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The applicant presented in their submission the following grounds for re-examination: The applicant emphasised that Qsiva phentermine is highly effective in achieving and maintaining weight loss in obese patients, of a magnitude greater than that of any other pharmacological treatment to date with expected improvement of cardiovascular, metabolic, and other outcomes, as well as demonstrated improvements in blood pressure, glycaemic control, lipids, quality of life, incidence of new onset type 2 diabetes and other outcomes .
With regard to the general safety profile, the applicant pointed out that Qsiva is a combination of two approved drugs with long histories phentermine of use at higher doses and well established safety profiles of both The applicant addressed specifically the CHMP´s four initial principal grounds for refusal: 1 .
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