Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/16/1683   
Active ingredient: Melatonin
Indication: Treatment of neonatal sepsis
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
29/06/2016 Orphan designation EMA/OD/007/16 (2016)4123 of 27/06/2016
13/07/2018 Change of name and/or address of sponsor
7/08/2018 Transfer of orphan designation EMA/OD/007/16/T/01 (2018)5407 of 3/08/2018