UnicomIG
0.1.0 - ci-build

UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions

: 013-LantusSolostar-EE-FullProduct - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="013-LantusSolostar-EE-FullProduct"/>
  <type value="collection"/>
  <entry>
    <fullUrl
             value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/MedicinalProductDefinition-LantusSolostar-EE-MPD"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="LantusSolostar-EE-MPD"/>
        <meta>
          <profile
                   value="http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_LantusSolostar-EE-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition LantusSolostar-EE-MPD</b></p><a name="LantusSolostar-EE-MPD"> </a><a name="hcLantusSolostar-EE-MPD"> </a><a name="hcLantusSolostar-EE-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/EE-100000869-3157</p><p><b>domain</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human use</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000005003 200000005004}">Current</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000007 100000074039}">Solution for injection in pre-filled pen</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 100000072084}">Medicinal product subject to medical prescription</span></p><p><b>classification</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 100000094023}">insulin glargine</span>, <span title="Codes:{http://www.whocc.no/atc A10AE04}">insulin glargine</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis</p><blockquote><p><b>part</b></p><p><b>part</b>: Lantus Solostar</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 100 ühikut/ml</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: süstelahus pen-süstlis</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><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:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}">Republic of Estonia</span></td><td><span title="Codes:{urn:ietf:bcp:47 et}">Estonian</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/fhir/mpId"/>
          <value value="EE-100000869-3157"/>
        </identifier>
        <domain>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
            <code value="100000000012"/>
            <display value="Human use"/>
          </coding>
        </domain>
        <status>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000005003"/>
            <code value="200000005004"/>
            <display value="Current"/>
          </coding>
        </status>
        <combinedPharmaceuticalDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000007"/>
            <code value="100000074039"/>
            <display value="Solution for injection in pre-filled pen"/>
          </coding>
        </combinedPharmaceuticalDoseForm>
        <legalStatusOfSupply>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
            <code value="100000072084"/>
            <display
                     value="Medicinal product subject to medical prescription"/>
          </coding>
        </legalStatusOfSupply>
        <classification>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
            <code value="100000094023"/>
            <display value="insulin glargine"/>
          </coding>
        </classification>
        <classification>
          <coding>
            <system value="http://www.whocc.no/atc"/>
            <code value="A10AE04"/>
            <display value="insulin glargine"/>
          </coding>
        </classification>
        <name>
          <productName
                       value="Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis"/>
          <part>
            <part value="Lantus Solostar"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
                <code value="220000000002"/>
                <display value="Invented name part"/>
              </coding>
            </type>
          </part>
          <part>
            <part value="100 ühikut/ml"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
                <code value="220000000004"/>
                <display value="Strength part"/>
              </coding>
            </type>
          </part>
          <part>
            <part value="süstelahus pen-süstlis"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
                <code value="220000000005"/>
                <display value="Pharmaceutical dose form part"/>
              </coding>
            </type>
          </part>
          <usage>
            <country>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
                <code value="100000000388"/>
                <display value="Republic of Estonia"/>
              </coding>
            </country>
            <language>
              <coding>
                <system value="urn:ietf:bcp:47"/>
                <code value="et"/>
                <display value="Estonian"/>
              </coding>
            </language>
          </usage>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/RegulatedAuthorization-LantusSolostar-EE-RA"/>
    <resource>
      <RegulatedAuthorization>
        <id value="LantusSolostar-EE-RA"/>
        <meta>
          <profile
