Diacomit (stiripentol)
- Region
- 🇪🇺 EU
- Active substance
- stiripentol
- Company
- Biocodex
- Status
- Authorised
- Therapeutic area
- Myoclonic Epilepsy, Juvenile
- EU approval
- Wed 03 Jan 2007
- Application
- EMEA/H/C/000664
- ATC
- N03AX17
- Official record
- www.ema.europa.eu
Indication
Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.
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.