【機密性2】

ReportontheDeliberationResults

September14,2016

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau,

MinistryofHealth,LabourandWelfare

BrandNamePrizbindIntravenousSolution2.5g

Non-proprietaryNameIdarucizumab(GeneticalRecombination)(JAN*)

ApplicantNipponBoehringerIngelheimCo.Ltd.

DateofApplicationFebruary23,2016

ResultsofDeliberation

InitsmeetingheldonSeptember7,2016,theFirstCommitteeonNewDrugsconcludedthattheproductmay

beapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis8years.Neitherthedrugproductnoritsdrugsubstanceisclassifiedasa

poisonousdrugorapowerfuldrug.Theproductisclassifiedasabiologicalproduct.

ConditionsofApproval

Theapplicantisrequiredto:

1.Developandappropriatelyimplementariskmanagementplan.

2.Conductause-resultssurveyencompassingallpatientstreatedwiththeproduct.Becauseoftheverylimited

experienceinJapanesepatients,thesurveyshouldbeconductedinallpatientstreatedwiththeproductuntil

dataarecollectedonacertainnumberofpatientsinordertoidentifythecharacteristicsofthetreatedpatients,

collectdataonthesafetyandefficacyoftheproductwithoutdelay,andtakenecessarymeasurestoensure

theproperuseofthedrugproduct.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtose