Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014P1004047Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10241237Date Received13/06/2014transmissiondate12/12/2014serious1Date Last Updated13/06/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age25Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionRash macular

2)

reactionmeddraversionpt17.0ReactionEye swelling

3)

reactionmeddraversionpt17.0ReactionVomiting

4)

reactionmeddraversionpt17.0ReactionSwelling face

5)

reactionmeddraversionpt17.0ReactionLip swelling

6)

reactionmeddraversionpt17.0ReactionRash generalised

7)

reactionmeddraversionpt17.0ReactionNausea

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb40drugstructuredosageunit003drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate08/04/2014drugenddateformat102drugenddate08/04/2014drugrecurreadministration1drugadditional1

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

2)

drugcharacterization2medicinalproductKELNOR 1/35

openFDA Info on Medication

Application NumberANDA072723, ANDA076785Brand NameKELNOR 1/50, KELNOR 1/35Generic NameETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0093-8073, 0555-9064Product TypeHUMAN PRESCRIPTION DRUGRXCUI315096, 748797, 748806, 2000695, 310228, 748804, 753483spl_id01e4da7d-39ab-4731-88c3-607bb40b2366, f77c79ff-0227-4d26-8662-4428d1da7355spl_set_ided075d59-4b6f-467c-bcb1-4dda272d27aa, 96a73786-22b1-457e-be73-80b699996d40Package NDC0093-8073-28, 0093-8073-16, 0555-9064-79, 0555-9064-58, 0555-9064-67

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014P1004047