Miscellaneous ePI Test
0.1.0 - CI Build
Miscellaneous ePI Test
0.1.0 - CI Build
Miscellaneous ePI Test, published by . This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-test/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Composition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "CLDTemplate"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi> ] )
] ; #
fhir:language [ fhir:v "en"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p><b>Generated Narrative: Composition</b><a name=\"CLDTemplate\"> </a><a name=\"hcCLDTemplate\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Composition "CLDTemplate" (Language "en") </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.mhra.gov.uk/</code>/6e1f47ac-76c7-11ee-b962-0242ac120002</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000155538)</span></p><p><b>date</b>: 2023-08-24 00:00:00+0000</p><p><b>author</b>: <a href=\"Organization-PfEUMA.html\">Organization/PfEUMA</a> "Pfizer Europe MA EEIG"</p><p><b>title</b>: SmPCtemplate</p></div>"
] ; #
fhir:identifier ( [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "6e1f47ac-76c7-11ee-b962-0242ac120002" ]
] ) ; #
fhir:status [ fhir:v "final"] ; #
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000155538" ] ] ) ;
fhir:text [ fhir:v "Package Leaflet" ]
] ; #
fhir:date [ fhir:v "2023-08-24T00:00:00Z"^^xsd:dateTime] ; #
fhir:author ( [
fhir:reference [ fhir:v "Organization/PfEUMA" ]
] ) ; #
fhir:title [ fhir:v "SmPCtemplate"] ; #
fhir:section ( [
fhir:title [ fhir:v "Cover Page" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929791" ] ] ) ;
fhir:text [ fhir:v "Cover Page" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] [
fhir:title [ fhir:v "1. INDICATIONS AND USAGE" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929792" ] ] ) ;
fhir:text [ fhir:v "1. INDICATIONS AND USAGE" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] [
fhir:title [ fhir:v "2. DOSAGE AND ADMINISTRATION" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929793" ] ] ) ;
fhir:text [ fhir:v "2. DOSAGE AND ADMINISTRATION" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ;
( fhir:section [
fhir:title [ fhir:v "2.1 Recommended Dose and Schedule" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929794" ] ] ) ;
fhir:text [ fhir:v "2.1 Recommended Dose and Schedule" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "2.2 Dose Modification" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929795" ] ] ) ;
fhir:text [ fhir:v "2.2 Dose Modification" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] )
] [
fhir:title [ fhir:v "3. DOSAGE FORMS AND STRENGTHS" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929796" ] ] ) ;
fhir:text [ fhir:v "3. PHARMACEUTICAL FORM" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] [
fhir:title [ fhir:v "5. WARNINGS AND PRECAUTIONS" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929798" ] ] ) ;
fhir:text [ fhir:v "5. WARNINGS AND PRECAUTIONS" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ;
( fhir:section [
fhir:title [ fhir:v "5.1 Neutropenia" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929799" ] ] ) ;
fhir:text [ fhir:v "5.1 Neutropenia" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "5.3 Embryo-Fetal Toxicity" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929800" ] ] ) ;
fhir:text [ fhir:v "5.3 Embryo-Fetal Toxicity" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] )
] [
fhir:title [ fhir:v "6. ADVERSE REACTIONS" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929801" ] ] ) ;
fhir:text [ fhir:v "6. ADVERSE REACTIONS" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ;
( fhir:section [
fhir:title [ fhir:v "6.1 Clinical Studies Experience" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929802" ] ] ) ;
fhir:text [ fhir:v "6.1 Clinical Studies Experience" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "6.2 Postmarketing Experience" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929803" ] ] ) ;
fhir:text [ fhir:v "6.2 Postmarketing Experience" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] )
] [
fhir:title [ fhir:v "7. DRUG INTERACTIONS" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929804" ] ] ) ;
fhir:text [ fhir:v "7. DRUG INTERACTIONS" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ;
( fhir:section [
fhir:title [ fhir:v "7.1 Agents that may Increase Palbociclib Plasma Concentrations" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929805" ] ] ) ;
fhir:text [ fhir:v "7.1 Agents that may Increase Palbociclib Plasma Concentrations" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "7.2 Agents that may Decrease Palbociclib Plasma Concentrations" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929806" ] ] ) ;
