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ReportontheDeliberationResults
August3,2010
EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau
MinistryofHealth,LabourandWelfare
[Brandname]InavirDryPowderInhaler20mg
[Non-proprietaryname]LaninamivirOctanoateHydrate(JAN*)
[Applicant]DaiichiSankyoCompany,Limited
[Dateofapplication]January29,2010
[Resultsofdeliberation]
InthemeetingheldonJuly29,2010,theSecondCommitteeonNewDrugsconcludedthatthe
productmaybeapprovedandthatthisresultshouldbereportedtothePharmaceuticalAffairs
DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.
Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct,andthere-
examinationperiodis8years.Neitherthedrugsubstancenorthedrugproductisclassifiedasa
poisonousdrugorapowerfuldrug.
*JapaneseAcceptedName(modifiedINN)
ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconveniencefor
users.IntheeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.
ThePMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.
ReviewReport
July7,2010
PharmaceuticalsandMedicalDevicesAgency
TheresultsofaregulatoryreviewconductedbythePharmaceuticalsandMedicalDevicesAgency
onthefollowingpharmaceuticalproductsubm
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