Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00338Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10662109Date Received16/12/2014transmissiondate29/05/2015serious1Date Last Updated16/12/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age45Unit of Onset AgeyearsWeight58SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionVitamin D decreased

2)

reactionmeddraversionpt18.0ReactionAbdominal pain

3)

reactionmeddraversionpt18.0ReactionUterine leiomyoma

4)

reactionmeddraversionpt18.0ReactionVaginal discharge

5)

reactionmeddraversionpt18.0ReactionVaginal odour

6)

reactionmeddraversionpt18.0ReactionOff label use

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugbatchnumb7804.035drugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, 3X/WEEK, ORALdrugadministrationroute048drugindicationROSACEAdrugstartdateformat102drugstartdate17/01/2014drugenddateformat102drugenddate22/10/2014

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076485Brand NameMYORISANGeneric NameISOTRETINOINManufacturersVersapharm Incorporatedproduct_ndc61748-301, 61748-302, 61748-303, 61748-304Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1242611, 1242613, 1242615, 1663728spl_id703dd363-236a-4a17-85e9-feb1b3ae540bspl_set_id51ff6346-9256-4c01-9f52-417d13f2df05Package NDC 61748-301-13, 61748-301-11, 61748-301-01, 61748-302-13, 61748-302-11, 61748-302- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

summary

narrativeincludeclinicalCASE EVENT DATE: 20140117

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00338