Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-BIOGENIDEC-2014BI036240occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10085491Date Received18/04/2014transmissiondate12/12/2014serious2Date Last Updated18/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPain in extremityOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionMusculoskeletal painOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionMyalgiaOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionMuscle spasmsOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionDepressionOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionArthralgiaOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTYSABRIdrugauthorizationnumb125104drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosageformINTRAVENOUS INFUSIONdrugadministrationroute042drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate14/05/2013actiondrug4

openFDA Info on Medication

Application NumberBLA125104Brand NameTYSABRIGeneric NameNATALIZUMABManufacturersBiogen Inc.product_ndc64406-008Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsNATALIZUMABRXCUI477484, 603541spl_id7628d515-59db-47b7-8ba9-95dc94363af5spl_set_idc5fdde91-1989-4dd2-9129-4f3323ea2962Package NDC64406-008-01NUIN0000175775, N0000175774Established Pharmacologic ClassIntegrin Receptor Antagonist [EPC]Mechanism of ActionIntegrin Receptor Antagonists [MoA]UNII3JB47N2Q2P

2)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

3)

drugcharacterization2medicinalproductLISINOPRIL/HYDROCHLOROTHIAZIDEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

4)

drugcharacterization2medicinalproductHYDROXYZINE HCLdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA086880Brand NameHYDROXYZINE HCLGeneric NameHYDROXYZINE HCLManufacturersSTI Pharma LLCproduct_ndc54879-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE HYDROCHLORIDERXCUI995241spl_id969ddc10-9046-9104-e053-2995a90a727dspl_set_idfe0c3083-2a8f-4f5f-af9f-b1f668e77417Package NDC54879-006-16UNII76755771U3

5)

drugcharacterization2medicinalproductMEDROLdrugstructuredosagenumb4drugstructuredosageunit003drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA011153Brand NameMEDROLGeneric NameMETHYLPREDNISOLONEManufacturersPharmacia and Upjohn Company LLCproduct_ndc0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPREDNISOLONERXCUI 197969, 197971, 197973, 207136, 207137, 207138, 207141, 259966, 260330, 328161, ... spl_id8f9c2163-1d7f-4e6e-bbe5-d758de474744spl_set_id39d5270b-d957-4821-93d6-501b7b9f02d4Package NDC 0009-0049-02, 0009-0056-02, 0009-0056-04, 0009-0022-01, 0009-0073-01, 0009-0176- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIX4W7ZR7023

6)

drugcharacterization2medicinalproductAMANTADINE HCLdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA078720Brand NameAMANTADINE HCLGeneric NameAMANTADINE HYDROCHLORIDEManufacturersBionpharma Inc.product_ndc69452-142Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMANTADINE HYDROCHLORIDERXCUI849389spl_id2ace017d-fb67-4265-9106-e30eed548622spl_set_idd6ca4d20-72c5-496c-9ac7-1f5cb407a742Package NDC69452-142-20, 69452-142-30UNIIM6Q1EO9TD0

7)

drugcharacterization2medicinalproductCETIRIZINE HCLdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA204226, NDA022429, ANDA209274, ANDA090474, ANDA078780, ANDA207235, ANDA20529 ... Brand Name HEALTH MART CHILDRENS ALL DAY ALLERGY, CHILDRENS CETIRIZINE HYDROCHLORIDE, ALLER ... Generic NameCETIRIZINE HCL, CETIRIZINE HYDROCHLORIDEManufacturers Strategic Sourcing Services LLC, Major Pharmaceuticals, Western Family Foods, In ... product_ndc 62011-0323, 0904-6765, 55312-211, 59726-806, 46122-613, 63868-433, 11673-475, 55 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014673, 1014675, 1014678, 1087169, 1482533, 1020017, 1014674, 1549337spl_id ddeda4a6-126d-4938-ad67-1b4bc75927f2, 6a59e630-2a83-4093-bc3b-1f15a12d359e, 825f ... spl_set_id a947dbe8-aa58-447a-8b09-a38e0c87aee7, db297aa4-4384-48f2-b2bd-c842efc8a844, 4f04 ... Package NDC 62011-0323-1, 0904-6765-20, 55312-211-25, 59726-806-05, 59726-806-14, 46122-613- ... UNII64O047KTOA

8)

drugcharacterization2medicinalproductPRESNISONEdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

9)

drugcharacterization2medicinalproductIRON SUPPLEMENTdrugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI036240