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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-9"/>
  <!--  <meta>  -->
  <!--  <versionId value="2.0.0+20240208"/>   -->
  <!--  not to be set by exporter  -->
  <!--  <lastUpdated value="2025-06-25T17:08:49.470+02:00"/>  -->
  <!--  should be moved to Bundle.timestamp  -->
  <!--  </meta>  -->
  <identifier>
    <value value="1.2.40.0.34.4.16"/>
  </identifier>
  <type value="collection"/>
  <timestamp value="2025-06-25T17:08:49.470+02:00"/>
  <entry>
    <fullUrl
             value="https://www.ages.at/MedicinalProductDefinition/101273992"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="101273992"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_101273992"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 101273992</b></p><a name="101273992"> </a><a name="hc101273992"> </a><p><b>identifier</b>: <code>https://www.ages.at/fhir/referenceNumber</code>/101273992</p><p><b>domain</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human use</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000116186}">Pulver zur Herstellung einer Injektions-/Infusionslösung</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 100000096140}, {http://www.whocc.no/atc J01CE01}">Benzylpenicillin</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>Penicillin G Kabi 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung</td></tr></table></div>
        </text>
        <identifier>
          <system value="https://www.ages.at/fhir/referenceNumber"/>
          <value value="101273992"/>
        </identifier>
        <domain>
          <!--  use correct display names  -->
          <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 use"/>
          </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/200000000004"/>
            <!--  200000000006 has been used before - maybe 200000000004 shall be used? CodeSystem and code do not match  -->
            <code value="100000116186"/>
            <!--  belongs to https://spor.ema.europa.eu/v1/lists/200000000004  -->
            <display
                     value="Pulver zur Herstellung einer Injektions-/Infusionslösung"/>
          </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"/>
            <!--  Veterinary medicinal product subject to veterinary prescription - does not match german text  -->
            <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"/>
            <!--  CodeSystem should be included in IG  -->
            <code value="100000096140"/>
            <display value="Benzylpenicillin"/>
          </coding>
          <coding>
            <!--  no extension is necessary here  -->
            <!--  <extension url="http://ema.europa.eu/fhir/extension/atcGroup">
                     <valueString value="???"/>
                  </extension>  -->
            <system value="http://www.whocc.no/atc"/>
            <code value="J01CE01"/>
            <display value="Benzylpenicillin"/>
          </coding>
        </classification>
        <name>
          <productName
                       value="Penicillin G Kabi 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung"/>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="https://www.ages.at/PackagedProductDefinition/6058839"/>
    <resource>
      <PackagedProductDefinition>
        <id value="6058839"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_6058839"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition 6058839</b></p><a name="6058839"> </a><a name="hc6058839"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/dataCarrierIdentifier</code>/6058839</p><p><b>packageFor</b>: <a href="Bundle-asp-liste-9.html#MedicinalProductDefinition_101273992">Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200</a></p><p><b>containedItemQuantity</b>: 10.0 Durchstechflasche<span style="background: LightGoldenRodYellow"> (Details: Units Of Presentation  code200000002158 = 'Durchstechflasche')</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"/>
          <!--  What kind of identifier is this - not specified in IG  -->
          <value value="6058839"/>
        </identifier>
        <packageFor>
          <reference value="MedicinalProductDefinition/101273992"/>
        </packageFor>
        <containedItemQuantity>
          <value value="10.0"/>
          <unit value="Durchstechflasche"/>
          <system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
          <!--  https://spor.ema.europa.eu/v1/lists/200000000014 has to be used here  -->
          <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="https://www.ages.at/RegulatedAuthorization/142464"/>
    <resource>
      <RegulatedAuthorization>
        <id value="142464"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_142464"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 142464</b></p><a name="142464"> </a><a name="hc142464"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/142464</p><p><b>subject</b>: <a href="Bundle-asp-liste-9.html#MedicinalProductDefinition_101273992">Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200</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>: Fresenius Kabi Austria GmbH (Identifier: <code>https://spor.ema.europa.eu/omswi</code>/LOC-100001746)</p></div>
        </text>
        <identifier>
          <system
                  value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
          <value value="142464"/>
        </identifier>
        <subject>
          <reference value="MedicinalProductDefinition/101273992"/>
        </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>
          <!--  wrongly created  -->
          <identifier>
            <system value="https://spor.ema.europa.eu/omswi"/>
            <value value="LOC-100001746"/>
          </identifier>
          <display value="Fresenius Kabi Austria GmbH"/>
        </holder>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="https://www.ages.at/AdministrableProductDefinition/2038377"/>
    <resource>
      <AdministrableProductDefinition>
