Poteligeo
mogamulizumab
Table of contents
Overview
Poteligeo is a cancer medicine used to treat mycosis fungoides and Sezary syndrome – two cancers of blood cells that affect mainly the skin. It is used in patients who have received previous treatment by mouth or injection.
Both mycosis fungoides and Sezary syndrome belong to a group of rare cancers (cutaneous T-cell lymphomas), and Poteligeo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 October 2016. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Poteligeo contains the active substance mogamulizumab.
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Poteligeo : EPAR - Medicine overview (PDF/75.31 KB)
First published: 28/01/2019
EMA/654511/2018 -
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Poteligeo : EPAR - Risk-management-plan summary (PDF/74.45 KB)
First published: 28/01/2019
Authorisation details
Product details | |
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Name |
Poteligeo
|
Agency product number |
EMEA/H/C/004232
|
Active substance |
Mogamulizumab
|
International non-proprietary name (INN) or common name |
mogamulizumab
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01XC25
|
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Kyowa Kirin Holdings B.V.
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
22/11/2018
|
Contact address |
Bloemlaan 2 |
Product information
01/09/2023 Poteligeo - EMEA/H/C/004232 - R/0021
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.