European Union - English - EMA (European Medicines Agency)

orexigen therapeutics ireland limited - bupropion hydrochloride, naltrexone hydrochloride - obesity; overweight - antiobesity preparations, excl. diet products - 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.