Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
ZYNYZ 500 mg concentrate for solution for infusion.
Pharmaceutical Form |
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Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale yellow solution, with a pH of 5.1 and osmolality between 275 and 355 mOsm/kg. |
One vial of 20 mL concentrate contains 500 mg of retifanlimab.
Each mL of concentrate contains 25 mg of retifanlimab.
Retifanlimab is an anti-programmed cell death protein-1 (PD-1) immunoglobulin G4 (IgG4) humanised monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Retifanlimab |
Retifanlimab is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed death receptor-1 (PD-1) and blocks its interaction with its ligands PD-L1 and PD-L2. Engagement of PD-1 with its ligands PD-L1 and PD-L2, which are expressed by antigen presenting cells and may be expressed by tumour cells and/or other cells in the tumour microenvironment, results in inhibition of T-cell function such as proliferation, cytokine secretion and cytotoxic activity. Retifanlimab binds to the PD-1 receptor, blocks interaction with its ligands PD-L1 and PD-L2, and potentiates T-cell activity. |
List of Excipients |
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Sodium acetate trihydrate (for pH adjustment) (E262) |
Type I glass vial, closed with a FluroTec-coated chlorobutyl rubber stopper, aluminium seal and plastic flip-off cap, containing 20 mL concentrate.
Each carton contains one vial.
Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
EU/1/24/1800/001
Drug | Countries | |
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ZYNYZ | Lithuania, United States |
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