Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: BeiGene Ireland Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland, Tel. +353 1 566 7660, E-mail: bg.ireland@beigene.com
Tevimbra 100 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to slightly yellowish solution. The solution has a pH of approximately 6.5 and an osmolality of approximately 270 to 330 mOsm/kg. |
Each ml of concentrate for solution for infusion contains 10 mg tislelizumab.
Each vial of 10 ml contains 100 mg tislelizumab.
Tislelizumab is an Fc-engineered humanised immunoglobulin G4 (IgG4) variant monoclonal antibody produced in recombinant Chinese hamster ovary cells.
Excipient with known effect: Each ml of concentrate for solution for infusion contains 0.069 mmol (or 1.6 mg) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tislelizumab |
Tislelizumab is a humanised immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1, binding to the extracellular domain of human PD-1. It competitively blocks the binding of both PD-L1 and PD-L2, inhibiting PD-1-mediated negative signalling and enhancing the functional activity in T cells in in vitro cell-based assays. |
| List of Excipients |
|---|
|
Sodium citrate dihydrate |
10 ml of Tevimbra concentrate is provided in a clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Tevimbra is available in unit packs containing 1 vial and in multipacks containing 2 (2 packs of 1) vials.
BeiGene Ireland Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland, Tel. +353 1 566 7660, E-mail: bg.ireland@beigene.com
EU/1/23/1758/001-002
| Drug | Countries | |
|---|---|---|
| TEVIMBRA | Austria, Estonia, Croatia, Lithuania |
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