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Register of orphan medicinal products


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Product information

(2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide

EU orphan designation number: EU/3/17/1946   
Active ingredient: (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide
Indication: Treatment of paroxysmal nocturnal haemoglobinuria
Sponsor: FGK Representative Service GmbH
Heimeranstraße 35, 80339 München, Deutschland

   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
14/12/2017 Orphan designation EMA/OD/156/17 (2017)8778 of 12/12/2017