Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11048973primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/08/2015reporttype1serious2receivedateformat102Date Received20/04/2015receiptdateformat102Date Last Updated20/04/2015fulfillexpeditecriteria2companynumbUS-MYLANLABS-2015M1002410duplicate1

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2015M1002410

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionNeurological symptomOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionTherapeutic response changedOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionDyspnoeaOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionLethargyOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.0ReactionAmnesiaOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.0ReactionReaction to drug excipientsOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt18.0ReactionPanic attackOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.0ReactionUnevaluable eventOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugauthorizationnumb091151drugdosagetextUNKdrugdosageformTABLETdrugindicationSLEEP DISORDERactiondrug4

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