Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. 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/gravitate-health/ and changes regularly. See the Directory of published versions

: ePI document Bundle for Ogivri 150 mg powder for concentrate for solution for infusion Package Leaflet for language en - XML Representation

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          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_ap-5af3df1132d20d744a88dab06e924e5e"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition ap-5af3df1132d20d744a88dab06e924e5e</b></p><a name="ap-5af3df1132d20d744a88dab06e924e5e"> </a><a name="hcap-5af3df1132d20d744a88dab06e924e5e"> </a><a name="ap-5af3df1132d20d744a88dab06e924e5e-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/id</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073863}">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002158}">Vial</span></p><p><b>producedFrom</b>: <a href="Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#ManufacturedItemDefinition_mid-5af3df1132d20d744a88dab06e924e5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073611}">Intravenous use</span></p><h3>TargetSpecies</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/rmswi 100000109093}">Human</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="https://spor.ema.europa.eu/pmswi"/>
          <value value="id"/>
        </identifier>
        <status value="active"/>
        <formOf>
          <reference
                     value="MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"/>
        </formOf>
        <administrableDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000073863"/>
            <display value="Solution for injection"/>
          </coding>
        </administrableDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="200000002158"/>
            <display value="Vial"/>
          </coding>
        </unitOfPresentation>
        <producedFrom>
          <reference
                     value="ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e"/>
        </producedFrom>
        <routeOfAdministration>
          <code>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="100000073611"/>
              <display value="Intravenous use"/>
            </coding>
          </code>
          <targetSpecies>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi"/>
                <code value="100000109093"/>
                <display value="Human"/>
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  <entry>
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             value="http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization5af3df1132d20d744a88dab06e924e5e0"/>
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      <RegulatedAuthorization>
        <id value="authorization5af3df1132d20d744a88dab06e924e5e0"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_authorization5af3df1132d20d744a88dab06e924e5e0"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization authorization5af3df1132d20d744a88dab06e924e5e0</b></p><a name="authorization5af3df1132d20d744a88dab06e924e5e0"> </a><a name="hcauthorization5af3df1132d20d744a88dab06e924e5e0"> </a><a name="authorization5af3df1132d20d744a88dab06e924e5e0-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1341/001 (use: official, )</p><p><b>subject</b>: <a href="Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000061}">Marketing Authorisation</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2018-12-12 00:00:00+0000</p><p><b>holder</b>: <a href="Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#Organization_mah-5192019d531d0f82a0e8d8ffcb39b68a">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/pmswi"/>
          <value value="EU/1/18/1341/001"/>
        </identifier>
        <subject>
          <reference
                     value="MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"/>
        </subject>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="220000000061"/>
            <display value="Marketing Authorisation"/>
          </coding>
        </type>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="Active"/>
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        <statusDate value="2018-12-12T00:00:00Z"/>
        <holder>
          <reference
                     value="Organization/mah-5192019d531d0f82a0e8d8ffcb39b68a"/>
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  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-5192019d531d0f82a0e8d8ffcb39b68a"/>
    <resource>
      <Organization>
        <id value="mah-5192019d531d0f82a0e8d8ffcb39b68a"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_mah-5192019d531d0f82a0e8d8ffcb39b68a"> </a><p class="res-header-id"><b>Generated Narrative: Organization mah-5192019d531d0f82a0e8d8ffcb39b68a</b></p><a name="mah-5192019d531d0f82a0e8d8ffcb39b68a"> </a><a name="hcmah-5192019d531d0f82a0e8d8ffcb39b68a"> </a><a name="mah-5192019d531d0f82a0e8d8ffcb39b68a-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/ORG-100034260 (use: official, )</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000034}">Marketing authorisation holder</span></p><p><b>name</b>: Viatris Limited</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Damastown Industrial Park, Mulhuddart, Dublin 15 Dublin IR(work)</td></tr></table></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/omswi"/>
          <value value="ORG-100034260"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="220000000034"/>
            <display value="Marketing authorisation holder"/>
          </coding>
        </type>
        <name value="Viatris Limited"/>
        <contact>
          <address>
            <use value="work"/>
            <type value="physical"/>
            <text
                  value="Damastown Industrial Park, Mulhuddart, Dublin 15 Dublin IR"/>
            <line value="Damastown Industrial Park, Mulhuddart, Dublin 15"/>
            <city value="Dublin"/>
            <country value="IR"/>
          </address>
        </contact>
      </Organization>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-e7c391536e9fc6ff50198d09558da8c0"/>
    <resource>
      <PackagedProductDefinition>
        <id value="ppd-e7c391536e9fc6ff50198d09558da8c0"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-e7c391536e9fc6ff50198d09558da8c0"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-e7c391536e9fc6ff50198d09558da8c0</b></p><a name="ppd-e7c391536e9fc6ff50198d09558da8c0"> </a><a name="hcppd-e7c391536e9fc6ff50198d09558da8c0"> </a><a name="ppd-e7c391536e9fc6ff50198d09558da8c0-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/18/1341/001 (use: official, )</p><p><b>name</b>: Ogivri 150 mg powder for concentrate for solution for infusion  1</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000155527}">Chemical Medicinal Product</span></p><p><b>packageFor</b>: <a href="Bundle-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2015-02-07 13:28:17+0000</p><p><b>containedItemQuantity</b>: 150 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM  codemg = 'mg')</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003529}">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/123456</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073563}">Vial</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003204}">Glass type I</span></p><blockquote><p><b>containedItem</b></p><h3>Items</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-bundlepackageleaflet-en-5af3df1132d20d744a88dab06e924e5e.html#ManufacturedItemDefinition_mid-5af3df1132d20d744a88dab06e924e5e">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#7027e635478c3b3a26b4c7ea7238a57c; type = document; timestamp = 2023-06-27 10:09:22+0000</a></td></tr></table></blockquote></blockquote></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/pmswi"/>
