Fintepla (fenfluramine)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- fenfluramine
- Company
- UCB Pharma S.A.
- Status
- Authorised
- Therapeutic area
- Epilepsies, Myoclonic
- CHMP opinion
- Thu 15 Oct 2020
- EU approval
- Fri 18 Dec 2020
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/003933
- ATC
- N03
- Official record
- www.ema.europa.eu
Indication
Treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.
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.