<?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>
  <contained>
    <Ingredient>
      <id value="EquilidoniumPhosphate"/>
      <status value="active"/>
      <for>
        <reference value="#"/>
      </for>
      <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>
          <presentationRatio>
            <numerator>
              <value value="22"/>
              <unit value="ml"/>
              <system value="http://unitsofmeasure.org"/>
              <code value="mL"/>
            </numerator>
            <denominator>
              <value value="1"/>
              <unit value="tablet"/>
            </denominator>
          </presentationRatio>
        </strength>
      </substance>
    </Ingredient>
  </contained>
  <contained>
    <Ingredient>
      <id value="CalciumCarbonate"/>
      <status value="active"/>
      <for>
        <reference value="#"/>
      </for>
      <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>
          <presentationRatio>
            <numerator>
              <value value="3"/>
              <unit value="ml"/>
              <system value="http://unitsofmeasure.org"/>
              <code value="mL"/>
            </numerator>
            <denominator>
              <value value="1"/>
              <unit value="tablet"/>
            </denominator>
          </presentationRatio>
        </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>
  <name>
    <productName value="Equilidem 2.5 mg film-coated tablets"/>
  </name>
  <crossReference>
    <product>
      <reference>
        <reference value="MedicinalProductDefinition/genericEquilidonium"/>
      </reference>
    </product>
  </crossReference>
  <operation>
    <!--  licence holder uses RegulatedAuthorization  -->
    <organization>
      <display value="EquiliDrugCo Processing Inc."/>
    </organization>
  </operation>
</MedicinalProductDefinition>