EU/3/06/370: Orphan designation for the treatment of acute myeloid leukaemia



On 8 June 2006, orphan designation (EU/3/06/370) was granted by the European Commission to MGI Pharma Limited, United Kingdom, for decitabine for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to Janssen-Cilag International NV, Belgium, in March 2007.

Decitabine has been authorised in the EU as Dacogen since 20 September 2012.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Medicine name
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation
Janssen-Cilag International NV
Turnhoutseweg 30
2340 Beerse
Tel. +32 14 603470
Fax +32 14 606929

Review of designation

During its meeting of 4-5 September 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/06/370 for Dacogen (decitabine) as an orphan medicinal product for the treatment of acute myeloid leukaemia. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Dacogen (decitabine) for the treatment of acute myeloid leukaemia (PDF/79.08 KB)


    First published: 22/10/2012
    Last updated: 22/10/2012

  • Patients' organisations

    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

    • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

    • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

    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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