Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10026882serious1Date Last Updated15/04/2014receiptdateformat102companynumbPHHY2014IT015768occurcountryITduplicate1Date Received21/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryIT

Primary Source

reportercountryFRqualification5

Patient

Onset Age27Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionDrug abuseOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductENTUMINdrugstructuredosagenumb30drugstructuredosageunit031drugdosagetext30 DRP, ONCE/SINGLEdrugdosageformSOLUTIONdrugadministrationroute048drugindicationDRUG ABUSEdrugstartdateformat102drugstartdate30/01/2014drugenddateformat102drugenddate30/01/2014actiondrug5

2)

drugcharacterization1medicinalproductOLANZAPINEdrugauthorizationnumb201588drugstructuredosagenumb11drugstructuredosageunit002drugdosagetext11 G, ONCE/SINGLEdrugdosageformTABLETdrugadministrationroute048drugindicationDRUG ABUSEdrugstartdateformat102drugstartdate30/01/2014drugenddateformat102drugenddate30/01/2014actiondrug5

openFDA Info on Medication

Application Number ANDA204319, ANDA201588, ANDA076255, NDA020592, NDA021086, NDA021253, ANDA090798, ... Brand NameOLANZAPINE, ZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULARGeneric NameOLANZAPINEManufacturers Virtus Pharmaceuticals, LLC, Sandoz Inc, Dr. Reddy's Laboratories Inc., Eli Lill ... product_ndc 69543-380, 69543-381, 69543-382, 69543-383, 69543-384, 69543-385, 0781-9105, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 200034, 283639, 312077, 312078, 312079, 314154, 485968, 153046, 153047, 153048, ... spl_id a6c0f6d1-1550-41e3-e053-2a95a90aa46f, a0f9cb84-1dee-4dc5-96b7-ce259903b940, 06a3 ... spl_set_id 6a5db723-0f21-417e-a95c-cf0c438e8b44, c44a96cc-817d-4eb5-a13a-00977f76e666, d474 ... Package NDC 69543-380-30, 69543-380-90, 69543-381-30, 69543-381-90, 69543-382-30, 69543-382- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

3)

drugcharacterization2medicinalproductXANAXdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

4)

drugcharacterization2medicinalproductAMISULPRIDEdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA209510Brand NameBARHEMSYSGeneric NameAMISULPRIDEManufacturersAcacia Pharma Ltdproduct_ndc71390-125Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsAMISULPRIDERXCUI2284232, 2284237, 2467148, 2467149spl_idb6cee1a3-1caa-4b36-a919-5edab67c3d69spl_set_idab23bc6e-b6a8-165f-e053-2a95a90ab144Package NDC71390-125-21, 71390-125-20, 71390-125-51, 71390-125-50UNII8110R61I4U

5)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNK UKN, UNKactiondrug5drugrecurreadministration3

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

Report Duplicate

duplicatesourceSANDOZduplicatenumbPHHY2014IT015768

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use