ReportontheDeliberationResults

June3,2015

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]OfevCapsules100mg,OfevCapsules150mg

[Non-proprietaryname]NintedanibEthanesulfonate(JAN*)

[Applicant]NipponBoehringerIngelheimCo.,Ltd.

[Dateofapplication]October14,2014

[Resultsofreview]

InthemeetingheldonMay28,2015,theSecondCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis10years,thedrugsubstanceandthedrugproductarebothclassifiedas

powerfuldrugs,andtheproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.

[Conditionsforapproval]

Theapplicantisrequiredto:

1.Developariskmanagementplanandensurethattheplanisimplementedappropriately.

2.Conductapost-marketingdruguse-resultssurveytargetingallpatientstreatedwiththeproduct

untildatafromaspecifiednumberofthepatientsaregatheredforbetterunderstandingofthe

characteristicsofpatientsusingtheproduct,becauseofthelimitednumberofpatientsenrolledin

theJapaneseclinicalstudies;andensurethatsafetyandefficacydataoftheproductarecollected

early,therebytakingnecessarymeasuresfortheproperuseoftheproduct.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreport