POTELIGEO Concentrate for solution for infusion Ref.[7600] Active ingredients: Mogamulizumab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132 NP, Hoofddorp, Netherlands

Product name and form

POTELIGEO 4 mg/mL concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear to slightly opalescent, colourless solution.

Qualitative and quantitative composition

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
Glycine
Polysorbate 80
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132 NP, Hoofddorp, Netherlands

Marketing authorization dates and numbers

EU/1/18/1335/001

Date of first authorisation: 22 November 2018

Drugs

Drug Countries
POTELIGEO Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States

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