Acomplia
Withdrawn
This medicine's authorisation has been withdrawn
rimonabant
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 19 June 2006, the European Commission granted a marketing authorisation valid throughout the European Union for the medicinal product Acomplia (rimonabant), indicated 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.
On 13 November 2008, the marketing of Acomplia was suspended in all the Member States in which the product was being marketed.
On 5 December 2008, the marketing authorisation holder (MAH) responsible for Acomplia, sanofi-aventis, notified the European Commission of its decision to voluntarily withdraw its marketing authorisation. The MAH stated that no additional clinical data will now be available to lift the suspension of the marketing authorisation for Acomplia following its decision to discontinue the ongoing rimonabant clinical development program in all indications.
On 16 January 2009, the European Commission issued a decision to withdraw the marketing authorisation for Acomplia.
Pursuant to this decision the European Public Assessment Report for Acomplia is updated to reflect that the marketing authorisation is no longer valid.
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).
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 productsTherapeutic 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).
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