Adverse Event Report

Report

reporttype2Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10076982serious1Date Last Updated14/04/2014receiptdateformat102companynumbAU-SANOFI-AVENTIS-2013SA092171occurcountryAUseriousnessother1duplicate1Date Received14/04/2014transmissiondate12/12/2014primarysourcecountryAU

Primary Source

reportercountryAUqualification1

Patient

Onset Age30Unit of Onset AgeyearsWeight79SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionSuicidal ideationOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionPoor quality sleepOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionMood swingsOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionDepressed moodOutcomeRecovering/resolving

6)

reactionmeddraversionpt17.0ReactionEmotional distressOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionDecreased appetiteOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionFrequent bowel movementsOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionFatigueOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionStressOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionCoughOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionPostural tremorOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt17.0ReactionTremorOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt17.0ReactionGait disturbanceOutcomeUnknown

16)

reactionmeddraversionpt17.0ReactionGeneral physical health deteriorationOutcomeUnknown

17)

reactionmeddraversionpt17.0ReactionAffective disorderOutcomeUnknown

18)

reactionmeddraversionpt17.0ReactionParaesthesiaOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionAlopeciaOutcomeUnknown

20)

reactionmeddraversionpt17.0ReactionWeight decreasedOutcomeUnknown

21)

reactionmeddraversionpt17.0ReactionDiarrhoeaOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductAUBAGIOdrugbatchnumbUNKNOWNdrugauthorizationnumb202992drugstructuredosagenumb14drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCOATED TABLETdrugadministrationroute048drugindicationRELAPSING-REMITTING MULTIPLE SCLEROSISdrugstartdateformat102drugstartdate16/06/2013actiondrug4

openFDA Info on Medication

Application NumberNDA202992Brand NameAUBAGIOGeneric NameTERIFLUNOMIDEManufacturersGenzyme Corporationproduct_ndc58468-0210, 58468-0211Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERIFLUNOMIDERXCUI1310525, 1310531, 1310533, 1310535spl_id00ccc1a2-a63c-418a-9f40-1792b505f2c8spl_set_id4650d12c-b9c8-4525-b07f-a2d773eca155Package NDC 58468-0211-1, 58468-0211-2, 58468-0211-4, 58468-0211-3, 58468-0210-2, 58468-0210 ... NUIN0000185502, N0000185501Established Pharmacologic ClassPyrimidine Synthesis Inhibitor [EPC]Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors [MoA]UNII1C058IKG3B

2)

drugcharacterization2medicinalproductZOLOFTdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductEPILIMdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

4)

drugcharacterization2medicinalproductENDEPdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

5)

drugcharacterization2medicinalproductSANDOMIGRANdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

Report Duplicate

duplicatesourceAVENTISduplicatenumbAU-SANOFI-AVENTIS-2013SA092171

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use