Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Istodax
Active substance: romidepsin
Indication: Treatment of adult patients with peripheral T-cell lymphoma (PTCL) that has relapsed after or become refractory to at least two prior therapies
Marketing Authorisation Holder: Celgene Europe Limited

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/02/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2122 (2013)911 of 12/02/2013