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
Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
Raw XML (canonical form + also see XML Format Specification)
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 >= 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 >= 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.