        <id value="2038377"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_2038377"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition 2038377</b></p><a name="2038377"> </a><a name="hc2038377"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/2038377</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-asp-liste-9.html#MedicinalProductDefinition_101273992">Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073600}">intramuskuläre Anwendung</span></p></blockquote><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073611}">intravenöse Anwendung</span></p></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <!--  What kind of identifier is this - not specified in IG  -->
          <value value="2038377"/>
        </identifier>
        <!--  duplicated identifier  -->
        <!--  <identifier>
               <system value="http://ema.europa.eu/fhir/???"/>
               <value value="2038377"/>
            </identifier>  -->
        <!--  status missing  -->
        <status value="active"/>
        <formOf>
          <reference value="MedicinalProductDefinition/101273992"/>
        </formOf>
        <routeOfAdministration>
          <code>
            <coding>
              <!--  missing extension  -->
              <!--  missing system -->
              <system
                      value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
              <code value="100000073600"/>
              <display value="intramuskuläre Anwendung"/>
            </coding>
          </code>
        </routeOfAdministration>
        <routeOfAdministration>
          <code>
            <coding>
              <!--  missing extension  -->
              <!--  missing system  -->
              <system
                      value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
              <code value="100000073611"/>
              <display value="intravenöse Anwendung"/>
            </coding>
          </code>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="https://www.ages.at/Ingredient/1597141"/>
    <resource>
      <Ingredient>
        <id value="1597141"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_1597141"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 1597141</b></p><a name="1597141"> </a><a name="hc1597141"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/???</code>/1597141</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="Bundle-asp-liste-9.html#AdministrableProductDefinition_2038377">Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200</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 1708931}">BENZYLPENICILLIN NATRIUM</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 1000000.0 IE<span style="background: LightGoldenRodYellow"> (Details: Units Of Measurement  code100000110671 = 'international unit(s)')</span>/1.0 Durchstechflasche<span style="background: LightGoldenRodYellow"> (Details: Units Of Presentation  code200000002158 = 'Durchstechflasche')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-asp-liste-9.html#SubstanceDefinition_7421791">Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200</a></td></tr></table><p><b>strength</b>: 938323.0 IE<span style="background: LightGoldenRodYellow"> (Details: Units Of Measurement  code100000110671 = 'international unit(s)')</span>/1.0 Durchstechflasche<span style="background: LightGoldenRodYellow"> (Details: Units Of Presentation  code200000002158 = 'Durchstechflasche')</span></p></blockquote></blockquote></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/???"/>
          <value value="1597141"/>
        </identifier>
        <!--  status missing  -->
        <status value="active"/>
        <!--  assuming active  -->
        <for>
          <reference value="AdministrableProductDefinition/2038377"/>
        </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="1708931"/>
                <display value="BENZYLPENICILLIN NATRIUM"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationRatio>
              <numerator>
                <value value="1000000.0"/>
                <unit value="IE"/>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
                <code value="100000110671"/>
              </numerator>
              <denominator>
                <value value="1.0"/>
                <unit value="Durchstechflasche"/>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
                <code value="200000002158"/>
              </denominator>
            </presentationRatio>
            <referenceStrength>
              <substance>
                <reference>
                  <reference value="SubstanceDefinition/7421791"/>
                </reference>
              </substance>
              <strengthRatio>
                <numerator>
                  <value value="938323.0"/>
                  <unit value="IE"/>
                  <system
                          value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
                  <code value="100000110671"/>
                </numerator>
                <denominator>
                  <value value="1.0"/>
                  <unit value="Durchstechflasche"/>
                  <system
                          value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
                  <code value="200000002158"/>
                </denominator>
              </strengthRatio>
            </referenceStrength>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl value="https://www.ages.at/SubstanceDefinition/7421791"/>
    <resource>
      <SubstanceDefinition>
        <id value="7421791"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_7421791"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 7421791</b></p><a name="7421791"> </a><a name="hc7421791"> </a><h3>Codes</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:{https://spor.ema.europa.eu/v1/lists/substanceDefinition 100000091070}">BENZYLPENICILLIN</span></td></tr></table></div>
        </text>
        <code>
          <code>
            <coding>
              <system
                      value="https://spor.ema.europa.eu/v1/lists/substanceDefinition"/>
              <code value="100000091070"/>
              <display value="BENZYLPENICILLIN"/>
            </coding>
          </code>
        </code>
      </SubstanceDefinition>
    </resource>
  </entry>
</Bundle>