Evusheld
tixagevimab / cilgavimab
Table of contents
Overview
Evusheld is a medicine used to prevent COVID-19 in adults and adolescents (from 12 years of age weighing at least 40 kilograms). It is also used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.
Evusheld contains two active substances, tixagevimab and cilgavimab.
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List item
Evusheld : EPAR - Medicine overview (PDF/122.93 KB)
First published: 30/03/2022
Last updated: 07/11/2022
EMA/173193/2022 -
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List item
Evusheld : EPAR - Risk-management-plan (PDF/881.67 KB)
First published: 05/05/2022
Last updated: 07/11/2022
Authorisation details
Product details | |
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Name |
Evusheld
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Agency product number |
EMEA/H/C/005788
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
COVID-19 virus infection
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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 |
3
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Date of issue of marketing authorisation valid throughout the European Union |
25/03/2022
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Contact address |
151 85 Sodertalje |
Product information
16/08/2023 Evusheld - EMEA/H/C/005788 - PSUSA/00010992/202211
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
Therapeutic indication
Prevention of COVID-19.