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Pharmaceuticals - Community Register
List of nationally authorised medicinal products for human use
|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|
|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|
|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|