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"system": "http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure", "code": "Stroke" }], "text": "Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\nor knee replacement surgery.\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)." } }, "comorbidity": [{ "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/comorbidity", "code": "Atrialfibrillation" }] } }], "intendedEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/intendedeffect", "code": "PRYLX" }] } } } }, { 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systemic embolism in adult patients with non-valvular atrial fibrillation\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)." } }, "diseaseStatus": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/diseasestatus", "code": "Recurrent" }] } }, "intendedEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/intendedeffect", "code": "PRYLX" }] } } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2330", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": 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} }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Bloodandlymphaticsystemdisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2357", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Hypersensitivity,allergicoedemaand\nAnaphylaxis" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Immunesystemdisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Rare" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2370", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Hypersensitivity,allergicoedemaand\nAnaphylaxis" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Immunesystemdisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Rare" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2385", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Pruritus" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Immunesystemdisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2398", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Eyehaemorrhage(including\nconjunctivalhaemorrhage)" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Eyedisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Rare" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2411", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Haemorrhage,haematoma" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Vasculardisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Common" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2425", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Hypotension(includingprocedural\nhypotension)" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Vasculardisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2438", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Epistaxis" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Respiratory,thoracicandmediastinaldisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2451", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Haemoptysis" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Respiratory,thoracicandmediastinaldisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Rare" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2464", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Nausea" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Gastrointestinaldisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Common" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2477", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Gastrointestinalhaemorrhage" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Gastrointestinaldisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2490", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Haematochezia" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Gastrointestinaldisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2504", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Rectalhaemorrhage,gingivalbleeding" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Gastrointestinaldisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Rare" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2517", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2524", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Transaminasesincreased,aspartate\naminotransferaseincreased,gammaglutamyltransferase\nincreased,liver\nfunctiontestabnormal,bloodalkaline\nphosphataseincreased,bloodbilirubin\nincreased" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Hepatobiliarydisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2537", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Musclehaemorrhage" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Musculoskeletalandconnectivetissuedisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Rare" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2550", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Haematuria" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Renalandurinarydisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Rare" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2563", "type": "undesirable-effect", "subject": [{ "reference": 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"http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Postproceduralhaemorrhage(including\npostproceduralhaematoma,wound\nhaemorrhage,vesselpuncturesite\nhaematomaandcathetersite\nhaemorrhage),woundsecretion,\nincisionsitehaemorrhage(including\nincisionsitehaematoma),operative\nhaemorrhage" }], "text": "Prevention of\nVTE in adult\npatients who have\nundergone\nelective hip or\nknee replacement\nsurgery (VTEp)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Injury,poisoningandproceduralcomplications" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2590", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Hypersensitivity,allergicoedemaand\nAnaphylaxis" }], "text": "Prevention of\nstroke and\nsystemic\nembolism in adult\npatients with\nNVAF, with one\nor more risk\nfactors (NVAF)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Immunesystemdisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2603", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Pruritus" }], "text": "Treatment of\nDVT and PE,\nand prevention\nof recurrent\nDVT and PE\n(VTEt)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Immunesystemdisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": "http://ema.europa.eu/fhir/frequencyofoccurrence", "code": "Uncommon" }] } } }, { "resourceType":"ClinicalUseDefinition", "id": "Equilidem2-5mg-d3e2616", "type": "undesirable-effect", "subject": [{ "reference": "MedicinalProductDefinition/Equilidem-contained" }], "undesirableEffect": { "symptomConditionEffect": { "concept": { "coding": [{ "system": "http://ema.europa.eu/fhir/undesirableeffectassymptom-condition-effect", "code": "Brainhaemorrhage" }], "text": "Treatment of\nDVT and PE,\nand prevention\nof recurrent\nDVT and PE\n(VTEt)" } }, "classification": { "coding": [{ "system": "http://ema.europa.eu/fhir/symptom-condition-effectclassification", "code": "Nervoussystemdisorders" }] }, "frequencyOfOccurrence": { "coding": [{ "system": 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Generated Narrative

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: (Pharmacovigilence Master File)Master File

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