The marketing authorisation for Acomplia has been withdrawn at the request of the marketing authorisation holder.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||
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|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
17/07/2008 Acomplia - EMEA/H/C/000666 - II/0011
- 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
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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).