Xevudy

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sotrovimab

Authorised
This medicine is authorised for use in the European Union.

Overview

Xevudy is a medicine used for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Xevudy contains the active substance sotrovimab.

This EPAR was last updated on 28/07/2022

Authorisation details

Product details
Name
Xevudy
Agency product number
EMEA/H/C/005676
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
Additional monitoringAdditional 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
Marketing-authorisation holder
GlaxoSmithKline Trading Services Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
17/12/2021
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Product information

22/07/2022 Xevudy - EMEA/H/C/005676 - II/0005

Product information documents contain:

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

Immune sera and immunoglobulins

Therapeutic 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 (see section 5.1).

Assessment history

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