03.06.2025 - European Commission final decision

With the publication of the European Commission Decision on 22 May 2025, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No 726/2004 on "Mysimba - Naltrexone / Bupropion" was completed. The marketing authorisation for the medicinal product for human use ‘Mysimba - Naltrexone / Bupropion' granted by Decision C(2015)2237 (final) of 26. March 2015 is amended on the basis of the scientific conclusions of that Decision.

31.03.2025 - CHMP opinion

EMA concludes review of weight management medicine Mysimba

Benefits continue to outweigh risks, with new risk minimisation measures and more information to be provided about long-term effect on the heart

EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults with obesity or overweight. The review was prompted by concerns about a potential long-term cardiovascular risk (risk affecting the heart and blood circulation) with the medicine

15.09.2023 - Procedure started

EMA has started a review of Mysimba (naltrexone / bupropion), a medicine for weight management in adults who have obesity or are overweight. The medicine is recommended for use in addition to diet and exercise.

The review of Mysimba was prompted by remaining concerns regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation) with Mysimba and its impact on the benefit-risk balance of the medicine.

Further information:

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):