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
| Official URL: http://hl7.org/fhir/us/spl/ValueSet/splSectionCodes | Version: 0.2.1 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: SPLSectionCodes | ||
Copyright/Legal: 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. |
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Section Codes for SPL Product Submission documents
References
Generated Narrative: ValueSet splSectionCodes
http://loinc.org| Code | Display |
| 51945-4 | Principal display panel of package |
| 100382-1 | REMS addressed risk |
| 103572-4 | Cosmetic product listing |
| 103573-2 | Cosmetic facility registration |
| 34066-1 | Boxed warning section |
| 34067-9 | Indications and usage section |
| 34068-7 | Dosage and administration section |
| 34069-5 | How supplied section |
| 34070-3 | Contraindications section |
| 34071-1 | Warnings section |
| 34072-9 | General precautions section |
| 34073-7 | Drug interactions section |
| 34074-5 | Drug/laboratory test interactions section |
| 34075-2 | Laboratory tests section |
| 34076-0 | Information for patients section |
| 34077-8 | Teratogenic effects section |
| 34078-6 | Nonteratogenic effects section |
| 34079-4 | Labor and delivery section |
| 34080-2 | Nursing mothers section |
| 34081-0 | Pediatric use section |
| 34082-8 | Geriatric use section |
| 34083-6 | Carcinogenesis and mutagenesis and impairment of fertility section |
| 34084-4 | Adverse reactions section |
| 34085-1 | Controlled substance section |
| 34086-9 | Abuse section |
| 34087-7 | Dependence section |
| 34088-5 | Overdosage section |
| 34089-3 | Description section |
| 34090-1 | Clinical pharmacology section |
| 34091-9 | Animal pharmacology/toxicology section |
| 34092-7 | Clinical studies section |
| 34093-5 | References section |
| 38056-8 | Structured product laballing supplemental patient material |
| 42227-9 | Drug abuse and dependence section |
| 42228-7 | Pregnancy section |
| 42229-5 | Structured patient labelling unclassified section |
| 42230-3 | Structured product laballing patient package insert section |
| 42231-1 | Structured product labelling medguide section |
| 42232-9 | Precautions section |
| 43678-2 | Dosage forms and strengths section |
| 43679-0 | Mechanism of action section |
| 43680-8 | Nonclinical toxicology section |
| 43681-6 | Pharmacodynamics section |
| 43682-4 | Pharmacokinetics section |
| 43683-2 | Recent major changes section |
| 43684-0 | Use in specific populations section |
| 43685-7 | Warnings and precautions section |
| 44425-7 | Storage and handling section |
| 48779-3 | Structured product labelling indexing data elements section |
| 48780-1 | Structured product labelling listing data elements section |
| 49489-8 | Microbiology section |
| 54433-8 | User safety warnings section |
| 59845-8 | Instructions for use section |
| 60555-0 | Accessories |
| 60556-8 | Assembly or installation instructions |
| 60557-6 | Calibration instructions |
| 60558-4 | Cleaning, disinfecting, and sterilization instructions |
| 60559-2 | Components |
| 60560-0 | Intended use of the device |
| 60561-8 | Other safety information |
| 60562-6 | Route, method and frequency of administration |
| 60563-4 | Summary of safety and effectiveness |
| 60685-5 | Indexing - pharmacologic class |
| 64123-3 | Indexing - adverse reaction |
| 64124-1 | Indexing - substance |
| 66105-8 | Lot distribution data |
| 66106-6 | Pharmacogenomics section |
| 69758-1 | Diagram of device |
| 69759-9 | Risks |
| 69760-7 | Compatible accessories |
| 69761-5 | Alarms |
| 69762-3 | Troubleshooting |
| 69763-1 | Disposal and waste handling |
| 71446-9 | Indexing - billing unit |
| 71681-1 | PMI - Common side effects section |
| 71682-9 | PMI - Get emergency medical help section |
| 71683-7 | PMI - Stop taking and call your doctor section |
| 71684-5 | PMI - Directions for use section |
| 71685-2 | PMI - Tell your doctor before taking section |
| 71686-0 | PMI - Do not take section |
| 71687-8 | PMI - Important information section |
| 71688-6 | PMI - Uses section |
| 71744-7 | Health care provider letter |
| 73815-3 | Indexing - product concept |
| 77288-9 | Indexing - warning letter alert |
| 77289-7 | Identification of suspect product and notification |
| 77290-5 | Lactation |
| 77291-3 | Females and males reproductive potential |
| 77292-1 | eFacility |
| 82336-9 | REMS header |
| 82344-3 | REMS communication plan |
| 82345-0 | REMS elements to assure safe use |
| 82346-8 | REMS material |
| 82347-6 | REMS summary |
| 82348-4 | REMS elements |
| 82349-2 | REMS goals |
| 82350-0 | REMS implementation system |
| 82351-8 | Risk evaluation and mitigation strategies |
| 82352-6 | REMS timetable for submission assessments |
| 82353-4 | Indexing - risk evaluation and mitigation strategies |
| 82598-4 | REMS medication guide |
| 85273-1 | REMS conversion to shared system |
| 85274-9 | REMS release |
| 86445-4 | Blanket no changes certification of product listing |
| 87523-7 | REMS administrative information |
