ReportontheDeliberationResults

November26,2014

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]NopicorCapsules2.5μg

[Non-proprietaryname]NalfurafineHydrochloride(JAN*)

[Nameofapplicant]TorayMedicalCo.,Ltd.

[Dateofapplication]October25,2013

[Resultsofdeliberation]

InthemeetingheldonNovember21,2014,theFirstCommitteeonNewDrugsconcludedthatthe

productmaybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairs

DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis4years,andthedrugproductisclassifiedasapowerfuldrug.Theproduct

isnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.

[Conditionsforapproval]

Theapplicantisrequiredtoformulateariskmanagementplanandimplementitappropriately.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenienceforusers.In

theeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.ThePMDA

willnotberesponsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.

ReviewReport

October31,2014

PharmaceuticalsandMedicalDevicesAgency

Theresultsofaregulator