ReportontheDeliberationResults

December6,2017

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,Labour,andWelfare

BrandNameSolirisforIntravenousInfusion300mg

Non-proprietaryNameEculizumab(GeneticalRecombination)(JAN*)

ApplicantAlexionPharmaGodoKaisha

DateofApplicationMarch22,2017

ResultsofDeliberation

InitsmeetingheldonDecember4,2017,theFirstCommitteeonNewDrugsconcludedthatthepartial

changeapplicationfortheproductmaybeapprovedandthatthisresultshouldbepresentedtothe

PharmaceuticalAffairsDepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis10years.

ConditionsofApproval

1.Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

2.BecausedatafromJapaneseclinicalstudiesarelimited,theapplicantisrequiredtoconductause-

resultssurveyoveraspecifiedperiod,coveringallpatientstreatedwiththeproduct,tounderstand

thecharacteristicsofpatientstreatedwiththeproductandtoobtainsafetyandefficacydatasoasto

takenecessarymeasuresfortheproducttobeusedproperly.

3.Theapplicantisrequiredtotakenecessarypost-marketingmeasuressothattheproductis

administeredonlyunderthesupervisionofphysiciansandatmedicalinstitutionswithexpertisein

thediagnosisandtreatmentofgeneralizedmyastheniagravisandcapabilityformanagingtherisks,

etc.oftheproduct,andonly