Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. 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/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

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: Follow-up ICSR — case CH-SYNTHPHARMA-2026-000456

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<DocumentReference xmlns="http://hl7.org/fhir">
  <id value="docref-icsr-follow-up"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: DocumentReference docref-icsr-follow-up</b></p><a name="docref-icsr-follow-up"> </a><a name="hcdocref-icsr-follow-up"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-apix-documentreference.html">APIX Regulatory DocumentReference</a></p></div><p><b>identifier</b>: Document Set Identifier/urn:uuid:2a4760dd-5b90-5daa-9af8-2e479c3e1305, Document Version Number Identifier/urn:uuid:7713b9a6-5c3c-51ad-a580-5d6aaeabfd8a</p><p><b>version</b>: 1</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type icsr-message}">ICSR Message</span></p><p><b>date</b>: 2026-10-09 10:15:00+0200</p><p><b>author</b>: <a href="Organization-org-synthpharma-ag.html">SynthPharma AG</a></p><p><b>description</b>: </p><div><p>Follow-up ICH E2B(R3) ICSR: drug withdrawn, reaction resolved (positive dechallenge).</p>
</div><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style="display: none">*</td><td>application/xml</td><td><a href="Binary-binary-icsr-follow-up.html">Binary: application/xml (11332 bytes base64)</a></td><td>8499</td><td><code>SRpaH2+F1HAHq38YIf2K0P2T3Es=</code></td><td>icsr-follow-up.xml</td><td>2026-10-09 10:15:00+0200</td></tr></table></blockquote></div>
  </text>
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        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"/>
        <code value="docsetid"/>
        <display value="Document Set Identifier"/>
      </coding>
    </type>
    <system value="http://example.org/synthpharma/document-set-id"/>
    <value value="urn:uuid:2a4760dd-5b90-5daa-9af8-2e479c3e1305"/>
  </identifier>
  <identifier>
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      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"/>
        <code value="docverid"/>
        <display value="Document Version Number Identifier"/>
      </coding>
    </type>
    <system value="http://example.org/synthpharma/document-version-id"/>
    <value value="urn:uuid:7713b9a6-5c3c-51ad-a580-5d6aaeabfd8a"/>
  </identifier>
  <version value="1"/>
  <status value="current"/>
  <docStatus value="final"/>
  <type>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
      <code value="icsr-message"/>
      <display value="ICSR Message"/>
    </coding>
  </type>
  <date value="2026-10-09T10:15:00+02:00"/>
  <author>🔗 
    <reference value="Organization/org-synthpharma-ag"/>
    <display value="SynthPharma AG"/>
  </author>
  <description
               value="Follow-up ICH E2B(R3) ICSR: drug withdrawn, reaction resolved (positive dechallenge)."/>
  <content>
    <attachment>
      <contentType value="application/xml"/>
      <url value="Binary/binary-icsr-follow-up"/>
      <size value="8499"/>
      <hash value="SRpaH2+F1HAHq38YIf2K0P2T3Es="/>
      <title value="icsr-follow-up.xml"/>
      <creation value="2026-10-09T10:15:00+02:00"/>
    </attachment>
  </content>
</DocumentReference>