Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10177149serious1Date Last Updated14/12/2018receiptdateformat102companynumbUS-TEVA-481782USAoccurcountryUSseriousnessother1duplicate1Date Received16/05/2014transmissiondate04/02/2019primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age18Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionUnintended pregnancyOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionMaternal exposure during pregnancyOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb76135drugadministrationroute048drugstartdateformat102drugstartdate11/09/2012actiondrug1

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

2)

drugcharacterization2medicinalproductRECLIPSEN

activesubstance

activesubstancenameDESOGESTREL\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberANDA075256Brand NameRECLIPSEN 28 DAYGeneric NameDESOGESTREL AND ETHINYL ESTRADIOLManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0093-3304Product TypeHUMAN PRESCRIPTION DRUGRXCUI240707, 748797, 749848, 753543spl_id65e7cce0-ecf5-438e-945a-06f658771f2espl_set_ida1e00bc6-7487-4057-9dcc-d0e2327d1d12Package NDC0093-3304-28, 0093-3304-16

3)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb76135drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MILLIGRAM DAILY;drugadministrationroute048drugstartdateformat102drugstartdate11/10/2013drugenddateformat102drugenddate08/05/2014actiondrug1

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

4)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb76135drugadministrationroute048drugstartdateformat102drugstartdate12/12/2009actiondrug1

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: 20140418

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-481782USA

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use