fhir:text [ fhir:v "7.2 Agents that may Decrease Palbociclib Plasma Concentrations" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "7.3 Drugs that may have Their Plasma Concentrations Altered by Palbociclib" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929807" ] ] ) ;
fhir:text [ fhir:v "7.3 Drugs that may have Their Plasma Concentrations Altered by Palbociclib" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] )
] [
fhir:title [ fhir:v "8. USE IN SPECIFIC POPULATIONS" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929808" ] ] ) ;
fhir:text [ fhir:v "8. USE IN SPECIFIC POPULATIONS" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ;
( fhir:section [
fhir:title [ fhir:v "8.1 Pregnancy" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929809" ] ] ) ;
fhir:text [ fhir:v "8.1 Pregnancy" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "8.2 Lactation" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929810" ] ] ) ;
fhir:text [ fhir:v "8.2 Lactation" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "8.3 Females and Males of Reproductive Potential" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929811" ] ] ) ;
fhir:text [ fhir:v "8.3 Females and Males of Reproductive Potential" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "8.4 Pediatric Use" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929812" ] ] ) ;
fhir:text [ fhir:v "8.4 Pediatric Use" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "8.5 Geriatric Use" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929813" ] ] ) ;
fhir:text [ fhir:v "8.5 Geriatric Use" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "8.6 Hepatic Impairment" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929814" ] ] ) ;
fhir:text [ fhir:v "8.6 Hepatic Impairment" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "8.7 Renal Impairment" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929815" ] ] ) ;
fhir:text [ fhir:v "8.7 Renal Impairment" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] )
] [
fhir:title [ fhir:v "9. OVERDOSAGE" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929816" ] ] ) ;
fhir:text [ fhir:v "9. OVERDOSAGE" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] [
fhir:title [ fhir:v "10. DESCRIPTION" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929817" ] ] ) ;
fhir:text [ fhir:v "10. DESCRIPTION" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] [
fhir:title [ fhir:v "11. CLINICAL PHARMACOLOGY" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929818" ] ] ) ;
fhir:text [ fhir:v "11. CLINICAL PHARMACOLOGY" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ;
( fhir:section [
fhir:title [ fhir:v "11.1 Mechanism of Action" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929819" ] ] ) ;
fhir:text [ fhir:v "11.1 Mechanism of Action" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "11.2 Pharmacodynamics" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929820" ] ] ) ;
fhir:text [ fhir:v "11.2 Pharmacodynamics" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [
fhir:title [ fhir:v "11.3 Pharmacokinetics" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929821" ] ] ) ;
fhir:text [ fhir:v "11.3 Pharmacokinetics" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] )
] [
fhir:title [ fhir:v "12 NONCLINICAL TOXICOLOGY" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929822" ] ] ) ;
fhir:text [ fhir:v "12 NONCLINICAL TOXICOLOGY" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ;
( fhir:section [
fhir:title [ fhir:v "12.1 Carcinogenesis, Mutagenesis, Impairment of Fertility" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929823" ] ] ) ;
fhir:text [ fhir:v "12.1 Carcinogenesis, Mutagenesis, Impairment of Fertility" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] )
] [
fhir:title [ fhir:v "13 CLINICAL STUDIES" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929824" ] ] ) ;
fhir:text [ fhir:v "13 CLINICAL STUDIES" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] [
fhir:title [ fhir:v "14 HOW SUPPLIED/STORAGE AND HANDLING" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929825" ] ] ) ;
fhir:text [ fhir:v "14 HOW SUPPLIED/STORAGE AND HANDLING" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] [
fhir:title [ fhir:v "15 PATIENT COUNSELING INFORMATION" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ;
fhir:code [ fhir:v "999999929826" ] ] ) ;
fhir:text [ fhir:v "15 PATIENT COUNSELING INFORMATION" ] ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ]
] ) . #
IG © 2022+ . Package hl7.fhir.uv.epi-test#0.1.0 based on FHIR 5.0.0. Generated 2024-04-04
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QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
