Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
World
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
World
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "bundle-epi-type3-example-diflucan",
"meta" : {
"versionId" : "1.0",
"lastUpdated" : "2026-06-17T10:00:00Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type3"
]
},
"language" : "en",
"identifier" : {
"system" : "http://ema.europa.eu/identifier",
"value" : "DIFLUCAN-BUNDLE-TYPE3"
},
"type" : "document",
"timestamp" : "2026-06-17T10:00:00Z",
"entry" : [
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-diflucan",
"resource" : {
"resourceType" : "Composition",
"id" : "composition-diflucan",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2026-06-17T10:00:00Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><a name=\"Composition_composition-diflucan\"> </a><p>Diflucan Summary of Product Characteristics</p></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "composition-diflucan"
}
],
"version" : "1.0",
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000155532",
"display" : "Summary of Product Characteristics"
}
]
},
"subject" : [
{
🔗 "reference" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
}
],
"date" : "2026-06-17",
"author" : [
{
🔗 "reference" : "Organization/org-diflucan"
}
],
"title" : "Diflucan 150 mg capsule - Summary of Product Characteristics",
"section" : [
{
"id" : "diflucan-root",
"title" : "SUMMARY OF PRODUCT CHARACTERISTICS",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029791",
"display" : "SUMMARY OF PRODUCT CHARACTERISTICS"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Summary of Product Characteristics for Diflucan</div>"
},
"section" : [
{
"id" : "diflucan-4-1",
"title" : "4.1 Therapeutic indications",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029799",
"display" : "4.1 Therapeutic indications"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Treatment of mucosal and invasive candidiasis.</p></div>"
},
"entry" : [
{
🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-mucosal"
},
{
🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-invasive"
}
]
},
{
"id" : "diflucan-4-2",
"title" : "4.2 Posology and method of administration",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "200000029800",
"display" : "4.2 Posology and method of administration"
}
]
},
"text" : {
"status" : "generated",
"div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><p>Dose depends on the indication and the patient population (see structured dosing). Renal impairment requires dose adjustment for multiple-dose therapy.</p></div>"
},
"entry" : [
{
🔗 "reference" : "MedicationKnowledge/mk-diflucan"
},
{
🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-renal"
}
]
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-diflucan",
"resource" : {
"resourceType" : "Organization",
"id" : "org-diflucan",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_org-diflucan\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization org-diflucan</b></p><a name=\"org-diflucan\"> </a><a name=\"hcorg-diflucan\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/LOC-100000999</p><p><b>active</b>: true</p><p><b>name</b>: Example Pharma Ltd.</p></div>"
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/omswi",
"value" : "LOC-100000999"
}
],
"active" : true,
"name" : "Example Pharma Ltd."
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "mpd-diflucan",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpd-diflucan\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpd-diflucan</b></p><a name=\"mpd-diflucan\"> </a><a name=\"hcmpd-diflucan\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/DIFLUCAN-150MG</p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ProductName</b></td></tr><tr><td style=\"display: none\">*</td><td>Diflucan 150 mg capsule</td></tr></table></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/identifier",
"value" : "DIFLUCAN-150MG"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"name" : [
{
"productName" : "Diflucan 150 mg capsule"
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicationKnowledge/mk-diflucan",
"resource" : {
"resourceType" : "MedicationKnowledge",
"id" : "mk-diflucan",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicationKnowledge-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicationKnowledge_mk-diflucan\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicationKnowledge mk-diflucan</b></p><a name=\"mk-diflucan\"> </a><a name=\"hcmk-diflucan\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-MedicationKnowledge-uv-epi.html\">MedicationKnowledge (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/mk-diflucan</p><p><b>status</b>: Active</p><blockquote><p><b>indicationGuideline</b></p><h3>Indications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"ClinicalUseDefinition-cud-diflucan-mucosal.html\">ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-mucosal; type = indication; category = Indication; status = Active</a></td></tr></table><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Loading dose (Day 1)</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 200 to 400 mg on Day 1</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>200-400 mg</td></tr></table></blockquote></blockquote><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Maintenance</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 2</p><p><b>text</b>: 100 to 200 mg once daily for 7 to 21 days</p><p><b>timing</b>: Once per 1 day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>100-200 mg</td></tr></table></blockquote></blockquote><h3>PatientCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>18-? years</td></tr></table></blockquote><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Initial dose</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 6 mg/kg on the first day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>6 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span></td></tr></table></blockquote></blockquote><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Subsequent dose</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 2</p><p><b>text</b>: 3 mg/kg once daily</p><p><b>timing</b>: Once per 1 day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>3 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span></td></tr></table></blockquote></blockquote><h3>PatientCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>28-11 days</td></tr></table></blockquote><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Neonatal dose</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 3 mg/kg every 72 hours (max 12 mg/kg every 72 hours)</p><p><b>timing</b>: Once per 72 hours</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>3 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span></td></tr></table><p><b>maxDosePerPeriod</b>: 12 mg/kg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg/kg = 'mg/kg')</span>/72 hours<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeh = 'h')</span></p></blockquote></blockquote><h3>PatientCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>0-14 days</td></tr></table></blockquote></blockquote><blockquote><p><b>indicationGuideline</b></p><h3>Indications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"ClinicalUseDefinition-cud-diflucan-invasive.html\">ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-invasive; type = indication; category = Indication; status = Active</a></td></tr></table><blockquote><p><b>dosingGuideline</b></p><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Loading dose (Day 1)</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 1</p><p><b>text</b>: 800 mg on Day 1</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>800 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></td></tr></table></blockquote></blockquote><blockquote><p><b>dosage</b></p><p><b>type</b>: <span title=\"Codes:\">Maintenance</span></p><blockquote><p><b>dosage</b></p><p><b>sequence</b>: 2</p><p><b>text</b>: 400 mg once daily</p><p><b>timing</b>: Once per 1 day</p><h3>DoseAndRates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Dose[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>400 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></td></tr></table></blockquote></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "mk-diflucan"
}
],
"status" : "active",
"indicationGuideline" : [
{
"indication" : [
{
"reference" : {
🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-mucosal"
}
}
],
"dosingGuideline" : [
{
"dosage" : [
{
"type" : {
"text" : "Loading dose (Day 1)"
},
"dosage" : [
{
"sequence" : 1,
"text" : "200 to 400 mg on Day 1",
"doseAndRate" : [
{
"doseRange" : {
"low" : {
"value" : 200,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"high" : {
"value" : 400,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
}
}
}
]
}
]
},
{
"type" : {
"text" : "Maintenance"
},
"dosage" : [
{
"sequence" : 2,
"text" : "100 to 200 mg once daily for 7 to 21 days",
"timing" : {
"repeat" : {
"frequency" : 1,
"period" : 1,
"periodUnit" : "d"
}
},
"doseAndRate" : [
{
"doseRange" : {
"low" : {
"value" : 100,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"high" : {
"value" : 200,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
}
}
}
]
}
]
}
],
"patientCharacteristic" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code" : "age",
"display" : "Age"
}
]
},
"valueRange" : {
"low" : {
"value" : 18,
"unit" : "years",
"system" : "http://unitsofmeasure.org",
"code" : "a"
}
}
}
]
},
{
"dosage" : [
{
"type" : {
"text" : "Initial dose"
},
"dosage" : [
{
"sequence" : 1,
"text" : "6 mg/kg on the first day",
"doseAndRate" : [
{
"doseQuantity" : {
"value" : 6,
"unit" : "mg/kg",
