ReportontheDeliberationResults

June22,2015

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]OlanedineAntisepticSolution1.5%;

OlanedineSolution1.5%AntisepticApplicator10mL;

OlanedineSolution1.5%AntisepticApplicator25mL

[Non-proprietaryname]OlanexidineGluconate(JAN*)

[Applicant]OtsukaPharmaceuticalFactory,Inc.

[Dateofapplication]May20,2014

[Reviewresults]

InthemeetingheldonJune17,2015,theSecondCommitteeonNewDrugs

concludedthattheproductsmaybeapprovedandthatitsresultshouldbepresented

tothePharmaceuticalAffairsDepartmentofthePharmaceuticalAffairsandFood

SanitationCouncil.

There-examinationperiodis8years.Neitherthedrugsubstancenorthedrug

productisclassifiedasapoisonousdrug,powerfuldrug,biologicalproduct,or

specifiedbiologicalproduct.

[Conditionsforapproval]Theapplicantisrequiredtodevelopandappropriatelyimplementarisk

managementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialt