ReportontheDeliberationResults
February5,2010
EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau
MinistryofHealth,LabourandWelfare
[Brandname]RozeremTablets8mg
[Non-proprietaryname]Ramelteon(JAN*)
[Applicant]TakedaPharmaceuticalCompanyLimited
[Dateofapplication]February29,2008
[Resultsofdeliberation]
InthemeetingheldonJanuary29,2010,theFirstCommitteeonNewDrugsconcludedthattheproduct
maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe
PharmaceuticalAffairsandFoodSanitationCouncil.
Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct,there-examination
periodis8years,andthedrugsubstanceisclassifiedasapowerfuldrugandthedrugproductisnot
classifiedasapoisonousdrugorapowerfuldrug.
*JapaneseAcceptedName(modifiedINN)
ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenience
forusers.IntheeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformer
shallprevail.ThePMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.
ReviewReport
January15,2010
PharmaceuticalsandMedicalDevicesAgency
TheresultsofaregulatoryreviewconductedbythePharmaceuticalsandMedicalDevicesAgencyonthe
followingpharmaceuticalproductsubm