SPL Mapping FHIR R5 Implementation Guide
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SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

: SPL Section Codes - XML Representation

Page standards status: Trial-use Maturity Level: 1

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="splSectionCodes"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet splSectionCodes</b></p><a name="splSectionCodes"> </a><a name="hcsplSectionCodes"> </a><a name="splSectionCodes-en-US"> </a><ul><li>Include these codes as defined in <a href="http://loinc.org"><code>http://loinc.org</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href="https://loinc.org/51945-4/">51945-4</a></td><td>Principal display panel of package</td></tr><tr><td><a href="https://loinc.org/100382-1/">100382-1</a></td><td>REMS addressed risk</td></tr><tr><td><a href="https://loinc.org/103572-4/">103572-4</a></td><td>Cosmetic product listing</td></tr><tr><td><a href="https://loinc.org/103573-2/">103573-2</a></td><td>Cosmetic facility registration</td></tr><tr><td><a href="https://loinc.org/34066-1/">34066-1</a></td><td>Boxed warning section</td></tr><tr><td><a href="https://loinc.org/34067-9/">34067-9</a></td><td>Indications and usage section</td></tr><tr><td><a href="https://loinc.org/34068-7/">34068-7</a></td><td>Dosage and administration section</td></tr><tr><td><a href="https://loinc.org/34069-5/">34069-5</a></td><td>How supplied section</td></tr><tr><td><a href="https://loinc.org/34070-3/">34070-3</a></td><td>Contraindications section</td></tr><tr><td><a href="https://loinc.org/34071-1/">34071-1</a></td><td>Warnings section</td></tr><tr><td><a href="https://loinc.org/34072-9/">34072-9</a></td><td>General precautions section</td></tr><tr><td><a href="https://loinc.org/34073-7/">34073-7</a></td><td>Drug interactions section</td></tr><tr><td><a href="https://loinc.org/34074-5/">34074-5</a></td><td>Drug/laboratory test interactions section</td></tr><tr><td><a href="https://loinc.org/34075-2/">34075-2</a></td><td>Laboratory tests section</td></tr><tr><td><a href="https://loinc.org/34076-0/">34076-0</a></td><td>Information for patients section</td></tr><tr><td><a href="https://loinc.org/34077-8/">34077-8</a></td><td>Teratogenic effects section</td></tr><tr><td><a href="https://loinc.org/34078-6/">34078-6</a></td><td>Nonteratogenic effects section</td></tr><tr><td><a href="https://loinc.org/34079-4/">34079-4</a></td><td>Labor and delivery section</td></tr><tr><td><a href="https://loinc.org/34080-2/">34080-2</a></td><td>Nursing mothers section</td></tr><tr><td><a href="https://loinc.org/34081-0/">34081-0</a></td><td>Pediatric use section</td></tr><tr><td><a href="https://loinc.org/34082-8/">34082-8</a></td><td>Geriatric use section</td></tr><tr><td><a href="https://loinc.org/34083-6/">34083-6</a></td><td>Carcinogenesis and mutagenesis and impairment of fertility section</td></tr><tr><td><a href="https://loinc.org/34084-4/">34084-4</a></td><td>Adverse reactions section</td></tr><tr><td><a href="https://loinc.org/34085-1/">34085-1</a></td><td>Controlled substance section</td></tr><tr><td><a href="https://loinc.org/34086-9/">34086-9</a></td><td>Abuse section</td></tr><tr><td><a href="https://loinc.org/34087-7/">34087-7</a></td><td>Dependence section</td></tr><tr><td><a href="https://loinc.org/34088-5/">34088-5</a></td><td>Overdosage section</td></tr><tr><td><a href="https://loinc.org/34089-3/">34089-3</a></td><td>Description section</td></tr><tr><td><a href="https://loinc.org/34090-1/">34090-1</a></td><td>Clinical pharmacology section</td></tr><tr><td><a href="https://loinc.org/34091-9/">34091-9</a></td><td>Animal pharmacology/toxicology section</td></tr><tr><td><a href="https://loinc.org/34092-7/">34092-7</a></td><td>Clinical studies section</td></tr><tr><td><a href="https://loinc.org/34093-5/">34093-5</a></td><td>References section</td></tr><tr><td><a href="https://loinc.org/38056-8/">38056-8</a></td><td>Structured product laballing supplemental patient material</td></tr><tr><td><a href="https://loinc.org/42227-9/">42227-9</a></td><td>Drug abuse and dependence section</td></tr><tr><td><a href="https://loinc.org/42228-7/">42228-7</a></td><td>Pregnancy section</td></tr><tr><td><a href="https://loinc.org/42229-5/">42229-5</a></td><td>Structured patient labelling unclassified section</td></tr><tr><td><a href="https://loinc.org/42230-3/">42230-3</a></td><td>Structured product laballing patient package insert section</td></tr><tr><td><a href="https://loinc.org/42231-1/">42231-1</a></td><td>Structured product labelling medguide section</td></tr><tr><td><a href="https://loinc.org/42232-9/">42232-9</a></td><td>Precautions