EU/3/10/762: Orphan designation for the treatment of chronic myeloid leukaemia



On 4 August 2010, orphan designation (EU/3/10/762) was granted by the European Commission to Wyeth Europa Limited, United Kingdom, for bosutinib for the treatment of chronic myeloid leukaemia.

The sponsorship was transferred to Pfizer Limited, United Kingdom, in May 2011.

Bosutinib has been authorised in the EU as Bosulif since 27 March 2013.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in March 2018 upon request of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.

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 chronic myeloid leukaemia
Orphan designation status
EU designation number
Date of designation
Pfizer Limited
Ramsgate Road
Kent CT13 9NJ
United Kingdom
Tel. +44 (0)1304 616 161
Fax +44 (0)1304 652 144

Review of designation

In March 2018 the Committee for Orphan Medicinal Products reviewed the orphan designation of Bosulif at the time of the granting of a change to the terms of the marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee's final opinion. More information is available in the PDF icon withdrawal assessment report - orphan maintenance .

On 12 February 2013, the Committee for Orphan Medicinal Products (COMP) finalised the review of the designation EU/3/10/762 for Bosulif (bosutinib) as an orphan medicinal product for the treatment chronic myeloid leukaemia (CML). 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 maintained1.

1The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Bosulif (bosutinib) for the treatment chronic myeloid leukaemia (PDF/88.28 KB)


    First published: 11/04/2013
    Last updated: 11/04/2013

  • 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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