Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Poteligeo   
Auth. number : EU/1/18/1335
Active substance : Mogamulizumab
Orphan market exclusivity for "Treatment of cutaneous T-cell lymphoma" (based on designation EU/3/16/1756) started on 26/11/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 26/11/2028
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC25 - mogamulizumab
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Kyowa Kirin Holdings B.V.
Bloemlaan 2, 2132 NP Hoofddorp, Nederland

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/11/2018 Centralised - Authorisation EMEA/H/C/4232 (2018) 7975 of 22/11/2018