🇪🇺 STIRIPENTOL in European Union

EMA authorised STIRIPENTOL on 3 January 2007

Marketing authorisation

EMA — authorised 3 January 2007

  • Application: EMEA/H/C/000664
  • Marketing authorisation holder: Biocodex
  • Local brand name: Diacomit
  • 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.
  • Status: approved

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STIRIPENTOL in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is STIRIPENTOL approved in European Union?

Yes. EMA authorised it on 3 January 2007.

Who is the marketing authorisation holder for STIRIPENTOL in European Union?

Biocodex holds the EU marketing authorisation.