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Community register of orphan medicinal products


GRANTED  

Product information

N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)-propyl]-carbamoyl}-methyl)-2-[2-(2-fluoro-phenyl)-ethylamino]-N-isobutyl-acetamide

EU orphan designation number: EU/3/14/1248   
Active ingredient: N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)-propyl]-carbamoyl}-methyl)-2-[2-(2-fluoro-phenyl)-ethylamino]-N-isobutyl-acetamide
Indication: Treatment of optic neuritis
Sponsor: Bionure Farma SL
Dalmases 27, Local 1, 08017 Barcelona, España

   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
21/02/2014 Orphan designation EMA/OD/175/13 (2014)1223 of 19/02/2014