Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/06/375   
Active ingredient: Nilotinib
Indication: Treatment of chronic myeloid leukaemia
Sponsor: Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Tasigna on 19/11/2007 with the number EU/1/07/422

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/05/2006 Orphan designation EMEA/OD/003/06 (2006)2149 of 22/05/2006
29/08/2014 Change of name and/or address of sponsor
16/05/2018 Transfer of orphan designation EMA/OD/003/06/T/01 (2018)3033 of 8/05/2018