ReportontheDeliberationResults

February28,2019

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameSkyrizi75mgforS.C.InjectionSyringe0.83mL

Non-proprietaryNameRisankizumab(GeneticalRecombination)(JAN*)

ApplicantAbbVieGK

DateofApplicationMay25,2018

ResultsofDeliberation

InitsmeetingheldonFebruary22,2019,theSecondCommitteeonNewDrugsconcludedthatthe

productmaybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairs

DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisclassifiedasabiologicalproduct.There-examinationperiodis8years.Thedrug

productanditsdrugsubstancearebothclassifiedaspowerfuldrugs.

ApprovalCondition

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,the

Japaneseoriginalshalltakeprecedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthis

referenceEnglishtranslation.

ReviewReport

February13,2019