Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10086446serious1Date Last Updated18/04/2014receiptdateformat102companynumbFR-PFIZER INC-2014106058occurcountryFRseriousnessother1duplicate1seriousnesscongenitalanomali1Date Received18/04/2014transmissiondate12/12/2014primarysourcecountryFR

Primary Source

reportercountryFRqualification3

Patient

SexUnknown

Reaction

1)

reactionmeddraversionpt17.0ReactionFoetal exposure during pregnancyOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionTrisomy 21OutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZOLOFTdrugauthorizationnumb019839drugdosagetextUNKdrugdosageformCAPSULE, HARDdrugadministrationroute064drugindicationDEPRESSIONdrugenddateformat102drugenddate30/07/2010

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

2)

drugcharacterization1medicinalproductLEXOMILdrugdosagetextUNKdrugadministrationroute064drugindicationANXIETYdrugenddateformat102drugenddate30/07/2010

3)

drugcharacterization1medicinalproductNOCTAMIDdrugdosagetextUNKdrugadministrationroute064drugindicationANXIETYdrugenddateformat102drugenddate30/07/2010

4)

drugcharacterization2medicinalproductOMNISCANdrugdosagetextUNKdrugadministrationroute064drugindicationNUCLEAR MAGNETIC RESONANCE IMAGINGdrugstartdateformat102drugstartdate30/07/2010drugenddateformat102drugenddate30/07/2010

openFDA Info on Medication

Application NumberNDA022066, NDA020123Brand NameOMNISCANGeneric NameGADODIAMIDEManufacturersGE Healthcare Inc.product_ndc0407-0690, 0407-0691Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsGADODIAMIDEspl_id 36e6aaf2-b8a9-4405-8957-e6f09b3b3cad, f1bbe198-bc8d-4a2b-9107-5c25e8cbf79a, 2a6a ... spl_set_id f9fd4805-cbc1-4bc7-955f-e5cd4e1b03bb, 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a, d539 ... Package NDC 0407-0690-70, 0407-0690-05, 0407-0690-10, 0407-0690-15, 0407-0690-20, 0407-0690- ... NUIN0000175862, N0000180184Mechanism of ActionMagnetic Resonance Contrast Activity [MoA]Established Pharmacologic ClassParamagnetic Contrast Agent [EPC]UNII84F6U3J2R6

Report Duplicate

duplicatesourcePFIZERduplicatenumbFR-PFIZER INC-2014106058

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use