Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Horizon Therapeutics Ireland DAC, 70 St. Stephens Green, Dublin 2, D02 E2X4, Ireland
Uplizna 100 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 slightly yellow solution. The solution has a pH of approximately 6.0 and an osmolality of approximately 280 mOsm/kg. |
Each vial contains 100 mg of inebilizumab in 10 mL at a concentration of 10 mg/mL. The final concentration after dilution is 1.0 mg/mL.
Inebilizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cell line by recombinant DNA technology.
Excipient with known effect: This medicinal product contains 16.1 mg of sodium per vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Inebilizumab |
Inebilizumab is a monoclonal antibody that specifically binds to CD19, a cell surface antigen present on pre-B and mature B-cell lymphocytes, including plasmablasts and some plasma cells. Following cell surface binding to B lymphocytes, inebilizumab supports antibody-dependent cellular cytolysis (ADCC) and antibody-dependent cellular phagocytosis (ADCP). B cells are believed to play a central role in the pathogenesis of NMOSD. The precise mechanism by which inebilizumab exerts its therapeutic effects in NMOSD is unknown. |
| List of Excipients |
|---|
|
Histidine |
10 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a mist gray flip-off aluminium seal.
Pack size of 3 vials.
Horizon Therapeutics Ireland DAC, 70 St. Stephen’s Green, Dublin 2, D02 E2X4, Ireland
EU/1/21/1602/001
Date of first authorisation: 25 April 2022
| Drug | Countries | |
|---|---|---|
| UPLIZNA | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Japan, Lithuania, United States |
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