Adverse Event Report

Report

reporttype1Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10079204serious1Date Last Updated18/04/2017receiptdateformat102authoritynumbPT-INFARMED-L201403-54companynumbPHHY2014PT031594occurcountryPTseriousnessother1duplicate1Date Received15/04/2014transmissiondate29/08/2017primarysourcecountryPT

Primary Source

reportercountryPTqualification2

Patient

Onset Age42Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt20.0ReactionCondition aggravatedOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt20.0ReactionChloasmaOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt20.0ReactionLymphopeniaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt20.0ReactionAlopeciaOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductTRITICUM ACdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, PRNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2012actiondrug5drugadditional3

2)

drugcharacterization1medicinalproductGILENYAdrugbatchnumb50052drugauthorizationnumb022527drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate11/10/2013actiondrug4

activesubstance

activesubstancenameFINGOLIMOD HYDROCHLORIDE

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

3)

drugcharacterization2medicinalproductADVANTANdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, PRNdrugdosageformCREAMdrugadministrationroute061drugindicationCHLOASMAdrugstartdateformat102drugstartdate26/08/2013actiondrug5drugadditional3

activesubstance

activesubstancenameCORTICOSTEROID NOS

4)

drugcharacterization2medicinalproductHIDROSPOTdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, PRNdrugdosageformGELdrugadministrationroute061drugindicationCHLOASMAdrugstartdateformat102drugstartdate14/02/2013actiondrug5drugadditional3

5)

drugcharacterization2medicinalproductTYSABRIdrugbatchnumbDESCONHECIDOdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, UNKdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute042drugindicationMULTIPLE SCLEROSISdrugstartdateformat602drugstartdate//2010drugenddateformat602drugenddate//2013actiondrug5drugadditional3

activesubstance

activesubstancenameNATALIZUMAB

openFDA Info on Medication

Application NumberBLA125104Brand NameTYSABRIGeneric NameNATALIZUMABManufacturersBiogen Inc.product_ndc64406-008Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsNATALIZUMABRXCUI477484, 603541spl_id7628d515-59db-47b7-8ba9-95dc94363af5spl_set_idc5fdde91-1989-4dd2-9129-4f3323ea2962Package NDC64406-008-01NUIN0000175775, N0000175774Established Pharmacologic ClassIntegrin Receptor Antagonist [EPC]Mechanism of ActionIntegrin Receptor Antagonists [MoA]UNII3JB47N2Q2P

6)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2012actiondrug5drugadditional3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

summary

narrativeincludeclinicalCASE EVENT DATE: 201311

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2014PT031594

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use