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Community register of orphan medicinal products


Product information

Inotuzumab ozogamicin

EU orphan designation number: EU/3/13/1127   
Active ingredient: Inotuzumab ozogamicin
Indication: Treatment of B-cell acute lymphoblastic 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 Besponsa on 29/06/2017 with the number EU/1/17/1200

   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
11/06/2013 Orphan designation EMA/OD/194/12 (2013)3663 of 7/06/2013