特立帕肽注射液(Teriparatide)的NDA审评信息（PMDA）.pdfVIP

ReportontheDeliberationResults

May6,2010

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]ForteoSubcutaneousInjectionCartridge600μg

ForteoSubcutaneousInjectionKit600μg

[Non-proprietaryname]Teriparatide(GeneticalRecombination)(JAN*)

[Applicant]EliLillyJapanK.K.

[Dateofapplication]April28,2009

[Resultsofdeliberation]

InthemeetingheldonApril23,2010,theFirstCommitteeonNewDrugsconcludedthattheproductmaybe

approvedandthatthisresultshouldbepresentedtothePharmaceuticalAffairsDepartmentofthe

PharmaceuticalAffairsandFoodSanitationCouncil.

Theproductisnotclassifiedasabiologicalproductoraspecifiedbiologicalproduct,andthere-examination

periodis8years.Neitherthedrugsubstancenorthedrugproductisclassifiedasapoisonousdrugora

powerfuldrug.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconvenienceforusers.Inthe

eventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.ThePMDAwillnotbe

responsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.

ReviewReport

April6,2010