On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma. The company that applied for authorisation is Celgene Europe Ltd.
The applicant requested a re‑examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Questions and answers on the refusal of the marketing authorisation for Istodax (romidepsin) - Outcome of re-examination (PDF/54.94 KB)Adopted
First published: 16/11/2012
Last updated: 16/11/2012
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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.
Celgene Europe Ltd.
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Istodax : EPAR - Refusal public assessment report (PDF/1.43 MB)Adopted
First published: 14/03/2013
Last updated: 14/03/2013
Questions and answers on the refusal of the marketing authorisation for Istodax (romidepsin) (PDF/47.71 KB)
First published: 20/07/2012
Last updated: 20/07/2012