European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is Setmelanotide legal in European Union?
Approved, restrictedAuthorised EU-wide as Imcivree, only for rare genetic or hypothalamic obesity
Approved, but with limits on who can get it or how.
Imcivree was authorised centrally on 16 July 2021. Its EU label covers obesity and hunger control in specific rare conditions: genetic POMC/PCSK1 or LEPR deficiency, genetically confirmed Bardet-Biedl syndrome, and acquired hypothalamic obesity. It is a prescription-only specialist medicine and is not authorised for general obesity.
Last verified 2026-09-29 · how we verify
Setmelanotide elsewhere
Sources (2)
- 01Imcivree: EPAR (European public assessment report)European Medicines Agency · 2026-05-27 · accessed 2026-09-29
- 02EMA medicines data (JSON report): human and veterinary medicines, with authorisation statusEuropean Medicines Agency · 2026-09-29 · accessed 2026-09-29