Table of contents
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.
Fycompa : EPAR - Medicine overview (PDF/134.75 KB)
First published: 07/08/2012
Last updated: 13/01/2021
Fycompa : EPAR - Risk-management-plan (PDF/750.94 KB)
First published: 13/01/2021
Last updated: 24/02/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
27/04/2023 Fycompa - EMEA/H/C/002434 - PSUSA/00009255/202207
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
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.