Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

: bundle-epi-type2-example

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="bundle-epi-type2-example"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type2"/>
  </meta>
  <language value="en"/>
  <identifier>
    <system value="http://ema.europa.eu/fhir/epiDocument"/>
    <value value="type2-bundle-uuid"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2024-05-08T09:21:26.034+00:00"/>
  <entry>
    <fullUrl value="urn:uuid:comp-type2"/>
    <resource>
      <Composition>
        <id value="comp-type2"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type2"/>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_comp-type2"> </a><p class="res-header-id"><b>Generated Narrative: Composition comp-type2</b></p><a name="comp-type2"> </a><a name="hccomp-type2"> </a><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">Language: en</p><p style="margin-bottom: 0px">Profile: <code>http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type2</code></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000155531 100000155538}">B. PACKAGE LEAFLET</span></p><p><b>date</b>: 2024-05-08 09:21:26+0000</p><p><b>author</b>: <a href="Bundle-bundle-epi-type2-example.html#urn-uuid-org-type2">Organization AbbVie Ltd</a></p><p><b>title</b>: Humira Type 2 Example</p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Binary #binary-type2</b></p><a name="comp-type2/binary-type2"> </a><a name="hccomp-type2/binary-type2"> </a><p><b>contentType</b>: image/png</p><p><b>data</b>: <code>iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg==</code></p></blockquote></div>
        </text>
        <contained>
          <Binary>
            <id value="binary-type2"/>
            <contentType value="image/png"/>
            <data
                  value="iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg=="/>
          </Binary>
        </contained>
        <status value="final"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000155531"/>
            <code value="100000155538"/>
            <display value="B. PACKAGE LEAFLET"/>
          </coding>
        </type>
        <subject>
          <reference value="urn:uuid:mpd-type2"/>
        </subject>
        <date value="2024-05-08T09:21:26.034+00:00"/>
        <author>
          <reference value="urn:uuid:org-type2"/>
        </author>
        <title value="Humira Type 2 Example"/>
        <section>
          <title value="B. PACKAGE LEAFLET"/>
          <code>
            <coding>
              <system
                      value="https://spor.ema.europa.eu/v1/lists/100000155531"/>
              <code value="100000155538"/>
              <display value="B. PACKAGE LEAFLET"/>
            </coding>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">Type 2 Content</div>
          </text>
        </section>
      </Composition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:mpd-type2"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="mpd-type2"/>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-type2"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-type2</b></p><a name="mpd-type2"> </a><a name="hcmpd-type2"> </a><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td></tr><tr><td style="display: none">*</td><td>Humira 20 mg solution for injection</td></tr></table></div>
        </text>
        <name>
          <productName value="Humira 20 mg solution for injection"/>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:org-type2"/>
    <resource>
      <Organization>
        <id value="org-type2"/>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_org-type2"> </a><p class="res-header-id"><b>Generated Narrative: Organization org-type2</b></p><a name="org-type2"> </a><a name="hcorg-type2"> </a><p><b>name</b>: AbbVie Ltd</p></div>
        </text>
        <name value="AbbVie Ltd"/>
      </Organization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:auth-type2"/>
    <resource>
      <RegulatedAuthorization>
        <id value="auth-type2"/>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_auth-type2"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization auth-type2</b></p><a name="auth-type2"> </a><a name="hcauth-type2"> </a><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example.html#urn-uuid-mpd-type2">MedicinalProductDefinition</a></p><p><b>holder</b>: <a href="Bundle-bundle-epi-type2-example.html#urn-uuid-org-type2">Organization AbbVie Ltd</a></p></div>
        </text>
        <subject>
          <reference value="urn:uuid:mpd-type2"/>
        </subject>
        <holder>
          <reference value="urn:uuid:org-type2"/>
        </holder>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:mid-type2"/>
    <resource>
      <ManufacturedItemDefinition>
        <id value="mid-type2"/>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_mid-type2"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition mid-type2</b></p><a name="mid-type2"> </a><a name="hcmid-type2"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002150}">Syringe</span></p></div>
        </text>
        <status value="active"/>
        <manufacturedDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
            <code value="100000073863"/>
            <display value="Solution for injection"/>
          </coding>
        </manufacturedDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
            <code value="200000002150"/>
            <display value="Syringe"/>
          </coding>
        </unitOfPresentation>
      </ManufacturedItemDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:ing-type2"/>
    <resource>
      <Ingredient>
        <id value="ing-type2"/>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ing-type2"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ing-type2</b></p><a name="ing-type2"> </a><a name="hcing-type2"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundle-epi-type2-example.html#urn-uuid-mpd-type2">MedicinalProductDefinition</a></li><li><a href="Bundle-bundle-epi-type2-example.html#urn-uuid-mid-type2">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bundle-epi-type2-example.html#urn-uuid-sub-type2">SubstanceReferenceInformation</a></td></tr></table></blockquote></div>
        </text>
        <status value="active"/>
        <for>
          <reference value="urn:uuid:mpd-type2"/>
        </for>
        <for>
          <reference value="urn:uuid:mid-type2"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
            <code value="100000072072"/>
            <display value="Active"/>
          </coding>
        </role>
        <substance>
          <code>
            <reference>
              <reference value="urn:uuid:sub-type2"/>
            </reference>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:sub-type2"/>
    <resource>
      <SubstanceReferenceInformation>
        <id value="sub-type2"/>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceReferenceInformation_sub-type2"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceReferenceInformation sub-type2</b></p><a name="sub-type2"> </a><a name="hcsub-type2"> </a></div>
        </text>
      </SubstanceReferenceInformation>
    </resource>
  </entry>
</Bundle>