ReportontheDeliberationResults

March4,2024

PharmaceuticalEvaluationDivision,PharmaceuticalSafetyBureau

MinistryofHealth,LabourandWelfare

BrandNameSargmalinforInhalation250μg

Non-proprietaryNameSargramostim(GeneticalRecombination)(JAN*)

ApplicantNobelpharmaCo.,Ltd.

DateofApplicationJune30,2023

ResultsofDeliberation

InitsmeetingheldonMarch4,2024,theSecondCommitteeonNewDrugsconcludedthatthe

productmaybeapprovedandthatthisresultshouldbepresentedtothePharmaceuticalAffairs

DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisclassifiedasabiologicalproduct.There-examinationperiodis10years.Neitherthedrug

productnoritsdrugsubstanceisclassifiedasapoisonousdrugorapowerfuldrug.

ApprovalConditions

1.Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

2.Theapplicantisrequiredtoconductapost-marketinguse-resultssurvey,coveringallpatients

treatedwiththeproduct,untildatafromacertainnumberofpatientsareaccruedandto

promptlyobtainsafetyandefficacydataontheproduct.Onthebasisoftheobtaineddata,the

applicantshouldtakenecessaryactionsfortheproperuseoftheproduct.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishtranslationofthisJapanesereviewreportisintendedtoserveasreferencematerialmadeavailableforthe

convenienceofusers.Intheevent