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Imcivree is a medicine used to treat obesity and help control hunger caused by certain genetic conditions that affect how the brain controls feelings of hunger. It is used in adults and children aged 6 years and older with Bardet Biedl syndrome (BBS), and in those who have pro-opiomelanocortin (POMC) deficiency or leptin receptor (LEPR) deficiency resulting from changes (mutations) in both copies of the genes responsible for making POMC or LEPR.
Bardet Biedl syndrome, pro-opiomelanocortin deficiency and leptin receptor deficiency are rare, and Imcivree was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (pro-opiomelanocortin deficiency: 14 July 2016; leptin receptor deficiency: 19 November 2018; Bardet Biedl syndrome: 21 August 2019).
Imcivree contains the active substance setmelanotide.
Imcivree : EPAR - Medicine overview (PDF/110.68 KB)
First published: 22/07/2021
Last updated: 07/02/2023
Imcivree : EPAR - Risk-management-plan summary (PDF/129.71 KB)
First published: 22/07/2021
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This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Rhythm Pharmaceuticals Netherlands B.V.
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18/03/2023 Imcivree - EMEA/H/C/005089 - IB/0013
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Antiobesity preparations, excl. diet products
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 6 years of age and above.