Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
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. |
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 |
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 |
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.
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/21/1562/001
| Drug | Countries | |
|---|---|---|
| XEVUDY | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania, United Kingdom |
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