Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10190224serious1Date Last Updated22/05/2014receiptdateformat102companynumbIT-MYLANLABS-2014S1011282occurcountryITduplicate1Date Received22/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryITqualification1

Patient

Onset Age34Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionBradykinesiaOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionHypotensionOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionIntentional self-injuryOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionRhabdomyolysisOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionBradyphreniaOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionSoporOutcomeRecovering/resolving

7)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugauthorizationnumb076671drugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG TOTALdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

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)

drugcharacterization1medicinalproductLEXOTANdrugstructuredosagenumb60drugstructuredosageunit012drugdosagetext60 ML TOTALdrugdosageformORAL DROPS, SOLUTIONdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

3)

drugcharacterization1medicinalproductDEPAKINdrugstructuredosagenumb5drugstructuredosageunit032drugdosagetext5 DF TOTALdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

4)

drugcharacterization1medicinalproductSEROQUELdrugstructuredosagenumb5drugstructuredosageunit032drugdosagetext5 DF TOTALdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate16/04/2014drugenddateformat102drugenddate16/04/2014actiondrug1

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_id1a826d85-aac4-42e4-a3e2-a18df915dc33, bca31730-a1ed-4b8f-93d8-2f64143a91faspl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

Report Duplicate

duplicatesourceMYLANduplicatenumbIT-MYLANLABS-2014S1011282

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use