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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 in fact not lunesta the same as zopiclone, on both a scientific basis and within the intent of the applicable legislation .
In particular, lunesta supportive results of a recent head-to-head comparison including statistical evaluation (ESZ111503 have been provided to address limitations of the data set raised by the CHMP) .
lunesta drug dosages lunesta side effects sweating lunesta generic goodrx eszopiclone davis pdf According to the Applicant these additional, supportive results should be regarded as proof to the CHMP that the identified differences between eszopiclone and zopiclone are clinically meaningful, reliable and The Applicant proposes that there are several key questions of relevance when considering whether eszopiclone is an NAS: 1 .
Are lunesta generic launch lunesta vs ambien eszopiclone reviews eszopiclone en español eszopiclone there sufficient differentiating properties between eszopiclone and the racemate? 2 .
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Are the differences relevant and clinically meaningful? In the applicant’s view it is fundamentally important to understand that (R)-zopiclone is not an inert isomer, lunesta substitute lunesta and pregnancy lunesta sublingual lunesta vs ambien treato lunesta side and in the MAA they describe the manner in which it affects the pharmacokinetic and pharmacodynamic characteristics of zopiclone .
Eszopiclone, the (S)-isomer, possesses lunesta the desired therapeutic activity and it has been clearly established that it can be effectively and safely administered as a single-isomer drug .

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