Mysimba (naltrexone;bupropion)
- Region
- 🇪🇺 EU
- Active substance
- naltrexone;bupropion
- Company
- Orexigen Therapeutics Ireland Limited
- Status
- Authorised
- Therapeutic area
- Obesity; Overweight
- CHMP opinion
- Thu 18 Dec 2014
- EU approval
- Thu 26 Mar 2015
- Designations
- Additional monitoring
- Application
- EMEA/H/C/003687
- ATC
- A08AA
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.