Adverse Event Report

Report

reporttype2Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10141890serious1Date Last Updated04/11/2014receiptdateformat102companynumbUS-MYLANLABS-2014S1009447occurcountryUSseriousnessother1duplicate1Date Received29/04/2014transmissiondate28/05/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age19Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionAbortion inducedOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.0ReactionExposure during pregnancyOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionVaginal haemorrhageOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG,BIDdrugdosageformCAPSULEdrugstartdateformat102drugstartdate23/12/2013drugenddateformat102drugenddate10/04/2014actiondrug1

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

2)

drugcharacterization1medicinalproductACCUTANEdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG,QDdrugdosageformCAPSULEdrugstartdateformat610drugstartdate/01/2014drugenddateformat102drugenddate10/04/2014actiondrug1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

3)

drugcharacterization2medicinalproductORAL CONTRACEPTIVE NOSdrugdosagetextUNKdrugstartdateformat102drugstartdate01/05/2010drugenddateformat102drugenddate10/04/2014

activesubstance

activesubstancenameUNSPECIFIED INGREDIENT

summary

narrativeincludeclinicalCASE EVENT DATE: 20140318

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014S1009447

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use