基本信息
文件名称：帕瑞肽(Pasireotide pamoate)注射液的CTD资料（PMDA）.pdf
文件大小：453.56 KB
总页数：58 页
更新时间：2025-06-03
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文档摘要

ReportontheDeliberationResults

March8,2018

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameSigniforLARKitfori.m.injection10mg,

SigniforLARKitfori.m.injection20mg,

SigniforLARKitfori.m.injection30mg,and

SigniforLARKitfori.m.injection40mg

Non-proprietaryNamePasireotidePamoate(JAN*)

ApplicantNovartisPharmaK.K.

DateofApplicationJune30,2017

ResultsofDeliberation

InitsmeetingheldonMarch1,2018,theFirstCommitteeonNewDrugsconcludedthatpartialchange

applicationsforSigniforLARKitfori.m.injection20mgand40mg,andapplicationsforSigniforLAR

Kitfori.m.injection10mgand30mgmaybeapprovedandthatthisresultshouldbepresentedtothe

PharmaceuticalAffairsDepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

SigniforLARKitfori.m.injection10mgand30mgarenotclassifiedasabiologicalproductora

specifiedbiologicalproduct.Thedrugproductsareclassifiedaspowerfuldrugs.There-examination

periodofSigniforLARKitfori.m.injection10mg,20mg,30mg,and40mgis10yearsforthe

indicationandthedosageandadministrationproposedinthepresentapplication.

ConditionsofApproval

1.Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

2.Becauseoftheverylimitednumberofsubjectsinclud