Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
| Active as of 2024-07-15 |
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INSTALLATION INSTRUCTIONS</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/60557-6/\">60557-6</a></td><td>CALIBRATION INSTRUCTIONS</td></tr><tr><td><a href=\"https://loinc.org/34083-6/\">34083-6</a></td><td>CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY 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/60558-4/\">60558-4</a></td><td>CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS</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/90374-0/\">90374-0</a></td><td>CLINICAL TRIALS EXPERIENCE SECTION</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/60559-2/\">60559-2</a></td><td>COMPONENTS</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/34085-1/\">34085-1</a></td><td>CONTROLLED SUBSTANCE 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/34089-3/\">34089-3</a></td><td>DESCRIPTION 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/69763-1/\">69763-1</a></td><td>DISPOSAL AND WASTE HANDLING</td></tr><tr><td><a href=\"https://loinc.org/34068-7/\">34068-7</a></td><td>DOSAGE & ADMINISTRATION SECTION</td></tr><tr><td><a href=\"https://loinc.org/43678-2/\">43678-2</a></td><td>DOSAGE FORMS & STRENGTHS SECTION</td></tr><tr><td><a href=\"https://loinc.org/34074-5/\">34074-5</a></td><td>DRUG & OR LABORATORY TEST INTERACTIONS SECTION</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/34073-7/\">34073-7</a></td><td>DRUG INTERACTIONS SECTION</td></tr><tr><td><a href=\"https://loinc.org/50742-6/\">50742-6</a></td><td>ENVIRONMENTAL WARNING SECTION</td></tr><tr><td><a href=\"https://loinc.org/77291-3/\">77291-3</a></td><td>FEMALES & MALES OF REPRODUCTIVE POTENTIAL SECTION</td></tr><tr><td><a href=\"https://loinc.org/50743-4/\">50743-4</a></td><td>FOOD SAFETY WARNING 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/34082-8/\">34082-8</a></td><td>GERIATRIC USE SECTION</td></tr><tr><td><a href=\"https://loinc.org/50740-0/\">50740-0</a></td><td>GUARANTEED ANALYSIS OF FEED SECTION</td></tr><tr><td><a href=\"https://loinc.org/71744-7/\">71744-7</a></td><td>HEALTH CARE PROVIDER LETTER SECTION</td></tr><tr><td><a href=\"https://loinc.org/69719-3/\">69719-3</a></td><td>HEALTH CLAIM SECTION</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/34069-5/\">34069-5</a></td><td>HOW SUPPLIED SECTION</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/51727-6/\">51727-6</a></td><td>INACTIVE INGREDIENT SECTION</td></tr><tr><td><a href=\"https://loinc.org/34067-9/\">34067-9</a></td><td>INDICATIONS & USAGE SECTION</td></tr><tr><td><a href=\"https://loinc.org/50744-2/\">50744-2</a></td><td>INFORMATION FOR OWNERS/CAREGIVERS 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/59845-8/\">59845-8</a></td><td>INSTRUCTIONS FOR USE SECTION</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/34079-4/\">34079-4</a></td><td>LABOR & DELIVERY 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/77290-5/\">77290-5</a></td><td>LACTATION 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/49489-8/\">49489-8</a></td><td>MICROBIOLOGY 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/34078-6/\">34078-6</a></td><td>NONTERATOGENIC EFFECTS 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/60561-8/\">60561-8</a></td><td>OTHER SAFETY INFORMATION</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/55106-9/\">55106-9</a></td><td>OTC - ACTIVE INGREDIENT SECTION</td></tr><tr><td><a href=\"https://loinc.org/50569-3/\">50569-3</a></td><td>OTC - ASK DOCTOR SECTION</td></tr><tr><td><a href=\"https://loinc.org/50568-5/\">50568-5</a></td><td>OTC - ASK DOCTOR/PHARMACIST SECTION</td></tr><tr><td><a href=\"https://loinc.org/50570-1/\">50570-1</a></td><td>OTC - DO NOT USE SECTION</td></tr><tr><td><a href=\"https://loinc.org/50565-1/\">50565-1</a></td><td>OTC - KEEP OUT OF REACH OF CHILDREN SECTION</td></tr><tr><td><a href=\"https://loinc.org/53414-9/\">53414-9</a></td><td>OTC - PREGNANCY OR BREAST FEEDING SECTION</td></tr><tr><td><a href=\"https://loinc.org/55105-1/\">55105-1</a></td><td>OTC - PURPOSE SECTION</td></tr><tr><td><a href=\"https://loinc.org/53413-1/\">53413-1</a></td><td>OTC - QUESTIONS SECTION</td></tr><tr><td><a href=\"https://loinc.org/50566-9/\">50566-9</a></td><td>OTC - STOP USE SECTION</td></tr><tr><td><a href=\"https://loinc.org/50567-7/\">50567-7</a></td><td>OTC - WHEN USING SECTION</td></tr><tr><td><a href=\"https://loinc.org/51945-4/\">51945-4</a></td><td>PACKAGE LABEL.PRINCIPAL DISPLAY PANEL</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/68498-5/\">68498-5</a></td><td>PATIENT MEDICATION INFORMATION 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/43681-6/\">43681-6</a></td><td>PHARMACODYNAMICS SECTION</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/43682-4/\">43682-4</a></td><td>PHARMACOKINETICS SECTION</td></tr><tr><td><a href=\"https://loinc.org/90375-7/\">90375-7</a></td><td>POSTMARKETING EXPERIENCE 