On 11 April 2005, orphan designation (EU/3/05/272) was granted by the European Commission to Maxim Pharmaceuticals Europe Ltd, United Kingdom, for histamine dihydrochloride for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to EpiCept GmbH, Germany, in August 2006 and subsequently to Meda AB, Sweden, in October 2012.
Histamine dihydrochloride has been authorised in the EU as Ceplene since 7 October 2008.
The sponsorship was transferred to Noventia Pharma Srl, Italy, in December 2017.
Treatment of acute myeloid leukaemia
|Orphan designation status||
|EU designation number||
|Date of designation||
Documents related to this orphan designation evaluation
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: