European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build

European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: 02 SmPC Code Value Set - TTL Representation

Active as of 2025-04-02

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ValueSet ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "EUepismpcqrdcodesVs"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet EUepismpcqrdcodesVs</b></p><a name=\"EUepismpcqrdcodesVs\"> </a><a name=\"hcEUepismpcqrdcodesVs\"> </a><a name=\"EUepismpcqrdcodesVs-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-200000029659.html\"><code>http://ema.europa.eu/fhir/CodeSystem/200000029659</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-000000000000\">000000000000</a></td><td style=\"color: #cccccc\">Code for custom sub-sections (reserved)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029791\">200000029791</a></td><td style=\"color: #cccccc\">SUMMARY OF PRODUCT CHARACTERISTICS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029792\">200000029792</a></td><td style=\"color: #cccccc\">1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029793\">200000029793</a></td><td style=\"color: #cccccc\">2. QUALITATIVE AND QUANTITATIVE COMPOSITION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029794\">200000029794</a></td><td style=\"color: #cccccc\">2.1 General description</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029795\">200000029795</a></td><td style=\"color: #cccccc\">2.2 Qualitative and quantitative composition</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029796\">200000029796</a></td><td style=\"color: #cccccc\">Excipient(s) with known effect</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029797\">200000029797</a></td><td style=\"color: #cccccc\">3. PHARMACEUTICAL FORM</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029798\">200000029798</a></td><td style=\"color: #cccccc\">4. CLINICAL PARTICULARS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029799\">200000029799</a></td><td style=\"color: #cccccc\">4.1 Therapeutic indications</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029800\">200000029800</a></td><td style=\"color: #cccccc\">4.2 Posology and method of administration</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029801\">200000029801</a></td><td style=\"color: #cccccc\">Posology</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029802\">200000029802</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029803\">200000029803</a></td><td style=\"color: #cccccc\">Method of administration</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029804\">200000029804</a></td><td style=\"color: #cccccc\">Precautions to be taken before handling or administering the medicinal product</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029805\">200000029805</a></td><td style=\"color: #cccccc\">4.3 Contraindications</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029806\">200000029806</a></td><td style=\"color: #cccccc\">4.4 Special warnings and precautions for use</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029807\">200000029807</a></td><td style=\"color: #cccccc\">Traceability</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029808\">200000029808</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029809\">200000029809</a></td><td style=\"color: #cccccc\">4.5 Interaction with other medicinal products and other forms of interaction</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029810\">200000029810</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029811\">200000029811</a></td><td style=\"color: #cccccc\">4.6 Fertility, pregnancy and lactation</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029812\">200000029812</a></td><td style=\"color: #cccccc\">Pregnancy</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029813\">200000029813</a></td><td style=\"color: #cccccc\">Breast-feeding</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029814\">200000029814</a></td><td style=\"color: #cccccc\">Fertility</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029815\">200000029815</a></td><td style=\"color: #cccccc\">4.7 Effects on ability to drive and use machines</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029816\">200000029816</a></td><td style=\"color: #cccccc\">4.8 Undesirable effects</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029817\">200000029817</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029818\">200000029818</a></td><td style=\"color: #cccccc\">Reporting of suspected adverse reactions</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029819\">200000029819</a></td><td style=\"color: #cccccc\">4.9 Overdose</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029820\">200000029820</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029821\">200000029821</a></td><td style=\"color: #cccccc\">5. PHARMACOLOGICAL PROPERTIES</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029822\">200000029822</a></td><td style=\"color: #cccccc\">5.1 Pharmacodynamic properties</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029823\">200000029823</a></td><td style=\"color: #cccccc\">Mechanism of action</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029824\">200000029824</a></td><td style=\"color: #cccccc\">Pharmacodynamic effects</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029825\">200000029825</a></td><td style=\"color: #cccccc\">Clinical efficacy and safety</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029826\">200000029826</a></td><td style=\"color: #cccccc\">Paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029827\">200000029827</a></td><td style=\"color: #cccccc\">5.2 Pharmacokinetic properties</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029828\">200000029828</a></td><td style=\"color: #cccccc\">Absorption</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029829\">200000029829</a></td><td style=\"color: #cccccc\">Distribution</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029830\">200000029830</a></td><td style=\"color: #cccccc\">Biotransformation</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029831\">200000029831</a></td><td style=\"color: #cccccc\">Elimination</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029832\">200000029832</a></td><td style=\"color: #cccccc\">Linearity/non-linearity</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029833\">200000029833</a></td><td style=\"color: #cccccc\">Pharmacokinetic/pharmacodynamic