Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/13/1232   
Active ingredient: Allantoin
Indication: Treatment of epidermolysis bullosa
Sponsor: Amicus Therapeutics Europe Limited
Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Dublin, D15 AKK1, 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
21/01/2014 Orphan designation EMA/OD/145/13 (2014)302 of 16/01/2014
8/10/2014 Transfer of orphan designation EMA/OD/145/13/T/01 (2014)7398 of 6/10/2014
19/02/2016 Transfer of orphan designation EMA/OD/145/13/T/02 (2016)1119 of 17/02/2016
1/04/2019 Transfer of orphan designation EMA/OD/0000004625 (2019)2422 of 25/03/2019