Mysimba
·
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Naltrexone;bupropion
- Made by
- Orexigen Therapeutics Ireland Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Orexigen Therapeutics Ireland Limited |
|---|---|
| Active substance | Naltrexone;bupropion |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A08AA · Digestion, stomach, diabetes and nutrition |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2015-03-26 |
| Last updated by the regulator | 2026-04-10 |
| EMA product number | EMEA/H/C/003687 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).