| 87524-5 | REMS requirements |
| 87525-2 | REMS participant requirements |
| 87526-0 | REMS applicant requirements |
| 88436-1 | Patient counseling information |
| 88437-9 | How supplied and storage and handling section |
| 88828-9 | Renal Impairment subsection |
| 88829-7 | Hepatic Impairment subsection |
| 88830-5 | Immunogenicity |
| 90374-0 | Clinical trials experience section |
| 90375-7 | Postmarketing experience section |
Generated Narrative: ValueSet
Expansion based on Loinc v2.78
This value set contains 115 concepts
| Code | System | Display |
| 51945-4 | http://loinc.org | FDA product label Principal display panel of package |
| 100382-1 | http://loinc.org | FDA package insert REMS addressed risk |
| 103572-4 | http://loinc.org | FDA package insert Cosmetic product listing |
| 103573-2 | http://loinc.org | FDA package insert Cosmetic facility registration |
| 34066-1 | http://loinc.org | FDA package insert Boxed warning section |
| 34067-9 | http://loinc.org | FDA package insert Indications and usage section |
| 34068-7 | http://loinc.org | FDA package insert Dosage and administration section |
| 34069-5 | http://loinc.org | FDA package insert How supplied section |
| 34070-3 | http://loinc.org | FDA package insert Contraindications section |
| 34071-1 | http://loinc.org | FDA package insert Warnings section |
| 34072-9 | http://loinc.org | FDA package insert General precautions section |
| 34073-7 | http://loinc.org | FDA package insert Drug interactions section |
| 34074-5 | http://loinc.org | FDA package insert Drug/laboratory test interactions section |
| 34075-2 | http://loinc.org | FDA package insert Laboratory tests section |
| 34076-0 | http://loinc.org | FDA package insert Information for patients section |
| 34077-8 | http://loinc.org | FDA package insert Teratogenic effects section |
| 34078-6 | http://loinc.org | FDA package insert Nonteratogenic effects section |
| 34079-4 | http://loinc.org | FDA package insert Labor and delivery section |
| 34080-2 | http://loinc.org | FDA package insert Nursing mothers section |
| 34081-0 | http://loinc.org | FDA package insert Pediatric use section |
| 34082-8 | http://loinc.org | FDA package insert Geriatric use section |
| 34083-6 | http://loinc.org | FDA package insert Carcinogenesis and mutagenesis and impairment of fertility section |
| 34084-4 | http://loinc.org | FDA package insert Adverse reactions section |
| 34085-1 | http://loinc.org | FDA package insert Controlled substance section |
| 34086-9 | http://loinc.org | FDA package insert Abuse section |
| 34087-7 | http://loinc.org | FDA package insert Dependence section |
| 34088-5 | http://loinc.org | FDA package insert Overdosage section |
| 34089-3 | http://loinc.org | FDA package insert Description section |
| 34090-1 | http://loinc.org | FDA package insert Clinical pharmacology section |
| 34091-9 | http://loinc.org | FDA package insert Animal pharmacology/toxicology section |
| 34092-7 | http://loinc.org | FDA package insert Clinical studies section |
| 34093-5 | http://loinc.org | FDA package insert References section |
| 38056-8 | http://loinc.org | FDA package insert Structured product laballing supplemental patient material |
| 42227-9 | http://loinc.org | FDA package insert Drug abuse and dependence section |
| 42228-7 | http://loinc.org | FDA package insert Pregnancy section |
| 42229-5 | http://loinc.org | FDA package insert Structured patient labelling unclassified section |
| 42230-3 | http://loinc.org | FDA package insert Structured product laballing patient package insert section |
| 42231-1 | http://loinc.org | FDA package insert Structured product labelling medguide section |
| 42232-9 | http://loinc.org | FDA package insert Precautions section |
| 43678-2 | http://loinc.org | FDA package insert Dosage forms and strengths section |
| 43679-0 | http://loinc.org | FDA package insert Mechanism of action section |
| 43680-8 | http://loinc.org | FDA package insert Nonclinical toxicology section |
| 43681-6 | http://loinc.org | FDA package insert Pharmacodynamics section |
| 43682-4 | http://loinc.org | FDA package insert Pharmacokinetics section |
| 43683-2 | http://loinc.org | FDA package insert Recent major changes section |
| 43684-0 | http://loinc.org | FDA package insert Use in specific populations section |
| 43685-7 | http://loinc.org | FDA package insert Warnings and precautions section |
| 44425-7 | http://loinc.org | FDA package insert Storage and handling section |
| 48779-3 | http://loinc.org | FDA package insert Structured product labelling indexing data elements section |
| 48780-1 | http://loinc.org | FDA package insert Structured product labelling listing data elements section |
| 49489-8 | http://loinc.org | FDA package insert Microbiology section |
| 54433-8 | http://loinc.org | FDA package insert User safety warnings section |
| 59845-8 | http://loinc.org | FDA package insert Instructions for use section |
| 60555-0 | http://loinc.org | FDA package insert Accessories |
