Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

: Vulcan Dovato FHIR Package Insert EMA - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="cfsb1651596479132"/>
  <identifier>
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    <value value="EU/1/19/1370/001"/>
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  <timestamp value="2011-06-23T08:38:00+02:00"/>
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        <id value="cfsb1651231019151"/>
        <language value="en"/>
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          <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p><b>Generated Narrative: Composition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Composition "cfsb1651231019151"  (Language "en") </p></div><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000155538)</span></p><p><b>date</b>: 2022-04-29 01:28:17+0000</p><p><b>author</b>: <a href="#Organization_cfsb1651149636159">See above (Organization/cfsb1651149636159)</a></p><p><b>title</b>: TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets</p><p><b>confidentiality</b>: U</p><h3>Attesters</h3><table class="grid"><tr><td>-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td>*</td><td>Official <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://build.fhir.org/codesystem-composition-attestation-mode.html">CompositionAttestationMode</a>#official)</span></td><td>2002-08-01 01:28:17+0000</td></tr></table></div>
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               value="TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets"/>
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        <section>
          <title value="B. Package Leaflet"/>
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            <div xmlns="http://www.w3.org/1999/xhtml">Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.<ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
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          <title value="What is in this leaflet"/>
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            <div xmlns="http://www.w3.org/1999/xhtml">What in this leaflet<ol><li>What Dovato is and what it is used for</li><li>What you need to know before you take Dovato</li><li>How to take Dovato</li><li>Possible side effects</li><li>How to store Dovato</li><li>Contents of the pack and other information</li></ol></div>
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        <section>
          <title value="1. What Dovato is and what it is used for"/>
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            <div xmlns="http://www.w3.org/1999/xhtml"><b>1. What Dovato is and what it is used for</b> Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.</div>
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        <section>
          <title value="2. What you need to know before you take Dovato"/>
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            <div xmlns="http://www.w3.org/1999/xhtml"><b>2. What you need to know before you take Dovato</b> Do not take Dovato<ul><li>if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).</li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>
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        <section>
          <title value="3. How to take Dovato"/>
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            <div xmlns="http://www.w3.org/1999/xhtml"><b>How to take Dovato</b><p>Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure</p><ul><li>The recommended dose of Dovato is <b>one tablet once a day.</b></li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>
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          <title value="4. Possible side effects"/>
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            <div xmlns="http://www.w3.org/1999/xhtml"><p><b>4. Possible side effects</b></p><p>Like all medicines, this medicine can cause side effects, although not everybody gets them,<b>so it is very important to talk to your doctor about any changes in your health</b></p></div>
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          <title value="5. How to store Dovato"/>
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            <text value="B. PACKAGE LEAFLET"/>
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            <div xmlns="http://www.w3.org/1999/xhtml"><b>5. How to store Dovato</b><p>Keep this medicine out of the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.</p><p>This medicine does not require any special storage conditions.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>
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          <title value="6. Contents of the pack and other information"/>
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            <div xmlns="http://www.w3.org/1999/xhtml"><b>6. Contents of the pack and other information</b> <b>What Dovato contains</b><ul><li>The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.</li><li>The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).</li><li>This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.</li></ul></div>
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          <line value="Avda. Extremadura 3, 09400 Aranda De Duero"/>
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          <line
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          <city value="Amsterdam"/>
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          <country value="nl"/>
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          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Organization "cfsb1651149636159" </p></div><p><b>identifier</b>: id: ORG-100012958 (OFFICIAL)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#220000000034)</span></p><p><b>name</b>: ViiV Healthcare BV</p><p><b>address</b>: Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands(WORK)</p></div>
