Qsiva

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phentermine / topiramate

Refused
This medicine was refused authorisation for use in the European Union.

Overview

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.

This EPAR was last updated on 13/06/2013

Application details

Product details
Name
Qsiva
Active substance
  • phentermine
  • topiramate
International non-proprietary name (INN) or common name
phentermine / topiramate
Therapeutic area (MeSH)
Obesity
Application details
Marketing-authorisation applicant
Vivus BV
Date of opinion
21/02/2013
Date of refusal of marketing authorisation
14/05/2013

Assessment history

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