EU/3/09/628

About

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.

The sponsorship was transferred to Nova Laboratories Ireland Limited, Ireland, in December 2018.

 

Key facts

Active substance
Mercaptopurine (oral suspension)
Medicine name
Xaluprine
Disease / condition
Treatment of acute lymphoblastic leukaemia
Date of first decision
30/04/2009
Outcome
Positive
EU designation number
EU/3/09/628

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.

Sponsor's contact details

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

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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