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AGESMedicinalProductR5 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="asp-liste-8"/>
  <meta>
    <versionId value="2.0.0+20240208"/>
    <lastUpdated value="2025-06-25T17:17:45.024+02:00"/>
  </meta>
  <identifier>
    <value value="1.2.40.0.34.4.16"/>
  </identifier>
  <type value="collection"/>
  <entry>
    <fullUrl value="MedicinalProductDefinition/100406362"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="100406362"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_100406362"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 100406362</b></p><a name="100406362"> </a><a name="hc100406362"> </a><p><b>identifier</b>: <code>https://www.ages.at/fhir/referenceNumber</code>/100406362</p><p><b>domain</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000006 100000074068}">Injektionsdispersion</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 200000017698}">Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung</span></p><p><b>classification</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 200000030565}, {http://www.whocc.no/atc J07BX03}">COVID-19-mRNA-Impfstoff</span></p><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>Comirnaty 30 Mikrogramm/Dosis Injektionsdispersion; COVID-19-mRNA-Impfstoff (Nukleosid-modifiziert)</td></tr></table></div>
        </text>
        <identifier>
          <system value="https://www.ages.at/fhir/referenceNumber"/>
          <value value="100406362"/>
        </identifier>
        <domain>
          <coding>
            <extension
                       url="http://ema.europa.eu/fhir/extension/codeSystemName">
              <valueString value="Domain"/>
            </extension>
            <system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
            <code value="100000000012"/>
            <display value="Human"/>
          </coding>
        </domain>
        <combinedPharmaceuticalDoseForm>
          <coding>
            <extension
                       url="http://ema.europa.eu/fhir/extension/codeSystemName">
              <valueString value="Combined Pharmaceutical Dose Form"/>
            </extension>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000006"/>
            <code value="100000074068"/>
            <display value="Injektionsdispersion"/>
          </coding>
        </combinedPharmaceuticalDoseForm>
        <legalStatusOfSupply>
          <coding>
            <extension
                       url="http://ema.europa.eu/fhir/extension/codeSystemName">
              <valueString value="Legal Status for the Supply"/>
            </extension>
            <system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
            <code value="200000017698"/>
            <display
                     value="Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung"/>
          </coding>
        </legalStatusOfSupply>
        <classification>
          <coding>
            <extension
                       url="http://ema.europa.eu/fhir/extension/codeSystemName">
              <valueString
                           value="Anatomical Therapeutic Chemical classification system - Human"/>
            </extension>
            <system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
            <code value="200000030565"/>
            <display value="COVID-19-mRNA-Impfstoff"/>
          </coding>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/atcGroup">
              <valueString value="???"/>
            </extension>
            <system value="http://www.whocc.no/atc"/>
            <code value="J07BX03"/>
            <display value="COVID-19-mRNA-Impfstoff"/>
          </coding>
        </classification>
        <name>
          <productName
                       value="Comirnaty 30 Mikrogramm/Dosis Injektionsdispersion; COVID-19-mRNA-Impfstoff (Nukleosid-modifiziert)"/>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="PackagedProductDefinition/5506359"/>
    <resource>
      <PackagedProductDefinition>
        <id value="5506359"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_5506359"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition 5506359</b></p><a name="5506359"> </a><a name="hc5506359"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/dataCarrierIdentifier</code>/5506359</p><p><b>packageFor</b>: <a href="Bundle-asp-liste-8.html#MedicinalProductDefinition_100406362">Bundle: identifier = 1.2.40.0.34.4.16; type = collection</a></p><p><b>containedItemQuantity</b>: 1.0 Durchstechflasche<span style="background: LightGoldenRodYellow"> (Details: unitsOfPresentation  code200000002158 = '200000002158')</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072075}">Keine Daten übermittelt</span></td></tr></table><h3>Packagings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073563}">Durchstechflasche</span></td></tr></table></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/dataCarrierIdentifier"/>
          <value value="5506359"/>
        </identifier>
        <packageFor>
          <reference value="MedicinalProductDefinition/100406362"/>
        </packageFor>
        <containedItemQuantity>
          <value value="1.0"/>
          <unit value="Durchstechflasche"/>
          <system value="https://ema.europa.eu/fhir/vs/unitsOfPresentation"/>
          <code value="200000002158"/>
        </containedItemQuantity>
        <marketingStatus>
          <status>
            <coding>
              <extension
                         url="http://ema.europa.eu/fhir/extension/codeSystemName">
                <valueString value="Marketing Status"/>
              </extension>
              <system
                      value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
              <code value="100000072075"/>
              <display value="Keine Daten übermittelt"/>
            </coding>
          </status>
        </marketingStatus>
        <packaging>
          <type>
            <coding>
              <extension
                         url="http://ema.europa.eu/fhir/extension/codeSystemName">
                <valueString value="Packaging"/>
              </extension>
              <system
                      value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
              <code value="100000073563"/>
              <display value="Durchstechflasche"/>
            </coding>
          </type>
        </packaging>
      </PackagedProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="RegulatedAuthorization/EU/1/20/1528/002-003,013"/>
    <resource>
      <RegulatedAuthorization>
        <id value="002-003,013"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_002-003,013"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 002-003,013</b></p><a name="002-003,013"> </a><a name="hc002-003,013"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/EU/1/20/1528/002-003,013</p><p><b>subject</b>: <a href="Bundle-asp-liste-8.html#MedicinalProductDefinition_100406362">Bundle: identifier = 1.2.40.0.34.4.16; type = collection</a></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 200000010409}">Surrendered</span></p><p><b>holder</b>: <code>Biontech Manufacturing GmbH</code></p></div>
        </text>
        <identifier>
          <system
                  value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
          <value value="EU/1/20/1528/002-003,013"/>
        </identifier>
        <subject>
          <reference value="MedicinalProductDefinition/100406362"/>
        </subject>
        <status>
          <coding>
            <extension
                       url="http://ema.europa.eu/fhir/extension/codeSystemName">
              <valueString value="Regulatory Entitlement Status"/>
            </extension>
            <system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
            <code value="200000010409"/>
            <display value="Surrendered"/>
          </coding>
        </status>
        <holder>
          <reference value="LOC-100047650"/>
          <display value="Biontech Manufacturing GmbH"/>
        </holder>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="AdministrableProductDefinition/2031677"/>
    <resource>
      <AdministrableProductDefinition>
        <id value="2031677"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_2031677"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition 2031677</b></p><a name="2031677"> </a><a name="hc2031677"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/2031677</p><p><b>formOf</b>: <a href="Bundle-asp-liste-8.html#MedicinalProductDefinition_100406362">Bundle: identifier = 1.2.40.0.34.4.16; type = collection</a></p><h3>RouteOfAdministrations</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:">intramuskuläre Anwendung</span></td></tr></table></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <value value="2031677"/>
        </identifier>
        <formOf>
          <reference value="MedicinalProductDefinition/100406362"/>
        </formOf>
        <routeOfAdministration>
          <code>
            <coding>
              <code value="100000073600"/>
              <display value="intramuskuläre Anwendung"/>
            </coding>
          </code>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Ingredient/22582997"/>
    <resource>
      <Ingredient>
        <id value="22582997"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_22582997"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 22582997</b></p><a name="22582997"> </a><a name="hc22582997"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/22582997</p><p><b>for</b>: <a href="Bundle-asp-liste-8.html#AdministrableProductDefinition_2031677">Bundle: identifier = 1.2.40.0.34.4.16; type = collection</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}">Wirkstoff</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/substanceDefinition 101102201}">TOZINAMERAN</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>30.0 µg<span style="background: LightGoldenRodYellow"> (Details: Units Of Measurement  code100000110656 = 'microgram(s)')</span>/1.0 Durchstechflasche<span style="background: LightGoldenRodYellow"> (Details: Units Of Presentation  code200000002158 = 'Durchstechflasche')</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <value value="22582997"/>
        </identifier>
        <for>
          <reference value="AdministrableProductDefinition/2031677"/>
        </for>
        <role>
          <coding>
            <extension
                       url="http://ema.europa.eu/fhir/extension/codeSystemName">
              <valueString value="Ingredient Role"/>
            </extension>
            <system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
            <code value="100000072072"/>
            <display value="Wirkstoff"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/substanceDefinition"/>
                <code value="101102201"/>
                <display value="TOZINAMERAN"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationRatio>
              <numerator>
                <value value="30.0"/>
                <unit value="µg"/>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
                <code value="100000110656"/>
              </numerator>
              <denominator>
                <value value="1.0"/>
                <unit value="Durchstechflasche"/>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
                <code value="200000002158"/>
              </denominator>
            </presentationRatio>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
</Bundle>