Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
JEMPERLI 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 yellow solution, essentially free from visible particles. The concentrate for solution for infusion has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg. |
One vial of 10 mL concentrate for solution for infusion contains 500 mg of dostarlimab.
Each mL of concentrate for solution for infusion contains 50 mg of dostarlimab.
Dostarlimab is an anti-programmed cell death protein-1 (PD-1) immunoglobulin G4 (IgG4) humanised monoclonal antibody (mAb), produced by recombinant DNA technology in mammalian Chinese hamster ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dostarlimab |
Dostarlimab is a humanised mAb of the IgG4 isotype that binds to PD-1 receptors and blocks the interactions of binding with its ligands PD-L1 and PD-L2. The inhibition of PD-1 pathway-mediated immune response results in reactivation of T-cell function such as proliferation, cytokine production, and cytotoxic activity. Dostarlimab potentiates T-cell responses, including anti-tumour immuno responses through blockade of PD-1 binding to PD-L1 and PD-L2. |
| List of Excipients |
|---|
|
Trisodium citrate dihydrate |
10 mL type I borosilicate clear glass vial, with a grey chlorobutyl elastomer stopper laminated with fluoropolymer, sealed with an aluminium flip-off cap containing 500 mg dostarlimab.
Each carton contains one vial.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/21/1538/001
Date of first authorisation: 21 April 2021
Date of latest renewal: 15 February 2023
| Drug | Countries | |
|---|---|---|
| JEMPERLI | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom |
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