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