type: exampleresource: MedicinalProductDefinitionexample: medicinalproductdefinition-example-equilidem-using-ingredient-and-auth
MedicinalProductDefinition Example: medicinalproductdefinition-example-equilidem-using-ingredient-and-auth
Narrative
Generated Narrative
Id : equilidem-with-ing-and-auth
Identifier : Equilidem25
Combined Pharmaceutical Dose Form : tablet
Indication : 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 >= II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Legal Status Of Supply : Prescription only medicine
classification : B01A
Ingredients :
Role : active
substance : Equilidonium Phosphate
- Presentation * 22 ml/1 tablet
Role : excipient
substance : Calcium Carbonate
- Presentation * 3 ml/tablet
Names
| - | ProductName |
|---|---|
| * | Equilidem 2.5 mg film-coated tablets |
Cross References
| - | Product |
|---|---|
| * | Link to generic equivalent |
Manufacturing Business Operations
| - | Manufacturer |
|---|---|
| * | EquiliDrugCo Processing Inc. |
Example XML
<?xml version="1.0" encoding="UTF-8"?>
<MedicinalProductDefinition xmlns="http://hl7.org/fhir" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://hl7.org/fhir ../../schema/medicinalproductdefinition.xsd">
<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 >= 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 authorization 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"/>
<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 >= 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>
<organization>
<display value="EquiliDrugCo Processing Inc."/>
<!-- licence holder uses RegulatedAuthorization -->
</organization>
</operation>
</MedicinalProductDefinition>