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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/13/1115   
Active ingredient: 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one
Indication: Treatment of mantle cell lymphoma
Sponsor: Janssen-Cilag International NV
Turnhoutseweg 30, B-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
14/03/2013 Orphan designation EMA/OD/171/12 (2013)1609 of 12/03/2013
04/09/2014 Other procedure