Sovrima

Refused

This medicine has been refused authorisation

idebenone

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.

Questions and answers on the recommendation for the refusal of the marketing authorization for Sovrima

Product details

• Name of medicine:
  Sovrima
• Active substance:
  idebenone
• International non-proprietary name (INN) or common name:
  idebenone
• Therapeutic area (MeSH):
  Friedreich Ataxia
• Anatomical therapeutic chemical (ATC) code:
  N06BX13

Pharmacotherapeutic group

Psychoanaleptics

Application details

• EMA product number:
  EMEA/H/C/000908
• 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.

• Marketing authorisation applicant:
  Centocor B.V.
• Opinion adopted:
  20/11/2008
• Refusal of marketing authorisation:
  27/04/2009

Assessment history

Sovrima : EPAR - Public assessment report