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Bupropion + naltrexone (Mysimba°) for weight loss: set to be withdrawn from the market in the European Union?

 Marketing Authorisations   The pharmaceutical company Orexigen Therapeutics has failed to fulfil its obligation to conduct a post-authorisation trial to assess the long-term cardiovascular adverse effects of the fixed-dose combination of bupropion + naltrexone (Mysimba°), which is authorised in the European Union for use in patients with obesity or who are overweight. Now, 9 years after its authorisation, the European Commission has asked the European Medicines Agency to review its harm-benefit balance.
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©Prescrire 1 September 2024

Source: "Bupropion + naltrexone (Mysimba°) for weight loss: set to be withdrawn from the market in the European Union?" Prescrire Int 2024; 33 (262): 212. Subscribers only.

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