naltrexone / bupropion
Table of contents
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
Mysimba : EPAR - Risk management plan summary (PDF/293.72 KB)Adopted
First published: 30/05/2022
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This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Orexigen Therapeutics Ireland Limited
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2nd Floor, Palmerston House
27/02/2023 Mysimba - EMEA/H/C/003687 - IB/0062
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.