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):