Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10033970serious1Date Last Updated25/03/2014receiptdateformat102companynumbUS-ROCHE-1321752occurcountryUSseriousnessother1duplicate1Date Received25/03/2014transmissiondate02/10/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Weight194SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPlatelet count decreasedOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionWhite blood cell count decreasedOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionBlood count abnormalOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionPancytopeniaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionAnaemiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductPEGASYSdrugbatchnumbUNKNOWNdrugauthorizationnumb103964drugstructuredosagenumb180drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetextROTATING SITES (THIGH OR ABDOMEN),drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute030drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate28/10/2013actiondrug5

openFDA Info on Medication

Application NumberBLA103964Brand NamePEGASYSGeneric NamePEGINTERFERON ALFA-2AManufacturersGenentech, Inc.product_ndc0004-0350, 0004-0357Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsPEGINTERFERON ALFA-2ARXCUI351270, 352297, 731326, 731328spl_id5e9bb3e4-48f9-4b34-9c4f-7a6f27ffd98cspl_set_idde61685e-2b8c-4e22-84bb-869e13600440Package NDC0004-0350-09, 0004-0357-30NUIN0000175521, M0025711Established Pharmacologic ClassInterferon alpha [EPC]Chemical StructureInterferon-alpha [CS]UNIIQ46947FE7K

2)

drugcharacterization1medicinalproductPEGASYSdrugbatchnumbUNKNOWNdrugauthorizationnumb103964drugstructuredosagenumb180drugstructuredosageunit004drugadministrationroute058drugstartdateformat102drugstartdate25/02/2014actiondrug5

openFDA Info on Medication

Application NumberBLA103964Brand NamePEGASYSGeneric NamePEGINTERFERON ALFA-2AManufacturersGenentech, Inc.product_ndc0004-0350, 0004-0357Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsPEGINTERFERON ALFA-2ARXCUI351270, 352297, 731326, 731328spl_id5e9bb3e4-48f9-4b34-9c4f-7a6f27ffd98cspl_set_idde61685e-2b8c-4e22-84bb-869e13600440Package NDC0004-0350-09, 0004-0357-30NUIN0000175521, M0025711Established Pharmacologic ClassInterferon alpha [EPC]Chemical StructureInterferon-alpha [CS]UNIIQ46947FE7K

3)

drugcharacterization1medicinalproductCOPEGUSdrugauthorizationnumb021511drugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext600MG IN THE MORNING, 600MG AT NIGHTdrugadministrationroute048drugindicationHEPATITIS Cdrugstartdateformat102drugstartdate28/10/2013actiondrug5

4)

drugcharacterization1medicinalproductCOPEGUSdrugauthorizationnumb021511drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextDOSE REDUCEDdrugadministrationroute048drugstartdateformat102drugstartdate25/02/2014actiondrug5

5)

drugcharacterization1medicinalproductINCIVEKdrugstructuredosagenumb750drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3X A DAYdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5

6)

drugcharacterization2medicinalproductVITAMIN D3drugstructuredosagenumb2000drugstructuredosageunit025drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2000 UNITS DAILYdrugadministrationroute065

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

7)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute065

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

8)

drugcharacterization2medicinalproductTRAMADOLdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosagetext1 EVERY 6 HOURS IF NEEDEDdrugadministrationroute065

9)

drugcharacterization2medicinalproductSOVALDI

openFDA Info on Medication

Application NumberNDA204671, NDA212480Brand NameSOVALDIGeneric NameSOFOSBUVIRManufacturersGilead Sciences, Inc.product_ndc61958-1501, 61958-1503, 61958-1504, 61958-1505Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOFOSBUVIRRXCUI1484916, 1484922, 2203891, 2203893, 2203993, 2203999, 2204090, 2204092spl_idb6ff385d-224a-0bad-e053-2995a90adcd4spl_set_id80beab2c-396e-4a37-a4dc-40fdb62859cfPackage NDC61958-1501-1, 61958-1503-1, 61958-1504-1, 61958-1505-1NUIN0000191493, N0000191258, N0000175459Established Pharmacologic ClassHepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]Mechanism of ActionRNA Replicase Inhibitors [MoA]UNIIWJ6CA3ZU8B

Report Duplicate

duplicatesourceROCHEduplicatenumbUS-ROCHE-1321752

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use