Adverse Event Report

Report

reporttype1Version of Safety Report ID4receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10353630serious1Date Last Updated24/12/2014receiptdateformat102companynumbGB-RANBAXY-2014RR-83942occurcountryGBseriousnessother1duplicate1Date Received31/07/2014transmissiondate28/05/2015primarysourcecountryGB

Primary Source

reportercountryGBqualification3

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionPregnancyOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionAbortion inducedOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionOff label useOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb076041drugstructuredosagenumb60drugstructuredosageunit003drugdosagetext2 LOTS OF 60MG AT 8 WEEKS INTERVALSdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate12/03/2014drugenddateformat102drugenddate25/06/2014actiondrug1drugrecurreadministration3

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

duplicatesourceRANBAXYduplicatenumbGB-RANBAXY-2014RR-83942

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use