Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11247163primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received06/07/2015receiptdateformat102Date Last Updated06/07/2015fulfillexpeditecriteria2

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age52Unit of Onset AgeyearsWeight65.77SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionProduct substitution issue

2)

reactionmeddraversionpt18.1ReactionMiddle insomnia

3)

reactionmeddraversionpt18.1ReactionProduct quality issue

4)

reactionmeddraversionpt18.1ReactionDrug effect decreased

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb-1drugintervaldosageunitnumb-1drugintervaldosagedefinition812drugdosagetextTAKEN BY MOUTHdrugadministrationroute048drugindicationINSOMNIAdrugrecurreadministration1drugadditional2

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: 20150702