Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 03 October 2017

Indication(s)

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.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/003687
Orphan designation No
Date First Approved 26-03-2015
Type Medicinal product subject to medical prescription
Marketing authorisation holder Orexigen Therapeutics Ireland Limited
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions