ZYNYZ Concentrate for solution for infusion Ref.[110050] Active ingredients: Retifanlimab

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands

Product name and form

ZYNYZ 500 mg concentrate for solution for infusion.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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
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

Sodium acetate trihydrate (for pH adjustment) (E262)
Acetic acid, glacial (E260)
Sucrose
Polysorbate 80 (E433)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/24/1800/001

Drugs

Drug Countries
ZYNYZ Lithuania, United States

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