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.

Key facts

Active substance
Trans-N1-((1R,2S)-2-phenylcyclopropyl)cyclohexane-1,4-diamine bis-hydrochloride
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
Orphan decision number

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Oryzon Genomics SA
C. Sant Ferran 74
08940Cornella de Llobregat, Barcelona
Tel. +34 93 515 1313

Patients' organisations

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.

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