Sovrima

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idebenone

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 24 July 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sovrima 150 mg tablets, intended for the treatment of Friedreich’s ataxia. The company that applied for authorisation is Santhera Pharmaceuticals (Deutschland) GmbH. The applicant requested a re-examination of the opinion. After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 November 2008.

This EPAR was last updated on 31/12/2009

Application details

Product details
Name
Sovrima
Active substance
idebenone
International non-proprietary name (INN) or common name
idebenone
Therapeutic area (MeSH)
Friedreich Ataxia
Anatomical therapeutic chemical (ATC) code
N06BX13
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.

Application details
Marketing-authorisation applicant
Centocor B.V.
Date of opinion
20/11/2008
Date of refusal of marketing authorisation
27/04/2009

Assessment history

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