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
Document Details
version: 1.0; Last updated: 2026-06-17 10:00:00+0000; Language: en
Profile: Bundle - ePI Type 3
Final Document at 2026-06-17 by Organization Example Pharma Ltd. for MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#DIFLUCAN-150MG; status = Active
Document Subject
Language: en
Profile: MedicinalProductDefinition (ePI)
identifier: http://ema.europa.eu/identifier/DIFLUCAN-150MG
status: Active
| ProductName |
| Diflucan 150 mg capsule |
Document Content
Diflucan Summary of Product Characteristics
Treatment of mucosal and invasive candidiasis.
Dose depends on the indication and the patient population (see structured dosing). Renal impairment requires dose adjustment for multiple-dose therapy.
Entry 2 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-diflucan
Resource Organization:
Language: en
Profile: Organization (ePI)
identifier:
https://spor.ema.europa.eu/omswi/LOC-100000999active: true
name: Example Pharma Ltd.
Entry 3 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-diflucan
Resource MedicinalProductDefinition:
Language: en
Profile: MedicinalProductDefinition (ePI)
identifier:
http://ema.europa.eu/identifier/DIFLUCAN-150MGstatus: Active
Names
ProductName Diflucan 150 mg capsule
Entry 4 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicationKnowledge/mk-diflucan
Resource MedicationKnowledge:
Language: en
Profile: MedicationKnowledge (ePI)
identifier:
http://example.org/identifier/mk-diflucanstatus: Active
indicationGuideline
Indications
Reference ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-mucosal; type = indication; category = Indication; status = Active dosingGuideline
dosage
type: Loading dose (Day 1)
dosage
sequence: 1
text: 200 to 400 mg on Day 1
DoseAndRates
Dose[x] 200-400 mg dosage
type: Maintenance
dosage
sequence: 2
text: 100 to 200 mg once daily for 7 to 21 days
timing: Once per 1 day
DoseAndRates
Dose[x] 100-200 mg PatientCharacteristics
Type Value[x] Age 18-? years dosingGuideline
dosage
type: Initial dose
dosage
sequence: 1
text: 6 mg/kg on the first day
DoseAndRates
Dose[x] 6 mg/kg (Details: UCUM codemg/kg = 'mg/kg') dosage
type: Subsequent dose
dosage
sequence: 2
text: 3 mg/kg once daily
timing: Once per 1 day
DoseAndRates
Dose[x] 3 mg/kg (Details: UCUM codemg/kg = 'mg/kg') PatientCharacteristics
Type Value[x] Age 28-11 days dosingGuideline
dosage
type: Neonatal dose
dosage
sequence: 1
text: 3 mg/kg every 72 hours (max 12 mg/kg every 72 hours)
timing: Once per 72 hours
DoseAndRates
Dose[x] 3 mg/kg (Details: UCUM codemg/kg = 'mg/kg') maxDosePerPeriod: 12 mg/kg (Details: UCUM codemg/kg = 'mg/kg')/72 hours (Details: UCUM codeh = 'h')
PatientCharacteristics
Type Value[x] Age 0-14 days indicationGuideline
Indications
Reference ClinicalUseDefinition: identifier = http://example.org/identifier#cud-diflucan-invasive; type = indication; category = Indication; status = Active dosingGuideline
dosage
type: Loading dose (Day 1)
dosage
sequence: 1
text: 800 mg on Day 1
DoseAndRates
Dose[x] 800 mg (Details: UCUM codemg = 'mg') dosage
type: Maintenance
dosage
sequence: 2
text: 400 mg once daily
timing: Once per 1 day
DoseAndRates
Dose[x] 400 mg (Details: UCUM codemg = 'mg')
Entry 5 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-mucosal
Resource ClinicalUseDefinition:
Language: en
identifier:
http://example.org/identifier/cud-diflucan-mucosaltype: Indication
category: Indication
status: Active
indication
DiseaseSymptomProcedures
Concept Candidiasis of mouth
Entry 6 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-invasive
Resource ClinicalUseDefinition:
Language: en
identifier:
http://example.org/identifier/cud-diflucan-invasivetype: Indication
category: Indication
status: Active
indication
DiseaseSymptomProcedures
Concept Invasive candidiasis population: Adults
Entry 7 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-diflucan-renal
Resource ClinicalUseDefinition:
Language: en
Profile: ClinicalUseDefinition Warning (ePI)
identifier:
http://example.org/identifier/cud-diflucan-renaltype: Warning
category: Warning
status: Active
population: Renal impairment (CrCl ≤ 50 mL/min)
Warnings
Code 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.
Entry 8 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-adult
Resource Group:
Language: en
Profile: Group (ePI)
type: Person
membership: Definitional
name: Adults
Characteristics
Code Value[x] Exclude Age 18-? years false
Entry 9 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Group/group-diflucan-renal
Resource Group:
Language: en
Profile: Group (ePI)
type: Person
membership: Definitional
name: Renal impairment (CrCl ≤ 50 mL/min)
Characteristics
Code Value[x] Exclude Renal function ?-50 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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change