Fycompa

RSS

perampanel

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

Overview

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

This EPAR was last updated on 02/05/2018

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 Europe Ltd
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
23/07/2012
Contact address
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom

Product information

23/04/2018 Fycompa - EMEA/H/C/002434 - PSUSA/00009255/201707

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Anti epileptics
  • other anti epileptics

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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