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
| Active as of 2025-04-02 |
{
"resourceType" : "ValueSet",
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"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>"
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"url" : "http://ema.europa.eu/fhir/ValueSet/EUepismpcqrdcodesVs",
"version" : "1.0.0",
"name" : "EUepismpcqrdcodesVs",
"title" : "02 SmPC Code Value Set",
"status" : "active",
"experimental" : false,
"date" : "2025-04-02T11:27:42+01:00",
"publisher" : "European Medicines Agency",
"contact" : [
{
"name" : "European Medicines Agency",
"telecom" : [
{
"system" : "url",
"value" : "https://ema.europa.eu/fhir"
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]
},
{
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"telecom" : [
{
"system" : "url",
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}
],
"description" : "List of section codes allowed in SmPC documents, defined in EMA's Referentials Management Service.",
"compose" : {
"include" : [
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"concept" : [
{
"code" : "000000000000"
},
{
"code" : "200000029791"
},
{
"code" : "200000029792"
},
{
"code" : "200000029793"
},
{
"code" : "200000029794"
},
{
"code" : "200000029795"
},
{
"code" : "200000029796"
},
{
"code" : "200000029797"
},
{
"code" : "200000029798"
},
{
"code" : "200000029799"
},
{
"code" : "200000029800"
},
{
"code" : "200000029801"
},
{
"code" : "200000029802"
},
{
"code" : "200000029803"
},
{
"code" : "200000029804"
},
{
"code" : "200000029805"
},
{
"code" : "200000029806"
},
{
"code" : "200000029807"
},
{
"code" : "200000029808"
},
{
"code" : "200000029809"
},
{
"code" : "200000029810"
},
{
"code" : "200000029811"
},
{
"code" : "200000029812"
},
{
"code" : "200000029813"
},
{
"code" : "200000029814"
},
{
"code" : "200000029815"
},
{
"code" : "200000029816"
},
{
"code" : "200000029817"
},
{
"code" : "200000029818"
},
{
"code" : "200000029819"
},
{
"code" : "200000029820"
},
{
"code" : "200000029821"
},
{
"code" : "200000029822"
},
{
"code" : "200000029823"
},
{
"code" : "200000029824"
},
{
"code" : "200000029825"
},
{
"code" : "200000029826"
},
{
"code" : "200000029827"
},
{
"code" : "200000029828"
},
{
"code" : "200000029829"
},
{
"code" : "200000029830"
},
{
"code" : "200000029831"
},
{
"code" : "200000029832"
},
{
"code" : "200000029833"
},
{
"code" : "200000029834"
},
{
"code" : "200000029835"
},
{
"code" : "200000029836"
},
{
"code" : "200000029837"
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{
"code" : "200000029838"
},
{
"code" : "200000029839"
},
{
"code" : "200000029840"
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{
"code" : "200000029841"
},
{
"code" : "200000029842"
},
{
"code" : "200000029843"
},
{
"code" : "200000029844"
},
{
"code" : "200000029845"
},
{
"code" : "200000029846"
},
{
"code" : "200000029847"
},
{
"code" : "200000029848"
},
{
"code" : "200000029849"
},
{
"code" : "200000044333"
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{
"code" : "200000044347"
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}
]
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}