🇪🇺 Naltrexone-Bupropion Combination in European Union

EMA authorised Naltrexone-Bupropion Combination on 26 March 2015

Marketing authorisation

Application: EMEA/H/C/003687
Marketing authorisation holder: Orexigen Therapeutics Ireland Limited
Local brand name: Mysimba
Indication: Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Naltrexone-Bupropion Combination approved in European Union?

Yes. EMA authorised it on 26 March 2015.

Who is the marketing authorisation holder for Naltrexone-Bupropion Combination in European Union?

Orexigen Therapeutics Ireland Limited holds the EU marketing authorisation.