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Register of orphan medicinal products


Product information

N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide

EU orphan designation number: EU/3/12/996   
Active ingredient: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide
Indication: Treatment of meningioma
Sponsor: Sirius Regulatory Consulting Limited
29 Hamblin Meadow, Eddington, Hungerford, Berkshire, RG17 0HJ, 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
8/06/2012 Orphan designation EMA/OD/166/11 (2012)3840 of 6/06/2012
7/03/2017 Corrigendum (2012)3840 of 6/06/2012