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文件名称:佩玛贝特片(Pemafibrate)的CTD资料(PMDA).pdf
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更新时间:2025-05-29
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文档摘要

ReviewReport

May12,2023

PharmaceuticalsandMedicalDevicesAgency

Thefollowingaretheresultsofthereviewofthefollowingpharmaceuticalproductsubmittedfor

marketingapprovalconductedbythePharmaceuticalsandMedicalDevicesAgency(PMDA).

BrandNameParmodiaXRTablets0.2mg

ParmodiaXRTablets0.4mg

Non-proprietaryNamePemafibrate(JAN*)

ApplicantKowaCompany,Ltd.

DateofApplicationSeptember12,2022

DosageForm/StrengthExtended-releasetablets:Eachtabletcontains0.2or0.4mgof

Pemafibrate.

ApplicationClassificationPrescriptiondrugs(5)Drugsinnewdosageforms

ItemsWarrantingSpecialMentionNone

ReviewingOfficeOfficeofNewDrugII

ResultsofReview

Onthebasisofthedatasubmitted,PMDAhasconcludedthattheproducthasefficacyinthetreatment

ofhyperlipidemia,andthattheproducthasacceptablesafetyinviewofitsbenefits(seeAttachment).

Asaresultofitsreview,PMDAhasconcludedthattheproductmaybeapprovedfortheindication

anddosageandadministrationshownbelow,withthefollowingcondition.

Indication

Hyperlipidemia(includingfamilialhyperlipidemia)

DosageandAdministration

Theusualadultdosageis0.2mgofpemafibrateorallyadministeredoncedaily.Thedosemaybe

increasedupto0.4mgoncedailydependingontheextentoftheelevatedtriglyceridelevel.

ApprovalCondition

Theapplicantisrequiredtodevelopandappropriatelyimplementariskmanagementplan.

*JapaneseAcceptedNam