Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Propharma Group The Netherlands B.V., Schipholweg 73, 2316ZL Leiden, The Netherlands
Briumvi 150 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion [sterile solution]. Clear to opalescent, and colourless to slightly yellow solution. The pH of the solution is 6.3 to 6.7, and the osmolality is 340 to 380 mOsm/kg. |
Each vial contains 150 mg of ublituximab in 6 mL at a concentration of 25 mg/mL. The final concentration after dilution is approximately 0.6 mg/mL for the first infusion and 1.8 mg/mL for the second infusion and all subsequent infusions.
Ublituximab is a chimeric monoclonal antibody produced in a clone of the rat myeloma cell lineYB2/0 by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ublituximab |
Ublituximab is a chimeric monoclonal antibody that selectively targets CD20-expressing cells. CD20 is a cell surface antigen found on pre-B cells, mature and memory B cells but not expressed on lymphoid stem cells and plasma cells. The binding of ublituximab to CD20 induces lysis of CD20+ B cells. |
| List of Excipients |
|---|
|
Sodium chloride |
6 mL concentrate in a glass vial. Pack size of 1 vial.
Propharma Group The Netherlands B.V., Schipholweg 73, 2316ZL Leiden, The Netherlands
| Drug | Countries | |
|---|---|---|
| BRIUMVI | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United States |
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