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/42228-7/\">42228-7</a></td><td>PREGNANCY 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/34093-5/\">34093-5</a></td><td>REFERENCES SECTION</td></tr><tr><td><a href=\"https://loinc.org/53412-3/\">53412-3</a></td><td>RESIDUE WARNING SECTION</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/87523-7/\">87523-7</a></td><td>REMS ADMINISTRATIVE INFORMATION</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/82344-3/\">82344-3</a></td><td>REMS COMMUNICATION</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/82345-0/\">82345-0</a></td><td>REMS ELEMENTS TO ASSURE SAFE USE</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/82346-8/\">82346-8</a></td><td>REMS MATERIAL</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/87525-2/\">87525-2</a></td><td>REMS PARTICIPANT REQUIREMENTS</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/82347-6/\">82347-6</a></td><td>REMS SUMMARY</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/88828-9/\">88828-9</a></td><td>RENAL IMPAIRMENT SUBSECTION</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/60562-6/\">60562-6</a></td><td>ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION</td></tr><tr><td><a href=\"https://loinc.org/50741-8/\">50741-8</a></td><td>SAFE HANDLING WARNING SECTION</td></tr><tr><td><a href=\"https://loinc.org/48779-3/\">48779-3</a></td><td>SPL INDEXING DATA ELEMENTS SECTION</td></tr><tr><td><a href=\"https://loinc.org/48780-1/\">48780-1</a></td><td>SPL PRODUCT DATA ELEMENTS SECTION</td></tr><tr><td><a href=\"https://loinc.org/42231-1/\">42231-1</a></td><td>SPL MEDGUIDE SECTION</td></tr><tr><td><a href=\"https://loinc.org/42230-3/\">42230-3</a></td><td>SPL PATIENT PACKAGE INSERT SECTION</td></tr><tr><td><a href=\"https://loinc.org/42229-5/\">42229-5</a></td><td>SPL UNCLASSIFIED SECTION</td></tr><tr><td><a href=\"https://loinc.org/69718-5/\">69718-5</a></td><td>STATEMENT OF IDENTITY 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/60563-4/\">60563-4</a></td><td>SUMMARY OF SAFETY AND EFFECTIVENESS</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/69762-3/\">69762-3</a></td><td>TROUBLESHOOTING</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/54433-8/\">54433-8</a></td><td>USER SAFETY WARNINGS SECTION</td></tr><tr><td><a href=\"https://loinc.org/50745-9/\">50745-9</a></td><td>VETERINARY INDICATIONS 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/34071-1/\">34071-1</a></td><td>WARNINGS SECTION</td></tr></table></li></ul></div>"
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"code" : "34086-9",
"display" : "ABUSE SECTION"
},
{
"code" : "60555-0",
"display" : "ACCESSORIES"
},
{
"code" : "34084-4",
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{
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{
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{
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{
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{
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{
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},
{
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{
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{
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},
{
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},
{
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},
{
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"display" : "DRUG INTERACTIONS SECTION"
},
{
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"display" : "ENVIRONMENTAL WARNING SECTION"
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{
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"display" : "FEMALES & MALES OF REPRODUCTIVE POTENTIAL SECTION"
},
{
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"display" : "FOOD SAFETY WARNING SECTION"
},
{
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"display" : "GENERAL PRECAUTIONS SECTION"
},
{
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"display" : "GERIATRIC USE SECTION"
},
{
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"display" : "GUARANTEED ANALYSIS OF FEED SECTION"
},
{
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"display" : "HEALTH CARE PROVIDER LETTER SECTION"
},
{
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"display" : "HEALTH CLAIM SECTION"
},
{
"code" : "88829-7",
"display" : "HEPATIC IMPAIRMENT SUBSECTION"
},
{
"code" : "34069-5",
"display" : "HOW SUPPLIED SECTION"
},
{
"code" : "88830-5",
"display" : "IMMUNOGENICITY"
},
{
"code" : "51727-6",
"display" : "INACTIVE INGREDIENT SECTION"
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{
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"display" : "INDICATIONS & USAGE SECTION"
},
{
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"display" : "INFORMATION FOR OWNERS/CAREGIVERS SECTION"
},
{
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"display" : "INFORMATION FOR PATIENTS SECTION"
},
{
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"display" : "INSTRUCTIONS FOR USE SECTION"
