Adverse Event Report

Report

reporttype1receiptdateformat102companynumbAUR-APL-2014-03855Version of Safety Report ID2receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10047184Date Received27/03/2014transmissiondate26/03/2015serious1Date Last Updated30/07/2014primarysourcecountryIT

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryITqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age73Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionBipolar disorder

2)

reactionmeddraversionpt17.1ReactionOff label use

3)

reactionmeddraversionpt17.1ReactionMovement disorder

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb077206drugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DdrugdosageformFILM COATED TABLETdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat102drugstartdate01/01/2013drugenddateformat102drugenddate23/01/2014

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

2)

drugcharacterization1medicinalproductDELORAZEPAM (DELORAZEPAM)drugstructuredosagenumb500drugstructuredosageunit004drugdosagetextTOTALdrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat102drugstartdate01/01/2013drugenddateformat102drugenddate23/01/2014

activesubstance

activesubstancenameDELORAZEPAM

3)

drugcharacterization1medicinalproductNOZINAN (LEVOMEPROMAZINE) FILM-COATED TABLET, 100MGdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 Ddrugadministrationroute048drugindicationBIPOLAR DISORDERdrugstartdateformat102drugstartdate01/01/2013drugenddateformat102drugenddate23/01/2014

activesubstance

activesubstancenameLEVOMEPROMAZINE

summary

narrativeincludeclinicalCASE EVENT DATE: 20130101

Report Duplicate

duplicatesourceAUROBINDOduplicatenumbAUR-APL-2014-03855