On 22 May 2006, orphan designation (EU/3/06/375) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for nilotinib for the treatment of chronic myeloid leukaemia.
Nilotinib has been authorised in the EU as Tasigna since 19 November 2007.
The sponsorship was transferred to Novartis Europharm Limited, Ireland, in May 2018.
|Disease / condition||
Treatment of chronic myeloid leukaemia
|Date of decision||
|Orphan decision number||
Sponsor's contact details
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.