Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Henlius Europe GmbH, Sternstraße 67, 40479 Düsseldorf, Germany
HETRONIFLY 10 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Colourless to slightly yellow, clear to slightly opalescent solution, pH 5.2-5.8, osmolality of approximately 280-340 mOsm/kg. |
Each ml of concentrate for solution for infusion contains 10 mg of serplulimab.
One vial of 10 ml of concentrate contains 100 mg of serplulimab.
Serplulimab is a humanised antibody (IgG4/kappa isotype with a stabilising sequence alteration in the hinge region) produced in Chinese hamster ovary cells by recombinant DNA technology.
Excipient with known effect:
Each 10 ml vial contains 0.98 mmol (22.5 mg) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Serplulimab |
Serplulimab (HLX10) is a humanised monoclonal IgG4 antibody, which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion. |
| List of Excipients |
|---|
|
Citric acid monohydrate |
10 ml of concentrate in a 10 ml Type I clear glass vial with chlorobutyl rubber stopper and aluminium-plastic combination caps containing 100 mg of serplulimab.
Pack of 1 vial.
Henlius Europe GmbH, Sternstraße 67, 40479 Düsseldorf, Germany
EU/1/24/1870/001
| Drug | Countries | |
|---|---|---|
| HETRONIFLY | Lithuania |
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