EU/3/07/509: Orphan designation for the treatment of acute myeloid leukaemia


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in December 2018 at the end of the 10-year period of market exclusivity.

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.

Key facts

Active substance
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation

Celgene Europe B.V.
Winthontlaan 6N
3526 KV Utrecht
The Netherlands
Tel. +31 3028 44547

Documents related to this orphan designation evaluation

Patients' organisations

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:

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