Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/13/1153   
Active ingredient: Daratumumab
Indication: Treatment of plasma cell myeloma
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 Darzalex on 20/05/2016 with the number EU/1/16/1101

   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
19/07/2013 Orphan designation EMA/OD/038/13 (2013)4727 of 17/07/2013
30/07/2018 Other procedure