Pharmaceuticals - Community Register


Community register of 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, Slough, Berkshire 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 Centralised Orphan - Designation EMA/OD/066/13 (2013)5274 of 05/08/2013
29/11/2013 Centralised Orphan - Change of address