CH EPL (R5)
1.0.0 - trial-use Switzerland flag

CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions

: CH-68793001 - XML Representation

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<PackagedProductDefinition xmlns="http://hl7.org/fhir">
  <id value="PMP-Paxlovid-Filmcoatedtablet"/>
  <meta>
    <profile
             value="http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Paxlovid-Filmcoatedtablet</b></p><a name="PMP-Paxlovid-Filmcoatedtablet"> </a><a name="hcPMP-Paxlovid-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-packagedproductdefinition.html">IDMP PackagedProductDefinition</a></p></div><p><b>identifier</b>: <a href="NamingSystem-PCID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Clinical Product Identifier</a>/CH-7601001010604-6879301-001</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-Paxlovid-Filmcoatedtablet.html">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7601001010604-6879301; indication = Paxlovid wird angewendet für die Behandlung der Coronavirus-Krankheit 2019 (COVID-19) bei Erwachsenen, die keine Sauerstofftherapie oder Hospitalisierung aufgrund von COVID-19 benötigen und bei denen ein erhöhtes Risiko für einen schweren Verlauf von COVID-19 besteht (siehe «Klinische Wirksamkeit»).
Paxlovid ist nicht als Ersatz für eine Impfung gegen COVID-19 vorgesehen. Paxlovid sollte gemäss den offiziellen Empfehlungen und unter Berücksichtigung der lokalen epidemiologischen Daten zu zirkulierenden SARS-CoV-2-Varianten angewendet werden.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription single dispensation (A+); additionalMonitoringIndicator = Black Triangle Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = Protease inhibitors,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,08. INFEKTIONSKRANKHEITEN,08.03. Mittel gegen Viren</a></p><p><b>containedItemQuantity</b>: 30 Tablet<span style="background: LightGoldenRodYellow"> (Details: EDQM - Standard Terms  code15054000 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>PAXLOVID Filmtabl 4x150mg/2x100mg</p>
</div><h3>LegalStatusOfSupplies</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply 756005022002}">Medicinal product subject to medical or veterinary prescription single dispensation (A+)</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="NamingSystem-GTIN.html" title="GS1 defines trade items as products or services that are priced, ordered or invoiced at any point in the supply chain.">Global Trade Item Number</a>/7680687930017</p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30009000}">Box</span></p><p><b>quantity</b>: 1</p><h3>ShelfLifeStorages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>SpecialPrecautionsForStorage</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000073343 100000073403}">Shelf life of the medicinal product as packaged for sale</span></td><td><span title="Codes:{http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage 756005042001}">Do not freeze</span></td></tr></table></blockquote></div>
  </text>
  <identifier>
    <system value="http://fhir.ch/ig/ch-epl/sid/pcid"/>
    <value value="CH-7601001010604-6879301-001"/>
  </identifier>
  <packageFor>🔗 
    <reference value="MedicinalProductDefinition/Paxlovid-Filmcoatedtablet"/>
  </packageFor>
  <containedItemQuantity>
    <value value="30"/>
    <unit value="Tablet"/>
    <system value="http://standardterms.edqm.eu"/>
    <code value="15054000"/>
  </containedItemQuantity>
  <description value="PAXLOVID Filmtabl 4x150mg/2x100mg"/>
  <legalStatusOfSupply>
    <code>
      <coding>
        <system
                value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply"/>
        <code value="756005022002"/>
        <display
                 value="Medicinal product subject to medical or veterinary prescription single dispensation (A+)"/>
      </coding>
    </code>
  </legalStatusOfSupply>
  <packaging>
    <identifier>
      <system value="urn:oid:2.51.1.1"/>
      <value value="7680687930017"/>
    </identifier>
    <type>
      <coding>
        <system value="http://standardterms.edqm.eu"/>
        <code value="30009000"/>
        <display value="Box"/>
      </coding>
    </type>
    <quantity value="1"/>
    <shelfLifeStorage>
      <type>
        <coding>
          <system value="http://spor.ema.europa.eu/v1/lists/100000073343"/>
          <code value="100000073403"/>
          <display
                   value="Shelf life of the medicinal product as packaged for sale"/>
        </coding>
      </type>
      <specialPrecautionsForStorage>
        <coding>
          <system
                  value="http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage"/>
          <code value="756005042001"/>
          <display value="Do not freeze"/>
        </coding>
      </specialPrecautionsForStorage>
    </shelfLifeStorage>
  </packaging>
</PackagedProductDefinition>