Turalio (pexidartinib)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pexidartinib
- Company
- Daiichi Sankyo Europe GmbH
- Status
- Refused
- Therapeutic area
- Giant Cell Tumor of Tendon Sheath; Synovitis, Pigmented Villonodular
- CHMP opinion
- Thu 25 Jun 2020
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/004832
- ATC
- L01XE
- Official record
- www.ema.europa.eu
Indication
Treatment of tenosynovial giant cell tumour.
Regulatory milestones
No milestones recorded in the last year.
Follow Turalio
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.