Ledaga (chlormethine)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- chlormethine
- Company
- Helsinn Birex Pharmaceuticals Ltd.
- Status
- Authorised
- Therapeutic area
- Mycosis Fungoides
- CHMP opinion
- Thu 15 Dec 2016
- EU approval
- Fri 03 Mar 2017
- Designations
- Orphan
- Application
- EMEA/H/C/002826
- ATC
- L01AA05
- Official record
- www.ema.europa.eu
Indication
Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
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.