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 CLD Bundle - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="CLDBundleTemplate"/>
  <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="CLDBundleTemplateUniqueIdentifier"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2022-03-04T00:00:00Z"/>
  <entry>
    <fullUrl value="Composition/CLDTemplate"/>
    <resource>
      <Composition>
        <id value="CLDTemplate"/>
        <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_CLDTemplate"> </a><p><b>Generated Narrative: Composition</b><a name="CLDTemplate"> </a><a name="hcCLDTemplate"> </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;CLDTemplate&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>/6e1f47ac-76c7-11ee-b962-0242ac120002</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="6e1f47ac-76c7-11ee-b962-0242ac120002"/>
        </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="Cover Page"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929791"/>
            </coding>
            <text value="Cover Page"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="1. INDICATIONS AND USAGE"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929792"/>
            </coding>
            <text value="1. INDICATIONS AND USAGE"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="2. DOSAGE AND ADMINISTRATION"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929793"/>
            </coding>
            <text value="2. DOSAGE AND ADMINISTRATION"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="2.1 Recommended Dose and Schedule"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929794"/>
              </coding>
              <text value="2.1 Recommended Dose and Schedule"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="2.2 Dose Modification"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929795"/>
              </coding>
              <text value="2.2 Dose Modification"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="3. DOSAGE FORMS AND STRENGTHS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929796"/>
            </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="5. WARNINGS AND PRECAUTIONS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929798"/>
            </coding>
            <text value="5. WARNINGS AND PRECAUTIONS"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="5.1	Neutropenia"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929799"/>
              </coding>
              <text value="5.1	Neutropenia"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="5.3	Embryo-Fetal Toxicity"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929800"/>
              </coding>
              <text value="5.3	Embryo-Fetal Toxicity"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="6. ADVERSE REACTIONS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929801"/>
            </coding>
            <text value="6. ADVERSE REACTIONS"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="6.1	Clinical Studies Experience"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929802"/>
              </coding>
              <text value="6.1	Clinical Studies Experience"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="6.2 Postmarketing Experience"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929803"/>
              </coding>
              <text value="6.2 Postmarketing Experience"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="7.	DRUG INTERACTIONS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929804"/>
            </coding>
            <text value="7.	DRUG INTERACTIONS"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title
                   value="7.1	Agents that may Increase Palbociclib Plasma Concentrations"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929805"/>
              </coding>
              <text
                    value="7.1	Agents that may Increase Palbociclib Plasma Concentrations"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title
                   value="7.2	Agents that may Decrease Palbociclib Plasma Concentrations"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929806"/>
              </coding>
              <text
                    value="7.2	Agents that may Decrease Palbociclib Plasma Concentrations"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title
                   value="7.3	Drugs that may have Their Plasma Concentrations Altered by Palbociclib"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929807"/>
              </coding>
              <text
                    value="7.3	Drugs that may have Their Plasma Concentrations Altered by Palbociclib"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="8.	USE IN SPECIFIC POPULATIONS"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929808"/>
            </coding>
            <text value="8.	USE IN SPECIFIC POPULATIONS"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="8.1	Pregnancy"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929809"/>
              </coding>
              <text value="8.1	Pregnancy"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="8.2	Lactation"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929810"/>
              </coding>
              <text value="8.2	Lactation"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="8.3	Females and Males of Reproductive Potential"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929811"/>
              </coding>
              <text value="8.3	Females and Males of Reproductive Potential"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="8.4	Pediatric Use"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929812"/>
              </coding>
              <text value="8.4	Pediatric Use"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="8.5	Geriatric Use"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929813"/>
              </coding>
              <text value="8.5	Geriatric Use"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="8.6	Hepatic Impairment"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929814"/>
              </coding>
              <text value="8.6	Hepatic Impairment"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="8.7	Renal Impairment"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929815"/>
              </coding>
              <text value="8.7	Renal Impairment"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="9.	OVERDOSAGE"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929816"/>
            </coding>
            <text value="9.	OVERDOSAGE"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="10.	DESCRIPTION"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929817"/>
            </coding>
            <text value="10.	DESCRIPTION"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="11.	CLINICAL PHARMACOLOGY"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929818"/>
            </coding>
            <text value="11.	CLINICAL PHARMACOLOGY"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title value="11.1	Mechanism of Action"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929819"/>
              </coding>
              <text value="11.1	Mechanism of Action"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="11.2	Pharmacodynamics"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929820"/>
              </coding>
              <text value="11.2	Pharmacodynamics"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
          <section>
            <title value="11.3	Pharmacokinetics"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929821"/>
              </coding>
              <text value="11.3	Pharmacokinetics"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="12	NONCLINICAL TOXICOLOGY"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929822"/>
            </coding>
            <text value="12	NONCLINICAL TOXICOLOGY"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
          <section>
            <title
                   value="12.1	Carcinogenesis, Mutagenesis, Impairment of Fertility"/>
            <code>
              <coding>
                <system value="https://www.mhra.gov.uk/"/>
                <code value="999999929823"/>
              </coding>
              <text
                    value="12.1	Carcinogenesis, Mutagenesis, Impairment of Fertility"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml"></div>
            </text>
          </section>
        </section>
        <section>
          <title value="13	CLINICAL STUDIES"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929824"/>
            </coding>
            <text value="13	CLINICAL STUDIES"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="14	HOW SUPPLIED/STORAGE AND HANDLING"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929825"/>
            </coding>
            <text value="14	HOW SUPPLIED/STORAGE AND HANDLING"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
        <section>
          <title value="15	PATIENT COUNSELING INFORMATION"/>
          <code>
            <coding>
              <system value="https://www.mhra.gov.uk/"/>
              <code value="999999929826"/>
            </coding>
            <text value="15	PATIENT COUNSELING INFORMATION"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml"></div>
          </text>
        </section>
      </Composition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Organization/OrgTemplate"/>
    <resource>
      <Organization>
        <id value="OrgTemplate"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_OrgTemplate"> </a><p><b>Generated Narrative: Organization</b><a name="OrgTemplate"> </a><a name="hcOrgTemplate"> </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 Organization &quot;OrgTemplate&quot; </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/OrgTemplate (use: official)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#220000000034)</span></p><p><b>name</b>: Orgname OrgTemplate</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Boulevard de la Plaine 17, 1050 Bruxelles, Belgium(work)</td></tr></table></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/omswi"/>
          <value value="OrgTemplate"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="220000000034"/>
            <display value="Marketing authorisation holder"/>
          </coding>
          <text value="Marketing authorisation holder"/>
        </type>
        <name value="Orgname OrgTemplate"/>
        <contact>
          <address>
            <use value="work"/>
            <type value="physical"/>
            <text value="Boulevard de la Plaine 17, 1050 Bruxelles, Belgium"/>
            <line value="Boulevard de la Plaine 17"/>
            <city value="1050 Bruxelles"/>
            <country value="Belgium"/>
          </address>
        </contact>
      </Organization>
    </resource>
  </entry>
</Bundle>