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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-epi-type3-example-diflucan"/>
<meta>
<versionId value="1.0"/>
<lastUpdated value="2026-06-17T10:00:00Z"/>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type3"/>
</meta>
<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="DIFLUCAN-BUNDLE-TYPE3"/>
</identifier>
<type value="document"/>
<timestamp value="2026-06-17T10:00:00Z"/>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-diflucan"/>
<resource>
<Composition>
<id value="composition-diflucan"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2026-06-17T10:00:00Z"/>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="composition-diflucan"/>
</identifier>
<version value="1.0"/>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155532"/>
<display value="Summary of Product Characteristics"/>
</coding>
</type>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"/>
</subject>
<date value="2026-06-17"/>
<author>🔗
<reference value="Organization/org-diflucan"/>
</author>
<title
value="Diflucan 150 mg capsule - Summary of Product Characteristics"/>
<section id="diflucan-root">
<title value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029791"/>
<display value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">Summary of Product Characteristics for Diflucan</div>
</text>
<section id="diflucan-4-1">
<title value="4.1 Therapeutic indications"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029799"/>
<display value="4.1 Therapeutic indications"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><p>Treatment of mucosal and invasive candidiasis.</p></div>
</text>
<entry>🔗
<reference value="ClinicalUseDefinition/cud-diflucan-mucosal"/>
</entry>
<entry>🔗
<reference value="ClinicalUseDefinition/cud-diflucan-invasive"/>
</entry>
</section>
<section id="diflucan-4-2">
<title value="4.2 Posology and method of administration"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000029800"/>
<display value="4.2 Posology and method of administration"/>
</coding>
</code>
<text>
<status value="generated"/>
<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>
</text>
<entry>🔗
<reference value="MedicationKnowledge/mk-diflucan"/>
</entry>
<entry>🔗
<reference value="ClinicalUseDefinition/cud-diflucan-renal"/>
</entry>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-diflucan"/>
<resource>
<Organization>
<id value="org-diflucan"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="LOC-100000999"/>
</identifier>
<active value="true"/>
<name value="Example Pharma Ltd."/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"/>
<resource>
<MedicinalProductDefinition>
<id value="mpd-diflucan"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="DIFLUCAN-150MG"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<name>
<productName value="Diflucan 150 mg capsule"/>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicationKnowledge/mk-diflucan"/>
<resource>
<MedicationKnowledge>
<id value="mk-diflucan"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicationKnowledge-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="mk-diflucan"/>
</identifier>
<status value="active"/>
<indicationGuideline>
<indication>
<reference>🔗
<reference value="ClinicalUseDefinition/cud-diflucan-mucosal"/>
</reference>
</indication>
<dosingGuideline>
<dosage>
<type>
<text value="Loading dose (Day 1)"/>
</type>
<dosage>
<sequence value="1"/>
<text value="200 to 400 mg on Day 1"/>
<doseAndRate>
<doseRange>
<low>
<value value="200"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</low>
<high>
<value value="400"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</high>
</doseRange>
</doseAndRate>
</dosage>
</dosage>
<dosage>
<type>
<text value="Maintenance"/>
</type>
<dosage>
<sequence value="2"/>
<text value="100 to 200 mg once daily for 7 to 21 days"/>
<timing>
<repeat>
<frequency value="1"/>
<period value="1"/>
<periodUnit value="d"/>
</repeat>
</timing>
<doseAndRate>
<doseRange>
<low>
<value value="100"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</low>
<high>
<value value="200"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</high>
</doseRange>
</doseAndRate>
</dosage>
</dosage>
<patientCharacteristic>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type"/>
<code value="age"/>
<display value="Age"/>
</coding>
</type>
<valueRange>
<low>
<value value="18"/>
<unit value="years"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
</low>
</valueRange>
</patientCharacteristic>
</dosingGuideline>
<dosingGuideline>
<dosage>
<type>
<text value="Initial dose"/>
</type>
<dosage>
<sequence value="1"/>
<text value="6 mg/kg on the first day"/>
<doseAndRate>
<doseQuantity>
<value value="6"/>
<unit value="mg/kg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/kg"/>
</doseQuantity>
</doseAndRate>
</dosage>
</dosage>
<dosage>
<type>
<text value="Subsequent dose"/>
</type>
<dosage>
<sequence value="2"/>
<text value="3 mg/kg once daily"/>
<timing>
<repeat>
<frequency value="1"/>
<period value="1"/>
<periodUnit value="d"/>
</repeat>
</timing>
<doseAndRate>
<doseQuantity>
<value value="3"/>
<unit value="mg/kg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/kg"/>
</doseQuantity>
</doseAndRate>
</dosage>
</dosage>
<patientCharacteristic>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type"/>
<code value="age"/>
<display value="Age"/>
</coding>
</type>
<valueRange>
<low>
<value value="28"/>
<unit value="days"/>
<system value="http://unitsofmeasure.org"/>
<code value="d"/>
</low>
<high>
<value value="11"/>
<unit value="years"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
</high>
</valueRange>
