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-type2-example-acetaminophen

Document Subject

Language: en

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

domain: Human use

status: Active

legalStatusOfSupply: Medicinal product subject to medical prescription

Contacts

-Contact
*Organization Acme Pharma 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

name

productName: WonderDrug 100 mg tablets

part

part: WonderDrug

type: Invented Name Part

part

part: 100 mg

type: Strength part

part

part: tablets

type: Form part

Document Subject

Language: en

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

name

productName: WonderDrug 200 mg tablets

part

part: WonderDrug

type: Invented Name Part

part

part: 200 mg

type: Strength part

part

part: tablets

type: Form part

Document Content

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-type2-example-acme

Resource Organization:

Language: en

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

active: true

type: Marketing authorisation holder

name: Acme Pharma 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-type2-example-acetaminophen

Resource MedicinalProductDefinition:

Language: en

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

domain: Human use

status: Active

legalStatusOfSupply: Medicinal product subject to medical prescription

Contacts

-Contact
*Organization Acme Pharma 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 - 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; legalStatusOfSupply = Medicinal product subject to medical prescription

type: Marketing Authorisation

region: Estonia

holder: Organization Acme Pharma Inc.

Entry 5 - 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; legalStatusOfSupply = Medicinal product subject to medical prescription

packaging

type: Box

quantity: 1

packaging

type: Blister

containedItem

Items

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

amount: 30 Tablet

Entry 6 - 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 7 - 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; legalStatusOfSupply = Medicinal product subject to medical prescription

administrableDoseForm: Tablet

unitOfPresentation: Tablet

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

RouteOfAdministrations

-Code
*Oral use

Entry 8 - 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 9 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-1

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Pregelatinised starch

Entry 10 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-2

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Maize starch

Entry 11 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-3

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Magnesium stearate

Entry 12

Resource MedicinalProductDefinition:

Language: en

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

name

productName: WonderDrug 100 mg tablets

part

part: WonderDrug

type: Invented Name Part

part

part: 100 mg

type: Strength part

part

part: tablets

type: Form part

Entry 13

Resource PackagedProductDefinition:

Language: en

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-100MG

packaging

type: Box

quantity: 1

packaging

type: Blister

quantity: 2

containedItem

Items

-Reference
*​ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg

amount: 60 Tablet

Entry 14

Resource PackagedProductDefinition:

Language: en

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-100MG

packaging

type: Box

quantity: 1

packaging

type: Bottle

containedItem

Items

-Reference
*​ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg

amount: 30 Tablet

Entry 15

Resource MedicinalProductDefinition:

Language: en

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

name

productName: WonderDrug 200 mg tablets

part

part: WonderDrug

type: Invented Name Part

part

part: 200 mg

type: Strength part

part

part: tablets

type: Form part

Entry 16

Resource PackagedProductDefinition:

Language: en

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-200MG

packaging

type: Box

quantity: 1

packaging

type: Blister

quantity: 2

containedItem

Items

-Reference
*​ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg

amount: 20 Tablet

Entry 17

Resource PackagedProductDefinition:

Language: en

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-200MG

packaging

type: Box

quantity: 1

packaging

type: Bottle

containedItem

Items

-Reference
*​ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg

amount: 40 Tablet