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 |
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<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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<title value="02 SmPC Code Value Set"/>
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