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The supportive information on safety phentermine of phentermine from the literature provided by the applicant was considered by CHMP to be very limited due to factors such as only retrospective, cohort studies submitted, absence of a reliable control group, etc .
Although the amount of phentermine in the high dose of Qsiva is half of that currently licensed for use as a single agent in the US and the UK, the addition of topiramate was shown to increase exposure to phentermine by 40% phentermine in the PK studies .
Therefore the cardiovascular effects of Qsiva cannot be implied from data for phentermine weight loss prescription adipex 30 mg extended release order phentermine cheap adipex higher doses of phentermine as a single agent .
phentermine 37.5 sale discount phentermine diet pills phentermine substitute how to order Psychiatric safety –Depression, anxiety and cognitive impairment were more commonly reported in patients treated with Qsiva than placebo .
The collection of psychiatry data with screening instruments such as QPH-9 and C-SSRS was found by CHMP to be inadequate since diagnostic instruments are more powerful and would be needed to reliably establish the clinical relevance and magnitude of the psychiatry adverse events adipex 15mg average weight loss adipex and anxiety medications adipex results in drug test adipex 37 (AEs) observed with Qsiva .
Dropout rates for depression with Qsiva significantly outnumbered those with phentermine placebo; thus close surveillance in trials may have stopped progression to more severe symptoms .
The applicant’s claim that by applying the 3 month stopping rule for non-responders, the number of drop-outs due to neuropsychiatric AEs in the Qsiva group would not exceed those in the placebo group was questioned by phentermine CHMP .
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