Miscellaneous ePI Test
0.1.0 - CI Build

Miscellaneous ePI Test, published by . This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-test/ and changes regularly. See the Directory of published versions

: Template of Bundle - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="BundleTemplate"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
  </meta>
  <language value="en"/>
  <identifier>
    <system value="https://www.mhra.gov.uk/"/>
    <value value="BundleTemplateUniqueIdentifier"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2022-03-04T00:00:00Z"/>
  <entry>
    <fullUrl value="Composition/SmPCtemplate"/>
    <resource>
      <Composition>
        <id value="SmPCtemplate"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_SmPCtemplate"> </a><p><b>Generated Narrative: Composition</b><a name="SmPCtemplate"> </a><a name="hcSmPCtemplate"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Composition &quot;SmPCtemplate&quot;  (Language &quot;en&quot;) </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.mhra.gov.uk/</code>/b5ffe6c3-ac12-44c4-a0a1-b13a1f7740ad</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000155538)</span></p><p><b>date</b>: 2023-08-24 00:00:00+0000</p><p><b>author</b>: <a href="Organization-PfEUMA.html">Organization/PfEUMA</a> &quot;Pfizer Europe MA EEIG&quot;</p><p><b>title</b>: SmPCtemplate</p></div>
        </text>
        <identifier>
          <system value="https://www.mhra.gov.uk/"/>
          <value value="b5ffe6c3-ac12-44c4-a0a1-b13a1f7740ad"/>
        </identifier>
        <status value="final"/>
        <type>
          <coding>
            <system value="https://www.mhra.gov.uk/"/>
            <code value="100000155538"/>
          </coding>
          <text value="Package Leaflet"/>
        </type>
        <date value="2023-08-24T00:00:00Z"/>
        <author>🔗 
          <reference value="Organization/PfEUMA"/>
        </author>
        <title value="SmPCtemplate"/>
        <section>
          <title value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="200000029791"/>
            </coding>
            <text value="SUMMARY OF PRODUCT CHARACTERISTICS"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="1. NAME OF THE MEDICINAL PRODUCT"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="200000029792"/>
            </coding>
            <text value="1. NAME OF THE MEDICINAL PRODUCT"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="200000029793"/>
            </coding>
            <text value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="2.1 General description"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029794"/>
              </coding>
              <text value="2.1 General description"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="2.2 Qualitative and quantitative composition"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029795"/>
              </coding>
              <text value="2.2 Qualitative and quantitative composition"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="Excipient(s) with known effect"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029796"/>
              </coding>
              <text value="Excipient(s) with known effect"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="3. PHARMACEUTICAL FORM"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="200000029797"/>
            </coding>
            <text value="3. PHARMACEUTICAL FORM"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="4. CLINICAL PARTICULARS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="200000029798"/>
            </coding>
            <text value="4. CLINICAL PARTICULARS"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="4.1 Therapeutic indications"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029799"/>
              </coding>
              <text value="4.1 Therapeutic indications"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="4.2 Posology and method of administration"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029800"/>
              </coding>
              <text value="4.2 Posology and method of administration"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Posology"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029801"/>
                </coding>
                <text value="Posology"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Paediatric population"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029802"/>
                </coding>
                <text value="Paediatric population"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Method of administration"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029803"/>
                </coding>
                <text value="Method of administration"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title
                     value="Precautions to be taken before handling or administering the medicinal product"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029804"/>
                </coding>
                <text
                      value="Precautions to be taken before handling or administering the medicinal product"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
          <section>
            <title value="4.3 Contraindications"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029805"/>
              </coding>
              <text value="4.3 Contraindications"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="4.4 Special warnings and precautions for use"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029806"/>
              </coding>
              <text value="4.4 Special warnings and precautions for use"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Traceability"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029807"/>
                </coding>
                <text value="Traceability"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Paediatric population"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029808"/>
                </coding>
                <text value="Paediatric population"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
          <section>
            <title
                   value="4.5 Interaction with other medicinal products and other forms of interaction"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029809"/>
              </coding>
              <text
                    value="4.5 Interaction with other medicinal products and other forms of interaction"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Paediatric population"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029810"/>
                </coding>
                <text value="Paediatric population"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
          <section>
            <title value="4.6 Fertility, pregnancy and lactation"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029811"/>
              </coding>
              <text value="4.6 Fertility, pregnancy and lactation"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Pregnancy"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029812"/>
                </coding>
                <text value="Pregnancy"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Breast-feeding"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029813"/>
                </coding>
                <text value="Breast-feeding"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Fertility"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029814"/>
