Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2012 on request of the sponsor.
On 26 August 2005, orphan designation (EU/3/05/304) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for imatinib mesilate for the treatment of acute lymphoblastic leukaemia.
Imatinib mesilate for treatment of acute lymphoblastic leukaemia has been authorised in the EU as Glivec since 13 September 2006.
For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.
Treatment of acute lymphoblastic leukaemia
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Documents related to this orphan designation evaluation
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: