ReportontheDeliberationResults

September4,2015

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]MulpletaTablets3mg

[Non-proprietaryname]Lusutrombopag(JAN*)

[Applicant]ShionogiCo.,Ltd.

[Dateofapplication]December17,2014

[Resultsofdeliberation]

InthemeetingheldonAugust28,2015,theFirstCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis8years.Neitherthedrugsubstancenorthedrugproductisclassifiedasa

poisonousdrugorapowerfuldrug.Theproductisnotclassifiedasabiologicalproductoraspecified

biologicalproduct.

[Conditionsforapproval]

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenienceforusers.In

theeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.ThePMDA

willnotberesponsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.

ReviewReport

August17,2015

PharmaceuticalsandMedicalDevicesAgency

Theresultsofaregulatoryre