Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. 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

Example Bundle: bundle-epi-type3-example-wonderdrug

Document Subject

Language: en

identifier: http://ema.europa.eu/identifier/WONDERDRUG-500MG

domain: Human use

status: Active

Contacts

-Contact
*Organization WonderPharma Inc.

name

productName: WonderDrug 500 mg tablets

part

part: WonderDrug

type: Invented Name Part

part

part: 500 mg

type: Strength part

part

part: tablets

type: Form part

Usages

-CountryLanguage
*EstoniaEstonian

Document Subject

Language: en

identifier: http://ema.europa.eu/identifier/WONDERDRUG-100MG

Names

-ProductName
*WonderDrug 100 mg tablets

Document Subject

Language: en

identifier: http://ema.europa.eu/identifier/WONDERDRUG-200MG

Names

-ProductName
*WonderDrug 200 mg tablets

Document Content

Clinical Particulars

1. What is in this leaflet

1. What is in this leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Additional Resources Included in Document

Entry 2 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type3-example-pharma

Resource Organization:

Language: en

identifier: https://spor.ema.europa.eu/omswi/LOC-100000000

active: true

type: Marketing authorisation holder

name: WonderPharma Inc.

Contacts

-Address
*123 Pharma Way, 102 37 Prague 10, Czech Republic

Entry 3 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug

Resource MedicinalProductDefinition:

Language: en

identifier: http://ema.europa.eu/identifier/WONDERDRUG-500MG

domain: Human use

status: Active

Contacts

-Contact
*Organization WonderPharma Inc.

name

productName: WonderDrug 500 mg tablets

part

part: WonderDrug

type: Invented Name Part

part

part: 500 mg

type: Strength part

part

part: tablets

type: Form part

Usages

-CountryLanguage
*EstoniaEstonian

Entry 4

Resource MedicinalProductDefinition:

Language: en

identifier: http://ema.europa.eu/identifier/WONDERDRUG-100MG

Names

-ProductName
*WonderDrug 100 mg tablets

Entry 5

Resource MedicinalProductDefinition:

Language: en

identifier: http://ema.europa.eu/identifier/WONDERDRUG-200MG

Names

-ProductName
*WonderDrug 200 mg tablets

Entry 6

Resource ClinicalUseDefinition:

type: Indication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

indication

DiseaseSymptomProcedures

-Concept
*Fever

Entry 7

Resource ClinicalUseDefinition:

type: Indication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

indication

DiseaseSymptomProcedures

-Concept
*Pain

Entry 8

Resource ClinicalUseDefinition:

type: Contraindication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

contraindication

DiseaseSymptomProcedures

-Concept
*Severe hepatic insufficiency

Entry 9

Resource ClinicalUseDefinition:

type: Contraindication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

contraindication

otherTherapy

Treatments

-Concept
*Medicinal product containing paracetamol

Entry 10

Resource ClinicalUseDefinition:

type: Interaction

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

interaction

Interactants

-Item[x]
*Warfarin

Effects

-Concept
*Enhanced anticoagulant effect

Entry 11

Resource ClinicalUseDefinition:

type: Interaction

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

interaction

Interactants

-Item[x]
*Chloramphenicol

Entry 12

Resource ClinicalUseDefinition:

type: Undesirable Effect

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

undesirableEffect

SymptomConditionEffects

-Concept
*Thrombocytopenia

Entry 13

Resource ClinicalUseDefinition:

type: Undesirable Effect

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

undesirableEffect

SymptomConditionEffects

-Concept
*Diarrhea

Entry 14

Resource ClinicalUseDefinition:

type: Warning

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

Warnings

-Description
*

Do not exceed the stated dose.

Entry 15

Resource ClinicalUseDefinition:

type: Warning

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

Warnings

-Description
*

Keep out of the sight and reach of children.

Entry 16 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/RegulatedAuthorization/ra-epi-type2-example-acetaminophen

Resource RegulatedAuthorization:

Language: en

identifier: http://ema.europa.eu/identifier/MA-123456789

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

type: Marketing Authorisation

region: Estonia

holder: Organization WonderPharma Inc.

Entry 17 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/PackagedProductDefinition/ppd-epi-type2-example-acetaminophen

Resource PackagedProductDefinition:

Language: en

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

packaging

type: Box

quantity: 1

packaging

type: Blister

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

amount: 30 Tablet

Entry 18 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen

Resource ManufacturedItemDefinition:

Language: en

status: Active

manufacturedDoseForm: Tablet

unitOfPresentation: Tablet

Properties

-TypeValue[x]
*colourWhite

Entry 19 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/AdministrableProductDefinition/apd-epi-type2-example-acetaminophen

Resource AdministrableProductDefinition:

Language: en

status: Active

formOf: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

administrableDoseForm: Tablet

unitOfPresentation: Tablet

producedFrom: ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

RouteOfAdministrations

-Code
*Oral use

Entry 20 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-active

Resource Ingredient:

Language: en

status: Active

for:

role: Active

substance

Codes

-Concept
*Paracetamol

Strengths

-Presentation[x]
*500 mg (Details: UCUM codemg = 'mg')/1 tablet (Details: unit-of-presentation codetablet = 'tablet')

Entry 21

Resource MedicationKnowledge:

Language: en

Profile: MedicationKnowledge (ePI)

code: Paracetamol

status: Active

indicationGuideline

dosingGuideline

treatmentIntent: Fever

dosage

Dosages

-Text
*1 tablet every 4 to 6 hours