relationship(s)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029834\">200000029834</a></td><td style=\"color: #cccccc\">5.3 Preclinical safety data</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029835\">200000029835</a></td><td style=\"color: #cccccc\">Environmental risk assessment (ERA)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029836\">200000029836</a></td><td style=\"color: #cccccc\">6. PHARMACEUTICAL PARTICULARS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029837\">200000029837</a></td><td style=\"color: #cccccc\">6.1 List of excipients</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029838\">200000029838</a></td><td style=\"color: #cccccc\">6.2 Incompatibilities</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029839\">200000029839</a></td><td style=\"color: #cccccc\">6.3 Shelf life</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029840\">200000029840</a></td><td style=\"color: #cccccc\">6.4 Special precautions for storage</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029841\">200000029841</a></td><td style=\"color: #cccccc\">6.5 Nature and contents of container [and special equipment for use, administration or implantation]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029842\">200000029842</a></td><td style=\"color: #cccccc\">6.6 Special precautions for disposal [and other handling]</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029843\">200000029843</a></td><td style=\"color: #cccccc\">Use in the paediatric population</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029844\">200000029844</a></td><td style=\"color: #cccccc\">7. MARKETING AUTHORISATION HOLDER</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029845\">200000029845</a></td><td style=\"color: #cccccc\">8. MARKETING AUTHORISATION NUMBER(S)</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029846\">200000029846</a></td><td style=\"color: #cccccc\">9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029847\">200000029847</a></td><td style=\"color: #cccccc\">10. DATE OF REVISION OF THE TEXT</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029848\">200000029848</a></td><td style=\"color: #cccccc\">11. DOSIMETRY</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000029849\">200000029849</a></td><td style=\"color: #cccccc\">12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000044333\">200000044333</a></td><td style=\"color: #cccccc\">Level=H4 SmPC custom subsection</td></tr><tr><td><a href=\"CodeSystem-200000029659.html#200000029659-200000044347\">200000044347</a></td><td style=\"color: #cccccc\">Level=H5 SmPC custom subsection</td></tr></table></li></ul></div>"
  ] ; # 
  fhir:url [ fhir:v "http://ema.europa.eu/fhir/ValueSet/EUepismpcqrdcodesVs"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "1.0.0"] ; # 
  fhir:name [ fhir:v "EUepismpcqrdcodesVs"] ; # 
  fhir:title [ fhir:v "02 SmPC Code Value Set"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2025-04-02T11:27:42+01:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "European Medicines Agency"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "European Medicines Agency" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://ema.europa.eu/fhir" ]     ] )
  ] [
fhir:name [ fhir:v "FHIR at EMA" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://ema.europa.eu/fhir" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "List of section codes allowed in SmPC documents, defined in EMA's Referentials Management Service."] ; # 
  fhir:compose [
    ( fhir:include [
fhir:system [ fhir:v "http://ema.europa.eu/fhir/CodeSystem/200000029659"^^xsd:anyURI ] ;
      ( fhir:concept [
fhir:code [ fhir:v "000000000000" ]       ] [
fhir:code [ fhir:v "200000029791" ]       ] [
fhir:code [ fhir:v "200000029792" ]       ] [
fhir:code [ fhir:v "200000029793" ]       ] [
fhir:code [ fhir:v "200000029794" ]       ] [
fhir:code [ fhir:v "200000029795" ]       ] [
fhir:code [ fhir:v "200000029796" ]       ] [
fhir:code [ fhir:v "200000029797" ]       ] [
fhir:code [ fhir:v "200000029798" ]       ] [
fhir:code [ fhir:v "200000029799" ]       ] [
fhir:code [ fhir:v "200000029800" ]       ] [
fhir:code [ fhir:v "200000029801" ]       ] [
fhir:code [ fhir:v "200000029802" ]       ] [
fhir:code [ fhir:v "200000029803" ]       ] [
fhir:code [ fhir:v "200000029804" ]       ] [
fhir:code [ fhir:v "200000029805" ]       ] [
fhir:code [ fhir:v "200000029806" ]       ] [
fhir:code [ fhir:v "200000029807" ]       ] [
fhir:code [ fhir:v "200000029808" ]       ] [
fhir:code [ fhir:v "200000029809" ]       ] [
fhir:code [ fhir:v "200000029810" ]       ] [
fhir:code [ fhir:v "200000029811" ]       ] [
fhir:code [ fhir:v "200000029812" ]       ] [
fhir:code [ fhir:v "200000029813" ]       ] [
fhir:code [ fhir:v "200000029814" ]       ] [
fhir:code [ fhir:v "200000029815" ]       ] [
fhir:code [ fhir:v "200000029816" ]       ] [
fhir:code [ fhir:v "200000029817" ]       ] [
fhir:code [ fhir:v "200000029818" ]       ] [
fhir:code [ fhir:v "200000029819" ]       ] [
fhir:code [ fhir:v "200000029820" ]       ] [
fhir:code [ fhir:v "200000029821" ]       ] [
fhir:code [ fhir:v "200000029822" ]       ] [
fhir:code [ fhir:v "200000029823" ]       ] [
fhir:code [ fhir:v "200000029824" ]       ] [
fhir:code [ fhir:v "200000029825" ]       ] [
fhir:code [ fhir:v "200000029826" ]       ] [
fhir:code [ fhir:v "200000029827" ]       ] [
fhir:code [ fhir:v "200000029828" ]       ] [
fhir:code [ fhir:v "200000029829" ]       ] [
fhir:code [ fhir:v "200000029830" ]       ] [
fhir:code [ fhir:v "200000029831" ]       ] [
fhir:code [ fhir:v "200000029832" ]       ] [
fhir:code [ fhir:v "200000029833" ]       ] [
fhir:code [ fhir:v "200000029834" ]       ] [
fhir:code [ fhir:v "200000029835" ]       ] [
fhir:code [ fhir:v "200000029836" ]       ] [
fhir:code [ fhir:v "200000029837" ]       ] [
fhir:code [ fhir:v "200000029838" ]       ] [
fhir:code [ fhir:v "200000029839" ]       ] [
fhir:code [ fhir:v "200000029840" ]       ] [
fhir:code [ fhir:v "200000029841" ]       ] [
fhir:code [ fhir:v "200000029842" ]       ] [
fhir:code [ fhir:v "200000029843" ]       ] [
fhir:code [ fhir:v "200000029844" ]       ] [
fhir:code [ fhir:v "200000029845" ]       ] [
fhir:code [ fhir:v "200000029846" ]       ] [
fhir:code [ fhir:v "200000029847" ]       ] [
fhir:code [ fhir:v "200000029848" ]       ] [
fhir:code [ fhir:v "200000029849" ]       ] [
fhir:code [ fhir:v "200000044333" ]       ] [
fhir:code [ fhir:v "200000044347" ]       ] )     ] )
  ] . #