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Register of orphan medicinal products


Product information


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: Reglntel Ltd
Templetown, Carlingford, County Louth, 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
19/07/2018 Transfer of orphan designation EMA/OD/138/16/T/02 (2018)4810 of 16/07/2018