Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10086856serious1Date Last Updated14/12/2018receiptdateformat102companynumbUS-TEVA-476313USAoccurcountryUSseriousnessother1duplicate1Date Received18/04/2014transmissiondate04/02/2019primarysourcecountryUS

Primary Source

reportercountryUSqualification2

Patient

Onset Age27Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionUnintended pregnancyOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionMaternal exposure during pregnancyOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb76135drugstructuredosagenumb70drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext70 MILLIGRAM DAILY;drugadministrationroute048drugstartdateformat102drugstartdate18/12/2013actiondrug1

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20140415

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-476313USA

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use