基本信息
文件名称：托伐普坦磷酸钠（Tolvaptan Sodium Phosphate）注射液的CTD资料（PMDA）.pdf
文件大小：1.04 MB
总页数：83 页
更新时间：2025-06-03
总字数：约33万字
文档摘要

ReportontheDeliberationResults

March2,2022

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameSamtasuforI.V.Infusion8mg

SamtasuforI.V.Infusion16mg

Non-proprietaryNameTolvaptanSodiumPhosphate(JAN*)

ApplicantOtsukaPharmaceuticalCo.,Ltd.

DateofApplicationMarch22,2021

ResultsofDeliberation

InitsmeetingheldonFebruary25,2022,theFirstCommitteeonNewDrugsconcludedthattheproductmay

beapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.There-examination

periodis8years.Thedrugproductanditsdrugsubstancearebothclassifiedaspowerfuldrugs.

ApprovalCondition

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailablefortheconvenience

ofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapaneseoriginalshalltake

precedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreferenceEnglishtranslation.

ReviewReport