Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10078488serious1Date Last Updated15/04/2014receiptdateformat102companynumbGB-DRREDDYS-GER/UKI/14/0039634occurcountryGBseriousnessother1duplicate1seriousnesscongenitalanomali1Date Received15/04/2014transmissiondate12/12/2014primarysourcecountryGB

Primary Source

reportercountryGBqualification1

Patient

SexUnknown

Reaction

1)

reactionmeddraversionpt17.0ReactionAnencephalyOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionCraniorachischisisOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionCystic lymphangiomaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionTeratogenicityOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionFoetal exposure during pregnancyOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugstructuredosagenumb150drugstructuredosageunit003drugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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)

drugcharacterization2medicinalproductTHYROXINEdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugenddateformat102drugenddate07/02/2014

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbGB-DRREDDYS-GER/UKI/14/0039634

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use