ReportontheDeliberationResults
December4,2019
PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau
MinistryofHealth,LabourandWelfare
BrandNameOrkediaTablets1mg
OrkediaTablets2mg
Non-proprietaryNameEvocalcet(JAN*)
ApplicantKyowaKirinCo.,Ltd.
DateofApplicationApril24,2019
ResultsofDeliberation
InitsmeetingheldonNovember29,2019,theFirstCommitteeonNewDrugsconcludedthatthe
partialchangeapplicationfortheproductmaybeapprovedandthatthisresultshouldbepresentedto
thePharmaceuticalAffairsDepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.
There-examinationperiodis10years.
ApprovalConditions
1.Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.
2.SinceonlyalimitednumberofpatientsparticipatedinclinicalstudiesoftheproductinJapan,the
applicantisrequiredtoconductapost-marketingdruguse-resultssurveyinvolvingallpatients
treatedwiththeproductuntildatafromaspecifiednumberofpatientshavebeengatheredinorder
tounderstandthecharacteristicsofpatientstreatedwiththeproduct,andtocollectsafetyand
efficacydataasearlyaspossible,sothatnecessarymeasuresaretakentoensureproperuseofthe
product.
*JapaneseAcceptedName(modifiedINN)
ThisEnglishtranslationofthi