Acomplia

Withdrawn

This medicine's authorisation has been withdrawn

rimonabant

Overview

The marketing authorisation for Acomplia has been withdrawn at the request of the marketing authorisation holder.

Acomplia : EPAR - Summary for the public

Product information

Acomplia : EPAR - Product Information

Latest procedure affecting product information: II/0011

17/07/2008

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).

Acomplia : EPAR - All Authorised presentations

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

Changes since initial authorisation of medicine

Acomplia : EPAR - Procedural steps taken and scientific information after authorisation

Acomplia-H-C-666-II-04 : EPAR - Scientific Discussion - Variation

Adopted

Acomplia-H-C-666-A20-12 : EPAR - Assessment Report - Variation

Reference Number: EMEA/65105/2009

Initial marketing authorisation documents

Acomplia : EPAR - Scientific Discussion

Acomplia : EPAR - Procedural steps taken before authorisation