Raxone
idebenone
Table of contents
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.
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List item
Raxone : EPAR - Summary for the public (PDF/77.03 KB)
First published: 17/09/2015
Last updated: 17/09/2015
EMA/452944/2015 -
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List item
Raxone : EPAR - Risk-management-plan summary (PDF/113.75 KB)
First published: 17/09/2015
Last updated: 27/10/2022
Authorisation details
Product details | |
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Name |
Raxone
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Agency product number |
EMEA/H/C/003834
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Active substance |
idebenone
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International non-proprietary name (INN) or common name |
idebenone
|
Therapeutic area (MeSH) |
Optic Atrophy, Hereditary, Leber
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Anatomical therapeutic chemical (ATC) code |
N06BX13
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Additional 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 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. |
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 | |
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Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A
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Revision |
9
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Date of issue of marketing authorisation valid throughout the European Union |
08/09/2015
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Contact address |
Via Palermo 26/A |
Product information
19/10/2023 Raxone - EMEA/H/C/003834 - T/0034
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
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Psychoanaleptics
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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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 201826/01/2018
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13/10/2017
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15/09/2017
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26/06/2015