Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-009507513-1405USA002202occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10155417Date Received06/05/2014transmissiondate12/12/2014serious2Date Last Updated06/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age70Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAmnesiaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionInfluenza like illnessOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionProduct quality issueOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductPEGINTRONdrugbatchnumb2IRJ60414drugauthorizationnumb103949drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetextONCE WEEKLY INJECTIONdrugdosageformPOWDER FOR INJECTIONdrugindicationHEPATITIS Cdrugstartdateformat102drugstartdate29/04/2014actiondrug4

openFDA Info on Medication

Application NumberBLA103949Brand NamePEGINTRONGeneric NamePEGINTERFERON ALFA-2BManufacturersMerck Sharp & Dohme Corp.product_ndc 0085-1297, 0085-1323, 0085-1316, 0085-1370, 0085-4353, 0085-4354, 0085-4355, 008 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsPEGINTERFERON ALFA-2BRXCUI 284192, 284193, 284194, 284195, 731333, 731334, 731345, 731348, 760029, 760039, ... spl_id519a40d2-566f-4d64-8ffb-35813db6c6aespl_set_idb70816bb-913a-467f-acb8-67ef62cf8dacPackage NDC 0085-1323-01, 0085-1323-02, 0085-1316-01, 0085-1316-02, 0085-1297-03, 0085-1297- ... NUIN0000175521, M0025711Established Pharmacologic ClassInterferon alpha [EPC]Chemical StructureInterferon-alpha [CS]UNIIG8RGG88B68

2)

drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDEdrugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductOMEPRAZOLEdrugdosageformCAPSULEdrugadministrationroute048drugrecurreadministration3

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

4)

drugcharacterization2medicinalproductMETOPROLOLdrugrecurreadministration3

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

Report Duplicate

duplicatesourceMERCKduplicatenumbUS-009507513-1405USA002202