Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10583065primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate29/05/2015reporttype1serious2receivedateformat102Date Received14/11/2014receiptdateformat102Date Last Updated14/11/2014fulfillexpeditecriteria2companynumbUS-TEVA-501398USAduplicate1

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-501398USA

Primary Source

reportercountryUSqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionAgitationOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionDrug effect decreasedOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionHangoverOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionAdverse eventOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugbatchnumbUNKNOWNdrugauthorizationnumb091169drugstructuredosagenumb3drugstructuredosageunit003drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

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