          <value value="EU/1/18/1341/001"/>
        </identifier>
        <name
              value="Ogivri 150 mg powder for concentrate for solution for infusion  1"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000155527"/>
            <display value="Chemical Medicinal Product"/>
          </coding>
        </type>
        <packageFor>
          <reference
                     value="MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"/>
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        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="Active"/>
          </coding>
        </status>
        <statusDate value="2015-02-07T13:28:17Z"/>
        <containedItemQuantity>
          <value value="150"/>
          <system value="http://unitsofmeasure.org"/>
          <code value="mg"/>
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        <packaging>
          <type>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="100000073498"/>
              <display value="Box"/>
            </coding>
          </type>
          <quantity value="1"/>
          <material>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="200000003529"/>
              <display value="Cardboard"/>
            </coding>
          </material>
          <packaging>
            <identifier>
              <system value="https://spor.ema.europa.eu/pmswi"/>
              <value value="123456"/>
            </identifier>
            <type>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi"/>
                <code value="100000073563"/>
                <display value="Vial"/>
              </coding>
            </type>
            <quantity value="1"/>
            <material>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi"/>
                <code value="200000003204"/>
                <display value="Glass type I"/>
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            </material>
            <containedItem>
              <item>
                <reference>
                  <reference
                             value="ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e"/>
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          </packaging>
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  </entry>
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             value="http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpaae8d931abe2f2d9085b87555b9bb088"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="mpaae8d931abe2f2d9085b87555b9bb088"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpaae8d931abe2f2d9085b87555b9bb088"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpaae8d931abe2f2d9085b87555b9bb088</b></p><a name="mpaae8d931abe2f2d9085b87555b9bb088"> </a><a name="hcmpaae8d931abe2f2d9085b87555b9bb088"> </a><a name="mpaae8d931abe2f2d9085b87555b9bb088-en-US"> </a><p><b>identifier</b>: <code>https://www.who-umc.org/phpid/4</code>/7532F47F36A3585D1F348BBDDA057862</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Ogivri 150 mg powder for concentrate for solution for infusion</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Ogivri</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: trastuzumab</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 150 mg</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: powder for concentrate for solution for infusion</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/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>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 NOR}">Norway</span></td><td><span title="Codes:{urn:iso:std:iso:3166 NOR}">Norway</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td></tr></table></blockquote></div>
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          <coding>
            <system value="http://hl7.org/fhir/medicinal-product-type"/>
            <code value="MedicinalProduct"/>
            <display value="Medicinal Product"/>
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          <coding>
            <system value="http://hl7.org/fhir/medicinal-product-domain"/>
            <code value="Human"/>
            <display value="Human use"/>
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        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="active"/>
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        <legalStatusOfSupply>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072084"/>
            <display
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        <name>
          <productName
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          <type>
            <coding>
              <system value="https://spor.ema.europa.eu/lists/220000000000"/>
              <code value="220000000001"/>
              <display value="Full name"/>
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          <part>
            <part value="Ogivri"/>
            <type>
              <coding>
                <system
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                <code value="220000000002"/>
                <display value="Invented name part"/>
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          <part>
            <part value="trastuzumab"/>
            <type>
              <coding>
                <system
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                <code value="220000000003"/>
                <display value="Scientific name part"/>
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          </part>
          <part>
            <part value="150 mg"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000004"/>
                <display value="Strength part"/>
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          <part>
            <part value="powder for concentrate for solution for infusion"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000005"/>
                <display value="Pharmaceutical dose form part"/>
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            </type>
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          <usage>
            <country>
              <coding>
                <system value="urn:iso:std:iso:3166"/>
                <code value="NOR"/>
                <display value="Norway"/>
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            </country>
            <jurisdiction>
              <coding>
                <system value="urn:iso:std:iso:3166"/>
                <code value="NOR"/>
                <display value="Norway"/>
              </coding>
            </jurisdiction>
            <language>
              <coding>
                <system value="urn:ietf:bcp:47"/>
                <code value="en"/>
                <display value="English"/>
              </coding>
            </language>
          </usage>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-5af3df1132d20d744a88dab06e924e5e"/>
    <resource>
      <ManufacturedItemDefinition>
        <id value="mid-5af3df1132d20d744a88dab06e924e5e"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
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        </text>
        <identifier>
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