Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
EVUSHELD 150 mg + 150 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection) Clear to opalescent, colourless to slightly yellow, pH 6.0 solution. |
Each carton contains two vials:
Each vial of tixagevimab contains 150 mg of tixagevimab in 1.5 mL (100 mg/mL).
Each vial of cilgavimab contains 150 mg of cilgavimab in 1.5 mL (100 mg/mL).
Tixagevimab and cilgavimab are produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tixagevimab and Cilgavimab |
Tixagevimab and cilgavimab are two recombinant human IgG1 monoclonal antibodies, with amino acid substitutions in the Fc regions, to extend antibody half-life and to reduce antibody effector function and potential risk of antibody-dependent enhancement of disease. Tixagevimab and cilgavimab can simultaneously bind to non-overlapping regions of the spike protein receptor binding domain (RBD) of SARS-CoV-2. Tixagevimab, cilgavimab and their combination bind to spike blocking its interaction with the human ACE2 receptor, resulting in a blockade of virus entry. |
| List of Excipients |
|---|
|
Histidine |
Tixagevimab vial: 1.5 mL of solution for injection in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a dark-grey aluminium flip-off top.
Cilgavimab vial: 1.5 mL of solution for injection in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a white aluminium flip-off top.
Pack size: Each carton contains 2 vials: 1 vial of tixagevimab and 1 vial of cilgavimab.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/22/1651/001
| Drug | Countries | |
|---|---|---|
| EVUSHELD | Austria, Australia, Canada, Estonia, Ireland, Japan, Lithuania, Poland, Romania, United States |
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