Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Sibutramine

Product name: Sibutramine
Also marketed in the EU under the name(s): Afibron, ECTIVA, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Reductil, Reduxade, Reduxate, Sibutral, Sibutramin, Sibutramina, Sibutramina, Sibutril, Siluton, Sitrane, Zelium, Zelixa
INN: Sibutramine
Indication: Sibutramine is an orally administered serotonin and noradrenaline reuptake inhibitor that is indicated as adjunctive therapy for adult patients within a weight management programme, including weight loss and maintenance of weight loss. Sibutramine should be used in conjunction with a reduced calorie diet and increased physical activity in- Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m2 or higher.- Patients with nutritional excess weight and a BMI of 27 kg/m2 or higher, if other obesity-related risk factors such as type 2 diabetes or dyslipidaemia are present.
Marketing Authorisation Holder: Not applicable

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/03/2001 Referral EMEA/H/A-12/349 (2001)789 of 26/03/2001
16/10/2002 Referral EMEA/H/A-31/479 (2002)4010 of 15/10/2002
04/03/2010 Referral EMEA/H/A-107/1256 (2010)1211 of 03/03/2010
10/08/2010 Referral EMEA/H/A-107/1256 (2010)5597 of 06/08/2010