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- 2025-06-02 发布于江苏
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ReportontheDeliberationResults
June1,2018
PharmaceuticalEvaluationDivision,PharmaceuticalSafetyandEnvironmentalHealthBureauMinistryof
Health,LabourandWelfare
BrandNameRefixiaI.V.Injection500
RefixiaI.V.Injection1000
RefixiaI.V.Injection2000
Non-proprietaryNameNonacogBetaPegol(GeneticalRecombination)
ApplicantNovoNordiskPharmaLtd.
DateofApplicationJuly11,2017
ResultsoftheDeliberation
InitsmeetingheldonMay23,2018,theSecondCommitteeonNewDrugsconcludedthattheproductmaybe
approvedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe
PharmaceuticalAffairsandFoodSanitationCouncil.
Theproductisclassifiedasabiologicalproduct,andthereexaminationperiodofthisproductis8years.Neither
thedrugproductnoritsdrugsubstanceisclassifiedasapoisonousdrugorapowerfuldrug.
ConditionsforApproval
Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.
ThisEnglishtranslationofthisJapanesereviewreportisinte
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