ReportontheDeliberationResults
March10,2015
EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau
MinistryofHealth,LabourandWelfare
[Brandname]NovoThirteen2500IUforIntravenousInjection
[Non-proprietaryname]Catridecacog(GeneticalRecombination)(JAN*)
[Applicant]NovoNordiskPharmaLtd.
[Dateofapplication]August29,2014
[Reviewresults]
InthemeetingheldonMarch5,2015,theSecondCommitteeonNewDrugsconcludedthattheproduct
maybeapprovedandthatitsresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe
PharmaceuticalAffairsandFoodSanitationCouncil.
There-examinationperiodis10years.Neitherthedrugsubstancenorthedrugproductisclassifiedas
apoisonousdrugorapowerfuldrugandtheproductisnotclassifiedasabiologicalproductora
specifiedbiologicalproduct.
[Conditionsforapproval]
Theapplicantisrequiredto:
?Developandappropriatelyimplementariskmanagementplan.
?Conductause-resultssurveythatshouldcoverallJapanesepatientsreceivingtheproduct,toidentify
thecharacteristicsofpatientsreceivingtheproduct,tocollectefficacyandsafetydata,andtotake
appropriatemeasurestoensuretheproperuseoftheproduct,whereverpossible,sincethenumber
ofsubjectsenrolledintheJapaneseclinicalstudiesoftheproductisextremelylimited.Thesurvey
shouldbecontinuedforacertainperiodoftime.
*JapaneseAcceptedName(modifiedINN)
ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenienc