Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132 NP, Hoofddorp, Netherlands
POTELIGEO 4 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear to slightly opalescent, colourless solution. |
Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL.
Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mogamulizumab |
Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells. |
| List of Excipients |
|---|
|
Citric acid monohydrate |
5 mL solution in a 10 mL glass vial (type I glass) with a rubber stopper, an aluminium seal and a polypropylene flip-off cap.
Pack of 1 vial.
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132 NP, Hoofddorp, Netherlands
EU/1/18/1335/001
Date of first authorisation: 22 November 2018
| Drug | Countries | |
|---|---|---|
| POTELIGEO | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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