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

: SmPCtemplate - XML Representation

Raw xml | Download



<Composition xmlns="http://hl7.org/fhir">
  <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"><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
             value="6.6 Special precautions for disposal &lt;and other handling&gt;&gt;"/>
      <code>
        <coding>
          <system value="https://www.mhra.gov.uk/"/>
          <code value="200000029842"/>
        </coding>
        <text
              value="6.6 Special precautions for disposal &lt;and other handling&gt;"/>
      </code>
      <text>
        <status value="additional"/>
        <div xmlns="http://www.w3.org/1999/xhtml"></div>
      </text>
      <section>
        <title value="Use in the paediatric population"/>
        <code>
          <coding>
            <system value="https://www.mhra.gov.uk/"/>
            <code value="200000029843"/>
          </coding>
          <text value="Use in the paediatric population"/>
        </code>
        <text>
          <status value="additional"/>
          <div xmlns="http://www.w3.org/1999/xhtml"></div>
        </text>
      </section>
    </section>
  </section>
  <section>
    <title value="7. MARKETING AUTHORISATION HOLDER"/>
    <code>
      <coding>
        <system value="https://www.mhra.gov.uk/"/>
        <code value="200000029844"/>
      </coding>
      <text value="7. MARKETING AUTHORISATION HOLDER"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"></div>
    </text>
  </section>
  <section>
    <title value="8. MARKETING AUTHORISATION NUMBER(S)"/>
    <code>
      <coding>
        <system value="https://www.mhra.gov.uk/"/>
        <code value="200000029845"/>
      </coding>
      <text value="8. MARKETING AUTHORISATION NUMBER(S)"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"></div>
    </text>
  </section>
  <section>
    <title
           value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"/>
    <code>
      <coding>
        <system value="https://www.mhra.gov.uk/"/>
        <code value="200000029846"/>
      </coding>
      <text
            value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"></div>
    </text>
  </section>
  <section>
    <title value="10. DATE OF REVISION OF THE TEXT"/>
    <code>
      <coding>
        <system value="https://www.mhra.gov.uk/"/>
        <code value="200000029847"/>
      </coding>
      <text value="10. DATE OF REVISION OF THE TEXT"/>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml"></div>
    </text>
  </section>
</Composition>