EU/3/07/526: Orphan designation for the treatment of acute myeloid leukaemia

N- (2-Amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide (mocetinostat)

Table of contents


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.

Key facts

Active substance
N- (2-Amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide (mocetinostat)
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation
ICON Clinical Research Limited
South County Business Park
Dublin 18
Tel. +353 86 0244646

Update history

May 2022This product was withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.
February 2018The sponsorship was transferred to ICON Clinical Research Limited, Ireland.
November 2015CanReg (Europe) Limited changed name to Mapi Ireland Limited.
March 2009The sponsorship was transferred to CanReg (Europe) Limited, Ireland.
November 2008The sponsorship was transferred to Celgene Europe Limited, United Kingdom.

Documents related to this orphan designation evaluation

Patients' organisations

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:

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