Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11422928primarysourcecountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessother1receivedateformat102Date Received26/08/2015receiptdateformat102Date Last Updated26/08/2015fulfillexpeditecriteria2

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age54Unit of Onset AgeyearsWeight70.31SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionHypoaesthesia

2)

reactionmeddraversionpt18.1ReactionInitial insomnia

3)

reactionmeddraversionpt18.1ReactionMiddle insomnia

Drug

1)

drugcharacterization2medicinalproductMULTI VITIMAN

2)

drugcharacterization1medicinalproductESZOPICLONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1drugadministrationroute048drugindicationINSOMNIAdrugstartdateformat102drugstartdate24/06/2015drugenddateformat102drugenddate24/07/2015drugadditional2

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

3)

drugcharacterization2medicinalproductIBPHEROPEN

summary

narrativeincludeclinicalCASE EVENT DATE: 20150624