Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Qsiva
Active substance: phentermine/topiramate
Indication: Treatment of obesity, including weight loss and maintenance of weight loss in adults, as an adjunct to reduced calorie diet and physical activity. Qsiva is recommended for obese patients (BMI ≥ 35 kg/m2), or obese patients (BMI ≥ 30 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes or dyslipidaemia. Qsiva should be prescribed by physicians experienced in the management of obesity and obesity-related co-morbidities.
Marketing Authorisation Holder: VIVUS B.V.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/05/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2350 (2013)2897 of 14/05/2013