This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions
Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: No 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"/> <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>
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.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot1 generated on Mon, Dec 18, 2023 15:17+1100.
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