"system" : "http://unitsofmeasure.org",
"code" : "mg/kg"
}
}
]
}
]
},
{
"type" : {
"text" : "Subsequent dose"
},
"dosage" : [
{
"sequence" : 2,
"text" : "3 mg/kg once daily",
"timing" : {
"repeat" : {
"frequency" : 1,
"period" : 1,
"periodUnit" : "d"
}
},
"doseAndRate" : [
{
"doseQuantity" : {
"value" : 3,
"unit" : "mg/kg",
"system" : "http://unitsofmeasure.org",
"code" : "mg/kg"
}
}
]
}
]
}
],
"patientCharacteristic" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code" : "age",
"display" : "Age"
}
]
},
"valueRange" : {
"low" : {
"value" : 28,
"unit" : "days",
"system" : "http://unitsofmeasure.org",
"code" : "d"
},
"high" : {
"value" : 11,
"unit" : "years",
"system" : "http://unitsofmeasure.org",
"code" : "a"
}
}
}
]
},
{
"dosage" : [
{
"type" : {
"text" : "Neonatal dose"
},
"dosage" : [
{
"sequence" : 1,
"text" : "3 mg/kg every 72 hours (max 12 mg/kg every 72 hours)",
"timing" : {
"repeat" : {
"frequency" : 1,
"period" : 72,
"periodUnit" : "h"
}
},
"doseAndRate" : [
{
"doseQuantity" : {
"value" : 3,
"unit" : "mg/kg",
"system" : "http://unitsofmeasure.org",
"code" : "mg/kg"
}
}
],
"maxDosePerPeriod" : [
{
"numerator" : {
"value" : 12,
"unit" : "mg/kg",
"system" : "http://unitsofmeasure.org",
"code" : "mg/kg"
},
"denominator" : {
"value" : 72,
"unit" : "hours",
"system" : "http://unitsofmeasure.org",
"code" : "h"
}
}
]
}
]
}
],
"patientCharacteristic" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code" : "age",
"display" : "Age"
}
]
},
"valueRange" : {
"low" : {
"value" : 0,
"unit" : "days",
"system" : "http://unitsofmeasure.org",
"code" : "d"
},
"high" : {
"value" : 14,
"unit" : "days",
"system" : "http://unitsofmeasure.org",
"code" : "d"
}
}
}
]
}
]
},
{
"indication" : [
{
"reference" : {
🔗 "reference" : "ClinicalUseDefinition/cud-diflucan-invasive"
}
}
],
"dosingGuideline" : [
{
"dosage" : [
{
"type" : {
"text" : "Loading dose (Day 1)"
},
"dosage" : [
{
"sequence" : 1,
"text" : "800 mg on Day 1",
"doseAndRate" : [
{
"doseQuantity" : {
"value" : 800,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
}
}
]
}
]
},
{
"type" : {
"text" : "Maintenance"
},
"dosage" : [
{
"sequence" : 2,
"text" : "400 mg once daily",
"timing" : {
"repeat" : {
"frequency" : 1,
"period" : 1,
"periodUnit" : "d"
}
},
"doseAndRate" : [
{
"doseQuantity" : {
"value" : 400,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
}
}
]
}
]
}
]
}
]
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-mucosal",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-diflucan-mucosal",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-diflucan-mucosal\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-diflucan-mucosal</b></p><a name=\"cud-diflucan-mucosal\"> </a><a name=\"hccud-diflucan-mucosal\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-indication-uv-epi.html\">ClinicalUseDefinition Indication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-diflucan-mucosal</p><p><b>type</b>: Indication</p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig indication}\">Indication</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type3-example-diflucan.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 79740000}\">Candidiasis of mouth</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "cud-diflucan-mucosal"
}
],
"type" : "indication",
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "indication",
"display" : "Indication"
}
]
}
],
"subject" : [
{
🔗 "reference" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "79740000",
"display" : "Candidiasis of mouth"
}
]
}
}
}
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-invasive",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-diflucan-invasive",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-diflucan-invasive\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-diflucan-invasive</b></p><a name=\"cud-diflucan-invasive\"> </a><a name=\"hccud-diflucan-invasive\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-indication-uv-epi.html\">ClinicalUseDefinition Indication (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-diflucan-invasive</p><p><b>type</b>: Indication</p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig indication}\">Indication</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type3-example-diflucan.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 70572005}\">Invasive candidiasis</span></td></tr></table></blockquote><p><b>population</b>: <a href=\"Group-group-diflucan-adult.html\">Adults</a></p></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "cud-diflucan-invasive"
}
],
"type" : "indication",
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "indication",
"display" : "Indication"
}
]
}
],
"subject" : [
{
🔗 "reference" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "70572005",
"display" : "Invasive candidiasis"
}
]
}
}
},
"population" : [
{
