Istodax

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romidepsin

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

Overview

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.

This EPAR was last updated on 14/03/2013

Application details

Product details
Name
Istodax
Active substance
romidepsin
International non-proprietary name (INN) or common name
romidepsin
Therapeutic area (MeSH)
Lymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code
L01XX39
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-autorisation applicant
Celgene Europe Ltd.
Date of opinion
15/11/2012
Date of refusal of marketing authorisation
12/02/2013

Assessment history

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