</patientCharacteristic>
</dosingGuideline>
<dosingGuideline>
<dosage>
<type>
<text value="Neonatal dose"/>
</type>
<dosage>
<sequence value="1"/>
<text
value="3 mg/kg every 72 hours (max 12 mg/kg every 72 hours)"/>
<timing>
<repeat>
<frequency value="1"/>
<period value="72"/>
<periodUnit value="h"/>
</repeat>
</timing>
<doseAndRate>
<doseQuantity>
<value value="3"/>
<unit value="mg/kg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/kg"/>
</doseQuantity>
</doseAndRate>
<maxDosePerPeriod>
<numerator>
<value value="12"/>
<unit value="mg/kg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/kg"/>
</numerator>
<denominator>
<value value="72"/>
<unit value="hours"/>
<system value="http://unitsofmeasure.org"/>
<code value="h"/>
</denominator>
</maxDosePerPeriod>
</dosage>
</dosage>
<patientCharacteristic>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type"/>
<code value="age"/>
<display value="Age"/>
</coding>
</type>
<valueRange>
<low>
<value value="0"/>
<unit value="days"/>
<system value="http://unitsofmeasure.org"/>
<code value="d"/>
</low>
<high>
<value value="14"/>
<unit value="days"/>
<system value="http://unitsofmeasure.org"/>
<code value="d"/>
</high>
</valueRange>
</patientCharacteristic>
</dosingGuideline>
</indicationGuideline>
<indicationGuideline>
<indication>
<reference>🔗
<reference value="ClinicalUseDefinition/cud-diflucan-invasive"/>
</reference>
</indication>
<dosingGuideline>
<dosage>
<type>
<text value="Loading dose (Day 1)"/>
</type>
<dosage>
<sequence value="1"/>
<text value="800 mg on Day 1"/>
<doseAndRate>
<doseQuantity>
<value value="800"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</doseQuantity>
</doseAndRate>
</dosage>
</dosage>
<dosage>
<type>
<text value="Maintenance"/>
</type>
<dosage>
<sequence value="2"/>
<text value="400 mg once daily"/>
<timing>
<repeat>
<frequency value="1"/>
<period value="1"/>
<periodUnit value="d"/>
</repeat>
</timing>
<doseAndRate>
<doseQuantity>
<value value="400"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</doseQuantity>
</doseAndRate>
</dosage>
</dosage>
</dosingGuideline>
</indicationGuideline>
</MedicationKnowledge>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-mucosal"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-diflucan-mucosal"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-diflucan-mucosal"/>
</identifier>
<type value="indication"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="indication"/>
<display value="Indication"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="79740000"/>
<display value="Candidiasis of mouth"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-invasive"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-diflucan-invasive"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-diflucan-invasive"/>
</identifier>
<type value="indication"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="indication"/>
<display value="Indication"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="70572005"/>
<display value="Invasive candidiasis"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</indication>
<population>🔗
<reference value="Group/group-diflucan-adult"/>
<display value="Adults"/>
</population>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-renal"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-diflucan-renal"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-warning-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="http://example.org/identifier"/>
<value value="cud-diflucan-renal"/>
</identifier>
<type value="warning"/>
<category>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-ig"/>
<code value="warning"/>
<display value="Warning"/>
</coding>
</category>
<subject>🔗
<reference
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan"/>
</subject>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<population>🔗
<reference value="Group/group-diflucan-renal"/>
<display value="Renal impairment (CrCl ≤ 50 mL/min)"/>
</population>
<warning>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="723188008"/>
<display value="Renal insufficiency"/>
</coding>
<text
value="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."/>
</code>
</warning>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-adult"/>
<resource>
<Group>
<id value="group-diflucan-adult"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Group-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<type value="person"/>
<membership value="definitional"/>
<name value="Adults"/>
<characteristic>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type"/>
<code value="age"/>
<display value="Age"/>
</coding>
</code>
<valueRange>
<low>
<value value="18"/>
<unit value="years"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
</low>
</valueRange>
<exclude value="false"/>
</characteristic>
</Group>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-renal"/>
<resource>
<Group>
<id value="group-diflucan-renal"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Group-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<type value="person"/>
<membership value="definitional"/>
<name value="Renal impairment (CrCl ≤ 50 mL/min)"/>
<characteristic>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/epi-group-characteristic-type"/>
<code value="renal-function"/>
<display value="Renal function"/>
</coding>
</code>
<valueRange>
<high>
<value value="50"/>
<unit value="mL/min"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL/min"/>
</high>
</valueRange>
<exclude value="false"/>
</characteristic>
</Group>
</resource>
</entry>
</Bundle>
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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