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Community register of orphan medicinal products


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Product information

2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid

EU orphan designation number: EU/3/11/899   
Active ingredient: 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid
Indication: Treatment of multiple myeloma
Sponsor: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ninlaro on 21/11/2016 with the number EU/1/16/1094

   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
29/09/2011 Orphan designation EMA/OD/048/11 (2011)7032 of 27/09/2011
12/11/2013 Change of name and/or address of sponsor
23/03/2015 Transfer of orphan designation EMA/OD/048/11/T/01 (2015)2045 of 19/03/2015