Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Dexfenfluramine
Also marketed in the EU under the name(s): Adifax, Dexfenfluramine Servier, Dipondal, Glypolix, Isomeran, Isomeride, Obedial
Active substance: Dexfenfluramine
Indication: Adjunctive therapy to diet, in patients with obesity and a body mass index (BMI) of 30 kg/m2 or higher who have not responded to an appropriate weight-reducing regimen alone
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
10/12/1996 Referral (96)3608 of 9/12/1996
11/03/2000 Referral (2000)573 of 9/03/2000