基本信息
文件名称：NEXVIADYME(耐而赞_注射用艾夫糖苷酶α_avalglucosidase?alfa)的NDA审评信息（PMDA）.pdf
文件大小：1.37 MB
总页数：72 页
更新时间：2025-05-27
总字数：约32.43万字
文档摘要

ReportontheDeliberationResults

September7,2021

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameNexviazymeforI.V.Infusion100mg

Non-proprietaryNameAvalglucosidaseAlfa(GeneticalRecombination)(JAN*)

ApplicantSanofiK.K.

DateofApplicationJanuary19,2021

ResultsofDeliberation

InitsmeetingheldonAugust30,2021,theFirstCommitteeonNewDrugsconcludedthattheproductmaybe

approvedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisclassifiedasabiologicalproduct,andthere-examinationperiodis10years.Thedrugproduct

anditsdrugsubstancearebothclassifiedaspowerfuldrugs.

ApprovalCondition

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailablefortheconvenience

ofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapaneseoriginalshall

takeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreferenceEnglishtranslation.

ReviewReport

August6,2021