Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
EXDENSUR 100 mg solution for injection in pre-filled pen.
EXDENSUR 100 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless, yellow to brown, clear to opalescent solution, with a pH of 6.0 and an osmolality of 350 mOsm/kg. |
Each mL of solution for injection contains 100 mg of depemokimab.
Depemokimab is a recombinant humanised (IgG1, kappa) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipients with known effect:
Each mL of solution for injection contains 0.2 mg polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Depemokimab targets human IL-5 with a binding affinity of 10.5 pM, thereby blocking the binding to the IL-5 receptor alpha expressed on the cell surface with picomolar potency (IC50 4 pM) in vitro. IL-5 is a pleiotropic cytokine with established impact on eosinophils and other immune and structural cells. In severe asthma, inhibition of IL-5 has demonstrated an improvement in epithelial integrity, mucus plugging and reduction in tissue remodelling. However, the mechanism of action has not been definitively established. |
| List of Excipients |
|---|
|
Histidine |
EXDENSUR 100 mg solution for injection in pre-filled pen:
1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Pack size: 1 pre-filled pen.
EXDENSUR 100 mg solution for injection in pre-filled syringe:
1 mL solution in a Type 1 glass syringe with a fixed needle (stainless steel) and passive safety needle guard.
Pack size: 1 pre-filled syringe.
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
EXDENSUR 100 mg solution for injection in pre-filled pen: EU/1/25/2007/001
EXDENSUR 100 mg solution for injection in pre-filled syringe: EU/1/25/2007/002
| Drug | Countries | |
|---|---|---|
| EXDENSUR | Estonia, Lithuania, United States |
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