Evusheld
Withdrawn
This medicine's authorisation has been withdrawn
tixagevimab / cilgavimab
MedicineHumanWithdrawn
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- Rolling review
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 12 September 2025, the European Commission withdrew the marketing authorisation for Evusheld (tixagevimab / cilgavimab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Evusheld was granted marketing authorisation in the EU on 25 March 2022 for pre-exposure prophylaxis and treatment of COVID-19. The marketing authorisation was initially valid for a 5-year period.
Product information
Latest procedure affecting product information:IB/0019
11/10/2024
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).
Product details
- Name of medicine
- Evusheld
- Active substance
- tixagevimab
- cilgavimab
- International non-proprietary name (INN) or common name
- tixagevimab
- cilgavimab
- Therapeutic area (MeSH)
- COVID-19 virus infection
Therapeutic indication
Prevention of COVID-19.
Assessment history
News on Evusheld
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