                </coding>
                <text value="Fertility"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
          <section>
            <title value="4.7 Effects on ability to drive and use machines"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029815"/>
              </coding>
              <text value="4.7 Effects on ability to drive and use machines"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="4.8 Undesirable effects"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029816"/>
              </coding>
              <text value="4.8 Undesirable effects"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Paediatric population"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029817"/>
                </coding>
                <text value="Paediatric population"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Reporting of suspected adverse reactions"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029818"/>
                </coding>
                <text value="Reporting of suspected adverse reactions"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
          <section>
            <title value="4.9 Overdose"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029819"/>
              </coding>
              <text value="4.9 Overdose"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Paediatric population"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029820"/>
                </coding>
                <text value="Paediatric population"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
        </section>
        <section>
          <title value="5. PHARMACOLOGICAL PROPERTIES"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="200000029821"/>
            </coding>
            <text value="5. PHARMACOLOGICAL PROPERTIES"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="5.1 Pharmacodynamic properties"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029822"/>
              </coding>
              <text value="5.1 Pharmacodynamic properties"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Mechanism of action"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029823"/>
                </coding>
                <text value="Paediatric population"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Pharmacodynamic effects"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029824"/>
                </coding>
                <text value="Pharmacodynamic effects"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Clinical efficacy and safety"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029825"/>
                </coding>
                <text value="Clinical efficacy and safety"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Paediatric population"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029826"/>
                </coding>
                <text value="Paediatric population"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
          <section>
            <title value="5.2 Pharmacokinetic properties"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029827"/>
              </coding>
              <text value="5.2 Pharmacokinetic properties"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Absorption"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029828"/>
                </coding>
                <text value="Absorption"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Distribution"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029829"/>
                </coding>
                <text value="Distribution"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="	Biotransformation"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029830"/>
                </coding>
                <text value="Biotransformation"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Elimination"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029831"/>
                </coding>
                <text value="Elimination"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Linearity/non-linearity"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029832"/>
                </coding>
                <text value="Linearity/non-linearity"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
            <section>
              <title value="Pharmacokinetic/pharmacodynamic relationship(s)"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029833"/>
                </coding>
                <text
                      value="Pharmacokinetic/pharmacodynamic relationship(s)"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
          <section>
            <title value="5.3 Preclinical safety data"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029834"/>
              </coding>
              <text value="5.3 Preclinical safety data"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
            <section>
              <title value="Environmental risk assessment (ERA)"/>
              <code>
                <coding>
                  <system value="https://www.mhra.gov.uk/"/>
                  <code value="200000029835"/>
                </coding>
                <text value="Environmental risk assessment (ERA)"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml"></div>
              </text>
            </section>
          </section>
        </section>
        <section>
          <title value="6. PHARMACEUTICAL PARTICULARS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="200000029836"/>
            </coding>
            <text value="6. PHARMACEUTICAL PARTICULARS"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="6.1 List of excipients"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029837"/>
              </coding>
              <text value="6.1 List of excipients"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="6.2 Incompatibilities"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029838"/>
              </coding>
              <text value="6.2 Incompatibilities"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="6.3 Shelf life"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029839"/>
              </coding>
              <text value="6.3 Shelf life"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="6.4 Special precautions for storage"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029840"/>
              </coding>
              <text value="6.4 Special precautions for storage"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title
                   value="6.5 Nature and contents of container &lt;and special equipment for use, administration or implantation&gt;"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="200000029841"/>
              </coding>
              <text
                    value="6.5 Nature and contents of container &lt;and special equipment for use, administration or implantation&gt;"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title
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              <title value="Use in the paediatric population"/>
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            <text value="Boulevard de la Plaine 17, 1050 Bruxelles, Belgium"/>
            <line value="Boulevard de la Plaine 17"/>
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            <country value="Belgium"/>
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