Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/09/648   
Active ingredient: Afamelanotide
Indication: Treatment of solar urticaria
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
30/07/2009 Orphan designation EMEA/OD/019/09 (2009)6075 of 24/07/2009
13/07/2015 Change of name and/or address of sponsor
8/03/2019 Transfer of orphan designation EMA/OD/0000004299 (2019)1949 of 6/03/2019