基本信息
文件名称：地诺单抗（denosumab,又称AMC-162，商品名Prolia）注射液的CTD资料（PMDA）.pdf
文件大小：515.69 KB
总页数：36 页
更新时间：2025-05-31
总字数：约11.78万字
文档摘要

ReportontheDeliberationResults

June7,2017

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,Labour,andWelfare

BrandNamePraliaSubcutaneousInjection60mgSyringe

Non-proprietaryNameDenosumab(GeneticalRecombination)(JAN*)

ApplicantDaiichiSankyoCo.,Ltd.

DateofApplicationSeptember23,2016

ResultsofDeliberation

InitsmeetingheldonMay30,2017,theSecondCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis4years.

ConditionsofApproval

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapanese

originalshalltakeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreference

Englishtranslation.

ReviewReport

May12,2017