Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014P1002917Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10098161Date Received21/04/2014transmissiondate12/12/2014serious1Date Last Updated21/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age15Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionWeight decreased

2)

reactionmeddraversionpt17.0ReactionDecreased appetite

3)

reactionmeddraversionpt17.0ReactionIrritability

4)

reactionmeddraversionpt17.0ReactionMood altered

Drug

1)

drugcharacterization1medicinalproductMYORISAN 40 MGdrugauthorizationnumb76485drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate20/02/2014drugenddateformat102drugenddate15/03/2014drugadditional1

2)

drugcharacterization1medicinalproductCLARAVISdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate20/11/2013drugadditional1

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

3)

drugcharacterization1medicinalproductABSORICAdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate24/12/2013drugadditional1

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014P1002917