Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2011 at the end of the period of market exclusivity.
On 14 February 2001, orphan designation (EU/3/01/021) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for imatinib mesilate for the treatment of chronic myeloid leukaemia.
Imatinib mesilate for treatment of chronic myeloid leukaemia has been authorised in the EU as Glivec since 7 November 2001.
For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.
Treatment of chronic myeloid leukaemia
|Orphan designation status||
|EU designation number||
|Date of designation||
Novartis Europharm Limited
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: