ReportontheDeliberationResults
June10,2014
EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau
MinistryofHealth,LabourandWelfare
[Brandname]RapalimusTablets1mg
[Non-proprietaryname]Sirolimus(JAN*)
[Applicant]NobelpharmaCo.,Ltd.
[Dateofapplication]October21,2013
[Resultsofdeliberation]
InthemeetingheldonMay26,2014,theSecondCommitteeonNewDrugsconcludedthatthe
productmaybeapprovedandthatthisresultshouldbereportedtothePharmaceuticalAffairs
DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.
There-examinationperiodis10years,thedrugsubstanceandthedrugproductarebothclassified
aspowerfuldrugs,andtheproductisnotclassifiedasabiologicalproductoraspecifiedbiological
product.
[Conditionsforapproval]
Theapplicantisrequiredtoconductadruguse-resultssurveyinallpatientsuntildatafroma
certainnumberofpatientshavebeenaccumulatedtounderstandthedemographicinformationof
patientstreatedwiththisproduct,becausethereareextremelyfewJapanesepatientswhohave
beentreatedwiththedrug.Atthesametime,safetyandefficacydataontheproductshouldbe
collectedearlyandnecessarymeasuresshouldbetakentofacilitatetheproperuseoftheproduct.
*JapaneseAcceptedName(modifiedINN)
ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconveniencefor
users.IntheeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.
ThePMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseoft