Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
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 |
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) |
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) |
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 |
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 |