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Medicinalproductdefinition-example-equilidem-using-ingredient-and-auth.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any defined compartments

Raw XML (canonical form + also see XML Format Specification)

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Simple version of a product (more than basic), only using MedicinalProductDefinition, Ingredient and RegulatedAuthorization (id = "equilidem-with-ing-and-auth")

<?xml version="1.0" encoding="UTF-8"?>

<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
  <id value="equilidem-with-ing-and-auth"/> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> 
        <b> 
          Generated Narrative
        </b> 
      </p> 
      <p> 
        <b> 
          Id
        </b> 
        : equilidem-with-ing-and-auth
      </p> 
      <p> 
        <b> 
          Identifier
        </b> 
        : Equilidem25
      </p> 
      <p> 
        <b> 
          Combined Pharmaceutical Dose Form
        </b> 
        :
        <span title="Codes: {http://example.org.uk/fhir/dosefom tablet}">
          tablet
        </span> 
      </p> 
      <p> 
        <b> 
          Indication
        </b> 
        : Prevention of venous thromboembolic events (VTE) in adult patients who have undergone
         elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in
         adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors,
         such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension;
         diabetes mellitus; symptomatic heart failure (NYHA Class &gt;= II). Treatment of deep
         vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and
         PE in adults.
      </p> 
      <p> 
        <b> 
          Legal Status Of Supply
        </b> 
        :
        <span title="Codes: {http://example.org.uk/fhir/legalstatusofsupply POM}">
          Prescription only medicine
        </span> 
      </p> 
      <p> 
        <b> 
          classification
        </b> 
        :
        <span title="Codes: {http://www.whocc.no/atc/example B01A}">
          B01A
        </span> 
      </p> 
      <p> 
        <b> 
          Ingredients
        </b> 
        :
      </p> 
      <blockquote> 
        <p> 
          <b> 
            Role
          </b> 
          :
          <span title="Codes: {http://example.org.uk/fhir/ingredientType active}">
            active
          </span> 
        </p> 
        <blockquote> 
          <p> 
            <b> 
              substance
            </b> 
            :
            <span title="Codes: {http://example.org.uk/fhir/substances 123456}">
              Equilidonium Phosphate
            </span> 
          </p> 
          <table class="grid">
            <tr> 
              <td> 
                -
              </td> 
              <td> 
                <b> 
                  Presentation
                </b> 
              </td> 
            </tr> 
            <tr> 
              <td> 
                *
              </td> 
              <td> 
                22 ml/1 tablet
              </td> 
            </tr> 
          </table> 
        </blockquote> 
      </blockquote> 
      <blockquote> 
        <p> 
          <b> 
            Role
          </b> 
          :
          <span title="Codes: {http://example.org.uk/fhir/ingredientType excipient}">
            excipient
          </span> 
        </p> 
        <blockquote> 
          <p> 
            <b> 
              substance
            </b> 
            :
            <span title="Codes: {http://example.org.uk/fhir/substances 456789}">
              Calcium Carbonate
            </span> 
          </p> 
          <table class="grid">
            <tr> 
              <td> 
                -
              </td> 
              <td> 
                <b> 
                  Presentation
                </b> 
              </td> 
            </tr> 
            <tr> 
              <td> 
                *
              </td> 
              <td> 
                3 ml/tablet
              </td> 
            </tr> 
          </table> 
        </blockquote> 
      </blockquote> 
      <h3> 
        Names
      </h3> 
      <table class="grid">
        <tr> 
          <td> 
            -
          </td> 
          <td> 
            <b> 
              ProductName
            </b> 
          </td> 
        </tr> 
        <tr> 
          <td> 
            *
          </td> 
          <td> 
            Equilidem 2.5 mg film-coated tablets
          </td> 
        </tr> 
      </table> 
      <h3> 
        Cross References
      </h3> 
      <table class="grid">
        <tr> 
          <td> 
            -
          </td> 
          <td> 
            <b> 
              Product
            </b> 
          </td> 
        </tr> 
        <tr> 
          <td> 
            *
          </td> 
          <td> 
            Link to generic equivalent
          </td> 
        </tr> 
      </table> 
      <h3> 
