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-type1-example

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="bundle-epi-type1-example"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/bundle-epi-type1"/>
  </meta>
  <language value="en"/>
  <identifier>
    <system value="http://ema.europa.eu/fhir/epiDocument"/>
    <value value="b99c95f8-bb0b-ef11-9f8a-000d3aa845fb"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2024-05-08T09:21:26.034+00:00"/>
  <entry>
    <fullUrl value="urn:uuid:fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"/>
    <resource>
      <Composition>
        <id value="fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"/>
        </meta>
        <language value="en"/>
        <text>
          <status value="additional"/>
          <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><a name="Composition_fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"> </a>electronic Product Information (ePI) document</div>
        </text>
        <contained>
          <Binary>
            <id value="d15f2fb1-ca0b-ef11-9f89-7c1e5212dc19"/>
            <contentType value="image/png"/>
            <data
                  value="iVBORw0KGgoAAAANSUhEUgAAAAEAAAABCAYAAAAfFcSJAAAADUlEQVR42mP8z8BQDwAEhQGAhKw66AAAAABJRU5ErkJggg=="/>
          </Binary>
        </contained>
        <identifier>
          <system value="http://ema.europa.eu/fhir/epiComposition"/>
          <value value="fe63fd6a-afe8-4b61-a203-0cf4a69ffb60"/>
        </identifier>
        <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="MedicinalProductDefinition/medprod-example"/>
        </subject>
        <date value="2024-05-08T09:21:26.034+00:00"/>
        <author>
          <reference value="Organization/mah-example"/>
        </author>
        <title
               value="Humira 20 mg solution for injection in pre-filled syringe (market authorization)"/>
        <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">Package Leaflet Text</div>
          </text>
        </section>
      </Composition>
    </resource>
  </entry>
</Bundle>