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RE-EXAMINATION OF THE CHMP OPINION Grounds for re-examination Further to the positive CHMP opinion dated 23 October 2008, Sepracor Pharmaceuticals, Ltd is requesting re-examination of the CHMP’s recommendation not to classify eszopiclone as lunesta a new active substance .
In addition the applicant asked for a discussion eszopiclone maximum dosage lunesta generic available date lunesta boxing bed lunesta erowid lunesta of these issues by the Clinical Neuro Sciences (CNS) Scientific Advisory Group (SAG) .
In summary, the grounds for the re-examination The Applicant is of the opinion that eszopiclone differs from the racemate, zopiclone with respect to properties lunesta relating to safety and efficacy .
According to them the available evidence included head-tohead comparisons of pharmacokinetics, pharmacodynamics and tolerability of eszopiclone and zopiclone and the CHMP was not able to conclude in its initial lunesta assessment that these data established that eszopiclone is sufficiently different from zopiclone so as to be considered an NAS .
Based on the feedback the applicant received at the oral explanation meeting during the first round of assessment, they presented supportive evidence that in his view eszopiclone is lunesta patient assistance application eszopiclone bangladesh generic for lunesta 3 mg lunesta in fact not the same as zopiclone, on both a scientific basis and within the intent of the applicable legislation .
In particular, supportive results of a recent head-to-head comparison including statistical evaluation (ESZ111503 have been provided to address limitations lunesta of the data set raised by the CHMP) .

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