Navigation path

Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Nilotinib hydrochloride monohydrate

EU orphan designation number: EU/3/07/447
Active ingredient: Nilotinib hydrochloride monohydrate
Indication: Treatment of gastro intestinal stromal tumours
Sponsor: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
17/04/2007 Orphan designation EMEA/OD/093/06 (2007)1771 of 13/04/2007
06/05/2013 Removal of orphan designation from Community Register