Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/13/1175
Active ingredient: Tolvaptan
Indication: Treatment of autosomal dominant polycystic kidney disease
Sponsor: Otsuka Pharmaceutical Europe Ltd
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

   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
09/08/2013 Orphan designation EMA/OD/066/13 (2013)5274 of 05/08/2013
29/11/2013 Change of name and/or address of sponsor
26/03/2015 Removal of orphan designation from Community Register