| 60556-8 | http://loinc.org | FDA package insert Assembly or installation instructions |
| 60557-6 | http://loinc.org | FDA package insert Calibration instructions |
| 60558-4 | http://loinc.org | FDA package insert Cleaning, disinfecting, and sterilization instructions |
| 60559-2 | http://loinc.org | FDA package insert Components |
| 60560-0 | http://loinc.org | FDA package insert Intended use of the device |
| 60561-8 | http://loinc.org | FDA package insert Other safety information |
| 60562-6 | http://loinc.org | FDA package insert Route, method and frequency of administration |
| 60563-4 | http://loinc.org | FDA package insert Summary of safety and effectiveness |
| 60685-5 | http://loinc.org | FDA package insert Indexing - pharmacologic class |
| 64123-3 | http://loinc.org | FDA package insert Indexing - adverse reaction |
| 64124-1 | http://loinc.org | FDA package insert Indexing - substance |
| 66105-8 | http://loinc.org | FDA package insert Lot distribution data |
| 66106-6 | http://loinc.org | FDA package insert Pharmacogenomics section |
| 69758-1 | http://loinc.org | FDA package insert Diagram of device |
| 69759-9 | http://loinc.org | FDA package insert Risks |
| 69760-7 | http://loinc.org | FDA package insert Compatible accessories |
| 69761-5 | http://loinc.org | FDA package insert Alarms |
| 69762-3 | http://loinc.org | FDA package insert Troubleshooting |
| 69763-1 | http://loinc.org | FDA package insert Disposal and waste handling |
| 71446-9 | http://loinc.org | FDA package insert Indexing - billing unit |
| 71681-1 | http://loinc.org | FDA package insert PMI - Common side effects section |
| 71682-9 | http://loinc.org | FDA package insert PMI - Get emergency medical help section |
| 71683-7 | http://loinc.org | FDA package insert PMI - Stop taking and call your doctor section |
| 71684-5 | http://loinc.org | FDA package insert PMI - Directions for use section |
| 71685-2 | http://loinc.org | FDA package insert PMI - Tell your doctor before taking section |
| 71686-0 | http://loinc.org | FDA package insert PMI - Do not take section |
| 71687-8 | http://loinc.org | FDA package insert PMI - Important information section |
| 71688-6 | http://loinc.org | FDA package insert PMI - Uses section |
| 71744-7 | http://loinc.org | FDA package insert Health care provider letter |
| 73815-3 | http://loinc.org | FDA package insert Indexing - product concept |
| 77288-9 | http://loinc.org | FDA package insert Indexing - warning letter alert |
| 77289-7 | http://loinc.org | FDA package insert Identification of suspect product and notification |
| 77290-5 | http://loinc.org | FDA package insert Lactation |
| 77291-3 | http://loinc.org | FDA package insert Females and males reproductive potential |
| 77292-1 | http://loinc.org | FDA package insert eFacility |
| 82336-9 | http://loinc.org | FDA package insert REMS header |
| 82344-3 | http://loinc.org | FDA package insert REMS communication plan |
| 82345-0 | http://loinc.org | FDA package insert REMS elements to assure safe use |
| 82346-8 | http://loinc.org | FDA package insert REMS material |
| 82347-6 | http://loinc.org | FDA package insert REMS summary |
| 82348-4 | http://loinc.org | FDA package insert REMS elements |
| 82349-2 | http://loinc.org | FDA package insert REMS goals |
| 82350-0 | http://loinc.org | FDA package insert REMS implementation system |
| 82351-8 | http://loinc.org | FDA package insert Risk evaluation and mitigation strategies |
| 82352-6 | http://loinc.org | FDA package insert REMS timetable for submission assessments |
| 82353-4 | http://loinc.org | FDA package insert Indexing - risk evaluation and mitigation strategies |
| 82598-4 | http://loinc.org | FDA package insert REMS medication guide |
| 85273-1 | http://loinc.org | FDA package insert REMS conversion to shared system |
| 85274-9 | http://loinc.org | FDA package insert REMS release |
| 86445-4 | http://loinc.org | FDA package insert Blanket no changes certification of product listing |
| 87523-7 | http://loinc.org | FDA package insert REMS administrative information |
| 87524-5 | http://loinc.org | FDA package insert REMS requirements |
| 87525-2 | http://loinc.org | FDA package insert REMS participant requirements |
| 87526-0 | http://loinc.org | FDA package insert REMS applicant requirements |
| 88436-1 | http://loinc.org | FDA package insert Patient counseling information |
| 88437-9 | http://loinc.org | FDA package insert How supplied and storage and handling section |
| 88828-9 | http://loinc.org | FDA package insert Renal Impairment subsection |
| 88829-7 | http://loinc.org | FDA package insert Hepatic Impairment subsection |
| 88830-5 | http://loinc.org | FDA package insert Immunogenicity |
| 90374-0 | http://loinc.org | FDA package insert Clinical trials experience section |
| 90375-7 | http://loinc.org | FDA package insert Postmarketing experience section |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |
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
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