On 29 November 2007, orphan designation (EU/3/07/509) was granted by the European Commission to Pharmion Ltd, United Kingdom, for azacitidine for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to Celgene Europe Limited, United Kingdom, in October 2008.
Azacitidine in treatment of acute myeloid leukaemia has been authorised in the EU as Vidaza since 17 December 2008.
The sponsorship was transferred to Celgene Europe B.V., The Netherlands, in June 2018.
Treatment of acute myeloid leukaemia
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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: