Adverse Event Report

Report

reporttype2receiptdateformat102companynumbUS-MYLANLABS-2014S1007265occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10865107Date Received24/02/2015transmissiondate21/07/2015serious2Date Last Updated24/02/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age22Unit of Onset AgeyearsWeight58.06SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionTinnitusOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionViral infectionOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb60drugcumulativedosageunit003drugdosagetext30 MG,QDdrugdosageformCAPSULEdrugindicationACNEdrugstartdateformat102drugstartdate04/02/2014drugenddateformat102drugenddate06/02/2014actiondrug1

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)

drugcharacterization2medicinalproductGIANVIdrugdosagetextUNKdrugstartdateformat610drugstartdate/12/2013

activesubstance

activesubstancenameDROSPIRENONE\ETHINYL ESTRADIOL

openFDA Info on Medication

Application NumberNDA021676Brand NameGIANVIGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersTeva Pharmaceuticals USA Incproduct_ndc0093-5423Product TypeHUMAN PRESCRIPTION DRUGRXCUI630734, 748797, 748798, 993804spl_idde8ebfb6-ee3a-4030-a51b-29c51ccf7cb0spl_set_id723d0427-cf3f-4ad7-8b93-cb1250f345f6Package NDC0093-5423-28, 0093-5423-62, 0093-5423-58

summary

narrativeincludeclinicalCASE EVENT DATE: 20140206

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014S1007265