Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-TEVA-401548USAoccurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10155255Date Received06/05/2014transmissiondate12/12/2014serious2Date Last Updated06/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age47Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionTransaminases increasedOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionHepatic enzyme increasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb076135drugstructuredosagenumb40drugstructuredosageunit003drugstartdateformat102drugstartdate21/09/2012actiondrug1

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)

drugcharacterization2medicinalproductNORVASC

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id3f5ca9a3-9076-49ab-b247-669c337f3364spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

3)

drugcharacterization2medicinalproductDIOVAN

openFDA Info on Medication

Application NumberNDA021283Brand NameDIOVANGeneric NameVALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0358, 0078-0423, 0078-0359, 0078-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVALSARTANRXCUI349199, 349200, 349201, 349483, 351761, 351762, 352001, 352274spl_id48f59b36-64c2-46ef-827a-b9ed53df270fspl_set_id5ddba454-f3e6-43c2-a7a6-58365d297213Package NDC0078-0423-15, 0078-0358-34, 0078-0359-34, 0078-0360-34NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII80M03YXJ7I

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-401548USA