Public Assessment Report

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1、PublicAssessmentReportDecentralisedProcedureLamivudineMylan150mgand300mgFilm-coatedTablets(lamivudine)ProcedureNo:UK/H/4520/001-2/DCUKLicenceNo:PL04569/1173-4GenericsUKt/aMylanPARLamivudineMylan150mgand300mgFilm-coatedTabletsUK/H/4520/001-2/DCLAYSUMMARYLamivudineMylan150mgand300mgFilm-coated

2、Tablets(lamivudine)Thisisasummaryofthepublicassessmentreport(PAR)forLamivudineMylan150mgand300mgFilm-coatedTablets(PL04569/1173-4;UK/H/4520/001-2/DC).ItexplainshowLamivudineMylan150mgand300mgFilm-coatedTabletswereassessedandtheirauthorisationrecommended,aswellastheirconditionsofuse.Itisnotin

3、tendedtoprovidepracticaladviceonhowtouseLamivudineMylan150mgand300mgFilm-coatedTablets.ThesemedicinalproductswillbecollectivelyreferredtoasLamivudineinthissummary.ForpracticalinformationaboutusingLamivudine,patientsshouldreadthepackageleafletorcontacttheirdoctororpharmacist.WhatisLamivudinea

4、ndwhatisitusedfor?Lamivudineisa‘genericmedicine’.ThismeansthatLamivudineissimilarto‘referencemedicines’alreadyauthorisedintheEuropeanUnion(EU)calledEpivir150mgand300mgfilm-coatedtablets(ViiVHealthcareUKLimited,UK).LamivudineisusedtotreatHIV(humanimmunodeficiencyvirus)infectioninadultsandchil

5、dren.HowisLamivudineused?ThepharmaceuticalformofLamivudineisafilm-coatedtabletandtherouteofadministrationisoral(bymouth).Thewholetabletshouldbeswallowed,withsomewater,andcanbetakenwithorwithoutfood.Pleasereadsection3ofthepackageleafletfordetaileddosingrecommendations,therouteofadministration

6、,andthedurationoftreatment.Thepatientshouldalwaystakethismedicineexactlyastheirdoctororpharmacisthastoldthemto.Thepatientshouldcheckwiththeirdoctororpharmacistiftheyarenotsure.Lamivudinehelpstocontrolthepatient’scondition.Thepatientneedstokeeptakingiteverydaytostoptheirillnessfromgettingwors

7、e.Thepatientmustalsokeepintouchwiththeirdoctorandnotstoptakingthismedicinewithoutadvicefromtheirdoctor.150mgTherecommendeddoseofLamivudineinadults,adolescentsandchildrenwhoweighatleast25kgis300mgaday.Thismaybetakenaseitherone150mgtablettwiceaday,le