Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10057538serious1Date Last Updated29/05/2014receiptdateformat102seriousnessdeath1companynumbES-ROCHE-1376504occurcountryESduplicate1Date Received04/04/2014transmissiondate12/12/2014primarysourcecountryES

Primary Source

reportercountryESqualification1

Patient

Onset Age50Unit of Onset AgeyearsWeight110SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionRenal failureOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionConstipationOutcomeFatal

3)

reactionmeddraversionpt17.0ReactionVomitingOutcomeFatal

4)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductZELBORAFdrugauthorizationnumb202429drugstructuredosagenumb480drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationMALIGNANT MELANOMAdrugstartdateformat102drugstartdate18/03/2014drugenddateformat102drugenddate22/03/2014

openFDA Info on Medication

Application NumberNDA202429Brand NameZELBORAFGeneric NameVEMURAFENIBManufacturersGenentech, Inc.product_ndc50242-090Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVEMURAFENIBRXCUI1147223, 1147228spl_id901837e3-ac02-4cd9-b99a-5c9ce9edfd16spl_set_id38eea320-7e0c-485a-bc30-98c3c45e2763Package NDC50242-090-01, 50242-090-02, 50242-090-86NUIN0000175605, N0000175076, N0000182138, N0000185503Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of Action Protein Kinase Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], P-Glycopr ... UNII207SMY3FQT

2)

drugcharacterization2medicinalproductVEMURAFENIBdrugauthorizationnumb202429drugadministrationroute065

openFDA Info on Medication

Application NumberNDA202429Brand NameZELBORAFGeneric NameVEMURAFENIBManufacturersGenentech, Inc.product_ndc50242-090Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVEMURAFENIBRXCUI1147223, 1147228spl_id901837e3-ac02-4cd9-b99a-5c9ce9edfd16spl_set_id38eea320-7e0c-485a-bc30-98c3c45e2763Package NDC50242-090-01, 50242-090-02, 50242-090-86NUIN0000175605, N0000175076, N0000182138, N0000185503Established Pharmacologic ClassKinase Inhibitor [EPC]Mechanism of Action Protein Kinase Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], P-Glycopr ... UNII207SMY3FQT

3)

drugcharacterization2medicinalproductSERTRALINE

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

4)

drugcharacterization2medicinalproductTRANXILIUM

5)

drugcharacterization2medicinalproductALPRAZOLAMdrugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia and Upjohn Co ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, dfdd ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

Report Duplicate

duplicatesourceROCHEduplicatenumbES-ROCHE-1376504

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use