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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-5"/>
  <meta>
    <versionId value="2.0.0+20240208"/>
    <lastUpdated value="2025-06-25T17:14:26.409+02:00"/>
  </meta>
  <identifier>
    <value value="1.2.40.0.34.4.16"/>
  </identifier>
  <type value="collection"/>
  <entry>
    <fullUrl value="MedicinalProductDefinition/946126"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="946126"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_946126"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 946126</b></p><a name="946126"> </a><a name="hc946126"> </a><p><b>identifier</b>: <code>https://www.ages.at/fhir/referenceNumber</code>/946126</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 100000074063}">Suspension for injection in pre-filled syringe</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 100000096601}, {http://www.whocc.no/atc J07CA02}">Diphtherie-Pertussis-Poliomyelitis-Tetanus</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>Repevax Injektionssuspension in einer Fertigspritze</td></tr></table></div>
        </text>
        <identifier>
          <system value="https://www.ages.at/fhir/referenceNumber"/>
          <value value="946126"/>
        </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="100000074063"/>
            <display value="Suspension for injection in pre-filled syringe"/>
          </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="100000096601"/>
            <display value="Diphtherie-Pertussis-Poliomyelitis-Tetanus"/>
          </coding>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/atcGroup">
              <valueString value="???"/>
            </extension>
            <system value="http://www.whocc.no/atc"/>
            <code value="J07CA02"/>
            <display value="Diphtherie-Pertussis-Poliomyelitis-Tetanus"/>
          </coding>
        </classification>
        <name>
          <productName
                       value="Repevax Injektionssuspension in einer Fertigspritze"/>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="PackagedProductDefinition/6056875"/>
    <resource>
      <PackagedProductDefinition>
        <id value="6056875"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_6056875"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition 6056875</b></p><a name="6056875"> </a><a name="hc6056875"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/dataCarrierIdentifier</code>/6056875</p><p><b>packageFor</b>: <a href="Bundle-asp-liste-5.html#MedicinalProductDefinition_946126">Bundle: identifier = 1.2.40.0.34.4.16; type = collection</a></p><p><b>containedItemQuantity</b>: 10.0 Spritze<span style="background: LightGoldenRodYellow"> (Details: unitsOfPresentation  code200000002150 = '200000002150')</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 100000073544}">Fertigspritze</span></td></tr></table></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/dataCarrierIdentifier"/>
          <value value="6056875"/>
        </identifier>
        <packageFor>
          <reference value="MedicinalProductDefinition/946126"/>
        </packageFor>
        <containedItemQuantity>
          <value value="10.0"/>
          <unit value="Spritze"/>
          <system value="https://ema.europa.eu/fhir/vs/unitsOfPresentation"/>
          <code value="200000002150"/>
        </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="100000073544"/>
              <display value="Fertigspritze"/>
            </coding>
          </type>
        </packaging>
      </PackagedProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="RegulatedAuthorization/2-00284"/>
    <resource>
      <RegulatedAuthorization>
        <id value="2-00284"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_2-00284"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 2-00284</b></p><a name="2-00284"> </a><a name="hc2-00284"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/2-00284</p><p><b>subject</b>: <a href="Bundle-asp-liste-5.html#MedicinalProductDefinition_946126">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 100000072099}">Valid</span></p><p><b>holder</b>: <code>Sanofi Winthrop Industrie</code></p></div>
        </text>
        <identifier>
          <system
                  value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
          <value value="2-00284"/>
        </identifier>
        <subject>
          <reference value="MedicinalProductDefinition/946126"/>
        </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="100000072099"/>
            <display value="Valid"/>
          </coding>
        </status>
        <holder>
          <reference value="LOC-100021551"/>
          <display value="Sanofi Winthrop Industrie"/>
        </holder>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="AdministrableProductDefinition/2035865"/>
    <resource>
      <AdministrableProductDefinition>
        <id value="2035865"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_2035865"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition 2035865</b></p><a name="2035865"> </a><a name="hc2035865"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/2035865</p><p><b>formOf</b>: <a href="Bundle-asp-liste-5.html#MedicinalProductDefinition_946126">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="2035865"/>
        </identifier>
        <formOf>
          <reference value="MedicinalProductDefinition/946126"/>
        </formOf>
        <routeOfAdministration>
          <code>
            <coding>
              <code value="100000073600"/>
              <display value="intramuskuläre Anwendung"/>
            </coding>
          </code>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Ingredient/115684"/>
    <resource>
      <Ingredient>
        <id value="115684"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_115684"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 115684</b></p><a name="115684"> </a><a name="hc115684"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/115684</p><p><b>for</b>: <a href="Bundle-asp-liste-5.html#AdministrableProductDefinition_2035865">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 1708114}">CORYNEBACTERIUM DIPHTHERIAE (AUSZUG, PRODUKTE)</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <value value="115684"/>
        </identifier>
        <for>
          <reference value="AdministrableProductDefinition/2035865"/>
        </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="1708114"/>
                <display
                         value="CORYNEBACTERIUM DIPHTHERIAE (AUSZUG, PRODUKTE)"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Ingredient/327186"/>
    <resource>
      <Ingredient>
        <id value="327186"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_327186"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 327186</b></p><a name="327186"> </a><a name="hc327186"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/327186</p><p><b>for</b>: <a href="Bundle-asp-liste-5.html#AdministrableProductDefinition_2035865">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 1708214}">BORDETELLA PERTUSSIS</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <value value="327186"/>
        </identifier>
        <for>
          <reference value="AdministrableProductDefinition/2035865"/>
        </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="1708214"/>
                <display value="BORDETELLA PERTUSSIS"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Ingredient/1606254"/>
    <resource>
      <Ingredient>
        <id value="1606254"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_1606254"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 1606254</b></p><a name="1606254"> </a><a name="hc1606254"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/1606254</p><p><b>for</b>: <a href="Bundle-asp-liste-5.html#AdministrableProductDefinition_2035865">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 1708219}">CLOSTRIDIUM TETANI (AUSZUG, PRODUKTE)</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <value value="1606254"/>
        </identifier>
        <for>
          <reference value="AdministrableProductDefinition/2035865"/>
        </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="1708219"/>
                <display value="CLOSTRIDIUM TETANI (AUSZUG, PRODUKTE)"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl value="Ingredient/875640"/>
    <resource>
      <Ingredient>
        <id value="875640"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_875640"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 875640</b></p><a name="875640"> </a><a name="hc875640"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/875640</p><p><b>for</b>: <a href="Bundle-asp-liste-5.html#AdministrableProductDefinition_2035865">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 1709005}">POLIOMYELITISVIRUS</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <value value="875640"/>
        </identifier>
        <for>
          <reference value="AdministrableProductDefinition/2035865"/>
        </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="1709005"/>
                <display value="POLIOMYELITISVIRUS"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
</Bundle>