EU/3/07/509

Table of contents

About

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
azacitidine
Medicine name
Vidaza
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
29/11/2007
Outcome
Positive
Orphan decision number
EU/3/07/509

Sponsor's contact details

Celgene Europe B.V.
Winthontlaan 6N
3526 KV Utrecht
The Netherlands
Tel. +31 3028 44547
E-mail: medinfo.intl@celgene.com

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;

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