Basic Information
Fycompa
Regulatory Information
EMEA/H/C/002434
July 23, 2012
May 24, 2012
33
October 31, 2023
Company Information
Germany
Edmund-Rumpler-Straße 3 60549 Frankfurt am Main
Eisai GmbH
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
Fycompa is an epilepsy medicine for treating: - partial seizures (fits starting in one specific part of the brain), including those followed by generalised seizures affecting all of the brain, in patients from 4 years of age; - primary generalised tonic-clonic seizures (major fits fit affecting most or all of the brain) in patients from 7 years of age when the cause of epilepsy is unknown. Fycompa must only be used as an ‘add-on’ therapy to other anti-epileptic medicines. It contains the active substance perampanel.