Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Udenafil

EU orphan designation number: EU/3/16/1807   
Active ingredient: Udenafil
Indication: Treatment of functional single ventricle congenital heart disease
Sponsor: Mapi Ireland Limited
Templetown, Carlingford, County Louth, 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
14/12/2016 Orphan designation EMA/OD/218/16 (2016)8707 of 12/12/2016