EU/3/11/942: Orphan designation for the treatment of acute myeloid leukaemia

cytarabine / daunorubicin


On 11 January 2012, orphan designation (EU/3/11/942) was granted by the European Commission to Celator (UK) Ltd, United Kingdom, for liposomal combination of cytarabine and daunorubicin for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to Jazz Pharmaceuticals Ireland Ltd, in December 2016.

Liposomal combination of cytarabine and daunorubicin has been authorised in the EU as Vyxeos since 23 August 2018.

This medicine is now known as daunorubicin / cytarabine.

Key facts

Active substance
  • cytarabine
  • daunorubicin
Medicine name
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation

Jazz Pharmaceuticals Ireland Ltd
Fifth Floor, Waterloo Exchange
Waterloo Road
Dublin 4
Ireland D04 E5W7
Tel: +35316347800

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Vyxeos at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report

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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