},
{
"code" : "60560-0",
"display" : "INTENDED USE OF THE DEVICE"
},
{
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"display" : "LABOR & DELIVERY SECTION"
},
{
"code" : "34075-2",
"display" : "LABORATORY TESTS SECTION"
},
{
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"display" : "LACTATION SECTION"
},
{
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"display" : "MECHANISM OF ACTION SECTION"
},
{
"code" : "49489-8",
"display" : "MICROBIOLOGY SECTION"
},
{
"code" : "43680-8",
"display" : "NONCLINICAL TOXICOLOGY SECTION"
},
{
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},
{
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"display" : "NURSING MOTHERS SECTION"
},
{
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"display" : "OTHER SAFETY INFORMATION"
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{
"code" : "34088-5",
"display" : "OVERDOSAGE SECTION"
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{
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{
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},
{
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"display" : "OTC - ASK DOCTOR/PHARMACIST SECTION"
},
{
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},
{
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{
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},
{
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},
{
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"display" : "OTC - QUESTIONS SECTION"
},
{
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},
{
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{
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"display" : "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"
},
{
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"display" : "PATIENT COUNSELING INFORMATION"
},
{
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"display" : "PATIENT MEDICATION INFORMATION SECTION"
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{
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},
{
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},
{
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"display" : "PHARMACOGENOMICS SECTION"
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{
"code" : "43682-4",
"display" : "PHARMACOKINETICS SECTION"
},
{
"code" : "90375-7",
"display" : "POSTMARKETING EXPERIENCE SECTION"
},
{
"code" : "42232-9",
"display" : "PRECAUTIONS SECTION"
},
{
"code" : "42228-7",
"display" : "PREGNANCY SECTION"
},
{
"code" : "43683-2",
"display" : "RECENT MAJOR CHANGES SECTION"
},
{
"code" : "34093-5",
"display" : "REFERENCES SECTION"
},
{
"code" : "53412-3",
"display" : "RESIDUE WARNING SECTION"
},
{
"code" : "100382-1",
"display" : "REMS ADDRESSED RISK"
},
{
"code" : "87523-7",
"display" : "REMS ADMINISTRATIVE INFORMATION"
},
{
"code" : "87526-0",
"display" : "REMS APPLICANT REQUIREMENTS"
},
{
"code" : "82344-3",
"display" : "REMS COMMUNICATION"
},
{
"code" : "82348-4",
"display" : "REMS ELEMENTS"
},
{
"code" : "82345-0",
"display" : "REMS ELEMENTS TO ASSURE SAFE USE"
},
{
"code" : "82349-2",
"display" : "REMS GOALS"
},
{
"code" : "82350-0",
"display" : "REMS IMPLEMENTATION SYSTEM"
},
{
"code" : "82346-8",
"display" : "REMS MATERIAL"
},
{
"code" : "82598-4",
"display" : "REMS MEDICATION GUIDE"
},
{
"code" : "87525-2",
"display" : "REMS PARTICIPANT REQUIREMENTS"
},
{
"code" : "87524-5",
"display" : "REMS REQUIREMENTS"
},
{
"code" : "82347-6",
"display" : "REMS SUMMARY"
},
{
"code" : "82352-6",
"display" : "REMS TIMETABLE FOR SUBMISSION ASSESSMENTS"
},
{
"code" : "88828-9",
"display" : "RENAL IMPAIRMENT SUBSECTION"
},
{
"code" : "69759-9",
"display" : "RISKS"
},
{
"code" : "60562-6",
"display" : "ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION"
},
{
"code" : "50741-8",
"display" : "SAFE HANDLING WARNING SECTION"
},
{
"code" : "48779-3",
"display" : "SPL INDEXING DATA ELEMENTS SECTION"
},
{
"code" : "48780-1",
"display" : "SPL PRODUCT DATA ELEMENTS SECTION"
},
{
"code" : "42231-1",
"display" : "SPL MEDGUIDE SECTION"
},
{
"code" : "42230-3",
"display" : "SPL PATIENT PACKAGE INSERT SECTION"
},
{
"code" : "42229-5",
"display" : "SPL UNCLASSIFIED SECTION"
},
{
"code" : "69718-5",
"display" : "STATEMENT OF IDENTITY SECTION"
},
{
"code" : "44425-7",
"display" : "STORAGE AND HANDLING SECTION"
},
{
"code" : "60563-4",
"display" : "SUMMARY OF SAFETY AND EFFECTIVENESS"
},
{
"code" : "34077-8",
"display" : "TERATOGENIC EFFECTS SECTION"
},
{
"code" : "69762-3",
"display" : "TROUBLESHOOTING"
},
{
"code" : "43684-0",
"display" : "USE IN SPECIFIC POPULATIONS SECTION"
},
{
"code" : "54433-8",
"display" : "USER SAFETY WARNINGS SECTION"
},
{
"code" : "50745-9",
"display" : "VETERINARY INDICATIONS SECTION"
},
{
"code" : "43685-7",
"display" : "WARNINGS AND PRECAUTIONS SECTION"
},
{
"code" : "34071-1",
"display" : "WARNINGS SECTION"
}
]
}
]
}
}
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2024-07-15
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