NICOTINE POLACRILEX
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{
"_id": "69d435a13b3830196fa5690b",
"safetyreportid": "25957864",
"authoritynumb": null,
"companynumb": "US-PERRIGO-25US007620",
"duplicate": null,
"fulfillexpeditecriteria": 2,
"occurcountry": "US",
"patient": {
"patientonsetage": 82.0,
"patientonsetageunit": 801,
"patientagegroup": null,
"patientweight": 58.957,
"patientsex": 2,
"reaction": [
{
"reactionmeddraversionpt": "28.1",
"reactionmeddrapt": "Lip dry",
"reactionoutcome": 3
},
{
"reactionmeddraversionpt": "28.1",
"reactionmeddrapt": "Hiccups",
"reactionoutcome": 3
}
],
"drug": [
{
"drugcharacterization": 1,
"medicinalproduct": "NICOTINE POLACRILEX",
"drugauthorizationnumb": "203690",
"drugbatchnumb": "4KR0337",
"drugstructuredosagenumb": null,
"drugstructuredosageunit": null,
"drugseparatedosagenumb": null,
"drugintervaldosageunitnumb": null,
"drugintervaldosagedefinition": null,
"drugcumulativedosagenumb": null,
"drugcumulativedosageunit": null,
"drugdosagetext": "2 MG, 4 TO 5 TIMES DAILY",
"drugdosageform": "Lozenge",
"drugadministrationroute": "002",
"drugindication": "Smoking cessation therapy",
"drugstartdateformat": "102",
"drugstartdate": "2025-06-06T00:00:00",
"drugenddateformat": null,
"drugenddate": null,
"drugtreatmentduration": null,
"drugtreatmentdurationunit": null,
"drugrecurreadministration": null,
"drugadditional": 4,
"actiondrug": 6,
"activesubstance": {
"activesubstancename": "NICOTINE"
},
"drugrecurrence": []
}
],
"summary_narrativeincludeclinical": "CASE EVENT DATE: 20250606"
},
"primarysource": {
"reportercountry": "US",
"qualification": 5,
"literaturereference": null
},
"primarysourcecountry": "US",
"quarter": "2025Q4",
"receiptdate": "2025-10-24T00:00:00",
"receiptdateformat": "102",
"receivedate": "2025-10-24T00:00:00",
"receivedateformat": "102",
"receiver": {
"receivertype": 6,
"receiverorganization": "FDA"
},
"reportduplicate": [],
"reporttype": 1,
"safetyreportversion": 1,
"sender": {
"sendertype": 6,
"senderorganization": "GALPHARM INTERNATIONAL"
},
"serious": 2,
"seriousnesscongenitalanomali": 2,
"seriousnessdeath": 2,
"seriousnessdisabling": 2,
"seriousnesshospitalization": 2,
"seriousnesslifethreatening": 2,
"seriousnessother": 2,
"source_file": "1_ADR25Q4.xml",
"transmissiondate": "2026-01-17T00:00:00",
"transmissiondateformat": "102"
}