EMA — authorised 19 November 2018
- Marketing authorisation holder: Rhythm Pharmaceuticals Limited
- Status: approved
🇪🇺 Imcivree in European Union
EMA authorised Imcivree on 19 November 2018
Marketing authorisations
EMA — authorised 16 July 2021
- Application: EMEA/H/C/005089
- Marketing authorisation holder: Rhythm Pharmaceuticals Netherlands B.V.
- Local brand name: Imcivree
- Indication: IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.
- Pathway: orphan, PRIME
- Status: approved
Imcivree in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Imcivree approved in European Union?
Yes. EMA authorised it on 19 November 2018; EMA authorised it on 16 July 2021.
Who is the marketing authorisation holder for Imcivree in European Union?
Rhythm Pharmaceuticals Limited holds the EU marketing authorisation.