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Psychiatric safety –Depression, anxiety and cognitive impairment were more commonly reported in patients treated with Qsiva than adipex 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 adipex needed to reliably establish the clinical relevance and magnitude of the psychiatry adverse events (AEs) observed with Qsiva .
Dropout rates for depression with duromine tablets reviews phentermine weight loss success stories phentermine amazon adipex vs Qsiva significantly outnumbered those with 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 adipex CHMP .
With regard to reported cases of suicidal ideation in patients treated with Qsiva during the clinical studies, regular assessments in this adipex 37.5 for weight loss adipex 30mg capsule kvk buy phentermine 37.5 online adipex and local regard would be required .
Another concern was the feasibility to exclude adipex patients with moderate depression from treatment .
Overall, the availability of psychiatric expertise at sites of treatment with Qsiva was considered to be adipex necessary by CHMP .
During the re-examination procedure, the applicant proposed a further revised SmPC which forgoes the top dose of Qsiva, associated with the adipex highest rate of psychiatric and cardiovascular adverse events .

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