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文件名称：来特莫韦(Letermovir)片的CTD资料（PMDA）.pdf
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文档摘要

ReportontheDeliberationResults

March8,2018

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNamePrevymisTablets240mg,PrevymisIntravenousInfusion240mg

Non-proprietaryNameLetermovir(JAN*)

ApplicantMSDK.K.

DateofApplicationJuly28,2017

ResultsofDeliberation

InitsmeetingheldonMarch2,2018,theSecondCommitteeonNewDrugsconcludedthattheproductsmay

beapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductsarenotclassifiedasabiologicalproductoraspecifiedbiologicalproduct,andthere-examination

periodis10years.Thedrugproductsandtheirdrugsubstancearebothclassifiedaspowerfuldrugs.

ConditionsofApproval

1.Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

2.BecausethenumberofpatientsstudiedinJapanisverylimited,theapplicantisrequiredtoconducta