On 20 December 2007, orphan designation (EU/3/07/516) was granted by the European Commission to SymbioTec GmbH, Germany, for recombinant human histone H1.3 and recombinant human N-bis-met-histone H1.3 for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to Xenetic Biosciences Plc, United Kingdom, in October 2012.
EU/3/07/516: Public summary of positive opinion for orphan designation of recombinant human histone H1.3 and recombinant human N-bis-met-histone H1.3 for the treatment of acute myeloid leukaemia (PDF/124.54 KB)
First published: 10/07/2008
Last updated: 13/03/2013
EMEA/COMP/130384/2008 Rev. 1
Recombinant human histone H1.3 and recombinant human N-bis-met-histone H1.3
|Disease / condition||
Treatment of acute myeloid leukaemia
|Date of first decision||
|EU designation number||
Sponsor's contact details
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.