Raxone

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idebenone

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

Overview

This is a summary of the European public assessment report (EPAR) for Raxone. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Raxone.

For practical information about using Raxone, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 27/10/2022

Authorisation details

Product details
Name
Raxone
Agency product number
EMEA/H/C/003834
Active substance
idebenone
International non-proprietary name (INN) or common name
idebenone
Therapeutic area (MeSH)
Optic Atrophy, Hereditary, Leber
Anatomical therapeutic chemical (ATC) code
N06BX13
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

OrphanOrphan

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
Santhera Pharmaceuticals (Deutschland) GmbH
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
08/09/2015
Contact address

Marie-Curie Strasse 8
79539 Lorrach
Germany

Product information

15/07/2022 Raxone - EMEA/H/C/003834 - S/0029

Other EU languages available icon 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:

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

  • Psychoanaleptics

  • Other psychostimulants and nootropics

Therapeutic indication

Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).

Assessment history

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