Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/17/1910   
Active ingredient: Sirolimus
Indication: Treatment of tuberous sclerosis
Sponsor: FGK Representative Service GmbH
Heimeranstraße 35, 80339 München, Deutschland

   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
25/08/2017 Orphan designation EMA/OD/047/17 (2017)5919 of 23/08/2017
28/03/2019 Transfer of orphan designation EMA/OD/0000005428 (2019)2404 of 25/03/2019