section</td></tr><tr><td><a href="https://loinc.org/43678-2/">43678-2</a></td><td>Dosage forms and strengths section</td></tr><tr><td><a href="https://loinc.org/43679-0/">43679-0</a></td><td>Mechanism of action section</td></tr><tr><td><a href="https://loinc.org/43680-8/">43680-8</a></td><td>Nonclinical toxicology section</td></tr><tr><td><a href="https://loinc.org/43681-6/">43681-6</a></td><td>Pharmacodynamics section</td></tr><tr><td><a href="https://loinc.org/43682-4/">43682-4</a></td><td>Pharmacokinetics section</td></tr><tr><td><a href="https://loinc.org/43683-2/">43683-2</a></td><td>Recent major changes section</td></tr><tr><td><a href="https://loinc.org/43684-0/">43684-0</a></td><td>Use in specific populations section</td></tr><tr><td><a href="https://loinc.org/43685-7/">43685-7</a></td><td>Warnings and precautions section</td></tr><tr><td><a href="https://loinc.org/44425-7/">44425-7</a></td><td>Storage and handling section</td></tr><tr><td><a href="https://loinc.org/48779-3/">48779-3</a></td><td>Structured product labelling indexing data elements section</td></tr><tr><td><a href="https://loinc.org/48780-1/">48780-1</a></td><td>Structured product labelling listing data elements section</td></tr><tr><td><a href="https://loinc.org/49489-8/">49489-8</a></td><td>Microbiology section</td></tr><tr><td><a href="https://loinc.org/54433-8/">54433-8</a></td><td>User safety warnings section</td></tr><tr><td><a href="https://loinc.org/59845-8/">59845-8</a></td><td>Instructions for use section</td></tr><tr><td><a href="https://loinc.org/60555-0/">60555-0</a></td><td>Accessories</td></tr><tr><td><a href="https://loinc.org/60556-8/">60556-8</a></td><td>Assembly or installation instructions</td></tr><tr><td><a href="https://loinc.org/60557-6/">60557-6</a></td><td>Calibration instructions</td></tr><tr><td><a href="https://loinc.org/60558-4/">60558-4</a></td><td>Cleaning, disinfecting, and sterilization instructions</td></tr><tr><td><a href="https://loinc.org/60559-2/">60559-2</a></td><td>Components</td></tr><tr><td><a href="https://loinc.org/60560-0/">60560-0</a></td><td>Intended use of the device</td></tr><tr><td><a href="https://loinc.org/60561-8/">60561-8</a></td><td>Other safety information</td></tr><tr><td><a href="https://loinc.org/60562-6/">60562-6</a></td><td>Route, method and frequency of administration</td></tr><tr><td><a href="https://loinc.org/60563-4/">60563-4</a></td><td>Summary of safety and effectiveness</td></tr><tr><td><a href="https://loinc.org/60685-5/">60685-5</a></td><td>Indexing - pharmacologic class</td></tr><tr><td><a href="https://loinc.org/64123-3/">64123-3</a></td><td>Indexing - adverse reaction</td></tr><tr><td><a href="https://loinc.org/64124-1/">64124-1</a></td><td>Indexing - substance</td></tr><tr><td><a href="https://loinc.org/66105-8/">66105-8</a></td><td>Lot distribution data</td></tr><tr><td><a href="https://loinc.org/66106-6/">66106-6</a></td><td>Pharmacogenomics section</td></tr><tr><td><a href="https://loinc.org/69758-1/">69758-1</a></td><td>Diagram of device</td></tr><tr><td><a href="https://loinc.org/69759-9/">69759-9</a></td><td>Risks</td></tr><tr><td><a href="https://loinc.org/69760-7/">69760-7</a></td><td>Compatible accessories</td></tr><tr><td><a href="https://loinc.org/69761-5/">69761-5</a></td><td>Alarms</td></tr><tr><td><a href="https://loinc.org/69762-3/">69762-3</a></td><td>Troubleshooting</td></tr><tr><td><a href="https://loinc.org/69763-1/">69763-1</a></td><td>Disposal and waste handling</td></tr><tr><td><a href="https://loinc.org/71446-9/">71446-9</a></td><td>Indexing - billing unit</td></tr><tr><td><a href="https://loinc.org/71681-1/">71681-1</a></td><td>PMI - Common side effects section</td></tr><tr><td><a href="https://loinc.org/71682-9/">71682-9</a></td><td>PMI - Get emergency medical help section</td></tr><tr><td><a href="https://loinc.org/71683-7/">71683-7</a></td><td>PMI - Stop taking and call your doctor section</td></tr><tr><td><a href="https://loinc.org/71684-5/">71684-5</a></td><td>PMI - Directions for use section</td></tr><tr><td><a href="https://loinc.org/71685-2/">71685-2</a></td><td>PMI - Tell your doctor before taking section</td></tr><tr><td><a href="https://loinc.org/71686-0/">71686-0</a></td><td>PMI - Do not take section</td></tr><tr><td><a href="https://loinc.org/71687-8/">71687-8</a></td><td>PMI - Important information section</td></tr><tr><td><a href="https://loinc.org/71688-6/">71688-6</a></td><td>PMI - Uses section</td></tr><tr><td><a href="https://loinc.org/71744-7/">71744-7</a></td><td>Health care provider letter</td></tr><tr><td><a href="https://loinc.org/73815-3/">73815-3</a></td><td>Indexing - product concept</td></tr><tr><td><a href="https://loinc.org/77288-9/">77288-9</a></td><td>Indexing - warning letter alert</td></tr><tr><td><a href="https://loinc.org/77289-7/">77289-7</a></td><td>Identification of suspect product and notification</td></tr><tr><td><a href="https://loinc.org/77290-5/">77290-5</a></td><td>Lactation</td></tr><tr><td><a href="https://loinc.org/77291-3/">77291-3</a></td><td>Females and males reproductive potential</td></tr><tr><td><a href="https://loinc.org/77292-1/">77292-1</a></td><td>eFacility</td></tr><tr><td><a href="https://loinc.org/82336-9/">82336-9</a></td><td>REMS header</td></tr><tr><td><a href="https://loinc.org/82344-3/">82344-3</a></td><td>REMS communication plan</td></tr><tr><td><a href="https://loinc.org/82345-0/">82345-0</a></td><td>REMS elements to assure safe use</td></tr><tr><td><a href="https://loinc.org/82346-8/">82346-8</a></td><td>REMS material</td></tr><tr><td><a href="https://loinc.org/82347-6/">82347-6</a></td><td>REMS summary</td></tr><tr><td><a href="https://loinc.org/82348-4/">82348-4</a></td><td>REMS elements</td></tr><tr><td><a href="https://loinc.org/82349-2/">82349-2</a></td><td>REMS goals</td></tr><tr><td><a href="https://loinc.org/82350-0/">82350-0</a></td><td>REMS implementation system</td></tr><tr><td><a href="https://loinc.org/82351-8/">82351-8</a></td><td>Risk evaluation and mitigation strategies</td></tr><tr><td><a href="https://loinc.org/82352-6/">82352-6</a></td><td>REMS timetable for submission assessments</td></tr><tr><td><a href="https://loinc.org/82353-4/">82353-4</a></td><td>Indexing - risk evaluation and mitigation strategies</td></tr><tr><td><a href="https://loinc.org/82598-4/">82598-4</a></td><td>REMS medication guide</td></tr><tr><td><a href="https://loinc.org/85273-1/">85273-1</a></td><td>REMS conversion to shared system</td></tr><tr><td><a href="https://loinc.org/85274-9/">85274-9</a></td><td>REMS release</td></tr><tr><td><a href="https://loinc.org/86445-4/">86445-4</a></td><td>Blanket no changes certification of product listing</td></tr><tr><td><a href="https://loinc.org/87523-7/">87523-7</a></td><td>REMS administrative information</td></tr><tr><td><a href="https://loinc.org/87524-5/">87524-5</a></td><td>REMS requirements</td></tr><tr><td><a href="https://loinc.org/87525-2/">87525-2</a></td><td>REMS participant requirements</td></tr><tr><td><a href="https://loinc.org/87526-0/">87526-0</a></td><td>REMS applicant requirements</td></tr><tr><td><a href="https://loinc.org/88436-1/">88436-1</a></td><td>Patient counseling information</td></tr><tr><td><a href="https://loinc.org/88437-9/">88437-9</a></td><td>How supplied and storage and handling section</td></tr><tr><td><a href="https://loinc.org/88828-9/">88828-9</a></td><td>Renal Impairment subsection</td></tr><tr><td><a href="https://loinc.org/88829-7/">88829-7</a></td><td>Hepatic Impairment subsection</td></tr><tr><td><a href="https://loinc.org/88830-5/">88830-5</a></td><td>Immunogenicity</td></tr><tr><td><a href="https://loinc.org/90374-0/">90374-0</a></td><td>Clinical trials experience section</td></tr><tr><td><a href="https://loinc.org/90375-7/">90375-7</a></td><td>Postmarketing experience section</td></tr></table></li></ul></div>
  </text>
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    <valueInteger value="1">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"/>
      </extension>
    </valueInteger>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"/>
      </extension>
    </valueCode>
  </extension>
  <url value="http://hl7.org/fhir/us/spl/ValueSet/splSectionCodes"/>
  <version value="0.2.1"/>
  <name value="SPLSectionCodes"/>
  <title value="SPL Section Codes"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-10-26T03:36:34+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
  </contact>
  <description value="Section Codes for SPL Product Submission documents"/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <copyright
             value="This material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc."/>
  <compose>
    <include>
      <system value="http://loinc.org"/>
      <concept>
        <code value="51945-4"/>
        <display value="Principal display panel of package"/>
      </concept>
      <concept>
        <code value="100382-1"/>
        <display value="REMS addressed risk"/>
      </concept>
      <concept>
        <code value="103572-4"/>
        <display value="Cosmetic product listing"/>
      </concept>
      <concept>
        <code value="103573-2"/>
        <display value="Cosmetic facility registration"/>
      </concept>
      <concept>
        <code value="34066-1"/>
