Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/16/1703   
Active ingredient: Setmelanotide
Indication: Treatment of pro-opiomelanocortin deficiency
Sponsor: TMC Pharma (EU) Limited
The Black Church, St Mary's Place, Dublin DO7 P4AX, 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
18/07/2016 Orphan designation EMA/OD/063/16 (2016)4689 of 14/07/2016
19/03/2019 Transfer of orphan designation EMA/OD/0000004730 (2019)2154 of 14/03/2019