Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Columvi 2.5 mg concentrate for solution for infusion.
Columvi 10 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Colourless, clear solution with a pH of 5.5 and osmolality of 270-350 mOsmol/kg. |
Columvi 2.5 mg concentrate for solution for infusion: Each vial of 2.5 mL of concentrate contains 2.5 mg of glofitamab at a concentration of 1 mg/mL.
Columvi 10 mg concentrate for solution for infusion: Each vial of 10 mL of concentrate contains 10 mg of glofitamab at a concentration of 1 mg/mL.
Glofitamab is a humanised anti-CD20/anti-CD3 bispecific monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glofitamab |
Glofitamab is a bispecific monoclonal antibody that binds bivalently to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells. By simultaneous binding to CD20 on the B cell and CD3 on the T cell, glofitamab mediates the formation of an immunological synapse with subsequent T-cell activation and proliferation, secretion of cytokines and release of cytolytic proteins that results in the lysis of CD20-expressing B cells. |
| List of Excipients |
|---|
|
L-histidine |
Columvi 2.5 mg concentrate for solution for infusion:
2.5 mL concentrate for solution for infusion in a 6 mL vial (colourless Type I glass) with stopper (butyl rubber).
Pack size of 1 vial.
Columvi 10 mg concentrate for solution for infusion:
10 mL concentrate for solution for infusion in a 15 mL vial (colourless Type I glass) with stopper (butyl rubber).
Pack size of 1 vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/23/1742/001
EU/1/23/1742/002
| Drug | Countries | |
|---|---|---|
| COLUMVI | Austria, Canada, Estonia, France, Croatia, Ireland, Israel, Lithuania, Romania, United Kingdom, United States |
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