Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
KAVIGALE 300 mg solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion (injection/infusion). Clear to opalescent, colourless to slightly yellow, pH 6.0 solution. |
Each vial contains 300 mg of sipavibart in 2 ml (150 mg/ml).
Sipavibart is a recombinant human immunoglobulin (Ig) G1 based antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipient with known effect:
Each vial contains 0.8 mg polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sipavibart |
Sipavibart is a recombinant human IgG1 monoclonal antibody that provides passive immunisation by binding the SARS-CoV-2 spike protein receptor binding domain (RBD). Sipavibart is long-acting, with amino acid substitutions to extend antibody half-life (YTE) and to reduce antibody effector function and potential risk of antibody-dependent enhancement of disease (TM). |
| List of Excipients |
|---|
|
Histidine |
2 ml of solution for injection/infusion in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a light green aluminium flip-off top.
Pack size of 1 vial.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/24/1900/001
| Drug | Countries | |
|---|---|---|
| KAVIGALE | Austria, Lithuania |
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