Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10741490serious1Date Last Updated13/12/2018receiptdateformat102companynumbUS-TEVA-536242USAoccurcountryUSseriousnessother1duplicate1Date Received27/01/2015transmissiondate04/02/2019primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age19Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionPregnancyOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionMaternal exposure before pregnancyOutcomeUnknown

3)

reactionmeddraversionpt21.1ReactionAbortion spontaneousOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb76135drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MILLIGRAM DAILY;drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate05/01/2010drugenddateformat102drugenddate01/06/2012actiondrug1

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: 2015

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-536242USA

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use