Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Regeneron Ireland Designated Activity Company (DAC), One Warrington Place, Dublin 2, D02 HH27, Ireland
Ordspono 2 mg concentrate for solution for infusion.
Ordspono 80 mg concentrate for solution for infusion.
Ordspono 320 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 5.8 and osmolality range of 276-414 mmol/kg for 2 mg/mL (2 mg), and a range of 291-437 mmol/kg for 20 mg/mL (80 mg and 320 mg). |
Ordspono 2 mg concentrate for solution for infusion: Each single-dose vial contains 2 mg of odronextamab in 1 mL at a concentration of 2 mg/mL.
Ordspono 80 mg concentrate for solution for infusion: Each single-dose vial contains 80 mg of odronextamab in 4 mL at a concentration of 20 mg/mL.
Ordspono 320 mg concentrate for solution for infusion: Each single-dose vial contains 320 mg of odronextamab in 16 mL at a concentration of 20 mg/mL.
Odronextamab is a recombinant human immunoglobulin (Ig)G4-based bispecific antibody that binds to CD20 and CD3. Odronextamab is 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 | |
|---|---|---|
| Odronextamab |
|
| List of Excipients |
|---|
|
L-histidine |
2 mg concentrate for solution for infusion:
1 mL of concentrate for solution for infusion in a 2 mL Type I clear glass vial with a grey chlorobutyl stopper with coating and an aluminium seal cap with a dark blue flip-off button containing 2 mg of odronextamab.
Pack of one vial.
80 mg concentrate for solution for infusion:
4 mL of concentrate for solution for infusion in a 10 mL Type I clear glass vial with a grey chlorobutyl stopper with coating and an aluminium seal cap with a light green flip-off button containing 80 mg of odronextamab.
Pack of one vial.
320 mg concentrate for solution for infusion:
16 mL of concentrate for solution for infusion in a 20 mL Type I clear glass vial with a grey chlorobutyl stopper with coating and an aluminium seal cap with a white flip-off button containing 320 mg of odronextamab.
Pack of one vial.
Regeneron Ireland Designated Activity Company (DAC), One Warrington Place, Dublin 2, D02 HH27, Ireland
EU/1/24/1843/001
EU/1/24/1843/002
EU/1/24/1843/003
| Drug | Countries | |
|---|---|---|
| ORDSPONO | Lithuania |
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