🇪🇺 fenfluramine HCl in European Union

EMA authorised fenfluramine HCl on 18 December 2020

Marketing authorisation

EMA — authorised 18 December 2020

  • Application: EMEA/H/C/003933
  • Marketing authorisation holder: UCB Pharma S.A.
  • Local brand name: Fintepla
  • 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.
  • Pathway: orphan
  • Status: approved

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Frequently asked questions

Is fenfluramine HCl approved in European Union?

Yes. EMA authorised it on 18 December 2020.

Who is the marketing authorisation holder for fenfluramine HCl in European Union?

UCB Pharma S.A. holds the EU marketing authorisation.