Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10152935serious1Date Last Updated18/07/2014receiptdateformat102companynumbIT-VIIV HEALTHCARE LIMITED-B0990362AoccurcountryITduplicate1Date Received05/05/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryIT

Primary Source

reportercountryITqualification1

Patient

Onset Age47Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionSuicide attemptOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductDARUNAVIRdrugstructuredosagenumb600drugstructuredosageunit004drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext600MCG TWICE PER DAYdrugadministrationroute048drugindicationHIV INFECTIONdrugstartdateformat102drugstartdate05/08/2010

activesubstance

activesubstancenameDARUNAVIR

openFDA Info on Medication

Application NumberNDA021976, NDA202895Brand NamePREZISTAGeneric NameDARUNAVIRManufacturersJanssen Products LPproduct_ndc59676-562, 59676-563, 59676-564, 59676-566, 59676-565Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDARUNAVIR ETHANOLATERXCUI 670026, 794610, 831868, 831870, 850455, 850457, 1236628, 1236632, 1359269, 13592 ... spl_idfb65bf9c-6389-11ea-a5c4-8c44fc2ca371spl_set_id814301f9-c990-46a5-b481-2879a521a16fPackage NDC59676-563-01, 59676-564-01, 59676-562-01, 59676-566-30, 59676-565-01UNII33O78XF0BW

2)

drugcharacterization2medicinalproductSERTRALINEdrugindicationDEPRESSIONdrugstartdateformat102drugstartdate06/04/2014drugenddateformat102drugenddate22/04/2014

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

3)

drugcharacterization1medicinalproductRITONAVIRdrugstructuredosagenumb100drugstructuredosageunit004drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100MCG TWICE PER DAYdrugadministrationroute048drugindicationHIV INFECTIONdrugstartdateformat102drugstartdate15/02/2011

activesubstance

activesubstancenameRITONAVIR

openFDA Info on Medication

Application NumberNDA020659, NDA022417, NDA209512, ANDA202573, ANDA208890, ANDA206614, ANDA204587Brand NameNORVIR, RITONAVIRGeneric NameRITONAVIRManufacturers AbbVie Inc., West-Ward Pharmaceuticals Corp., Amneal Pharmaceuticals LLC, Aurobi ... product_ndc0074-1940, 0074-3333, 0074-3399, 0054-0407, 65162-061, 65862-687, 31722-597Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRITONAVIRRXCUI152971, 199249, 900575, 900577, 1926066, 1926069spl_id 551acd76-c57f-3546-038d-c36559b90735, 7141a8a3-7329-4661-b79f-5aa54d9f190b, 3752 ... spl_set_id 2849298e-de6e-47bb-8194-56e075b33fc3, a7aded41-687a-4c09-a263-9273b0e5f6fd, a32c ... Package NDC 0074-3333-30, 0074-1940-63, 0074-3399-30, 0054-0407-13, 0054-0407-23, 65162-061- ... NUI N0000000246, N0000191001, N0000175889, N0000190114, N0000182137, N0000185607, N0 ... Mechanism of Action HIV Protease Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P ... Established Pharmacologic ClassCytochrome P450 3A Inhibitor [EPC], Protease Inhibitor [EPC]UNIIO3J8G9O825

4)

drugcharacterization1medicinalproductDOLUTEGRAVIRdrugauthorizationnumb204790drugdosageformTABLETdrugindicationHIV INFECTIONdrugstartdateformat102drugstartdate24/06/2013drugenddateformat102drugenddate22/04/2014actiondrug1

activesubstance

activesubstancenameDOLUTEGRAVIR

5)

drugcharacterization1medicinalproductMARAVIROCdrugauthorizationnumb022128drugstructuredosagenumb300drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300MCG PER DAYdrugadministrationroute048drugindicationHIV INFECTIONdrugstartdateformat102drugstartdate05/08/2010

activesubstance

activesubstancenameMARAVIROC

openFDA Info on Medication

Application NumberNDA022128, NDA208984Brand NameSELZENTRYGeneric NameMARAVIROCManufacturersViiV Healthcare Companyproduct_ndc49702-223, 49702-233, 49702-235, 49702-224, 49702-237, 49702-260Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMARAVIROCRXCUI 728223, 728225, 729201, 729203, 1857911, 1857913, 1857915, 1857917, 1857921, 185 ... spl_idf17c4b5d-2c85-44a6-9978-2b16d4d69b53spl_set_id46f30ac5-c96b-429e-976d-8c5ee1c0761bPackage NDC 49702-233-08, 49702-235-08, 49702-223-18, 49702-224-18, 49702-237-55, 49702-260- ... NUIN0000175572, N0000175445Established Pharmacologic ClassCCR5 Co-receptor Antagonist [EPC]Mechanism of ActionChemokine Co-receptor 5 Antagonists [MoA]UNIIMD6P741W8A

summary

narrativeincludeclinicalCASE EVENT DATE: 20140422

Report Duplicate

duplicatesourceGLAXOSMITHKLINEduplicatenumbIT-VIIV HEALTHCARE LIMITED-B0990362A

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use