        <display value="Boxed warning section"/>
      </concept>
      <concept>
        <code value="34067-9"/>
        <display value="Indications and usage section"/>
      </concept>
      <concept>
        <code value="34068-7"/>
        <display value="Dosage and administration section"/>
      </concept>
      <concept>
        <code value="34069-5"/>
        <display value="How supplied section"/>
      </concept>
      <concept>
        <code value="34070-3"/>
        <display value="Contraindications section"/>
      </concept>
      <concept>
        <code value="34071-1"/>
        <display value="Warnings section"/>
      </concept>
      <concept>
        <code value="34072-9"/>
        <display value="General precautions section"/>
      </concept>
      <concept>
        <code value="34073-7"/>
        <display value="Drug interactions section"/>
      </concept>
      <concept>
        <code value="34074-5"/>
        <display value="Drug/laboratory test interactions section"/>
      </concept>
      <concept>
        <code value="34075-2"/>
        <display value="Laboratory tests section"/>
      </concept>
      <concept>
        <code value="34076-0"/>
        <display value="Information for patients section"/>
      </concept>
      <concept>
        <code value="34077-8"/>
        <display value="Teratogenic effects section"/>
      </concept>
      <concept>
        <code value="34078-6"/>
        <display value="Nonteratogenic effects section"/>
      </concept>
      <concept>
        <code value="34079-4"/>
        <display value="Labor and delivery section"/>
      </concept>
      <concept>
        <code value="34080-2"/>
        <display value="Nursing mothers section"/>
      </concept>
      <concept>
        <code value="34081-0"/>
        <display value="Pediatric use section"/>
      </concept>
      <concept>
        <code value="34082-8"/>
        <display value="Geriatric use section"/>
      </concept>
      <concept>
        <code value="34083-6"/>
        <display
                 value="Carcinogenesis and mutagenesis and impairment of fertility section"/>
      </concept>
      <concept>
        <code value="34084-4"/>
        <display value="Adverse reactions section"/>
      </concept>
      <concept>
        <code value="34085-1"/>
        <display value="Controlled substance section"/>
      </concept>
      <concept>
        <code value="34086-9"/>
        <display value="Abuse section"/>
      </concept>
      <concept>
        <code value="34087-7"/>
        <display value="Dependence section"/>
      </concept>
      <concept>
        <code value="34088-5"/>
        <display value="Overdosage section"/>
      </concept>
      <concept>
        <code value="34089-3"/>
        <display value="Description section"/>
      </concept>
      <concept>
        <code value="34090-1"/>
        <display value="Clinical pharmacology section"/>
      </concept>
      <concept>
        <code value="34091-9"/>
        <display value="Animal pharmacology/toxicology section"/>
      </concept>
      <concept>
        <code value="34092-7"/>
        <display value="Clinical studies section"/>
      </concept>
      <concept>
        <code value="34093-5"/>
        <display value="References section"/>
      </concept>
      <concept>
        <code value="38056-8"/>
        <display
                 value="Structured product laballing supplemental patient material"/>
      </concept>
      <concept>
        <code value="42227-9"/>
        <display value="Drug abuse and dependence section"/>
      </concept>
      <concept>
        <code value="42228-7"/>
        <display value="Pregnancy section"/>
      </concept>
      <concept>
        <code value="42229-5"/>
        <display value="Structured patient labelling unclassified section"/>
      </concept>
      <concept>
        <code value="42230-3"/>
        <display
                 value="Structured product laballing patient package insert section"/>
      </concept>
      <concept>
        <code value="42231-1"/>
        <display value="Structured product labelling medguide section"/>
      </concept>
      <concept>
        <code value="42232-9"/>
        <display value="Precautions section"/>
      </concept>
      <concept>
        <code value="43678-2"/>
        <display value="Dosage forms and strengths section"/>
      </concept>
      <concept>
        <code value="43679-0"/>
        <display value="Mechanism of action section"/>
      </concept>
      <concept>
        <code value="43680-8"/>
        <display value="Nonclinical toxicology section"/>
      </concept>
      <concept>
