EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults, concerning the potential long-term cardiovascular risk.

The CHMP has concluded that the benefits of Mysimba continue to outweigh its risks. However, the company must provide more information from an ongoing study on the medicine’s cardiovascular effects in patients treated for longer than one year. New measures are also being implemented to minimise potential cardiovascular risks with long-term use.