匹米替比片 (Pimitespib)的NDA审评信息（PMDA）.pdfVIP

ReportontheDeliberationResults

June1,2022

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureau

MinistryofHealth,LabourandWelfare

BrandNameJeselhyTablets40mg

Non-proprietaryNamePimitespib(JAN*)

ApplicantTaihoPharmaceuticalCo.,Ltd.

DateofApplicationSeptember14,2021

ResultsofDeliberation

InitsmeetingheldonMay30,2022,theSecondCommitteeonNewDrugsconcludedthattheproduct

maybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentof

thePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct.The

re-examinationperiodis8years.Thedrugproductanditsdrugsubstanceareclassifiedasapowerful

drugandapoisonousdrug,respectively.

ApprovalConditions

1.Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

2.InviewofthelimitednumberofJapanesepatientsparticipatedintheclinicalstudies,the

applicantisrequiredtoconductadruguse-resultssurveyinvolvingallJapanesepatientstreated

withtheproductinthepost-marketingsettingsuntildataofacertainnumberofpatientsare

available,inordertounderstandthecharacteristicsofpatientsusingtheproduct,andtopromptly

collectsafetyandefficacydatasothatnecessarymeasuresaretakentoensuretheproperuseof

theproduct.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanese