Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10812374primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious2receivedateformat102Date Received18/02/2015receiptdateformat102Date Last Updated18/02/2015fulfillexpeditecriteria2companynumbUS-TEVA-520908USAduplicate1

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-520908USA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age71Unit of Onset Ageyears

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionProduct substitution issueOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionSleep disorderOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugbatchnumbUNKNOWNdrugauthorizationnumb091169drugstructuredosagenumb2drugstructuredosageunit003drugdosageformTABLETdrugindicationSLEEP DISORDERdrugstartdateformat610drugstartdate/10/2014actiondrug5

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

summary

narrativeincludeclinicalCASE EVENT DATE: 201410