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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide

EU orphan designation number: EU/3/16/1783   
Active ingredient: N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide
Indication: Treatment of acute pancreatitis
Sponsor: Cogas Pharma Limited
Spencer Harbour, N41W984 Drumkeeran, County Leitrim, 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
22/11/2016 Orphan designation EMA/OD/138/16 (2016)7627 of 18/11/2016
13/04/2017 Transfer of orphan designation EMA/OD/138/16/T/01 (2017)2527 of 11/04/2017