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        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PackagedProductDefinition "cfsb1650995718524" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>name</b>: Dovato 50 mg/300 mg film-coated tablets</p><p><b>type</b>: Chemical Medicinal Prodcut <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#100000155527)</span></p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_cfsb1650904258324">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://build.fhir.org/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2012-02-07 01:28:17+0000</p><p><b>containedItemQuantity</b>: 30 tablets</p><p><b>manufacturer</b>: <a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></p><h3>Packages</h3><table class="grid"><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td>*</td><td>id: 654321</td><td>Child-resistant closure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#100000073504)</span></td><td>1</td><td>Cardboard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#200000003529)</span></td></tr></table></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="$spor-prod"/>
          <value value="EU/1/19/1370/001"/>
        </identifier>
        <name value="Dovato 50 mg/300 mg film-coated tablets"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000155527"/>
          </coding>
          <text value="Chemical Medicinal Prodcut"/>
        </type>
        <packageFor>
          <reference value="MedicinalProductDefinition/cfsb1650904258324"/>
        </packageFor>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="Active"/>
          </coding>
        </status>
        <statusDate value="2012-02-07T13:28:17Z"/>
        <containedItemQuantity>
          <value value="30"/>
          <unit value="tablets"/>
        </containedItemQuantity>
        <manufacturer>
          <reference value="Organization/cfsb1650997423990"/>
        </manufacturer>
        <package>
          <identifier>
            <system value="https://spor.ema.europa.eu/pmswi"/>
            <value value="654321"/>
          </identifier>
          <type>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="100000073504"/>
              <display value="Child-resistant closure"/>
            </coding>
          </type>
          <quantity value="1"/>
          <material>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="200000003529"/>
              <display value="Cardboard"/>
            </coding>
          </material>
        </package>
      </PackagedProductDefinition>
    </resource>
  </entry>
  <entry>
    <resource>
      <AdministrableProductDefinition>
        <id value="cfsb1650999516847"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdministrableProductDefinition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource AdministrableProductDefinition "cfsb1650999516847" </p></div><p><b>identifier</b>: id: 123456</p><p><b>status</b>: active</p><p><b>formOf</b>: <a href="#MedicinalProductDefinition_cfsb1650904258324">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>administrableDoseForm</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#10219000)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#15054000)</span></p><p><b>producedFrom</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#20053000)</span></p><h3>TargetSpecies</h3><table class="grid"><tr><td>-</td><td><b>Code</b></td></tr><tr><td>*</td><td>Human <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000109093)</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <system value="https://www.who-umc.org/phpid"/>
          <value value="123456"/>
        </identifier>
        <status value="active"/>
        <formOf>
          <reference value="MedicinalProductDefinition/cfsb1650904258324"/>
        </formOf>
        <administrableDoseForm>
          <coding>
            <system
                    value="https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/"/>
            <code value="10219000"/>
          </coding>
          <text value="Tablet"/>
        </administrableDoseForm>
        <unitOfPresentation>
          <coding>
            <system
                    value="https://standardterms.edqm.eu/browse/get_concepts/UOP/"/>
            <code value="15054000"/>
          </coding>
          <text value="Tablet"/>
        </unitOfPresentation>
        <producedFrom>
          <reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
        </producedFrom>
        <routeOfAdministration>
          <code>
            <coding>
              <system
                      value="https://standardterms.edqm.eu/browse/get_concepts/ROA/"/>
              <code value="20053000"/>
            </coding>
            <text value="Oral use"/>
          </code>
          <targetSpecies>
            <code>
              <coding>
                <system value="https://spor.ema.europa.eu/rmswi/"/>
                <code value="/#100000109093"/>
              </coding>
              <text value="Human"/>
            </code>
          </targetSpecies>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <resource>
      <ManufacturedItemDefinition>
        <id value="cfsb1650998521654"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ManufacturedItemDefinition</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ManufacturedItemDefinition "cfsb1650998521654" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Film-coated tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000073665)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-CodeSystemUvEPIRrmswi.html">Referentials Management Services CodeSystem</a>#200000002152)</span></p><p><b>manufacturer</b>: <a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://spor.ema.europa.eu/pmswi/#/"/>
          <value value="EU/1/19/1370/001"/>
        </identifier>
        <status value="active"/>
        <manufacturedDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000073665"/>
          </coding>
          <text value="Film-coated tablet"/>
        </manufacturedDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="200000002152"/>
          </coding>
          <text value="Tablet"/>
        </unitOfPresentation>
        <manufacturer>
          <reference value="Organization/cfsb1650997423990"/>
        </manufacturer>
      </ManufacturedItemDefinition>
    </resource>
  </entry>
  <entry>
    <resource>
      <Ingredient>
