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Register of orphan medicinal products


GRANTED  

Product information

4’-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2’-(ethoxymethyl)-[1,1’-biphenyl]-2-sulfonamide

EU orphan designation number: EU/3/15/1574   
Active ingredient: 4’-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2’-(ethoxymethyl)-[1,1’-biphenyl]-2-sulfonamide
Indication: Treatment of focal segmental glomerulosclerosis
Sponsor: Retrophin Europe Limited
2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
13/11/2015 Orphan designation EMA/OD/115/15 (2015)8024 of 11/11/2015
21/12/2015 Change of name and/or address of sponsor
19/02/2016 Change of name and/or address of sponsor