罗米地辛注射液(Romidepsin)的NDA审评信息（PMDA）.pdfVIP

ReportontheDeliberationResults

June7,2017

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameIstodaxInjection10mg

Non-proprietaryNameRomidepsin(JAN*)

ApplicantCelgeneK.K.

DateofApplicationSeptember2,2016

ResultsofDeliberation

InthemeetingheldonMay30,2017,theSecondCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.There-

examinationperiodis10years.Thedrugproductanditsdrugsubstanceareclassifiedaspowerfuldrugs

andpoisonousdrugs,respectively.

ConditionsofApproval

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapanese

originalshalltakeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreference

Englishtranslation.

ReviewReport