Acomplia

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rimonabant

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Acomplia has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 30/01/2009

Authorisation details

Product details
Name
Acomplia
Agency product number
EMEA/H/C/000666
Active substance
rimonabant
International non-proprietary name (INN) or common name
rimonabant
Therapeutic area (MeSH)
Obesity
Anatomical therapeutic chemical (ATC) code
A08AX01
Publication details
Marketing-authorisation holder
sanofi-aventis
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
19/06/2006
Contact address
74, avenue de France
F - 75013 Paris
France

Product information

17/07/2008 Acomplia - EMEA/H/C/000666 - II/0011

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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).

Assessment history

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