Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10041454serious1Date Last Updated27/03/2014receiptdateformat102companynumbIT-FRI-1000065783occurcountryITduplicate1Date Received27/03/2014seriousnesshospitalization1transmissiondate02/10/2014primarysourcecountryFR

Primary Source

reportercountryFRqualification3

Patient

Onset Age33Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPsychomotor skills impairedOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductCAMPRALdrugauthorizationnumb021431drugstructuredosagenumb27972drugstructuredosageunit003drugdosageformTABLETdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014

2)

drugcharacterization1medicinalproductSERTRALINEdrugdosageformTABLETdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014

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

3)

drugcharacterization1medicinalproductDEPAKIN CHRONOdrugstructuredosagenumb15000drugstructuredosageunit003drugdosageformTABLETdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014

4)

drugcharacterization1medicinalproductRISPERIDONEdrugdosagetext1MG/ML IN 30ML FLACONdrugdosageformDROPSdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014

openFDA Info on Medication

Application Number ANDA077328, ANDA202386, ANDA076904, NDA020588, ANDA078116, ANDA079088, ANDA07851 ... Brand NameRISPERIDONE, PERSERIS, RISPERDAL, RISPERDAL M-TAB, RISPERDAL CONSTAGeneric NameRISPERIDONEManufacturers Dr. Reddy's Laboratories Limited, Lannett Company, Inc., Hikma Pharmaceuticals U ... product_ndc 55111-207, 55111-208, 55111-209, 55111-470, 55111-471, 54838-563, 0054-0063, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, SUBCUTANEOUSActive IngredientsRISPERIDONERXCUI 401953, 401954, 403825, 616698, 616705, 199387, 312828, 312829, 312830, 312831, ... spl_id 9293825e-f154-ffc9-20b0-5846d813b7ec, 95f6336f-cac0-40b5-a7ad-29df965445a1, af95 ... spl_set_id c00809e1-e632-f246-97d9-73e1f9804587, 1219dff4-0320-4530-b1ad-b6ecdac376cf, cd74 ... Package NDC 55111-207-81, 55111-207-78, 55111-207-79, 55111-208-81, 55111-208-78, 55111-208- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

5)

drugcharacterization1medicinalproductFLURAZEPAMdrugstructuredosagenumb450drugstructuredosageunit003drugdosageformCAPSULEdrugstartdateformat102drugstartdate27/02/2014drugenddateformat102drugenddate27/02/2014

Report Duplicate

duplicatesourceFORESTduplicatenumbIT-FRI-1000065783

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use