Overview

The marketing authorisation for Acomplia has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information: II/0011

17/07/2008

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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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Product details

Name of medicine
Acomplia
Active substance
rimonabant
International non-proprietary name (INN) or common name
rimonabant
Therapeutic area (MeSH)
Obesity
Anatomical therapeutic chemical (ATC) code
A08AX01

Pharmacotherapeutic group

Antiobesity preparations, excl. diet products

Therapeutic indication

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).

Authorisation details

EMA product number
EMEA/H/C/000666
Marketing authorisation holder
sanofi-aventis

74, avenue de France
F - 75013 Paris
France

Marketing authorisation issued
19/06/2006
Revision
8

Assessment history

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