Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/16/1755   
Active ingredient: Melatonin
Indication: Treatment of Smith-Magenis syndrome
Sponsor: Worphmed Srl
Via Malachia Marchesi de Taddei 21, 20146 Milano, Italia

   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
18/10/2016 Orphan designation EMA/OD/127/16 (2016)6746 of 14/10/2016
13/07/2018 Change of name and/or address of sponsor
7/08/2018 Transfer of orphan designation EMA/OD/127/16/T/01 (2018)5408 of 3/08/2018