Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10591516serious1Date Last Updated17/12/2018receiptdateformat102companynumbUS-TEVA-522845USAoccurcountryUSseriousnessother1duplicate1Date Received18/11/2014transmissiondate04/02/2019primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionPregnancyOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionMaternal exposure during pregnancyOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MILLIGRAM DAILY;drugstartdateformat102drugstartdate10/02/2012drugenddateformat102drugenddate12/03/2014actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-522845USA

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use