Xevudy
Withdrawn
This medicine's authorisation has been withdrawn
sotrovimab
MedicineHumanWithdrawn
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- Rolling review
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 18 February 2026, the European Commission withdrew the marketing authorisation for Xevudy (sotrovimab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, GlaxoSmithKline Trading Services Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Xevudy was granted marketing authorisation in the EU on 17 December 2021 for the treatment of coronavirus disease 2019 (COVID-19). The marketing authorisation was initially valid for a 5-year period.
Product information
Latest procedure affecting product information:VR/0000269654
16/06/2025
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
- Xevudy
- Active substance
- sotrovimab
- International non-proprietary name (INN) or common name
- sotrovimab
- Therapeutic area (MeSH)
- COVID-19 virus infection
- Anatomical therapeutic chemical (ATC) code
- J06BD05
Pharmacotherapeutic group
Immune sera and immunoglobulinsTherapeutic indication
Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19.
Assessment history
News on Xevudy
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