Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Ibrutinib

EU orphan designation number: EU/3/14/1264   
Active ingredient: Ibrutinib
Indication: Treatment of lymphoplasmacytic lymphoma
Sponsor: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name IMBRUVICA on 21/10/2014 with the number EU/1/14/945

   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
5/05/2014 Orphan designation EMA/OD/185/13 (2014)2970 of 29/04/2014
18/06/2015 Other procedure