On 5 August 2013, orphan designation (EU/3/13/1174) was granted by the European Commission to Oryzon Genomics SA, Spain, for trans-N1-((1R,2S)-2-phenylcyclopropyl)cyclohexane-1,4-diamine bis-hydrochloride for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to Roche Registration Limited, United Kingdom, in December 2014.
The sponsorship was transferred to Oryzon Genomics SA - Spain, in February 2018.
EU/3/13/1174: Public summary of opinion on orphan designation: Trans-N1-((1R,2S)-2-phenylcyclopropyl)cyclohexane-1,4-diamine bis-hydrochloride for the treatment of acute myeloid leukaemia (PDF/119.91 KB)
First published: 12/09/2013
Last updated: 12/03/2015
EMA/COMP/432481/2013 Rev. 1
|Disease / condition||
Treatment of acute myeloid leukaemia
|Date of decision||
|Orphan decision number||
Review of designation
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.