Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-BIOGENIDEC-2014BI021952occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10014355Date Received17/03/2014transmissiondate02/10/2014serious2Date Last Updated17/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionConstipationOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTECFIDERAdrugauthorizationnumb204063drugstructuredosagenumb120drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate06/02/2014drugenddateformat102drugenddate12/02/2014actiondrug4

openFDA Info on Medication

Application NumberNDA204063Brand NameTECFIDERAGeneric NameDIMETHYL FUMARATEManufacturersBiogen Inc.product_ndc64406-005, 64406-007, 64406-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIMETHYL FUMARATERXCUI1373483, 1373489, 1373491, 1373493, 1373497, 1373498spl_id9b17ffc0-f173-4a40-af22-80f21d069ebaspl_set_id665d7e74-036c-5f68-5b67-ab84b9b49151Package NDC64406-007-03, 64406-005-01, 64406-006-02UNIIFO2303MNI2

2)

drugcharacterization1medicinalproductTECFIDERAdrugauthorizationnumb204063drugstructuredosagenumb240drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformPROLONGED-RELEASE CAPSULEdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate13/02/2014actiondrug4

openFDA Info on Medication

Application NumberNDA204063Brand NameTECFIDERAGeneric NameDIMETHYL FUMARATEManufacturersBiogen Inc.product_ndc64406-005, 64406-007, 64406-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIMETHYL FUMARATERXCUI1373483, 1373489, 1373491, 1373493, 1373497, 1373498spl_id9b17ffc0-f173-4a40-af22-80f21d069ebaspl_set_id665d7e74-036c-5f68-5b67-ab84b9b49151Package NDC64406-007-03, 64406-005-01, 64406-006-02UNIIFO2303MNI2

3)

drugcharacterization2medicinalproductMECLIZINE

openFDA Info on Medication

Application Numberpart336, ANDA201451Brand NameMECLIZINE, MECLIZINE HYDROCHLORIDEGeneric NameMECLIZINE HCL 25MG, MECLIZINE HCL 12.5 MG, MECLIZINE, MECLIZINE HCL 12.5MGManufacturers Ulai Health LLC, Pharbest Pharmaceuticals, Inc., SDA Laboratories, Inc., RUGBY L ... product_ndc 73057-387, 16103-386, 66424-386, 66424-387, 0536-1297, 16103-387, 65162-441, 651 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMECLIZINE HYDROCHLORIDERXCUI995632, 995624, 995666, 995686spl_id 3c884e11-5f9b-4a8a-9a2b-179a19b20244, 4e199df3-49f3-42f2-add2-00b99d78cc10, 01ec ... spl_set_id ea2e6834-c11a-40f8-887c-e02419023e7b, 8b3c9283-b618-4d57-9f15-7cf73e8737f5, f258 ... Package NDC 73057-387-11, 73057-387-08, 16103-386-08, 16103-386-11, 66424-386-01, 66424-386- ... UNIIHDP7W44CIO

4)

drugcharacterization2medicinalproductXANAX

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

5)

drugcharacterization2medicinalproductZOLOFT

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

6)

drugcharacterization2medicinalproductNUVIGIL

openFDA Info on Medication

Application NumberNDA021875Brand NameNUVIGILGeneric NameARMODAFINILManufacturersCephalon, Inc.product_ndc63459-205, 63459-215, 63459-220, 63459-225Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARMODAFINILRXCUI724859, 724861, 724863, 805659, 805661, 805663, 861960, 861962spl_id12eab811-a6da-495f-8ba1-0cb52ccc5914spl_set_idd878aed0-ddbf-8fa1-abf7-d3e480260845Package NDC 63459-205-30, 63459-215-07, 63459-215-35, 63459-215-30, 63459-220-07, 63459-220- ... UNIIV63XWA605I

7)

drugcharacterization2medicinalproductVITAMIN E

8)

drugcharacterization2medicinalproductFLAX SEED OIL

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI021952