Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/14/1285   
Active ingredient: Afamelanotide
Indication: Treatment of familial benign chronic pemphigus (Hailey-Hailey disease)
Sponsor: Clinuvel Europe Limited
10 Earlsfort Terrace, Dublin 2, 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
8/07/2014 Orphan designation EMA/OD/019/14 (2014)4839 of 4/07/2014
13/07/2015 Change of name and/or address of sponsor
8/03/2019 Transfer of orphan designation EMA/OD/0000004300 (2019)1950 of 6/03/2019