Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Table of Contents

...0 Table of Contents
...1 Home
...2 Use Case
...3 Steps to create ePI Type 1
...4 Steps to create ePI Type 2
...5 Steps to create ePI Type 3
...6 Best Practice
...7 Downloads
...8 Credits
....9 Artifacts Summary
....9.1 AdministrableProductDefinition (ePI)
....9.2 Bundle - ePI
....9.3 ClinicalUseDefinition Contraindication (ePI)
....9.4 ClinicalUseDefinition Indication (ePI)
....9.5 ClinicalUseDefinition Interaction (ePI)
....9.6 ClinicalUseDefinition Undesirable Effect (ePI)
....9.7 ClinicalUseDefinition Warning (ePI)
....9.8 Composition (ePI)
....9.9 Ingredient (ePI)
....9.10 ManufacturedItemDefinition (ePI)
....9.11 MedicinalProductDefinition (ePI)
....9.12 Organization (ePI)
....9.13 PackagedProductDefinition (ePI)
....9.14 RegulatedAuthorization (ePI)
....9.15 SubstanceDefinition (ePI)
....9.16 Administrable Pharmaceutical Dose Form
....9.17 Color of the product
....9.18 Dose Form
....9.19 ePI document types
....9.20 Flavor of the product
....9.21 Ingredient Role
....9.22 ISO Country two letter code
....9.23 Manufactured Dose Form
....9.24 MedDRA Terms for clinical diseases and symptoms
....9.25 Route Of Administration
....9.26 Section Codes
....9.27 Shape of the product
....9.28 Substances
....9.29 Units of Presentation
....9.30 WHO ATC
....9.31 eMedicinal Product Information Code System
....9.32 Administrable Product for DrugX 75 mg tablets
....9.33 Clinical Use - Contraindication
....9.34 Clinical Use - Indication
....9.35 Clinical Use - Interaction
....9.36 Clinical Use - Undesirable Effect
....9.37 Clinical Use - Warning
....9.38 ePI Bundle Type 1 - DrugX Package Insert
....9.39 ePI Bundle Type 2 - DrugX Package Insert
....9.40 ePI Bundle Type 3 - DrugX Package Insert
....9.41 Ingredient - acetaminophen
....9.42 Ingredient - Carnauba wax
....9.43 Ingredient - Croscarmellose sodium
....9.44 Ingredient - Hypromellose
....9.45 Ingredient - Lactose Monohydrate
....9.46 Ingredient - Macrogol 3000
....9.47 Ingredient - Magnesium stearate
....9.48 Ingredient - Microcrystalline cellulose
....9.49 Ingredient - Silicon dioxide
....9.50 Ingredient - Titanium Dioxide
....9.51 Manufactured Item - 75 mg tablet
....9.52 Medicinal Product DrugX 75 tablet in a blister of x28 tablets
....9.53 Organization - Acme Inc.
....9.54 Package Leaflet with a medicinal product
....9.55 Package Leaflet without a medicinal product
....9.56 Packaging - Blister
....9.57 Regulated Authorization for the 75 mg tablet
....9.58 Substance - acetaminophen