Adverse Event Report

Report

reporttype2receiptdateformat102companynumbPHHY2014BR037121occurcountryBRVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10046832Date Received31/03/2014transmissiondate12/12/2014serious2Date Last Updated04/06/2014primarysourcecountryBR

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age35Unit of Onset AgeyearsWeight55SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionChest painOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionSomnolenceOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionNauseaOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.0ReactionVomitingOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionFeeling abnormalOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeRecovered/resolved

8)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeRecovered/resolved

9)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductGILENYAdrugauthorizationnumb022527drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate11/03/2014actiondrug4

openFDA Info on Medication

Application NumberNDA022527Brand NameGILENYAGeneric NameFINGOLIMOD HCLManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0607, 0078-0965Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINGOLIMOD HYDROCHLORIDERXCUI1012895, 1012899, 2045491, 2045493spl_idf4110640-5d3d-4957-83e2-71a0c7b71bd2spl_set_idcc9e1c8c-0e2b-44e2-878b-27057f786be9Package NDC0078-0607-15, 0078-0607-51, 0078-0607-89, 0078-0965-89UNIIG926EC510T

2)

drugcharacterization2medicinalproductCLONAZEPAMdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugindicationANXIETYdrugstartdateformat602drugstartdate//2007actiondrug4

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

3)

drugcharacterization2medicinalproductAMITRIPTYLINEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, QDdrugindicationANXIETYdrugstartdateformat602drugstartdate//2007actiondrug4

4)

drugcharacterization2medicinalproductSERTRALINEdrugindicationANXIETYdrugstartdateformat602drugstartdate//2013actiondrug4

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

duplicatesourceNOVARTISduplicatenumbPHHY2014BR037121