Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Loerrach, Germany
Cejemly 600 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear to opalescent, colourless to slight yellow solution, essentially free from visible particles, pH 5.3 to 5.7. |
One vial of 20 mL of concentrate for solution for infusion contains 600 mg of sugemalimab.
Each mL of concentrate contains 30 mg of sugemalimab.
Sugemalimab is a fully human anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (IgG4 isotype) produced in Chinese hamster ovary cells by recombinant DNA technology.
Excipient with known effect: One vial contains 25.8 mg of sodium.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Sugemalimab |
Sugemalimab is a fully human immunoglobulin G4 monoclonal antibody. It specifically binds to programmed cell death ligand 1 (PD-L1), thus blocking its ligation with PD-1. |
| List of Excipients |
|---|
|
Histidine |
20 mL of concentrate for solution for infusion in Type 1 glass vial with an elastomeric stopper and a blue flip-off aluminum seal containing 600 mg sugemalimab.
Pack size of 2 vials.
SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Loerrach, Germany
EU/1/24/1833/001
| Drug | Countries | |
|---|---|---|
| CEJEMLY | Lithuania |
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