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.
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-authorisation applicant |
Celgene Europe Ltd.
|
Date of opinion |
15/11/2012
|
Date of refusal of marketing authorisation |
12/02/2013
|
Assessment history
-
List item
Istodax : EPAR - Refusal public assessment report (PDF/1.43 MB)
Adopted
First published: 14/03/2013
Last updated: 14/03/2013
EMA/CHMP/27767/2013 -
List item
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
EMA/475603/2012