                   value="http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_LantusSolostar-EE-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization LantusSolostar-EE-RA</b></p><a name="LantusSolostar-EE-RA"> </a><a name="hcLantusSolostar-EE-RA"> </a><a name="hcLantusSolostar-EE-RA-en-US"> </a><p><b>identifier</b>: EU/1/00/134</p><p><b>subject</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000390}">European Union</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 200000017708}">Valid - Renewed/Varied</span></p><p><b>statusDate</b>: 2022-06-28</p><p><b>holder</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#Organization_LOC-100000869-Sanofi-Aventis-Deutchland">Bundle: type = collection</a></p></div>
        </text>
        <identifier>
          <value value="EU/1/00/134"/>
        </identifier>
        <subject>
          <reference
                     value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
        </subject>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
            <code value="220000000061"/>
            <display value="Marketing Authorisation"/>
          </coding>
        </type>
        <region>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
            <code value="100000000390"/>
            <display value="European Union"/>
          </coding>
        </region>
        <status>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
            <code value="200000017708"/>
            <display value="Valid - Renewed/Varied"/>
          </coding>
        </status>
        <statusDate value="2022-06-28"/>
        <holder>
          <reference
                     value="Organization/LOC-100000869-Sanofi-Aventis-Deutchland"/>
        </holder>
      </RegulatedAuthorization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization-LOC-100000869-Sanofi-Aventis-Deutchland"/>
    <resource>
      <Organization>
        <id value="LOC-100000869-Sanofi-Aventis-Deutchland"/>
        <meta>
          <profile
                   value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_LOC-100000869-Sanofi-Aventis-Deutchland"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100000869-Sanofi-Aventis-Deutchland</b></p><a name="LOC-100000869-Sanofi-Aventis-Deutchland"> </a><a name="hcLOC-100000869-Sanofi-Aventis-Deutchland"> </a><a name="hcLOC-100000869-Sanofi-Aventis-Deutchland-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100000869, <code>https://spor.ema.europa.eu/v1/organisations</code>/ORG-100001175</p><p><b>name</b>: Sanofi-Aventis Deutschland GmbH</p></div>
        </text>
        <identifier>
          <system value="https://spor.ema.europa.eu/v1/locations"/>
          <value value="LOC-100000869"/>
        </identifier>
        <identifier>
          <system value="https://spor.ema.europa.eu/v1/organisations"/>
          <value value="ORG-100001175"/>
        </identifier>
        <name value="Sanofi-Aventis Deutschland GmbH"/>
      </Organization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition-LantusSolostar-EE-APD"/>
    <resource>
      <AdministrableProductDefinition>
        <id value="LantusSolostar-EE-APD"/>
        <meta>
          <profile
                   value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_LantusSolostar-EE-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition LantusSolostar-EE-APD</b></p><a name="LantusSolostar-EE-APD"> </a><a name="hcLantusSolostar-EE-APD"> </a><a name="hcLantusSolostar-EE-APD-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002135}">Pen</span></p><p><b>producedFrom</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#ManufacturedItemDefinition_LantusSolostar-EE-MID">Bundle: 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:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073633}">Subcutaneous use</span></td></tr></table></div>
        </text>
        <status value="active"/>
        <formOf>
          <reference
                     value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
        </formOf>
        <administrableDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
            <code value="100000073863"/>
            <display value="Solution for injection"/>
          </coding>
        </administrableDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
            <code value="200000002135"/>
            <display value="Pen"/>
          </coding>
        </unitOfPresentation>
        <producedFrom>
          <reference
                     value="ManufacturedItemDefinition/LantusSolostar-EE-MID"/>
        </producedFrom>
        <routeOfAdministration>
          <code>
            <coding>
              <system
                      value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
              <code value="100000073633"/>
              <display value="Subcutaneous use"/>
            </coding>
          </code>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/ManufacturedItemDefinition-LantusSolostar-EE-MID"/>
    <resource>
      <ManufacturedItemDefinition>
        <id value="LantusSolostar-EE-MID"/>
        <meta>
          <profile
                   value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_LantusSolostar-EE-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition LantusSolostar-EE-MID</b></p><a name="LantusSolostar-EE-MID"> </a><a name="hcLantusSolostar-EE-MID"> </a><a name="hcLantusSolostar-EE-MID-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002135}">Pen</span></p></div>
        </text>
        <status value="active"/>
        <manufacturedDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
            <code value="100000073863"/>
            <display value="Solution for injection"/>
          </coding>
        </manufacturedDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
