🇪🇺 SOTROVIMAB in European Union

EMA authorised SOTROVIMAB on 18 February 2026

Marketing authorisation

EMA — authorised 18 February 2026

  • Application: EMEA/H/C/005676
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Xevudy
  • 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.
  • Status: withdrawn

The European Medicines Agency (EMA) granted marketing authorisation for SOTROVIMAB, also known as Xevudy, on 18 February 2026. This authorisation allows the treatment of adults and adolescents aged 12 years and over, weighing at least 40 kg, with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and are at increased risk of progressing to severe COVID-19. The marketing authorisation holder is GlaxoSmithKline Trading Services Limited.

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SOTROVIMAB in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is SOTROVIMAB approved in European Union?

Yes. EMA authorised it on 18 February 2026.

Who is the marketing authorisation holder for SOTROVIMAB in European Union?

GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.