
Authorisation details
Product details | |
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Name |
COVID-19 Vaccine AstraZeneca
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Agency product number |
EMEA/H/C/005675
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Active substance |
Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S)
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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 |
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. |
Conditional 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 | |
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Marketing-authorisation holder |
AstraZeneca AB
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Date of issue of marketing authorisation valid throughout the European Union |
29/01/2021
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Contact address |
Product information
29/01/2021 COVID-19 Vaccine AstraZeneca - EMEA/H/C/005675 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
COVID-19 Vaccine AstraZeneca 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.