Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10812373primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious2receivedateformat102Date Received18/02/2015receiptdateformat102Date Last Updated18/02/2015fulfillexpeditecriteria2companynumbUS-TEVA-535495USAduplicate1

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-535495USA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionNervous system disorderOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionHypersensitivityOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionParaesthesiaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugauthorizationnumb091169drugadministrationroute065drugindicationSLEEP DISORDERactiondrug1

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