ReportontheDeliberationResults

September13,2013

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]SovriadCapsules100mg

[Non-proprietaryname]SimeprevirSodium(JAN*)

[Applicant]JanssenPharmaceuticalK.K.

[Dateofapplication]February22,2013

[Resultsofdeliberation]

InthemeetingheldonSeptember13,2013,theSecondCommitteeonNewDrugsconcludedthatthe

productmaybeapproved,andthatthisresultshouldbepresentedtothePharmaceuticalAffairs

DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis8years,thedrugsubstanceandthedrugproductarebothclassifiedas

powerfuldrugs,andtheproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenienceforusers.In

theeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.ThePMDAwill

notberesponsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.

ReviewReport

September3,2013

PharmaceuticalsandMedicalDevicesAgency

TheresultsofaregulatoryreviewconductedbythePharmaceuticalsandMedicalDevices