        <id value="cfsb1651162710491"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651162710491" </p></div><p><b>identifier</b>: id: 1Q1V9V5WYQ (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#00000072072)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class="grid"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>50 mg</td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="1Q1V9V5WYQ"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="00000072072"/>
          </coding>
          <text value="active"/>
        </role>
        <manufacturer>
          <manufacturer>
            <reference value="Organization/cfsb1650997423990"/>
          </manufacturer>
        </manufacturer>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
                <code value="1Q1V9V5WYQ"/>
                <display value="DOLUTEGRAVIR SODIUM"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationQuantity>
              <value value="50"/>
              <unit value="mg"/>
            </presentationQuantity>
            <basis>
              <coding>
                <system
                        value="http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity"/>
                <code value="#ACTIB"/>
              </coding>
              <text value="active ingredient - basis of strength"/>
            </basis>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <resource>
      <Ingredient>
        <id value="cfsb1651164758053"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651164758053" </p></div><p><b>identifier</b>: id: 2T8Q726O95 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072072)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class="grid"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>300 mg</td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="2T8Q726O95"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000072072"/>
          </coding>
          <text value="active"/>
        </role>
        <manufacturer>
          <manufacturer>
            <reference value="Organization/cfsb1650997423990"/>
          </manufacturer>
        </manufacturer>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
                <code value="2T8Q726O95"/>
                <display value="lamivudine"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationQuantity>
              <value value="300"/>
              <unit value="mg"/>
            </presentationQuantity>
            <basis>
              <coding>
                <system
                        value="http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity"/>
                <code value="#ACTIB"/>
              </coding>
              <text value="active ingredient - basis of strength"/>
            </basis>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <resource>
      <Ingredient>
        <id value="cfsb1651170791283"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651170791283" </p></div><p><b>identifier</b>: id: OP1R32D61U (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="OP1R32D61U"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000072082"/>
          </coding>
          <text value="Excipient"/>
        </role>
        <manufacturer>
          <manufacturer>
            <reference value="Organization/cfsb1650997423990"/>
          </manufacturer>
        </manufacturer>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
                <code value="OP1R32D61U"/>
                <display value="microcrystalline cellulose"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <resource>
      <Ingredient>
        <id value="cfsb1651229974487"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651229974487" </p></div><p><b>identifier</b>: id: H8AV0SQX4D (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="H8AV0SQX4D"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000072082"/>
          </coding>
          <text value="Excipient"/>
        </role>
        <manufacturer>
          <manufacturer>
            <reference value="Organization/cfsb1650997423990"/>
          </manufacturer>
        </manufacturer>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
                <code value="H8AV0SQX4D"/>
                <display value="sodium starch glycolate"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <resource>
      <Ingredient>
        <id value="cfsb1651230170831"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651230170831" </p></div><p><b>identifier</b>: id: 70097M6I30 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="70097M6I30"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000072082"/>
          </coding>
          <text value="Excipient"/>
        </role>
        <manufacturer>
          <manufacturer>
            <reference value="Organization/cfsb1650997423990"/>
          </manufacturer>
        </manufacturer>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
                <code value="70097M6I30"/>
                <display value="magnesium stearate"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <resource>
      <Ingredient>
        <id value="cfsb1651230330246"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "cfsb1651230330246" </p></div><p><b>identifier</b>: id: 3OWL53L36A (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href="#ManufacturedItemDefinition_cfsb1650998521654">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000072082)</span></p><h3>Manufacturers</h3><table class="grid"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href="#Organization_cfsb1650997423990">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="3OWL53L36A"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference value="ManufacturedItemDefinition/cfsb1650998521654"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000072082"/>
          </coding>
          <text value="Excipient"/>
        </role>
        <manufacturer>
          <manufacturer>
            <reference value="Organization/cfsb1650997423990"/>
          </manufacturer>
        </manufacturer>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
                <code value="3OWL53L36A"/>
                <display value="mannitol"/>
              </coding>
            </concept>
          </code>
        </substance>
      </Ingredient>
    </resource>
  </entry>
</Bundle>