        <code value="43681-6"/>
        <display value="Pharmacodynamics section"/>
      </concept>
      <concept>
        <code value="43682-4"/>
        <display value="Pharmacokinetics section"/>
      </concept>
      <concept>
        <code value="43683-2"/>
        <display value="Recent major changes section"/>
      </concept>
      <concept>
        <code value="43684-0"/>
        <display value="Use in specific populations section"/>
      </concept>
      <concept>
        <code value="43685-7"/>
        <display value="Warnings and precautions section"/>
      </concept>
      <concept>
        <code value="44425-7"/>
        <display value="Storage and handling section"/>
      </concept>
      <concept>
        <code value="48779-3"/>
        <display
                 value="Structured product labelling indexing data elements section"/>
      </concept>
      <concept>
        <code value="48780-1"/>
        <display
                 value="Structured product labelling listing data elements section"/>
      </concept>
      <concept>
        <code value="49489-8"/>
        <display value="Microbiology section"/>
      </concept>
      <concept>
        <code value="54433-8"/>
        <display value="User safety warnings section"/>
      </concept>
      <concept>
        <code value="59845-8"/>
        <display value="Instructions for use section"/>
      </concept>
      <concept>
        <code value="60555-0"/>
        <display value="Accessories"/>
      </concept>
      <concept>
        <code value="60556-8"/>
        <display value="Assembly or installation instructions"/>
      </concept>
      <concept>
        <code value="60557-6"/>
        <display value="Calibration instructions"/>
      </concept>
      <concept>
        <code value="60558-4"/>
        <display
                 value="Cleaning, disinfecting, and sterilization instructions"/>
      </concept>
      <concept>
        <code value="60559-2"/>
        <display value="Components"/>
      </concept>
      <concept>
        <code value="60560-0"/>
        <display value="Intended use of the device"/>
      </concept>
      <concept>
        <code value="60561-8"/>
        <display value="Other safety information"/>
      </concept>
      <concept>
        <code value="60562-6"/>
        <display value="Route, method and frequency of administration"/>
      </concept>
      <concept>
        <code value="60563-4"/>
        <display value="Summary of safety and effectiveness"/>
      </concept>
      <concept>
        <code value="60685-5"/>
        <display value="Indexing - pharmacologic class"/>
      </concept>
      <concept>
        <code value="64123-3"/>
        <display value="Indexing - adverse reaction"/>
      </concept>
      <concept>
        <code value="64124-1"/>
        <display value="Indexing - substance"/>
      </concept>
      <concept>
        <code value="66105-8"/>
        <display value="Lot distribution data"/>
      </concept>
      <concept>
        <code value="66106-6"/>
        <display value="Pharmacogenomics section"/>
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      <concept>
        <code value="69758-1"/>
        <display value="Diagram of device"/>
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      <concept>
        <code value="69759-9"/>
        <display value="Risks"/>
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      <concept>
        <code value="69760-7"/>
        <display value="Compatible accessories"/>
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      <concept>
        <code value="69761-5"/>
        <display value="Alarms"/>
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      <concept>
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        <display value="Troubleshooting"/>
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      <concept>
        <code value="69763-1"/>
        <display value="Disposal and waste handling"/>
      </concept>
      <concept>
        <code value="71446-9"/>
        <display value="Indexing - billing unit"/>
      </concept>
      <concept>
        <code value="71681-1"/>
        <display value="PMI - Common side effects section"/>
      </concept>
      <concept>
        <code value="71682-9"/>
        <display value="PMI - Get emergency medical help section"/>
      </concept>
      <concept>
        <code value="71683-7"/>
        <display value="PMI - Stop taking and call your doctor section"/>
      </concept>
      <concept>
        <code value="71684-5"/>
        <display value="PMI - Directions for use section"/>
      </concept>
      <concept>
