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文件名称：Roszet(瑞舒伐他汀_依折麦布)片的CTD资料（PMDA）.pdf
文件大小：521.96 KB
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更新时间：2025-06-03
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文档摘要

ReportontheDeliberationResults

February26,2019

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameRosuzetCombinationTabletsLD

RosuzetCombinationTabletsHD

Non-proprietaryNameEzetimibe/RosuvastatinCalcium(JAN*)

ApplicantMSDK.K.

DateofApplicationMay22,2018

ResultsofDeliberation

InitsmeetingheldonFebruary21,2019,theFirstCommitteeonNewDrugsconcludedthattheproductmay

beapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.There-examination

periodis4years.Thedrugproductsarenotclassifiedasapoisonousdrugorapowerfuldrug.

ConditionofApproval

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailablefortheconvenience

ofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapaneseoriginalshalltake

precedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreferenceEnglishtranslation.

ReviewReport

February8,2019