SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
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
| Page standards status: Trial-use | Maturity Level: 1 |
{
"resourceType" : "ValueSet",
"id" : "splSectionCodes",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 1,
"_valueInteger" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical" : "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
}
]
}
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use",
"_valueCode" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical" : "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
}
]
}
}
],
"url" : "http://hl7.org/fhir/us/spl/ValueSet/splSectionCodes",
"version" : "0.2.1",
"name" : "SPLSectionCodes",
"title" : "SPL Section Codes",
"status" : "active",
"experimental" : false,
"date" : "2024-10-26T03:36:34+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
}
]
}
],
"description" : "Section Codes for SPL Product Submission documents",
"jurisdiction" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
]
}
],
"copyright" : "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" : "http://loinc.org",
"concept" : [
{
"code" : "51945-4",
"display" : "Principal display panel of package"
},
{
"code" : "100382-1",
"display" : "REMS addressed risk"
},
{
"code" : "103572-4",
"display" : "Cosmetic product listing"
},
{
"code" : "103573-2",
"display" : "Cosmetic facility registration"
},
{
"code" : "34066-1",
"display" : "Boxed warning section"
},
{
"code" : "34067-9",
"display" : "Indications and usage section"
},
{
"code" : "34068-7",
"display" : "Dosage and administration section"
},
{
"code" : "34069-5",
"display" : "How supplied section"
},
{
"code" : "34070-3",
"display" : "Contraindications section"
},
{
"code" : "34071-1",
"display" : "Warnings section"
},
{
"code" : "34072-9",
"display" : "General precautions section"
},
{
"code" : "34073-7",
"display" : "Drug interactions section"
},
{
"code" : "34074-5",
"display" : "Drug/laboratory test interactions section"
},
{
"code" : "34075-2",
"display" : "Laboratory tests section"
},
{
"code" : "34076-0",
"display" : "Information for patients section"
},
{
"code" : "34077-8",
"display" : "Teratogenic effects section"
},
{
"code" : "34078-6",
"display" : "Nonteratogenic effects section"
},
{
"code" : "34079-4",
"display" : "Labor and delivery section"
},
{
"code" : "34080-2",
"display" : "Nursing mothers section"
},
{
"code" : "34081-0",
"display" : "Pediatric use section"
},
{
"code" : "34082-8",
"display" : "Geriatric use section"
},
{
"code" : "34083-6",
"display" : "Carcinogenesis and mutagenesis and impairment of fertility section"
},
{
"code" : "34084-4",
"display" : "Adverse reactions section"
},
{
"code" : "34085-1",
"display" : "Controlled substance section"
},
{
"code" : "34086-9",
"display" : "Abuse section"
},
{
"code" : "34087-7",
"display" : "Dependence section"
},
{
"code" : "34088-5",
"display" : "Overdosage section"
},
{
"code" : "34089-3",
"display" : "Description section"
},
{
"code" : "34090-1",
"display" : "Clinical pharmacology section"
},
{
"code" : "34091-9",
"display" : "Animal pharmacology/toxicology section"
},
{
"code" : "34092-7",
"display" : "Clinical studies section"
},
{
"code" : "34093-5",
"display" : "References section"
},
{
"code" : "38056-8",
"display" : "Structured product laballing supplemental patient material"
},
{
"code" : "42227-9",
"display" : "Drug abuse and dependence section"
},
{
"code" : "42228-7",
"display" : "Pregnancy section"
},
{
"code" : "42229-5",
"display" : "Structured patient labelling unclassified section"
},
{
"code" : "42230-3",
"display" : "Structured product laballing patient package insert section"
},
{
"code" : "42231-1",
"display" : "Structured product labelling medguide section"
},
{
"code" : "42232-9",
"display" : "Precautions section"
},
{
"code" : "43678-2",
"display" : "Dosage forms and strengths section"
},
{
"code" : "43679-0",
"display" : "Mechanism of action section"
},
{
"code" : "43680-8",
"display" : "Nonclinical toxicology section"
},
{
"code" : "43681-6",
"display" : "Pharmacodynamics section"
},
{
"code" : "43682-4",
"display" : "Pharmacokinetics section"
},
{
"code" : "43683-2",
"display" : "Recent major changes section"
},
{
"code" : "43684-0",
"display" : "Use in specific populations section"
},
{
"code" : "43685-7",
"display" : "Warnings and precautions section"
},
{
"code" : "44425-7",
"display" : "Storage and handling section"
},
{
"code" : "48779-3",
"display" : "Structured product labelling indexing data elements section"
},
{
"code" : "48780-1",
