ReportontheDeliberationResults
June11,2015
EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau,
MinistryofHealth,LabourandWelfare
[Brandname](a)RadicutInjection30mg
(b)RadicutBagforIntravenousInfusion30mg
[Non-proprietaryname]Edaravone(JAN*)
[Nameofapplicant]MitsubishiTanabePharmaCorporation
[Dateofapplication]October29,2014
[Reviewresults]
InthemeetingheldonJune5,2015,theFirstCommitteeonNewDrugsconcludedthatthepartial
changeapplicationfortheproductsmaybeapprovedandthatthereviewresultsshouldbepresentedto
thePharmaceuticalAffairsDepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.
There-examinationperiodoftheproductsis10years.
[Conditionsforapproval]
Theapplicantisrequiredtodevelopariskmanagementplanandimplementitappropriately.
OnthebasisofthedeliberationattheCommittee,thestatementsofthedosageandadministrationhave
beenmodifiedasshownbelow.Thismodificationdoesnotaffectotherreviewresults.
AftermodificationBeforemodification
[DosageandAdministration][DosageandAdministration]
(a)RadicutInjection30mg:(a)RadicutInjection30mg:
1.Improvementofneurologicalsymptoms,1.Improvementofneurologicalsymptoms,
disabilityinactivitiesofdailyliving,anddisabilityinactivitiesofdailyliving,and
functiona