Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10242449serious1Date Last Updated13/12/2014receiptdateformat102companynumbUS-MYLANLABS-2014S1013970occurcountryUSseriousnessother1duplicate1Date Received17/06/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionMaternal exposure before pregnancyOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionMetrorrhagiaOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionVaginal haemorrhageOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG,QDdrugdosageformCAPSULEdrugstartdateformat102drugstartdate06/05/2014drugenddateformat102drugenddate27/05/2014actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA075945Brand NameAMNESTEEMGeneric NameISOTRETINOINManufacturersMylan Pharmaceuticals Inc.product_ndc0378-6611, 0378-6612, 0378-6614Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 404058, 404061, 404064spl_id47bb51b9-0613-4708-905f-e950dbfa5127spl_set_idb2cb63c9-f825-4991-9a2c-6260f1bbcc2cPackage NDC 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6614-85, 0378-6614- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014S1013970

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use