Adverse Event Report

Report

reporttype3Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10033342serious1Date Last Updated25/03/2014receiptdateformat102companynumbGB-LUPIN PHARMACEUTICALS INC.-E2B_00001830occurcountryGBseriousnessother1duplicate1Date Received25/03/2014transmissiondate02/10/2014primarysourcecountryGB

Primary Source

reportercountryGB

Patient

Onset Age60Unit of Onset AgeyearsWeight68.03SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionMultiple chemical sensitivityOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionNasal drynessOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionDry eyeOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.0ReactionStereotypyOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.0ReactionDisorientationOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.0ReactionTensionOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt17.0ReactionDry mouthOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.0ReactionDisturbance in attentionOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.0ReactionDizzinessOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.0ReactionTinnitusOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt17.0ReactionSleep disorderOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductSERTRALINE HYDROCHLORIDEdrugbatchnumbG304727drugauthorizationnumb077670drugstructuredosagenumb100drugstructuredosageunit003drugadministrationroute048drugindicationDEPRESSIONdrugstartdateformat102drugstartdate02/10/2013actiondrug4drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

2)

drugcharacterization2medicinalproductADCAL-D3drugstructuredosagenumb1500drugstructuredosageunit003drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

Report Duplicate

duplicatesourceLUPINduplicatenumbGB-LUPIN PHARMACEUTICALS INC.-E2B_00001830

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use