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

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: 05 PL Code Value Set - XML Representation

Active as of 2025-04-02

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="EUepiplqrdcodesVs"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet EUepiplqrdcodesVs</b></p><a name="EUepiplqrdcodesVs"> </a><a name="hcEUepiplqrdcodesVs"> </a><a name="EUepiplqrdcodesVs-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#200000029659-200000029894">200000029894</a></td><td style="color: #cccccc">PACKAGE LEAFLET</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029895">200000029895</a></td><td style="color: #cccccc">1. What X is and what it is used for</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029896">200000029896</a></td><td style="color: #cccccc">2. What you need to know before you [take] [use] X</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029897">200000029897</a></td><td style="color: #cccccc">Do not [take] [use] X</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029898">200000029898</a></td><td style="color: #cccccc">Warnings and precautions</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029899">200000029899</a></td><td style="color: #cccccc">Children [and adolescents]</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029900">200000029900</a></td><td style="color: #cccccc">Other medicines and X</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029901">200000029901</a></td><td style="color: #cccccc">X with [food] [and] [,] [drink] [and] [alcohol]</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029902">200000029902</a></td><td style="color: #cccccc">Pregnancy [and] [,] breast-feeding [and fertility]</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029903">200000029903</a></td><td style="color: #cccccc">Driving and using machines</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029904">200000029904</a></td><td style="color: #cccccc">X contains {name the excipient(s)}</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029905">200000029905</a></td><td style="color: #cccccc">3. How to [take] [use] X</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029906">200000029906</a></td><td style="color: #cccccc">Use in children [and adolescents]</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029907">200000029907</a></td><td style="color: #cccccc">If you [take] [use] more X than you should</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029908">200000029908</a></td><td style="color: #cccccc">If you forget to [take] [use] X</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029909">200000029909</a></td><td style="color: #cccccc">If you stop [taking] [using] X</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029910">200000029910</a></td><td style="color: #cccccc">4. Possible side effects</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029911">200000029911</a></td><td style="color: #cccccc">Additional side effects in children [and adolescents]</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029912">200000029912</a></td><td style="color: #cccccc">Reporting of side effects</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029913">200000029913</a></td><td style="color: #cccccc">5. How to store X</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029914">200000029914</a></td><td style="color: #cccccc">6. Contents of the pack and other information</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029915">200000029915</a></td><td style="color: #cccccc">What X contains</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029916">200000029916</a></td><td style="color: #cccccc">What X looks like and contents of the pack</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029917">200000029917</a></td><td style="color: #cccccc">Marketing Authorisation Holder and Manufacturer</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029918">200000029918</a></td><td style="color: #cccccc">This medicine is authorised in the Member States of the European Economic Area [and in the United Kingdom (Northern Ireland)] under the following names:</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029919">200000029919</a></td><td style="color: #cccccc">This leaflet was last revised in [{MM/YYYY}][{month YYYY}].</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029920">200000029920</a></td><td style="color: #cccccc">Other sources of information</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000029921">200000029921</a></td><td style="color: #cccccc">The following information is intended for healthcare professionals only:</td></tr><tr><td><a href="CodeSystem-200000029659.html#200000029659-200000044346">200000044346</a></td><td style="color: #cccccc">Level=H3 PL custom subsection</td></tr></table></li></ul></div>
  </text>
  <url value="http://ema.europa.eu/fhir/ValueSet/EUepiplqrdcodesVs"/>
  <version value="1.0.0"/>
  <name value="EUepiplqrdcodesVs"/>
  <title value="05 PL Code Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-04-02T11:27:42+01:00"/>
  <publisher value="European Medicines Agency"/>
  <contact>
    <name value="European Medicines Agency"/>
    <telecom>
      <system value="url"/>
      <value value="https://ema.europa.eu/fhir"/>
    </telecom>
  </contact>
  <contact>
    <name value="FHIR at EMA"/>
    <telecom>
      <system value="url"/>
      <value value="http://ema.europa.eu/fhir"/>
    </telecom>
  </contact>
  <description
               value="List of section codes allowed in Package Leaflet documents, defined in EMA's Referentials Management Service."/>
  <compose>
    <include>
      <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659"/>
      <concept>
        <code value="000000000000"/>
      </concept>
      <concept>
        <code value="200000029894"/>
      </concept>
      <concept>
        <code value="200000029895"/>
      </concept>
      <concept>
        <code value="200000029896"/>
      </concept>
      <concept>
        <code value="200000029897"/>
      </concept>
      <concept>
        <code value="200000029898"/>
      </concept>
      <concept>
        <code value="200000029899"/>
      </concept>
      <concept>
        <code value="200000029900"/>
      </concept>
      <concept>
        <code value="200000029901"/>
      </concept>
      <concept>
        <code value="200000029902"/>
      </concept>
      <concept>
        <code value="200000029903"/>
      </concept>
      <concept>
        <code value="200000029904"/>
      </concept>
      <concept>
        <code value="200000029905"/>
      </concept>
      <concept>
        <code value="200000029906"/>
      </concept>
      <concept>
        <code value="200000029907"/>
      </concept>
      <concept>
        <code value="200000029908"/>
      </concept>
      <concept>
        <code value="200000029909"/>
      </concept>
      <concept>
        <code value="200000029910"/>
      </concept>
      <concept>
        <code value="200000029911"/>
      </concept>
      <concept>
        <code value="200000029912"/>
      </concept>
      <concept>
        <code value="200000029913"/>
      </concept>
      <concept>
        <code value="200000029914"/>
      </concept>
      <concept>
        <code value="200000029915"/>
      </concept>
      <concept>
        <code value="200000029916"/>
      </concept>
      <concept>
        <code value="200000029917"/>
      </concept>
      <concept>
        <code value="200000029918"/>
      </concept>
      <concept>
        <code value="200000029919"/>
      </concept>
      <concept>
        <code value="200000029920"/>
      </concept>
      <concept>
        <code value="200000029921"/>
      </concept>
      <concept>
        <code value="200000044346"/>
      </concept>
    </include>
  </compose>
</ValueSet>