naltrexone / bupropion
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.
Mysimba : EPAR - Summary for the public (PDF/83.58 KB)
First published: 15/04/2015
Last updated: 15/04/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Orexigen Therapeutics Ireland Limited
|Date of issue of marketing authorisation valid throughout the European Union||
26/11/2020 Mysimba - EMEA/H/C/003687 - N/0045
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.