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EuropeanMedicinesAgency EvaluationofMedicinesforHumanUse Doc.Ref.:EMEA/CHMP/563746/2008 ASSESSMENTREPORT FOR IRESSA InternationalNonproprietaryName:gefitinib ProcedureNo.EMEA/H/C/001016 AssessmentReportasadoptedbytheCHMPwithallinformationofacommerciallyconfidential naturedeleted 7WestferryCircus,CanaryWharf,London,E144HB,UK Tel.(44-20)74188400Fax(44-20)75237051 E-mail:mail@emea.europa.euhttp://www.emea.europa.eu ©EuropeanMedicinesAgency,2009.Reproductionisauthorisedprovidedthesourceisacknowledged TABLEOFCONTENTS 1.BACKGROUNDINFORMATIONONTHEPROCEDURE...........................................3 1.1Submissionofthedossier........................................................................................................3 1.2Stepstakenfortheassessmentoftheproduct..........................................................................4 2.SCIENTIFICDISCUSSION.................................................................................................5 2.1Introduction..............................................................................................................................5 2.2Qualityaspects.........................................................................................................................5 2.3Non-clinicalaspects.................................................................................................................8 2.4Clinicalaspects......................................................................................................................18 2.5Pharmacovigilance.................................................................................................................78 2.6Overallconclusions,risk/benefitassessmentandrecommendation......................................82 Page2of86 1.BACKGROUNDINFORMATIONONTHEPROCEDURE 1.1Submissionofthedossier TheapplicantAstraZenecaABsubmittedon06May2008anapplicationforMarketingAuthorisation totheEuropeanMedicines