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Register of orphan medicinal products


Product information

(S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester

EU orphan designation number: EU/3/17/1861   
Active ingredient: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester
Indication: Treatment of pulmonary arterial hypertension
Sponsor: Roivant Sciences Ireland Limited
9 Exchange Place, International Financial Service Centre, Dublin 1, D01 X8H, 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
22/04/2017 Orphan designation EMA/OD/299/16 (2017)2780 of 20/04/2017
27/09/2017 Change of name and/or address of sponsor
21/03/2018 Transfer of orphan designation EMA/OD/299/16/T/01 (2018)1826 of 19/03/2018