            <code value="200000002135"/>
            <display value="Pen"/>
          </coding>
        </unitOfPresentation>
      </ManufacturedItemDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient-LantusSolostar-EE-I"/>
    <resource>
      <Ingredient>
        <id value="LantusSolostar-EE-I"/>
        <meta>
          <profile
                   value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusSolostar-EE-I"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusSolostar-EE-I</b></p><a name="LantusSolostar-EE-I"> </a><a name="hcLantusSolostar-EE-I"> </a><a name="hcLantusSolostar-EE-I-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></li><li><a href="Bundle-013-LantusSolostar-EE-FullProduct.html#ManufacturedItemDefinition_LantusSolostar-EE-MID">Bundle: type = collection</a></li><li><a href="Bundle-013-LantusSolostar-EE-FullProduct.html#AdministrableProductDefinition_LantusSolostar-EE-APD">Bundle: type = collection</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}">Active</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/v2/SubstanceDefinition 100000085460}">Insulin glargine</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concentration[x]</b></td></tr><tr><td style="display: none">*</td><td>100 unit(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA  code100000110756 = 'unit(s)')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA  code100000110662 = 'millilitre(s)')</span></td></tr></table></blockquote></div>
        </text>
        <status value="active"/>
        <for>
          <reference
                     value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
        </for>
        <for>
          <reference
                     value="ManufacturedItemDefinition/LantusSolostar-EE-MID"/>
        </for>
        <for>
          <reference
                     value="AdministrableProductDefinition/LantusSolostar-EE-APD"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
            <code value="100000072072"/>
            <display value="Active"/>
          </coding>
        </role>
        <substance>
          <code>
            <concept>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
                <code value="100000085460"/>
                <display value="Insulin glargine"/>
              </coding>
            </concept>
          </code>
          <strength>
            <concentrationRatio>
              <numerator>
                <value value="100"/>
                <unit value="unit(s)"/>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
                <code value="100000110756"/>
              </numerator>
              <denominator>
                <value value="1"/>
                <unit value="millilitre(s)"/>
                <system
                        value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
                <code value="100000110662"/>
              </denominator>
            </concentrationRatio>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition-LantusSolostar-EE-PPD-1265778"/>
    <resource>
      <PackagedProductDefinition>
        <id value="LantusSolostar-EE-PPD-1265778"/>
        <meta>
          <profile
                   value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_LantusSolostar-EE-PPD-1265778"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition LantusSolostar-EE-PPD-1265778</b></p><a name="LantusSolostar-EE-PPD-1265778"> </a><a name="hcLantusSolostar-EE-PPD-1265778"> </a><a name="hcLantusSolostar-EE-PPD-1265778-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/EE-100000869-3157-1265778</p><p><b>packageFor</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></p><p><b>containedItemQuantity</b>: 5 Pen<span style="background: LightGoldenRodYellow"> (Details: Unit of Presentation EMA  code200000002135 = 'Pen')</span></p><p><b>description</b>: </p><div><p>Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis. I tüüpi värvitust klaasist kolbampull musta värvi kolvi (broombutüülkumm), äärikkattega
(alumiinium) ja korgiga (broombutüülkumm või polüisopreenlaminaat ja broombutüülkumm);
sisaldab 3 ml süstelahust. Kolbampull on paigaldatud mittetäidetavasse pen-süstlisse. Nõelad ei sisaldu pakendis.
Pakendis on 5 pen-süstlit.</p>
</div><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}">Republic of Estonia</span></td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003529}">Cardboard</span></p><blockquote><p><b>packaging</b></p></blockquote></blockquote></div>
        </text>
        <identifier>
          <system value="http://ema.europa.eu/example/pcid"/>
          <value value="EE-100000869-3157-1265778"/>
        </identifier>
        <packageFor>
          <reference
                     value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
        </packageFor>
        <containedItemQuantity>
          <value value="5"/>
          <unit value="Pen"/>
          <system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
          <code value="200000002135"/>
        </containedItemQuantity>
        <description
                     value="Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis. I tüüpi värvitust klaasist kolbampull musta värvi kolvi (broombutüülkumm), äärikkattega
(alumiinium) ja korgiga (broombutüülkumm või polüisopreenlaminaat ja broombutüülkumm);
sisaldab 3 ml süstelahust. Kolbampull on paigaldatud mittetäidetavasse pen-süstlisse. Nõelad ei sisaldu pakendis.
Pakendis on 5 pen-süstlit."/>
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