Fycompa

perampanel

Table of contents

Opinion

On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Fycompa. The marketing authorisation holder for this medicinal product is Eisai GmbH.

The CHMP adopted an extension to the existing indication as follows:1

Fycompa (perampanel) is indicated for the adjunctive treatment of

  • partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older.

  • primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalised epilepsy (IGE).

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 (see section 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold, removed text as strikethrough.

Key facts

Name
Fycompa
Agency product number
EMEA/H/C/002434
International non-proprietary name (INN) or common name
  • perampanel
Active substance
  • perampanel
Therapeutic area
Epilepsies, Partial
Date opinion adopted
17/09/2020
Company name
Eisai GmbH
Status
Positive
Application type
Post-authorisation

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