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Example SubstanceDefinition/mipomersen (XML)

Responsible Owner: Biomedical Research and Regulation Work GroupStandards Status: InformativeCompartments: No defined compartments

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

Nucleic acid substance: Mipomersen sodium — antisense oligonucleotide targeting APOB-100 (id = "mipomersen")

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

<!--  Example transcribed/adapted from ISO 11238 Implementation Guide §D.5.2.1
     (Table D.1 — Mipomersen sodium). Demonstrates the new SubstanceDefinition
     nucleic-acid backbones added for FHIR-57660. Sequence chemistry is the
     published Mipomersen 20-mer antisense oligonucleotide; identifiers are
     illustrative.  --><SubstanceDefinition xmlns="http://hl7.org/fhir">
  <id value="mipomersen"/> 
  <identifier> 
    <system value="http://example.europa.eu/fhir/SMSId"/> 
    <value value="MIPO78654S"/> 
  </identifier> 
  <status> 
    <coding> 
      <system value="http://hl7.org/fhir/publication-status"/> 
      <code value="active"/> 
    </coding> 
  </status> 
  <classification> 
    <coding> 
      <system value="http://example.europa.eu/fhir/SubstanceType"/> 
      <code value="nucleic-acid"/> 
      <display value="Nucleic Acid"/> 
    </coding> 
  </classification> 
  <domain> 
    <coding> 
      <system value="http://example.europa.eu/fhir/Domain"/> 
      <code value="human"/> 
      <display value="Human use"/> 
    </coding> 
  </domain> 
  <description value="Mipomersen sodium — a synthetic second-generation 2'-methoxyethyl antisense oligonucleotide
   that inhibits the molecular target apolipoprotein B-100 (APOB-100). 20-mer phosphorothioate-l
  inked sequence with 2'-MOE wing chemistry."/> 
  <code> 
    <code> 
      <coding> 
        <system value="http://example.europa.eu/fhir/Substance"/> 
        <code value="MIPO78654S"/> 
      </coding> 
    </code> 
  </code> 
  <name> 
    <name value="Mipomersen Sodium"/> 
    <preferred value="true"/> 
    <language> 
      <coding> 
        <system value="urn:ietf:bcp:47"/> 
        <code value="en"/> 
        <display value="English"/> 
      </coding> 
    </language> 
    <official> 
      <authority> 
        <coding> 
          <system value="http://hl7.org/fhir/substance-name-authority"/> 
          <code value="INN"/> 
          <display value="INN"/> 
        </coding> 
      </authority> 
      <status> 
        <coding> 
          <system value="http://hl7.org/fhir/publication-status"/> 
          <code value="active"/> 
          <display value="Active"/> 
        </coding> 
      </status> 
    </official> 
  </name> 
  <nucleicAcid> 
    <sequenceType> 
      <coding> 
        <system value="http://hl7.org/fhir/substance-sequence-type"/> 
        <code value="complete"/> 
        <display value="Complete"/> 
      </coding> 
    </sequenceType> 
    <numberOfSubunits value="1"/> 
    <oligoNucleotideType> 
      <coding> 
        <system value="http://hl7.org/fhir/oligo-nucleotide-type"/> 
        <code value="antisense"/> 
        <display value="Antisense oligonucleotide"/> 
      </coding> 
    </oligoNucleotideType> 
    <subunit> 
      <subunit value="1"/> 
      <sequence value="GCCUCAGTCTGCTTCGCACC"/> 
      <length value="20"/> 
      <fivePrime> 
        <coding> 
          <system value="http://hl7.org/fhir/nucleotide-terminus"/> 
          <code value="G"/> 
          <display value="Guanosine"/> 
        </coding> 
      </fivePrime> 
      <threePrime> 
        <coding> 
          <system value="http://hl7.org/fhir/nucleotide-terminus"/> 
          <code value="C"/> 
          <display value="Cytidine"/> 
        </coding> 
      </threePrime> 
      <linkage> 
        <connectivity/>  
        <substance> 
          <concept> 
            <coding> 
              <system value="http://example.europa.eu/fhir/LinkageSubstance"/> 
              <code value="phosphorothioate"/> 
              <display value="Phosphorothioate linkage"/> 
            </coding> 
          </concept> 
        </substance> 
        <residueSite value="1-19"/> 
      </linkage> 
      <sugar> 
        <substance> 
          <concept> 
            <coding> 
              <system value="http://example.europa.eu/fhir/SugarSubstance"/> 
              <code value="2-MOE"/> 
              <display value="2'-O-(2-methoxyethyl) ribose"/> 
            </coding> 
          </concept> 
        </substance> 
        <residueSite value="1-5,16-20"/> 
      </sugar> 
      <sugar> 
        <substance> 
          <concept> 
            <coding> 
              <system value="http://example.europa.eu/fhir/SugarSubstance"/> 
              <code value="deoxyribose"/> 
              <display value="2'-deoxyribose"/> 
            </coding> 
          </concept> 
        </substance> 
        <residueSite value="6-15"/> 
      </sugar> 
    </subunit> 
    <gene> 
      <sequenceOrigin> 
        <coding> 
          <system value="http://hl7.org/fhir/gene-sequence-origin"/> 
          <code value="human"/> 
          <display value="Human"/> 
        </coding> 
      </sequenceOrigin> 
      <gene> 
        <concept> 
          <coding> 
            <system value="http://www.genenames.org"/> 
            <code value="APOB"/> 
            <display value="apolipoprotein B"/> 
          </coding> 
        </concept> 
      </gene> 
    </gene> 
  </nucleicAcid> 
  <relationship> 
    <substanceDefinitionCodeableConcept> 
      <coding> 
        <system value="https://www.uniprot.org"/> 
        <code value="P04114"/> 
        <display value="apolipoprotein B-100"/> 
      </coding> 
    </substanceDefinitionCodeableConcept> 
    <type> 
      <coding> 
        <system value="http://hl7.org/fhir/substance-relationship-type"/> 
        <code value="TherapeuticTarget"/> 
        <display value="Therapeutic target"/> 
      </coding> 
    </type> 
    <interaction> 
      <coding> 
        <system value="http://hl7.org/fhir/substance-interaction-type"/> 
        <code value="inhibition"/> 
        <display value="Inhibition"/> 
      </coding> 
    </interaction> 
  </relationship> 
</SubstanceDefinition> 

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.