Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-BIOGENIDEC-2014BI035358occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10083140Date Received17/04/2014transmissiondate12/12/2014serious2Date Last Updated17/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age39Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionTremorOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionDysphagiaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionPanic attackOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionHyperventilationOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionChest discomfortOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductAVONEXdrugauthorizationnumb103628drugstructuredosagenumb30drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTIONdrugadministrationroute030drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate01/05/2006actiondrug4

openFDA Info on Medication

Application NumberBLA103628Brand NameAVONEXGeneric NameINTERFERON BETA-1AManufacturersBiogen Inc.product_ndc59627-111, 59627-333, 59627-222, 59627-003, 59627-002Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARRXCUI153323, 153324, 727813, 727816, 797544, 1650899, 1650901spl_id2a66a68a-2391-4598-a662-d3c55b1547f7spl_set_idd70a39cc-de15-4c12-a1ec-8063b69ea0e1Package NDC 59627-333-04, 59627-222-05, 59627-111-04, 59627-111-03, 59627-003-01, 59627-003- ...

2)

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

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI035358