Pharmaceuticals - Community Register

  

Community list of not active orphan medicinal products


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Product information

Tolvaptan

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