🔗 "reference" : "Group/group-diflucan-adult",
"display" : "Adults"
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-renal",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-diflucan-renal",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-warning-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-diflucan-renal\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-diflucan-renal</b></p><a name=\"cud-diflucan-renal\"> </a><a name=\"hccud-diflucan-renal\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ClinicalUseDefinition-warning-uv-epi.html\">ClinicalUseDefinition Warning (ePI)</a></p></div><p><b>identifier</b>: <code>http://example.org/identifier</code>/cud-diflucan-renal</p><p><b>type</b>: Warning</p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig warning}\">Warning</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type3-example-diflucan.html#http-//hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan\">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>population</b>: <a href=\"Group-group-diflucan-renal.html\">Renal impairment (CrCl ≤ 50 mL/min)</a></p><h3>Warnings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 723188008}\">For multiple-dose therapy, after a normal loading dose, give 50% of the recommended daily dose when CrCl ≤ 50 mL/min (no haemodialysis); give 100% of the recommended dose after each haemodialysis session. Single-dose therapy needs no adjustment. This rule applies to every multiple-dose indication.</span></td></tr></table></div>"
},
"identifier" : [
{
"system" : "http://example.org/identifier",
"value" : "cud-diflucan-renal"
}
],
"type" : "warning",
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig",
"code" : "warning",
"display" : "Warning"
}
]
}
],
"subject" : [
{
🔗 "reference" : "http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"
}
],
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "Active"
}
]
},
"population" : [
{
🔗 "reference" : "Group/group-diflucan-renal",
"display" : "Renal impairment (CrCl ≤ 50 mL/min)"
}
],
"warning" : {
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "723188008",
"display" : "Renal insufficiency"
}
],
"text" : "For multiple-dose therapy, after a normal loading dose, give 50% of the recommended daily dose when CrCl ≤ 50 mL/min (no haemodialysis); give 100% of the recommended dose after each haemodialysis session. Single-dose therapy needs no adjustment. This rule applies to every multiple-dose indication."
}
}
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-adult",
"resource" : {
"resourceType" : "Group",
"id" : "group-diflucan-adult",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Group-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Group_group-diflucan-adult\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Group group-diflucan-adult</b></p><a name=\"group-diflucan-adult\"> </a><a name=\"hcgroup-diflucan-adult\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Group-uv-epi.html\">Group (ePI)</a></p></div><p><b>type</b>: Person</p><p><b>membership</b>: Definitional</p><p><b>name</b>: Adults</p><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type age}\">Age</span></td><td>18-? years</td><td>false</td></tr></table></div>"
},
"type" : "person",
"membership" : "definitional",
"name" : "Adults",
"characteristic" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code" : "age",
"display" : "Age"
}
]
},
"valueRange" : {
"low" : {
"value" : 18,
"unit" : "years",
"system" : "http://unitsofmeasure.org",
"code" : "a"
}
},
"exclude" : false
}
]
}
},
{
"fullUrl" : "http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-renal",
"resource" : {
"resourceType" : "Group",
"id" : "group-diflucan-renal",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Group-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Group_group-diflucan-renal\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Group group-diflucan-renal</b></p><a name=\"group-diflucan-renal\"> </a><a name=\"hcgroup-diflucan-renal\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Group-uv-epi.html\">Group (ePI)</a></p></div><p><b>type</b>: Person</p><p><b>membership</b>: Definitional</p><p><b>name</b>: Renal impairment (CrCl ≤ 50 mL/min)</p><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type renal-function}\">Renal function</span></td><td>?-50</td><td>false</td></tr></table></div>"
},
"type" : "person",
"membership" : "definitional",
"name" : "Renal impairment (CrCl ≤ 50 mL/min)",
"characteristic" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type",
"code" : "renal-function",
"display" : "Renal function"
}
]
},
"valueRange" : {
"high" : {
"value" : 50,
"unit" : "mL/min",
"system" : "http://unitsofmeasure.org",
"code" : "mL/min"
}
},
"exclude" : false
}
]
}
}
]
}
IG © 2022+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-07-01
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