Poteligeo (mogamulizumab)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- mogamulizumab
- Company
- Kyowa Kirin Holdings B.V.
- Status
- Authorised
- Therapeutic area
- Sezary Syndrome; Mycosis Fungoides
- CHMP opinion
- Thu 20 Sep 2018
- EU approval
- Thu 22 Nov 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004232
- ATC
- L01XC25
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.