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