Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Topalliance Biosciences Europe Limited, Ground Floor, Two Dockland Central, Guild Street, I.f.s.c., Dublin 1, Co. Dublin, D01 K2C5, Ireland
LOQTORZI 240 mg concentrate for solution for infusion.
| Pharmaceutical Form |
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Concentrate for solution for infusion. Clear to slightly opalescent, colourless to slightly yellow solution essentially free from visible particles. The concentrate for solution has a pH of 5.5 – 6.5 and an osmolality of 260-340 mOsmol/kg. |
One vial of concentrate for solution for infusion contains 240 mg of toripalimab.
Each mL of concentrate for solution for infusion contains 40 mg of toripalimab.
Toripalimab is an immunoglobulin G4 (IgG4) humanised monoclonal antibody (mAb), produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1
| Active Ingredient |
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Toripalimab is a humanised IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumour immune response. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation, cytokine production, and cytotoxic activity. |
| List of Excipients |
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Citric acid monohydrate |
Type 1 neutral borosilicate glass vial capped sealed with a chlorobutyl rubber stopper and sealed with a 20 mm flip-off seal (aluminium), containing 6 mL of concentrate for solution for infusion.
Each carton contains one vial.
Topalliance Biosciences Europe Limited, Ground Floor, Two Dockland Central, Guild Street, I.f.s.c., Dublin 1, Co. Dublin, D01 K2C5, Ireland
EU/1/24/1853/001
Date of first authorisation: 19-09-2024
| Drug | Countries | |
|---|---|---|
| LOQTORZI | Austria, Lithuania, United States |
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