        <code value="71685-2"/>
        <display value="PMI - Tell your doctor before taking section"/>
      </concept>
      <concept>
        <code value="71686-0"/>
        <display value="PMI - Do not take section"/>
      </concept>
      <concept>
        <code value="71687-8"/>
        <display value="PMI - Important information section"/>
      </concept>
      <concept>
        <code value="71688-6"/>
        <display value="PMI - Uses section"/>
      </concept>
      <concept>
        <code value="71744-7"/>
        <display value="Health care provider letter"/>
      </concept>
      <concept>
        <code value="73815-3"/>
        <display value="Indexing - product concept"/>
      </concept>
      <concept>
        <code value="77288-9"/>
        <display value="Indexing - warning letter alert"/>
      </concept>
      <concept>
        <code value="77289-7"/>
        <display value="Identification of suspect product and notification"/>
      </concept>
      <concept>
        <code value="77290-5"/>
        <display value="Lactation"/>
      </concept>
      <concept>
        <code value="77291-3"/>
        <display value="Females and males reproductive potential"/>
      </concept>
      <concept>
        <code value="77292-1"/>
        <display value="eFacility"/>
      </concept>
      <concept>
        <code value="82336-9"/>
        <display value="REMS header"/>
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      <concept>
        <code value="82344-3"/>
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      <concept>
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      <concept>
        <code value="82346-8"/>
        <display value="REMS material"/>
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      <concept>
        <code value="82347-6"/>
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      <concept>
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        <display value="REMS elements"/>
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      <concept>
        <code value="82349-2"/>
        <display value="REMS goals"/>
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      <concept>
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        <display value="REMS implementation system"/>
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      <concept>
        <code value="82351-8"/>
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      <concept>
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        <display value="REMS timetable for submission assessments"/>
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      <concept>
        <code value="82353-4"/>
        <display
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      </concept>
      <concept>
        <code value="82598-4"/>
        <display value="REMS medication guide"/>
      </concept>
      <concept>
        <code value="85273-1"/>
        <display value="REMS conversion to shared system"/>
      </concept>
      <concept>
        <code value="85274-9"/>
        <display value="REMS release"/>
      </concept>
      <concept>
        <code value="86445-4"/>
        <display value="Blanket no changes certification of product listing"/>
      </concept>
      <concept>
        <code value="87523-7"/>
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      <concept>
        <code value="87524-5"/>
        <display value="REMS requirements"/>
      </concept>
      <concept>
        <code value="87525-2"/>
        <display value="REMS participant requirements"/>
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      <concept>
        <code value="87526-0"/>
        <display value="REMS applicant requirements"/>
      </concept>
      <concept>
        <code value="88436-1"/>
        <display value="Patient counseling information"/>
      </concept>
      <concept>
        <code value="88437-9"/>
        <display value="How supplied and storage and handling section"/>
      </concept>
      <concept>
        <code value="88828-9"/>
        <display value="Renal Impairment subsection"/>
      </concept>
      <concept>
        <code value="88829-7"/>
        <display value="Hepatic Impairment subsection"/>
      </concept>
      <concept>
        <code value="88830-5"/>
        <display value="Immunogenicity"/>
      </concept>
      <concept>
        <code value="90374-0"/>
        <display value="Clinical trials experience section"/>
      </concept>
      <concept>
        <code value="90375-7"/>
        <display value="Postmarketing experience section"/>
      </concept>
    </include>
  </compose>
</ValueSet>