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: ePI Bundle Type 3 - DrugX Package Insert

Document Subject

identifier: http://example.org/sid/product/medicinalproduct75

type: Medicinal Product

domain: Human use

status: Active

statusDate: 2018-06-23 08:38:00+0200

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: DrugX

Parts

-PartType
*tabletInvented name part

Usages

-CountryJurisdictionLanguage
*FranceFranceEnglish

Document Content

B. Package Leaflet

Package leaflet: Information for the user

DrugX 75 mg tablets

acetaminophen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  • What DrugX is and what it is used for
  • What you need to know before you take DrugX
  • How to take DrugX
  • Possible side effects
  • How to store DrugX
  • Contents of the pack and other information

1. What DrugX is and what it is used for

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

2. What you need to know before you take DrugX

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

3. How to take DrugX

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

4. Possible side effects

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

5. How to store DrugX

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

6. Contents of the pack and other information

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:d71bf884-90eb-47f9-81b7-fa81ecec7e75

Resource Organization:

identifier: http://example.org/sid/org/ORG1 (use: official, )

active: true

type: Marketing authorisation holder

name: acme inc

Contacts

-Address
*54, Yonge Street, Paris, France(work)

Entry 3 - fullUrl = urn:uuid:297e405a-b6f9-4273-bc01-ae031efe47f8

Resource RegulatedAuthorization:

identifier: http://example.org/sid/product/authorization75mg (use: official, )

subject: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

type: Marketing Authorization

region: European Union

status: Active

statusDate: 2015-02-07 13:28:17+0000

holder: Organization acme inc

Entry 4 - fullUrl = urn:uuid:800a51a2-d81d-49a4-a4eb-f2417d301837

Resource MedicinalProductDefinition:

identifier: http://example.org/sid/product/medicinalproduct75

type: Medicinal Product

domain: Human use

status: Active

statusDate: 2018-06-23 08:38:00+0200

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: DrugX

Parts

-PartType
*tabletInvented name part

Usages

-CountryJurisdictionLanguage
*FranceFranceEnglish

Entry 5 - fullUrl = urn:uuid:eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d

Resource PackagedProductDefinition:

identifier: http://example.org/sid/product/EU/1/97/049/001 (use: official, )

name: DrugX 75 mg tablet blister x28 tablets

type: Medicinal Product

packageFor: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

status: Active

statusDate: 2018-06-23 08:38:00+0200

containedItemQuantity: 75 mg

manufacturer: Organization acme inc

Packagings

-IdentifierTypeQuantityMaterial
*http://example.org/sid/product/123456Blister28PolyVinyl Chloride

Entry 6 - fullUrl = urn:uuid:373b9bf3-1fae-47a1-a7cd-230106def069

Resource AdministrableProductDefinition:

identifier: https://www.who-umc.org/phpid/DrugXphpidplaceholder

status: Active

formOf: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

administrableDoseForm: Tablet

unitOfPresentation: Tablet

producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

RouteOfAdministrations

-Code
*Oral route

Entry 7 - fullUrl = urn:uuid:3214f286-b8ec-4ef5-bc8d-0aec39d97468

Resource ManufacturedItemDefinition:

identifier: https://spor.ema.europa.eu/pmswi/#//EU/1/96/007/035 (use: official, )

status: Active

manufacturedDoseForm: Tablet

unitOfPresentation: Tablet

manufacturer: Organization acme inc

Entry 8 - fullUrl = urn:uuid:745c01bc-936e-45ca-9880-57e97608f43e

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/362O9ITL9D (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Active

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*acetaminophen

Strengths

-Presentation[x]Basis
*75 mgactive ingredient - basis of strength

Entry 9 - fullUrl = urn:uuid:09c13040-8fd5-4818-972d-f01d4ee169b6

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/ETJ7Z6XBU4 (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Silicon dioxide

Entry 10 - fullUrl = urn:uuid:a4b7b60c-998f-4f93-89c7-860396af0fe3

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/R12CBM0EIZ (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Carnauba wax

Entry 11 - fullUrl = urn:uuid:fbf58407-83d3-42db-be3d-506b2006d431

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/M28OL1HH48 (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Croscarmellose sodium

Entry 12 - fullUrl = urn:uuid:1c10b441-6bd3-40b8-b14b-514e7c2f79d0

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/3NXW29V3WO (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Hypromellose

Entry 13 - fullUrl = urn:uuid:7a3c0b14-2473-4541-9e45-a24d24cceddf

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/EWQ57Q8I5X (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Lactose Monohydrate

Entry 14 - fullUrl = urn:uuid:ceba5cd1-321f-4bc3-b203-92d97fcf472e

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/SA1B764746 (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Macrogol 3000

Entry 15 - fullUrl = urn:uuid:eee155e8-e442-491d-9a82-7af3cefac57f

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/70097M6I30 (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Magnesium stearate

Entry 16 - fullUrl = urn:uuid:1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/OP1R32D61U (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Microcrystalline cellulose

Entry 17 - fullUrl = urn:uuid:a88891dc-7e9e-4d84-b462-95e53de3b6a6

Resource Ingredient:

identifier: Unique Ingredient Identifier (UNII)/15FIX9V2JP (use: official, )

status: Active

for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

Manufacturers

-Manufacturer
*Organization acme inc

substance

Codes

-Concept
*Titanium Dioxide

Entry 18 - fullUrl = urn:uuid:83f4a22f-9e5e-4941-9fdb-339a0f1f2055

Resource ClinicalUseDefinition:

identifier: http://example.org/sid/contra-example-1

type: Contraindication

subject: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

contraindication

DiseaseSymptomProcedures

-Concept
*Gastrointestinal disorders

Entry 19 - fullUrl = urn:uuid:bac1d528-6430-4310-bde6-b8b3471ce35a

Resource ClinicalUseDefinition:

identifier: http://example.org/sid/indication-example-1

type: Indication

subject: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

indication

DiseaseSymptomProcedures

-Concept
*Psoriasis

Entry 20 - fullUrl = urn:uuid:e60575aa-e7b3-4461-a456-d310514f4041

Resource ClinicalUseDefinition:

identifier: Unique Ingredient Identifier (UNII)/YL5FZ2Y5U1 (use: official, )

type: Interaction

subject: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

interaction

Interactants

-Item[x]
*METHOTREXATE

Entry 21 - fullUrl = urn:uuid:4312f8ec-43b6-4b25-9fca-d61a1188bfea

Resource ClinicalUseDefinition:

identifier: Unique Ingredient Identifier (UNII)/YL5FZ2Y5U1 (use: official, )

type: Undesirable Effect

subject: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

undesirableEffect

SymptomConditionEffects

-Concept
*Dysergia

frequencyOfOccurrence: Rare

Entry 22 - fullUrl = urn:uuid:ac21a804-cafa-41ff-b644-a14c8003edeb

Resource ClinicalUseDefinition:

identifier: http://example.org/sid/warning-example-1

type: Warning

subject: MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription

Warnings

-Description
*

Symptomatic hypotension, especially after the first dose, may occur in patients.

Entry 23 - fullUrl = urn:uuid:da33bd51-a726-4232-aaa0-4168b9bfe249

Resource SubstanceDefinition:

identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/362O9ITL9D (use: official, )

version: 1

status: Active

description:

White to off-white, biconvex, and oval-shaped with the number 1234 engraved on the other side.

manufacturer: Organization acme inc

MolecularWeights

-TypeAmount
*exact151.6

Structures

-MolecularFormula
*C8H9NO2

Names

-NameType
*acetaminophenScientific