Inovelon

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rufinamide

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

Overview

Inovelon is an epilepsy medicine used to treat patients aged one year or older who have Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but which can continue into adulthood. Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children. Its symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems. Inovelon is used as an add-on to other anti-epileptic medicines.

Lennox-Gastaut syndrome is rare, and Inovelon was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 October 2004.

Inovelon contains the active substance rufinamide.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Inovelon
Agency product number
EMEA/H/C/000660
Active substance
Rufinamide
International non-proprietary name (INN) or common name
rufinamide
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AF03
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Eisai GmbH
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
16/01/2007

Product information

21/09/2018 Inovelon - EMEA/H/C/000660 - T/0048

Contents

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Pharmacotherapeutic group

Anti epileptics

Therapeutic indication

Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.

Assessment history

Changes since initial authorisation of medicine

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