Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/17/1931   
Active ingredient: Siplizumab
Indication: Treatment in solid organ transplantation
Sponsor: ITB-MED AB
Sonja Kovalevskys Gata 4, 113 66 Stockholm, Sverige

   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
18/10/2017 Orphan designation EMA/OD/104/17 (2017)7064 of 16/10/2017
8/04/2019 Change of name and/or address of sponsor