EU/3/09/628: Orphan designation for the treatment of acute lymphoblastic leukaemia



On 30 April 2009, orphan designation (EU/3/09/628) was granted by the European Commission to Nova Laboratories Limited, United Kingdom, for mercaptopurine (oral suspension) for the treatment of acute lymphoblastic leukaemia.

Mercaptopurine (oral suspension) has been authorised in the EU as Xaluprine (previously Mercaptopurine Nova Laboratories) since 9 March 2012.


Key facts

Active substance
Medicine name
Intended use
Treatment of acute lymphoblastic leukaemia
Orphan designation status
EU designation number
Date of designation

Nova Laboratories Ireland Limited
3rd Floor  
Ulysses House 
Foley Street 
Dublin 1 
Tel: +353 (0)1 888 1004

Review of designation

During its meeting of 6-8 September 2011, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/09/628 for Mercaptopurine Nova Laboratories (mercaptopurine (oral suspension) previously known as Novapurine) as an orphan medicinal product for the treatment of acute lymphoblastic 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. The 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.

Update history

March 2022This product was withdrawn from the Community Register of designated orphan medicinal products at the end of the 10-year period of market exclusivity.
December 2018The sponsorship was transferred to Nova Laboratories Ireland Limited, Ireland.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Mercaptopurine Nova Laboratories (mercaptopurine (oral suspension)) for the treatment of acute lymphoblastic leukaemia (PDF/126.38 KB)


    First published: 10/04/2012
    Last updated: 10/04/2012

  • 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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