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Secondly, there were concerns about the long-term psychiatric effects (depression and anxiety were reported in the studies) and cognitive effects (such as problems with memory and attention) related to the topiramate component adipex of Qsiva .
Topiramate is also known to be potentially harmful to the unborn baby if taken by pregnant adipex women .
The Committee noted that there was a high probability adipex that, if approved, the medicine would not be used strictly for the intended patients .
The applicant did propose measures to reduce this adipex risk, but the measures were considered difficult to implement in practice .
Therefore, the CHMP concluded that the benefits of Qsiva did adipex not outweigh its risks and recommended that it be refused marketing authorisation .
The CHMP adipex refusal was confirmed after re-examination .
What consequences does this refusal have for patients in clinical trials? The company informed the CHMP that that there are no consequences for patients involved in clinical Refusal adipex of the marketing authorisation for Qsiva (phentermine / topiramate) .
21 February 2013 Questions and answers Refusal of the marketing authorisation for Qsiva (phentermine / topiramate) Outcome of re-examination 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, adipex intended for the treatment of obesity .
The company that adipex other weight loss medications phentermine reviews 2014 when does adipex withdrawal start applied for authorisation is Vivus BV .
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