This is a summary of the European public assessment report (EPAR) for Mysimba. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Mysimba. For practical information about using Mysimba, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
A08AA
ATC Item
中枢作用的减肥药品
Pharmacotherapeutic Group
Antiobesity preparations, excl. diet products
Active Substance (Summary)
INN / Common Names
EMA Name
Mysimba
Medicine Name
Mysimba
Aliases
N/A