        Manufacturing Business Operations
      </h3> 
      <table class="grid">
        <tr> 
          <td> 
            -
          </td> 
          <td> 
            <b> 
              Manufacturer
            </b> 
          </td> 
        </tr> 
        <tr> 
          <td> 
            *
          </td> 
          <td> 
            <span> 
              EquiliDrugCo Processing Inc.
            </span> 
          </td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <!--   an authorisation can also be contained if required (commented out temporarily due to
   build issues)   -->
  <!--  contained>
    <RegulatedAuthorization>
      <id value="authorization"/>
      <subject>
        <reference value="#"/>
      </subject>
      <type>
        <text value="Regulatory Drug Marketing Approval"/>
      </type>
      <status>
        <coding>
          <code value="active"/>
        </coding>
      </status>
      <statusDate value="2016-01-01"/>
      <holder>
        <display value="EquiliDrugCo Holdings Inc."/>
      </holder>
      <regulator>
        <display value="FDA"/>
      </regulator>
    </RegulatedAuthorization>
  </contained  -->
  <contained> 
    <Ingredient> 
      <id value="EquilidoniumPhosphate"/> 
      <role> 
        <coding> 
          <system value="http://example.org.uk/fhir/ingredientType"/> 
          <code value="active"/> 
        </coding> 
      </role> 
      <substance> 
        <code> 
          <concept> 
          <coding> 
            <system value="http://example.org.uk/fhir/substances"/> 
            <code value="123456"/> 
            <display value="Equilidonium Phosphate"/> 
          </coding> 
          </concept> 
        </code> 
        <strength> 
          <presentation> 
            <numerator> 
              <value value="22"/> 
              <unit value="ml"/> 
            </numerator> 
            <denominator> 
              <value value="1"/> 
              <unit value="tablet"/> 
            </denominator> 
          </presentation> 
        </strength> 
      </substance> 
    </Ingredient> 
  </contained> 
  <contained> 
    <Ingredient> 
      <id value="CalciumCarbonate"/> 
      <role> 
        <coding> 
          <system value="http://example.org.uk/fhir/ingredientType"/> 
          <code value="excipient"/> 
        </coding> 
      </role> 
      <substance> 
        <code> 
          <concept> 
          <coding> 
            <system value="http://example.org.uk/fhir/substances"/> 
            <code value="456789"/> 
            <display value="Calcium Carbonate"/> 
          </coding> 
          </concept> 
        </code> 
        <strength> 
          <presentation> 
            <numerator> 
              <value value="3"/> 
              <unit value="ml"/> 
            </numerator> 
            <denominator> 
              <value value="1"/> 
              <unit value="tablet"/> 
            </denominator> 
          </presentation> 
        </strength> 
      </substance> 
    </Ingredient> 
  </contained> 
  <identifier> 
    <system value="http://example.org.uk/fhir/product"/> 
    <value value="Equilidem25"/> 
  </identifier> 
  <combinedPharmaceuticalDoseForm> 
    <coding> 
      <system value="http://example.org.uk/fhir/dosefom"/> 
      <code value="tablet"/> 
    </coding> 
  </combinedPharmaceuticalDoseForm> 
  <indication value="Prevention of venous thromboembolic events (VTE) in adult patients who have undergone
   elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in
   adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors,
   such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension;
   diabetes mellitus; symptomatic heart failure (NYHA Class &gt;= II). Treatment of deep
   vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and
   PE in adults."/> 
  <legalStatusOfSupply> 
    <coding> 
      <system value="http://example.org.uk/fhir/legalstatusofsupply"/> 
      <code value="POM"/> 
      <display value="Prescription only medicine"/> 
    </coding> 
  </legalStatusOfSupply> 
  <classification> 
    <coding> 
      <system value="http://www.whocc.no/atc/example"/> 
      <code value="B01A"/> 
    </coding> 
  </classification> 
  <ingredient> 
    <reference> 
    <reference value="#EquilidoniumPhosphate"/> 
    </reference> 
  </ingredient> 
  <ingredient> 
    <reference> 
    <reference value="#CalciumCarbonate"/> 
    </reference> 
  </ingredient> 
  <name> 
    <productName value="Equilidem 2.5 mg film-coated tablets"/> 
  </name> 
  <crossReference> 
    <product> 
      <reference> 
        <reference value="MedicinalProductDefinition/genericEquilidonium"/> 
      </reference> 
    </product> 
  </crossReference> 
  <operation> 
    <organization> 
      <display value="EquiliDrugCo Processing Inc."/> 
      <!--   licence holder uses RegulatedAuthorization   -->
    </organization> 
  </operation> 
</MedicinalProductDefinition> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.