attachment extract from the clinical evaluation …

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1、TherapeuticGoodsAdministrationFirstroundCER:6June2012SecondroundCER:26September2012AusPARAttachment2ExtractfromtheClinicalEvaluationReportfortadalafilProprietaryProductName:CialisSponsor:EliLillyAustraliaPtyLtdSubmissionPM-2011-03166-3-3ExtractfromtheClinicalEva

2、luationReportforCialisPage2of163TherapeuticGoodsAdministrationAbouttheTherapeuticGoodsAdministration(TGA)·TheTherapeuticGoodsAdministration(TGA)ispartoftheAustralianGovernmentDepartmentofHealthandAgeing,andisresponsibleforregulatingmedicinesandmedicaldevices.·Th

3、eTGAadministerstheTherapeuticGoodsAct1989(theAct),applyingariskmanagementapproachdesignedtoensuretherapeuticgoodssuppliedinAustraliameetacceptablestandardsofquality,safetyandefficacy(performance),whennecessary.·TheworkoftheTGAisbasedonapplyingscientificandclinic

4、alexpertisetodecision-making,toensurethatthebenefitstoconsumersoutweighanyrisksassociatedwiththeuseofmedicinesandmedicaldevices.·TheTGAreliesonthepublic,healthcareprofessionalsandindustrytoreportproblemswithmedicinesormedicaldevices.TGAinvestigatesreportsreceive

5、dbyittodetermineanynecessaryregulatoryaction.·Toreportaproblemwithamedicineormedicaldevice,pleaseseetheinformationontheTGAwebsite.AbouttheExtractfromtheClinicalEvaluationReport·Thisdocumentprovidesamoredetailedevaluationoftheclinicalfindin

6、gs,extractedfromtheClinicalEvaluationReport(CER)preparedbytheTGA.ThisextractdoesnotincludesectionsfromtheCERregardingproductdocumentationorpostmarketactivities.·Thewords[Informationredacted],wheretheyappearinthisdocument,indicatethatconfidentialinformationhasbee

7、ndeleted.·ForthemostrecentProductInformation(PI),pleaserefertotheTGAwebsite.Copyright©CommonwealthofAustralia2013Thisworkiscopyright.Youmayreproducethewholeorpartofthisworkinunalteredformforyourownpersonalus

8、eor,ifyouarepartofanorganisation,forinternalusewithinyourorganisation,butonlyifyouoryourorganisationdonotusethereproductionforanycommercialpurposeandretainthiscopyrig