Acomplia

rimonabant

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The marketing authorisation for Acomplia has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Acomplia : EPAR - Summary for the public BG = bălgarski 2009-01-30  
Acomplia : EPAR - Summary for the public ES = español 2009-01-30  
Acomplia : EPAR - Summary for the public CS = čeština 2009-01-30  
Acomplia : EPAR - Summary for the public DA = dansk 2009-01-30  
Acomplia : EPAR - Summary for the public DE = Deutsch 2009-01-30  
Acomplia : EPAR - Summary for the public ET = eesti keel 2009-01-30  
Acomplia : EPAR - Summary for the public EL = elliniká 2009-01-30  
Acomplia : EPAR - Summary for the public EN = English 2009-01-30  
Acomplia : EPAR - Summary for the public FR = français 2009-01-30  
Acomplia : EPAR - Summary for the public IT = italiano 2009-01-30  
Acomplia : EPAR - Summary for the public LV = latviešu valoda 2009-01-30  
Acomplia : EPAR - Summary for the public LT = lietuvių kalba 2009-01-30  
Acomplia : EPAR - Summary for the public HU = magyar 2009-01-30  
Acomplia : EPAR - Summary for the public MT = Malti 2009-01-30  
Acomplia : EPAR - Summary for the public NL = Nederlands 2009-01-30  
Acomplia : EPAR - Summary for the public PL = polski 2009-01-30  
Acomplia : EPAR - Summary for the public PT = português 2009-01-30  
Acomplia : EPAR - Summary for the public RO = română 2009-01-30  
Acomplia : EPAR - Summary for the public SK = slovenčina 2009-01-30  
Acomplia : EPAR - Summary for the public SL = slovenščina 2009-01-30  
Acomplia : EPAR - Summary for the public FI = suomi 2009-01-30  
Acomplia : EPAR - Summary for the public SV = svenska 2009-01-30  

This EPAR was last updated on 30/01/2009 .

Authorisation details

Product details

Product details for Acomplia
NameAcomplia
Agency product numberEMEA/H/C/000666
Active substance

rimonabant

International non-proprietary name (INN) or common name

rimonabant

Therapeutic area Obesity
Anatomical therapeutic chemical (ATC) code A08AX01

Publication details

Publication details for Acomplia
Marketing-authorisation holder

sanofi-aventis

Revision8
Date of issue of marketing authorisation valid throughout the European Union19/06/2006

Contact address:

sanofi-aventis
74, avenue de France
F - 75013 Paris
France

Product information

Product information

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

Name Language First published Last updated
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  
Acomplia : EPAR - Product Information SV = svenska 2009-01-30  

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  
Acomplia : EPAR - All Authorised presentations SV = svenska 2009-01-30  

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Acomplia : EPAR - Procedural steps taken before authorisation SV = svenska 2009-01-30  
Acomplia : EPAR - Scientific Discussion SV = svenska 2009-01-30  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Acomplia