R6 Ballot (2nd Draft)

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Example MedicinalProductDefinition/equilidem-basics (XML)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

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

Jump past Narrative

Basic details of a product, only using MedicinalProductDefinition and no other resources (id = "equilidem-basics")

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

<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
  <id value="equilidem-basics"/> 
  <text> 
    <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml">
      <p> 
        <b> 
          Generated Narrative
        </b> 
      </p> 
      <p> 
        <b> 
          Id
        </b> 
        : equilidem-basics
      </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}">
          ATC: B01A
        </span> 
      </p> 
      <p> 
        <b> 
          Ingredient
        </b> 
        :
      </p> 
      <ul> 
        <li> 
          <span> 
            Equilidonium Phosphate
          </span> 
        </li> 
        <li> 
          <span> 
            Calcium Carbonate
          </span> 
        </li> 
      </ul> 
      <h3> 
        Names
      </h3> 
      <table class="grid">
        <tr> 
          <td> 
            -
          </td> 
          <td> 
            <b> 
              Product Name
            </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 Inc.
            </span> 
          </td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <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> 
    <text value="Equilidonium Phosphate"/> 
  </ingredient> 
  <ingredient> 
    <text value="Calcium Carbonate"/> 
  </ingredient> 
  <name> 
    <productName value="Equilidem 2.5 mg film-coated tablets"/> 
  </name> 
  <crossReference> 
    <product> 
      <reference> 
        <reference value="MedicinalProductDefinition/genericEquilidonium"/> 
      </reference> 
    </product> 
  </crossReference> 
  <operation> 
    <!--   licence holder would use RegulatedAuthorization   -->
    <organization> 
      <display value="EquiliDrugCo Inc."/> 
    </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.