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: Xospata 40 mg, Filmtabletten - XML Representation

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<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
  <id value="Xospata-Filmcoatedtablet"/>
  <meta>
    <profile
             value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Xospata-Filmcoatedtablet</b></p><a name="Xospata-Filmcoatedtablet"> </a><a name="hcXospata-Filmcoatedtablet"> </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-ch-idmp-medicinalproductdefinition.html">MedicinalProductDefinition</a></p></div><p><b>CH SMC - Authorized Dose Form</b>: <span title="Codes:{http://standardterms.edqm.eu 10221000}">Film-coated tablet</span></p><p><b>identifier</b>: <a href="NamingSystem-MPID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Medical Product Identifier</a>/CH-01100869-0672110010000</p><p><b>indication</b>: </p><div><p>Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}">A: Single dispensing requiring a medical or veterinary prescription</span></p><p><b>additionalMonitoringIndicator</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator 756005003002}">Not authorised for the treatment in children</span></p><p><b>classification</b>: <span title="Codes:{http://www.whocc.no/atc L01EX13}">gilteritinib</span>, <span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory 756005039000001}">Synthetic</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status 7560050074000003}">No interruption of distribution reported</span></td><td>2020-09-24 --&gt; (ongoing)</td></tr></table><p><b>attachedDocument</b>: </p><ul><li><a href="DocumentReference-DocRef-FI-Xospata.html">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-xyz-123; status = current; type = Information for healthcare professionals; date = 2021-11-09 00:00:00+0000</a></li><li><a href="DocumentReference-DocRef-PI-Xospata.html">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-abc-123; status = current; type = Patient Information; date = 2021-11-09 00:00:00+0000</a></li></ul><blockquote><p><b>name</b></p><p><b>productName</b>: Xospata 40 mg, Filmtabletten</p><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></td><td><span title="Codes:{urn:ietf:bcp:47 de-CH}">German (Switzerland)</span></td></tr></table></blockquote></div>
  </text>
  <extension
             url="http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm">
    <valueCodeableConcept>
      <coding>
        <system value="http://standardterms.edqm.eu"/>
        <code value="10221000"/>
        <display value="Film-coated tablet"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <identifier>
    <system value="http://fhir.ch/ig/ch-idmp/sid/mpid"/>
    <value value="CH-01100869-0672110010000"/>
  </identifier>
  <indication
              value="Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden."/>
  <legalStatusOfSupply>
    <coding>
      <system
              value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"/>
      <code value="756005034000001"/>
      <display
               value="A: Single dispensing requiring a medical or veterinary prescription"/>
    </coding>
  </legalStatusOfSupply>
  <additionalMonitoringIndicator>
    <coding>
      <system
              value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator"/>
      <code value="756005001003"/>
      <display value="No Warning"/>
    </coding>
  </additionalMonitoringIndicator>
  <pediatricUseIndicator>
    <coding>
      <system
              value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator"/>
      <code value="756005003002"/>
      <display value="Not authorised for the treatment in children"/>
    </coding>
  </pediatricUseIndicator>
  <classification>
    <coding>
      <system value="http://www.whocc.no/atc"/>
      <code value="L01EX13"/>
    </coding>
  </classification>
  <classification>
    <coding>
      <system
              value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory"/>
      <code value="756005039000001"/>
      <display value="Synthetic"/>
    </coding>
  </classification>
  <marketingStatus>
    <country>
      <coding>
        <system value="urn:iso:std:iso:3166"/>
        <code value="CH"/>
        <display value="Switzerland"/>
      </coding>
    </country>
    <status>
      <coding>
        <system
                value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status"/>
        <code value="7560050074000003"/>
        <display value="No interruption of distribution reported"/>
      </coding>
    </status>
    <dateRange>
      <start value="2020-09-24"/>
    </dateRange>
  </marketingStatus>
  <attachedDocument>🔗 
    <reference value="DocumentReference/DocRef-FI-Xospata"/>
  </attachedDocument>
  <attachedDocument>🔗 
    <reference value="DocumentReference/DocRef-PI-Xospata"/>
  </attachedDocument>
  <name>
    <productName value="Xospata 40 mg, Filmtabletten"/>
    <usage>
      <country>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="CH"/>
          <display value="Switzerland"/>
        </coding>
      </country>
      <language>
        <coding>
          <system value="urn:ietf:bcp:47"/>
          <code value="de-CH"/>
        </coding>
      </language>
    </usage>
  </name>
</MedicinalProductDefinition>