Mysimba

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naltrexone / bupropion

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 10/08/2018

Authorisation details

Product details
Name
Mysimba
Agency product number
EMEA/H/C/003687
Active substance
  • bupropion hydrochloride
  • naltrexone hydrochloride
International non-proprietary name (INN) or common name
naltrexone / bupropion
Therapeutic area (MeSH)
  • Obesity
  • Overweight
Anatomical therapeutic chemical (ATC) code
A08AA
Additional monitoring

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.

Publication details
Marketing-authorisation holder
Orexigen Therapeutics Ireland Limited
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
26/03/2015
Contact address
2nd Floor, Palmerston House
Fenian Street
Dublin 2
Ireland

Product information

02/07/2018 Mysimba - EMEA/H/C/003687 - PSUSA/00010366/201709

Contents

  • 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.

Pharmacotherapeutic group

  • Antiobesity preparations
  • excl. diet products

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 (see Section 5.1).

Assessment history

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