基本信息
文件名称：盐酸替纳帕诺(tenapanor hydrochloride)片的CTD资料（PMDA).pdf
文件大小：1.66 MB
总页数：94 页
更新时间：2025-05-29
总字数：约41.48万字
文档摘要

ReportontheDeliberationResults

August25,2023

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNamePhozevelTablets5mg

PhozevelTablets10mg

PhozevelTablets20mg

PhozevelTablets30mg

Non-proprietaryNameTenapanorHydrochloride(JAN*)

ApplicantKyowaKirinCo.,Ltd.

DateofApplicationOctober28,2022

ResultsofDeliberation

InitsmeetingheldonAugust21,2023,theFirstCommitteeonNewDrugsconcludedthattheproductmaybe

approvedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.There-examination

periodis8years.Neitherthedrugproductnoritsdrugsubstanceisclassifiedasapoisonousdrugorapowerful

drug.

ApprovalCondition

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailablefortheconvenience

ofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapaneseoriginalshalltake

precedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreferenceEnglishtranslation.

Revie