Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10040810serious1Date Last Updated27/03/2014receiptdateformat102companynumbIT-JNJFOC-20140312579occurcountryITduplicate1Date Received27/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryIT

Primary Source

reportercountryITqualification2

Patient

Onset Age33Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionPsychomotor skills impairedOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductRISPERDALdrugauthorizationnumb020588drugdosageformSOLUTIONdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020272, NDA020588Brand NameRISPERDALGeneric NameRISPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc 50458-300, 50458-301, 50458-302, 50458-320, 50458-330, 50458-350, 50458-395, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRISPERIDONEspl_idc17e6fd3-6e6c-4849-b230-71b731a9f818spl_set_id7e117c7e-02fc-4343-92a1-230061dfc5e0Package NDC 50458-301-04, 50458-301-50, 50458-301-01, 50458-302-06, 50458-302-50, 50458-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

2)

drugcharacterization1medicinalproductSERTRALINE HYDROCHLORIDEdrugdosageformUnspecifieddrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014actiondrug5

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

3)

drugcharacterization1medicinalproductDEPAKIN CHRONOdrugdosageformPROLONGED-RELEASE TABLETdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014actiondrug5

4)

drugcharacterization1medicinalproductCAMPRALdrugdosageformTABLETSdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014actiondrug5

5)

drugcharacterization1medicinalproductFELISONdrugdosageformCAPSULE, HARDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014actiondrug5

Report Duplicate

duplicatesourceJANSSENduplicatenumbIT-JNJFOC-20140312579

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use