Table of contents
The marketing authorisation for Acomplia has been withdrawn at the request of the marketing authorisation holder.
Acomplia : EPAR - Summary for the public (PDF/481.47 KB)
First published: 30/01/2009
Last updated: 30/01/2009
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
74, avenue de France
F - 75013 Paris
17/07/2008 Acomplia - EMEA/H/C/000666 - II/0011
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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).
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Antiobesity preparations, excl. diet products
As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).