Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/10/762
Active ingredient: Bosutinib
Indication: Treatment of chronic myeloid leukaemia
Sponsor: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Bosulif on 27/03/2013 with the number EU/1/13/818

   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
06/08/2010 Orphan designation EMEA/OD/160/09 (2010)5529 of 04/08/2010
18/05/2011 Transfer of orphan designation EMEA/OD/160/09/T/01 (2011)3483 of 13/05/2011
16/03/2018 Removal of orphan designation from Community Register