Inovelon
rufinamide
Table of contents
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.
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List item
Inovelon : EPAR - Medicine overview (PDF/86.56 KB)
First published: 01/02/2007
Last updated: 23/08/2018
EMA/857520/2011 -
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List item
Inovelon : EPAR - Risk-management-plan summary (PDF/141.36 KB)
First published: 23/08/2018
Last updated: 23/08/2018
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
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Eisai GmbH
|
| Revision |
23
|
| Date of issue of marketing authorisation valid throughout the European Union |
16/01/2007
|
Product information
16/02/2023 Inovelon - EMEA/H/C/000660 - N/0065
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antiepileptics
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.