Poteligeo

RSS

mogamulizumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 28/01/2019

Authorisation details

Product details
Name
Poteligeo
Agency product number
EMEA/H/C/004232
Active substance
Mogamulizumab
International non-proprietary name (INN) or common name
mogamulizumab
Therapeutic area (MeSH)
  • Sezary Syndrome
  • Mycosis Fungoides
Anatomical therapeutic chemical (ATC) code
L01XC25
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

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
Marketing-authorisation holder
Kyowa Kirin Holdings B.V.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
22/11/2018
Contact address

Bloemlaan 2
2132NP Hoofddorp
The Netherlands

Product information

20/09/2018 Poteligeo - EMEA/H/C/004232 - -

Contents

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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.

Assessment history

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