Release 5 Preview #3

This page is part of the FHIR Specification (v4.5.0: R5 Preview #3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

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)

Jump past Narrative

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"/> 
  <!--    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   -->
  <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> : id: Equilidem25</p> <p> <b> combinedPharmaceuticalDoseForm</b> : <span> 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> legalStatusOfSupply</b> : <span> Prescription only medicine</span> </p> <p> <b> classification</b> : <span> B01A</span> </p> <p> <b> ingredient</b> : </p> <ul> <li> <a>  </a> </li> <li> <a>  </a> </li> </ul> <blockquote> <p> <b> id</b> : EquilidoniumPhosphate</p> <p> <b> role</b> : <span> active</span> </p> <blockquote> <p> <b> substance</b> </p> <p> <b> code</b> : <span> Equilidonium Phosphate</span> </p> <h3> Strengths</h3> <table> <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> id</b> : CalciumCarbonate</p> <p> <b> role</b> : <span> excipient</span> </p> <blockquote> <p> <b> substance</b> </p> <p> <b> code</b> : <span> Calcium Carbonate</span> </p> <h3> Strengths</h3> <table> <tr> <td> -</td> <td> <b> Presentation</b> </td> </tr> <tr> <td> *</td> <td> 3 ml/1 tablet</td> </tr> </table> </blockquote> </blockquote> <h3> Names</h3> <table> <tr> <td> -</td> <td> <b> ProductName</b> </td> </tr> <tr> <td> *</td> <td> Equilidem 2.5 mg film-coated tablets</td> </tr> </table> <h3> CrossReferences</h3> <table> <tr> <td> -</td> <td> <b> Product</b> </td> </tr> <tr> <td> *</td> <td/>  </tr> </table> <h3> ManufacturingBusinessOperations</h3> <table> <tr> <td> -</td> <td> <b> Manufacturer</b> </td> </tr> <tr> <td> *</td> <td> <span> EquiliDrugCo Processing Inc.</span> </td> </tr> </table> </div> </text> <contained> 
    <Ingredient> 
      <id value="EquilidoniumPhosphate"/> 
      <role> 
        <coding> 
          <system value="http://example.org.uk/fhir/ingredientType"/> 
          <code value="active"/> 
        </coding> 
      </role> 
      <substance> 
        <codeCodeableConcept> 
          <coding> 
            <system value="http://example.org.uk/fhir/substances"/> 
            <code value="123456"/> 
            <display value="Equilidonium Phosphate"/> 
          </coding> 
        </codeCodeableConcept> 
        <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> 
        <codeCodeableConcept> 
          <coding> 
            <system value="http://example.org.uk/fhir/substances"/> 
            <code value="456789"/> 
            <display value="Calcium Carbonate"/> 
          </coding> 
        </codeCodeableConcept> 
        <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 value="#EquilidoniumPhosphate"/> 
  </ingredient> 
  <ingredient> 
    <reference value="#CalciumCarbonate"/> 
  </ingredient> 
  <name> 
    <productName value="Equilidem 2.5 mg film-coated tablets"/> 
  </name> 
  <crossReference> 
    <product> 
      <reference> 
        <reference value="MedicinalProductDefinition/genericEquilidonium"/> 
      </reference> 
    </product> 
  </crossReference> 
  <manufacturingBusinessOperation> 
    <manufacturer> 
      <display value="EquiliDrugCo Processing Inc."/> 
      <!--    licence holder uses RegulatedAuthorization    -->
    </manufacturer> 
  </manufacturingBusinessOperation> 
</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.