马来酸阿法替尼片（Afatinib Maleate)的NDA审评信息（PMDA）.pdfVIP

马来酸阿法替尼片（Afatinib Maleate)的NDA审评信息（PMDA）.pdf

此“医疗卫生”领域文档为创作者个人分享资料，不作为权威性指导和指引，仅供参考

ReportontheDeliberationResults

November26,2013

EvaluationandLicensingDivision,PharmaceuticalandFoodSafetyBureau

MinistryofHealth,LabourandWelfare

[Brandname]GiotrifTablets20mg,30mg,40mg,and50mg

[Non-proprietaryname]AfatinibMaleate(JAN*)

[Applicant]NipponBoehringerIngelheimCo.,Ltd.

[Dateofapplication]November30,2012

[Resultsofdeliberation]

InthemeetingheldonNovember18,2013,theSecondCommitteeonNewDrugsconcludedthat

theproductmaybeapprovedandthatthisresultshouldbereportedtothePharmaceuticalAffairs

DepartmentofthePharmaceuticalAffairsandFoodSanitationCouncil.

There-examinationperiodis8years.Boththedrugsubstanceandthedrugproductareclassified

aspowerfuldrugs.Theproductisnotclassifiedasabiologicalproductoraspecifiedbiological

product.

*JapaneseAcceptedName(modifiedINN)

ThisEnglishversionoftheJapanesereviewreportisintendedtobeareferencematerialtoprovideconveniencefor

users.IntheeventofinconsistencybetweentheJapaneseoriginalandthisEnglishtranslation,theformershallprevail.

ThePMDAwillnotberesponsibleforanyconsequenceresultingfromtheuseofthisEnglishversion.

ReviewReport

October31,2013

PharmaceuticalsandMedicalDevicesAgency

TheresultsofaregulatoryreviewconductedbythePharmaceuticalsandMedicalDevicesAgency

onthefollowingpharmaceuticalproductsubmittedforregistrationareasfoll

深度挖掘药品质量研究所涉及的文件

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