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Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/12/1033   
Active ingredient: N-Butyldeoxygalactonojirimycin
Indication: Treatment of Fabry disease
Sponsor: Idorsia Pharmaceuticals Deutschland GmbH
Wallbrunnstraße 24, 79539 Lörrach, 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
13/08/2012 Orphan designation EMA/OD/042/12 (2012)5797 of 09/08/2012
02/07/2014 Change of name and/or address of sponsor
20/11/2017 Transfer of orphan designation EMA/OD/042/12/T/01 (2017)7799 of 16/11/2017