Adverse Event Report

Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10035293serious1Date Last Updated08/04/2014receiptdateformat102companynumbPHEH2014US004711occurcountryUSduplicate1Date Received25/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age32Unit of Onset AgeyearsWeight113.38SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionMultiple sclerosis relapseOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionAstheniaOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionHypoaesthesiaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionDyslipidaemiaOutcomeRecovering/resolving

5)

reactionmeddraversionpt17.0ReactionNuclear magnetic resonance imaging abnormalOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductGILENYAdrugauthorizationnumb022527drugdosagetextUNK UKN, UNKdrugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate24/02/2014actiondrug4

openFDA Info on Medication

Application NumberNDA022527Brand NameGILENYAGeneric NameFINGOLIMOD HCLManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0607, 0078-0965Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFINGOLIMOD HYDROCHLORIDERXCUI1012895, 1012899, 2045491, 2045493spl_idf4110640-5d3d-4957-83e2-71a0c7b71bd2spl_set_idcc9e1c8c-0e2b-44e2-878b-27057f786be9Package NDC0078-0607-15, 0078-0607-51, 0078-0607-89, 0078-0965-89UNIIG926EC510T

2)

drugcharacterization2medicinalproductCAMRESEdrugdosagetextUNK UKN, DAILYdrugadministrationroute048drugindicationCONTRACEPTIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021840Brand NameCAMRESEGeneric NameLEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0093-3134Product TypeHUMAN PRESCRIPTION DRUGRXCUI238019, 248310, 749761, 1149667spl_idb8318330-cb1d-46c3-8629-12a4c5a8e132spl_set_id0e198d28-4986-4b93-833f-17c7ed4ce13ePackage NDC0093-3134-91, 0093-3134-82

3)

drugcharacterization2medicinalproductKLONOPINdrugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1 MG, QD/BIDdrugadministrationroute048drugindicationANXIETYactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersGenentech, Inc.product_ndc0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id7a882463-5215-477c-bc1c-2cce0801bf4bspl_set_id542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC0004-0068-01, 0004-0058-01, 0004-0098-01NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

4)

drugcharacterization2medicinalproductVITAMIN Ddrugstructuredosagenumb50000drugstructuredosageunit025drugdosagetext50000 IU, UNKdrugadministrationroute048drugindicationVITAMIN D DEFICIENCYdrugstartdateformat102drugstartdate22/12/2013actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

5)

drugcharacterization2medicinalproductRELPAXdrugdosagetextUNK UKN, PRNdrugadministrationroute048drugindicationMIGRAINEactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021016Brand NameRELPAXGeneric NameELETRIPTAN HYDROBROMIDEManufacturersRoerig, U.S. Pharmaceuticalsproduct_ndc0049-2330, 0049-2340, 63539-234Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsELETRIPTAN HYDROBROMIDERXCUI359493, 359494, 404443, 404444spl_id4fe86f16-7d84-4192-bfcb-f600ef55e29e, a35d1272-c5b6-4481-a447-d46fc12a8b11spl_set_id85745375-fcb6-4edc-b6db-a77b4a5f3e8c, 986dc112-b97b-44a3-bfaf-074f906f8bb2Package NDC 0049-2330-79, 0049-2330-45, 0049-2340-79, 0049-2340-45, 0049-2340-05, 63539-234- ... UNIIM41W832TA3

6)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb150drugstructuredosageunit003drugdosagetext150 MG, UNKdrugadministrationroute048drugindicationDEPRESSIONactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHEH2014US004711

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use