XEVUDY Concentrate for solution for infusion Ref.[28113] Active ingredients: Sotrovimab

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Xevudy 500 mg concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

A clear, colourless or yellow to brown solution, free from visible particles, with a pH of approximately 6 and an osmolality of approximately 290 mOsm/kg.

Qualitative and quantitative composition

Each vial contains 500 mg of sotrovimab in 8 mL (62.5 mg/mL).

Sotrovimab is a monoclonal antibody (IgG1, kappa) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description

Sotrovimab is a dual action, engineered human IgG1 mAb that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2. It is used for the treatment of symptomatic adults and adolescents with acute covid-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe covid infection.

List of Excipients

Histidine monohydrochloride
Polysorbate 80
Water for injections

Pack sizes and marketing

10 mL Type I borosilicate clear glass single-use vial, with a grey chlorobutyl elastomer stopper laminated with fluoropolymer, sealed with an aluminium flip-off cap.

Pack size: 1 vial.

Marketing authorization holder

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers



Drug Countries
XEVUDY Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania, United Kingdom

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