Adverse Event Report

Report

reporttype1receiptdateformat102companynumbFR-RANBAXY-2015R1-92984occurcountryFRVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10801668Date Received17/02/2015transmissiondate13/01/2021serious2Date Last Updated26/10/2020primarysourcecountryFR

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryFRqualification3literaturereference DUCROUX E, OCAMPO MA, KANITAKIS J, MORELON E, JULLIEN D, FAURE M, ET AL. HIDRADE ...

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age23Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt23.1ReactionCondition aggravatedOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductISOTRETINOIN.drugauthorizationnumb76041drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, DAILYdrugadministrationroute065drugindicationACNEdrugstartdateformat610drugstartdate/04/2010actiondrug5drugadditional3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application Number NDA211913, NDA021951, ANDA202099, ANDA076356, ANDA076135, ANDA075945, ANDA076485 ... Brand Name ABSORICA LD, ABSORICA, ZENATANE, ACCUTANE, CLARAVIS, ISOTRETINOIN, AMNESTEEM, MY ... Generic NameISOTRETINOINManufacturers Sun Pharmaceutical Industries, Inc., Dr. Reddy's Laboratories Limited, JG Pharma ... product_ndc 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_id a8d4793a-5043-40e1-b623-35812733499f, 1f5178c1-0f6f-824d-d0ee-1b973377ccc6, a599 ... spl_set_id 3ef0cff8-19c1-4441-b780-fca6c7ee1615, 27b3cf26-f22e-5b70-1c24-009933b7c6ee, a41c ... Package 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

duplicatesourceRANBAXYduplicatenumbFR-RANBAXY-2015R1-92984