"display" : "Structured product labelling listing data elements section"
},
{
"code" : "49489-8",
"display" : "Microbiology section"
},
{
"code" : "54433-8",
"display" : "User safety warnings section"
},
{
"code" : "59845-8",
"display" : "Instructions for use section"
},
{
"code" : "60555-0",
"display" : "Accessories"
},
{
"code" : "60556-8",
"display" : "Assembly or installation instructions"
},
{
"code" : "60557-6",
"display" : "Calibration instructions"
},
{
"code" : "60558-4",
"display" : "Cleaning, disinfecting, and sterilization instructions"
},
{
"code" : "60559-2",
"display" : "Components"
},
{
"code" : "60560-0",
"display" : "Intended use of the device"
},
{
"code" : "60561-8",
"display" : "Other safety information"
},
{
"code" : "60562-6",
"display" : "Route, method and frequency of administration"
},
{
"code" : "60563-4",
"display" : "Summary of safety and effectiveness"
},
{
"code" : "60685-5",
"display" : "Indexing - pharmacologic class"
},
{
"code" : "64123-3",
"display" : "Indexing - adverse reaction"
},
{
"code" : "64124-1",
"display" : "Indexing - substance"
},
{
"code" : "66105-8",
"display" : "Lot distribution data"
},
{
"code" : "66106-6",
"display" : "Pharmacogenomics section"
},
{
"code" : "69758-1",
"display" : "Diagram of device"
},
{
"code" : "69759-9",
"display" : "Risks"
},
{
"code" : "69760-7",
"display" : "Compatible accessories"
},
{
"code" : "69761-5",
"display" : "Alarms"
},
{
"code" : "69762-3",
"display" : "Troubleshooting"
},
{
"code" : "69763-1",
"display" : "Disposal and waste handling"
},
{
"code" : "71446-9",
"display" : "Indexing - billing unit"
},
{
"code" : "71681-1",
"display" : "PMI - Common side effects section"
},
{
"code" : "71682-9",
"display" : "PMI - Get emergency medical help section"
},
{
"code" : "71683-7",
"display" : "PMI - Stop taking and call your doctor section"
},
{
"code" : "71684-5",
"display" : "PMI - Directions for use section"
},
{
"code" : "71685-2",
"display" : "PMI - Tell your doctor before taking section"
},
{
"code" : "71686-0",
"display" : "PMI - Do not take section"
},
{
"code" : "71687-8",
"display" : "PMI - Important information section"
},
{
"code" : "71688-6",
"display" : "PMI - Uses section"
},
{
"code" : "71744-7",
"display" : "Health care provider letter"
},
{
"code" : "73815-3",
"display" : "Indexing - product concept"
},
{
"code" : "77288-9",
"display" : "Indexing - warning letter alert"
},
{
"code" : "77289-7",
"display" : "Identification of suspect product and notification"
},
{
"code" : "77290-5",
"display" : "Lactation"
},
{
"code" : "77291-3",
"display" : "Females and males reproductive potential"
},
{
"code" : "77292-1",
"display" : "eFacility"
},
{
"code" : "82336-9",
"display" : "REMS header"
},
{
"code" : "82344-3",
"display" : "REMS communication plan"
},
{
"code" : "82345-0",
"display" : "REMS elements to assure safe use"
},
{
"code" : "82346-8",
"display" : "REMS material"
},
{
"code" : "82347-6",
"display" : "REMS summary"
},
{
"code" : "82348-4",
"display" : "REMS elements"
},
{
"code" : "82349-2",
"display" : "REMS goals"
},
{
"code" : "82350-0",
"display" : "REMS implementation system"
},
{
"code" : "82351-8",
"display" : "Risk evaluation and mitigation strategies"
},
{
"code" : "82352-6",
"display" : "REMS timetable for submission assessments"
},
{
"code" : "82353-4",
"display" : "Indexing - risk evaluation and mitigation strategies"
},
{
"code" : "82598-4",
"display" : "REMS medication guide"
},
{
"code" : "85273-1",
"display" : "REMS conversion to shared system"
},
{
"code" : "85274-9",
"display" : "REMS release"
},
{
"code" : "86445-4",
"display" : "Blanket no changes certification of product listing"
},
{
"code" : "87523-7",
"display" : "REMS administrative information"
},
{
"code" : "87524-5",
"display" : "REMS requirements"
},
{
"code" : "87525-2",
"display" : "REMS participant requirements"
},
{
"code" : "87526-0",
"display" : "REMS applicant requirements"
},
{
"code" : "88436-1",
"display" : "Patient counseling information"
},
{
"code" : "88437-9",
"display" : "How supplied and storage and handling section"
},
{
"code" : "88828-9",
"display" : "Renal Impairment subsection"
},
{
"code" : "88829-7",
"display" : "Hepatic Impairment subsection"
},
{
"code" : "88830-5",
"display" : "Immunogenicity"
},
{
"code" : "90374-0",
"display" : "Clinical trials experience section"
},
{
"code" : "90375-7",
"display" : "Postmarketing experience section"
}
]
}
]
}
}
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.1 based on FHIR 5.0.0. Generated 2024-10-26
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change