🇪🇺 Fycompa in European Union

EMA authorised Fycompa on 23 July 2012

Marketing authorisation

EMA — authorised 23 July 2012

  • Application: EMEA/H/C/002434
  • Marketing authorisation holder: Eisai GmbH
  • Local brand name: Fycompa
  • Indication: Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.
  • Status: approved

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Fycompa in other countries

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

Other Neuroscience approved in European Union

Frequently asked questions

Is Fycompa approved in European Union?

Yes. EMA authorised it on 23 July 2012.

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

Eisai GmbH holds the EU marketing authorisation.