ReportontheDeliberationResults

March3,2016

EvaluationandLicensingDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

[BrandName]NucalaforS.C.Injection100mg

[Non-proprietaryName]Mepolizumab(GeneticalRecombination)(JAN*)

[Applicant]GlaxoSmithKlineK.K.

[DateofApplication]May22,2015

[ResultsofDeliberation]InthemeetingheldonFebruary26,2016,theSecondCommitteeon

NewDrugsconcludedthattheproductmaybeapprovedandthatthis

resultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis8years.Boththedrugproductanditsdrug

substanceareclassifiedaspowerfuldrugs.Theproductisclassifiedas

abiologicalproduct.

[ConditionofApproval]Theapplicantisrequiredtodevelopandappropriatelyimplementarisk

managementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenienceforusers.In

theeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.ThePMDAwill

notberesponsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.

Review