Fycompa
perampanel
Table of contents
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.
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List item
Fycompa : EPAR - Medicine overview (PDF/134.75 KB)
First published: 07/08/2012
Last updated: 13/01/2021
EMA/697784/2020 -
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List item
Fycompa : EPAR - Risk-management-plan summary (PDF/165.67 KB)
First published: 13/01/2021
Authorisation details
Product details | |
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Name |
Fycompa
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Agency product number |
EMEA/H/C/002434
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Active substance |
perampanel
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International non-proprietary name (INN) or common name |
perampanel
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Therapeutic area (MeSH) |
Epilepsies, Partial
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Anatomical therapeutic chemical (ATC) code |
N03AX22
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Publication details | |
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Marketing-authorisation holder |
Eisai GmbH
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Revision |
19
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Date of issue of marketing authorisation valid throughout the European Union |
23/07/2012
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Contact address |
Product information
10/11/2020 Fycompa - EMEA/H/C/002434 - II/0047
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
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Pharmacotherapeutic group
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Antiepileptics
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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.