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Community register of orphan medicinal products


GRANTED  

Product information

(R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea

EU orphan designation number: EU/3/15/1588   
Active ingredient: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea
Indication: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Sponsor: Trio Medicines Ltd
Hammersmith Medicines Research, Cumberland Avenue, London NW10 7EW, United Kingdom

   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
16/12/2015 Orphan designation EMA/OD/147/15 (2015)9510 of 14/12/2015