ReportontheDeliberationResults

November14,2016

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameParsabivIntravenousInjectionforDialysis2.5mg

ParsabivIntravenousInjectionforDialysis5mg

ParsabivIntravenousInjectionforDialysis10mg

Non-proprietaryNameEtelcalcetideHydrochloride(JAN*)

ApplicantOnoPharmaceuticalCo.,Ltd.

DateofApplicationJanuary14,2016

ResultsofDeliberation

InitsmeetingheldonOctober31,2016,theFirstCommitteeonNewDrugsconcludedthattheproductmay

beapprovedandthatthisresultshouldbereportedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.There-examination

periodis8years.Thedrugproductisclassifiedasapowerfuldruganditsdrugsubstanceisclassifiedasa

poisonousdrug.

ConditionofApproval

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailablefortheconvenience

ofusers.IntheeventofanyinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theJapaneseoriginalshalltake

precedence.PMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisreferenceEnglishtranslation.