基本信息
文件名称：米吉珠单抗（Mirikizumab）的NDA审评信息（PMDA）.pdf
文件大小：1.45 MB
总页数：85 页
更新时间：2025-05-28
总字数：约35.78万字
文档摘要

ReportontheDeliberationResults

March8,2023

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameOmvohIntravenousInfusion300mg

OmvohSubcutaneousInjection100mgAutoinjectors,

OmvohSubcutaneousInjection100mgSyringes

Non-proprietaryNameMirikizumab(GeneticalRecombination)(JAN*)

ApplicantEliLillyJapanK.K.

DateofApplicationMay27,2022

ResultsofDeliberation

InitsmeetingheldonMarch3,2023,theFirstCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisclassifiedasabiologicalproduct.There-examinationperiodis8years.Thedrugproduct

anditsdrugsubstancearebothclassifiedaspowerfuldrugs.

ApprovalConditions

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapanese

originalshalltakeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreference

Englishtranslation.

ReviewReport