On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Qsiva, intended for the treatment of obesity. The company that applied for authorisation is Vivus BV.
The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 21 February 2013.
Questions and answers on the refusal of the marketing authorisation for Qsiva (phentermine / topiramate) (PDF/104.4 KB)Adopted
First published: 22/02/2013
Last updated: 22/02/2013
|International non-proprietary name (INN) or common name||
phentermine / topiramate
|Therapeutic area (MeSH)||
|Date of opinion||
|Date of refusal of marketing authorisation||
Qsiva : EPAR - Public assessment report (PDF/1.29 MB)Adopted
First published: 13/06/2013
Last updated: 13/06/2013
Questions and answers on the refusal of the marketing authorisation for Qsiva (phentermine / topiramate) (PDF/106.44 KB)Adopted
First published: 19/10/2012
Last updated: 19/10/2012