On 31 January 2008, orphan designation EU/3/07/526 was granted by the European Commission to Pharmion Ltd, United Kingdom, for N- (2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide (mocetinostat) for the treatment of acute myeloid leukaemia.
This medicine is now known as mocetinostat.
N- (2-Amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide (mocetinostat)
Treatment of acute myeloid leukaemia
|Orphan designation status||
|EU designation number||
|Date of designation||
ICON Clinical Research Limited
South County Business Park
Tel. +353 86 0244646
|May 2022||This product was withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.|
|February 2018||The sponsorship was transferred to ICON Clinical Research Limited, Ireland.|
|November 2015||CanReg (Europe) Limited changed name to Mapi Ireland Limited.|
|March 2009||The sponsorship was transferred to CanReg (Europe) Limited, Ireland.|
|November 2008||The sponsorship was transferred to Celgene Europe Limited, United Kingdom.|
Documents related to this orphan designation evaluation
EU/3/07/526: Public summary of positive opinion for orphan designation of N- (2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide for the treatment of acute myeloid leukaemia (PDF/714.85 KB)
First published: 23/09/2009
Last updated: 23/09/2009
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: