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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information

Nanoliposomal irinotecan

EU orphan designation number: EU/3/11/933   
Active ingredient: Nanoliposomal irinotecan
Indication: Treatment of pancreatic cancer
Sponsor: Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Onivyde on 14/10/2016 with the number EU/1/16/1130

   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
13/12/2011 Orphan designation EMA/OD/051/11 (2011)9419 of 09/12/2011
05/12/2014 Transfer of orphan designation EMA/OD/051/11/T/01 (2014)9375 of 03/12/2014
28/05/2015 Change of name and/or address of sponsor