Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Opdualag 240 mg/80 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to slightly yellow liquid that is essentially free of particles. The solution has a pH of approximately 5.8 and an osmolality of approximately 310 mOsm/kg. |
Each mL of concentrate for solution for infusion contains 12 mg of nivolumab and 4 mg of relatlimab. One vial of 20 mL contains 240 mg of nivolumab and 80 mg of relatlimab.
Nivolumab and relatlimab are human immunoglobulin G4 (IgG4) monoclonal antibodies produced in Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Nivolumab |
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth. |
| List of Excipients |
|---|
|
Histidine |
Pack of one 25 mL vial (Type I glass), with a stopper (coated butyl rubber) and a yellow flip-off aluminium seal. Each vial is filled with 21.3 mL of solution, which includes an overfill of 1.3 mL.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/22/1679/001
| Drug | Countries | |
|---|---|---|
| OPDUALAG | Austria, France, Croatia, Israel, Italy, Lithuania, United States |
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