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1、ThomsonPharmaReportHTMLDownloadDRUGREPORTSUMMARYDrugnameesomeprazoleCompanyAstraAB(AstraZenecaplc)HighestdevstatusLaunchedErosiveEsophagitis-GastroesophagealRefluxDisease(Adult,Pediatric),ErosiveEsophagitis-GastroesophagealRefluxDisease(Adult),GastricUlcer;Prophylaxis-Nsaid-Associ
2、atedFDAApprovedGastropathy;Prophylaxis(Adult),Zollinger-EllisonSyndrome(Adult),DuodenalUlcerDisease-HelicobacterPyloriGastrointestinalTractInfection(Adult),GastroesophagealRefluxDisease-Heartburn(Adult,Pediatric)Gastroesophagealreflux;Zollinger-Ellisonsyndrome;Pepticulcer;Bleeding
3、;Duodenalulcer;TherapyareasEsophagitisGastrointestinalsystemagent;H+K+ATPaseinhibitor;AcidpumpinhibitorantiulcerantActionsproductOralcontrolledreleaseformulation;Oralformulation;Capsuleformulation;OralsuspensionTechnologiesformulation;Stereochemistry;Intravenousformulation;Smallmo
4、leculetherapeuticTargetH+K+ATPaseUpdatedate09-SEP-2010ReasonforupdateMinorEditorialAmendmentTopOVERVIEWEsomeprazole(Nexium)isaproton-pumpinhibitordevelopedandlaunchedbyAstraZeneca.Theproductisindicatedasanoral(delayed-releasecapsuleandsuspension)andivtreatmentforpepticulcer,gastro
5、esophagealrefluxdisease(GERD),duodenalulcer,esophagitis,Zollinger-EllisonSyndrome(ZES)andhemostasisandpreventionofre-bleedinginpatientsfollowingtherapeuticendoscopy[972470],[972471],[470932].Esomeprazoleisthe(S)-enantiomerofomeprazole,andwasdevelopedtoimprovethepharmacokineticprof
6、ileandpotencyoftheracemateproduct.ThedrugwasfirstlaunchedinSweden,andbyDecember2000,esomeprazolehadbeenlaunchedinanumberofEUcountries;inMarch2001,thedrugwaslaunchedintheUS[379476],[403212].TheUSlabelwasextendedtocovertheshorttermtreatmentofGERDinchildrenaged12to17yearsandaged1to11
7、yearsinMay2006andFebruary2008,respectively[664793],[881199].InJanuary2004,symptomresolutionuseinhealingandpreventionofgastrointestinalsideeffectsinresponsetotreatmentwithnonsteroidalanti-inflammatorydrugs(NSAIDs)wasdeemedpromotableintheEUasthesesymptomswerealreadycapturedintheGERD
8、label[520356].ByJuly2005,theprodu