Romvimza (vimseltinib)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- vimseltinib
- Company
- Deciphera Pharmaceuticals (Netherlands) B.V.
- Status
- Authorised
- Therapeutic area
- Giant Cell Tumor of Tendon Sheath
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 17 Sep 2025
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006363
- ATC
- L01EX
- Official record
- www.ema.europa.eu
Indication
Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.
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.