This is a summary of the European public assessment report (EPAR) for Fycompa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fycompa
Fycompa : EPAR - Summary for the public (PDF/101.72 KB)
First published: 07/08/2012
Last updated: 29/09/2016
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|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||
28/04/2020 Fycompa - EMEA/H/C/002434 - PSUSA/00009255/201907
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.