Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Behavior: Operation Definitions

These are custom operations that can be supported by and/or invoked by systems conforming to this implementation guide

calculate

This operation calculates an enhanced version of an ePI as well as

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide

AdministrableProductDefinition (ePI)

AdministrableProductDefinition (ePI)

Bundle - ePI

A medicine’s product information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs consumers about its safe and effective use. This profile represents the constraints applied to the Bundle resource used in the Electronic Product Information (ePI) FHIR Implementation Guide.

ClinicalUseDefinition Contraindication (ePI)

ClinicalUseDefinition Contraindication (ePI)

ClinicalUseDefinition Indication (ePI)

ClinicalUseDefinition Indication (ePI)

ClinicalUseDefinition Interaction (ePI)

ClinicalUseDefinition Interaction (ePI)

ClinicalUseDefinition Undesirable Effect (ePI)

ClinicalUseDefinition Undesirable Effect (ePI)

ClinicalUseDefinition Warning (ePI)

ClinicalUseDefinition Warning (ePI)

Composition (ePI)

The Composition captures the section headings, sub-section headings, and narrative text (For example, paragraphs, bulleted lists, tables) in an ePI.

Ingredient (ePI)

Ingredient (ePI)

List - ePI

This profile represents the constraints applied to the List resource by the Electronic Product Information (ePI) FHIR Implementation Guide.

ManufacturedItemDefinition (ePI)

ManufacturedItemDefinition (ePI)

MedicinalProductDefinition (ePI)

MedicinalProductDefinition (ePI)

Organization (ePI)

Organization (ePI)

PackagedProductDefinition (ePI)

PackagedProductDefinition (ePI)

RegulatedAuthorization (ePI)

RegulatedAuthorization (ePI)

SubstanceDefinition (ePI)

SubstanceDefinition (ePI)

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide

AdministrableProductDefinition identifier systems

AdministrableProductDefinition Identifier systems (uri)

ePI document types

ePI document types

ManufacturedItemDefinition identifier systems

ManufacturedItemDefinition Identifier systems (uri)

MedicinalProductDefinition identifier systems

MedicinalProductDefinition Identifier systems (uri)

Organization identifier systems

Organization Identifier systems (uri)

PackagedProductDefinition identifier systems

PackagedProductDefinition Identifier systems (uri)

RegulatedAuthorization identifier systems

RegulatedAuthorization Identifier systems (uri)

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide

Gravitate Health Project Code System

Gravitate Health Project Code System. Coded concepts defined for internal project use.

Organization Management Services CodeSystem

Items from https://spor.ema.europa.eu/omswi

Products Management Services CodeSystem

Items from https://spor.ema.europa.eu/pmswi

Referentials Management Services CodeSystem

Items from https://spor.ema.europa.eu/rmswi

Substances Management Services CodeSystem

Items from https://spor.ema.europa.eu/smswi

EMA example-sections-pl

Placeholder for EMA example-sections PL

EMA example-sections-smpc

Placeholder for EMA example-sections smpc

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like

0c81c330-cf57-45c2-9ca2-559aea4c8060

POLYETHYLENE GLYCOL 6000

16dc4148-5296-4f7a-8576-2e6bf9dde736

SILICON DIOXIDE

17c536c9-efd1-4427-a7b0-1bcdc266798f

exemestane-sub

23fed712-2d60-461d-83a6-5fb939b2a939

Manufactured Item - Aromasin (exemestane) Tablets 25 mg

32e98fc8-b8fb-4bd9-a4d3-2ce97c151d61

microcrystalline cellulose

363cbf4a-9c4d-442a-af67-b72a1225ca28

Package Leaflet

39151aef-f61a-40cb-86fc-d0e556fa07ef

30 in 1 BOTTLE; Type 0: Not a Combination Product

Vulcan Monuril FHIR Package Insert

instance of Monuril package insert for connectathon testing

56b3b73e-dba0-4447-b8cd-1e24ed637017

Regulated Authorization

5a574ff2-f3e6-4aaa-8d3c-27e6ab343533

EXEMESTANE

5acc6759-a7f7-4380-ab2e-ad72e8587598

MAGNESIUM STEARATE

5f2c1669-3991-4cc2-b252-958b738d5df8

METHYLPARABEN

6708560e-135d-4b2a-afde-9e3b03f27939

POLYSORBATE 80

733fb580-1139-4188-aff8-ad6efe243555

POLYVINYL ALCOHOL, UNSPECIFIED

7b23dea1-ce14-4c13-8004-f297bb75eda0

MANNITOL

854be59d-070a-44d7-a82e-bbb83200dc6a

TITANIUM DIOXIDE

85c5d81e-9d5a-4a15-8b9d-42bbbe0409c8

Marketing Authorization Holder

8cf05f7c-481d-4bd6-9a7c-9ca3275601c3

Aromasin (exemestane) Tablets 25 mg

b254f961-61ca-43f9-b3f9-5b0b5d4406a9

SODIUM STARCH GLYCOLATE TYPE A POTATO

c5a3cb57-3f3e-4309-ae34-0926300de57e

SUCROSE

cc5753cd-e648-47d2-a135-503cd8a3e1da

HYPROMELLOSE, UNSPECIFIED

cfsb1639753766266

Manufacturer

cfsb1639754108144

Market Authorization Holder

cfsb1639754408039

fosfomycin trometamol 3g

cfsb1639756818482

Monuril Granules for oral solution

cfsb1639758328687

Monuril 5 sachets of 8 g of granules (3 g fosfomycin)

cfsb1639760186202

Medicinal Product

cfsb1639760977050

Administrable Product

cfsb1639761980721

Regulated Authorization

cfsb1639762372321

Saccharin

cfsb1639762372322

Orange flavour

cfsb1639762372323

Mandarin flavour

cfsb1639762593730

Sucrose

cfsb1639764389611

Packaged Product - 2 sachets of 8 g of granules

cfsb1639764389612

Packaged Product - 1 sachet of 8 g of granules

cfsb1639991356428

Package Leaflet

cfsb1650904258324

EU/1/19/1370/001 Dovato 50 mg/300 mg film-coated tablets

cfsb1650995718524

50 mg/300 mg film-coated tablets

cfsb1650997423990

Manufacturer

cfsb1650998521654

Manufactured Item: Dovato 50 mg/300 mg film-coated tablets

cfsb1650999516847

Dovato 50 mg/300 mg film-coated tablets

cfsb1651148079894

Regulated authorization

cfsb1651149636159

Marketing Authorization Holder

cfsb1651152112409

Regulator

cfsb1651162710491

dolutegravir

cfsb1651164758053

lamivudine

cfsb1651170791283

microcrystalline cellulose

cfsb1651229974487

sodium starch glycolate

cfsb1651230170831

magnesium stearate

cfsb1651230330246

mannitol

cfsb1651231019151

Package Leaflet

cfsb1651234995610

Prospecto Dovato 50 mg/300 mg comprimidos recubiertos con película

Vulcan Dovato FHIR Package Insert EMA

English Instance of Dovato package insert for Connectathon testing

Vulcan Dovato FHIR Package Insert EMA ESP

Spanish Instance of Dovato package insert for Connectathon testing

db5e392b-e7b2-47dc-829c-ee5182986dca

MAGNESIUM CARBONATE

f1b25777-da7a-4a35-98af-ab18d3246d54

Aromasin (exemestane) Tablets 25 mg

Vulcan FHIR USA Patient Package Insert Test - Aromasin (exemestane) Tablets 25 mg

Instance of exemestane tablets JPI for Connectathon testing

f35c1543-e4e2-4215-b91c-f092b1fb9655

microcrystalline cellulose