Fycompa

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perampanel

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 13/10/2022

Authorisation details

Product details
Name
Fycompa
Agency product number
EMEA/H/C/002434
Active substance
perampanel
International non-proprietary name (INN) or common name
perampanel
Therapeutic area (MeSH)
Epilepsies, Partial
Anatomical therapeutic chemical (ATC) code
N03AX22
Publication details
Marketing-authorisation holder
Eisai GmbH
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
23/07/2012
Contact address

Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany

Product information

24/08/2022 Fycompa - EMEA/H/C/002434 - IB/0063

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Antiepileptics

  • Other antiepileptics

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.

Assessment history

Changes since initial authorisation of medicine

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