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 "SmPCtemplate"] ; # 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=\"SmPCtemplate\"> </a><a name=\"hcSmPCtemplate\"> </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 "SmPCtemplate" (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>/b5ffe6c3-ac12-44c4-a0a1-b13a1f7740ad</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 "b5ffe6c3-ac12-44c4-a0a1-b13a1f7740ad" ] ] ) ; # 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 "SUMMARY OF PRODUCT CHARACTERISTICS" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029791" ] ] ) ; fhir:text [ fhir:v "SUMMARY OF PRODUCT CHARACTERISTICS" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "1. NAME OF THE MEDICINAL PRODUCT" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029792" ] ] ) ; fhir:text [ fhir:v "1. NAME OF THE MEDICINAL PRODUCT" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "2. QUALITATIVE AND QUANTITATIVE COMPOSITION" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029793" ] ] ) ; fhir:text [ fhir:v "2. QUALITATIVE AND QUANTITATIVE COMPOSITION" ] ] ; 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 General description" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029794" ] ] ) ; fhir:text [ fhir:v "2.1 General description" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "2.2 Qualitative and quantitative composition" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029795" ] ] ) ; fhir:text [ fhir:v "2.2 Qualitative and quantitative composition" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Excipient(s) with known effect" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029796" ] ] ) ; fhir:text [ fhir:v "Excipient(s) with known effect" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "3. PHARMACEUTICAL FORM" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029797" ] ] ) ; 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 "4. CLINICAL PARTICULARS" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029798" ] ] ) ; fhir:text [ fhir:v "4. CLINICAL PARTICULARS" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "4.1 Therapeutic indications" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029799" ] ] ) ; fhir:text [ fhir:v "4.1 Therapeutic indications" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "4.2 Posology and method of administration" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029800" ] ] ) ; fhir:text [ fhir:v "4.2 Posology and method of 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 "Posology" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029801" ] ] ) ; fhir:text [ fhir:v "Posology" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Paediatric population" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029802" ] ] ) ; fhir:text [ fhir:v "Paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Method of administration" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029803" ] ] ) ; fhir:text [ fhir:v "Method of administration" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Precautions to be taken before handling or administering the medicinal product" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029804" ] ] ) ; fhir:text [ fhir:v "Precautions to be taken before handling or administering the medicinal product" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "4.3 Contraindications" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029805" ] ] ) ; fhir:text [ fhir:v "4.3 Contraindications" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "4.4 Special warnings and precautions for use" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029806" ] ] ) ; fhir:text [ fhir:v "4.4 Special warnings and precautions for use" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Traceability" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029807" ] ] ) ; fhir:text [ fhir:v "Traceability" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Paediatric population" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029808" ] ] ) ; fhir:text [ fhir:v "Paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "4.5 Interaction with other medicinal products and other forms of interaction" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029809" ] ] ) ; fhir:text [ fhir:v "4.5 Interaction with other medicinal products and other forms of interaction" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Paediatric population" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029810" ] ] ) ; fhir:text [ fhir:v "Paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "4.6 Fertility, pregnancy and lactation" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029811" ] ] ) ; fhir:text [ fhir:v "4.6 Fertility, pregnancy and lactation" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Pregnancy" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029812" ] ] ) ; fhir:text [ fhir:v "Pregnancy" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Breast-feeding" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029813" ] ] ) ; fhir:text [ fhir:v "Breast-feeding" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Fertility" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029814" ] ] ) ; fhir:text [ fhir:v "Fertility" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "4.7 Effects on ability to drive and use machines" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029815" ] ] ) ; fhir:text [ fhir:v "4.7 Effects on ability to drive and use machines" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "4.8 Undesirable effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029816" ] ] ) ; fhir:text [ fhir:v "4.8 Undesirable effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Paediatric population" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029817" ] ] ) ; fhir:text [ fhir:v "Paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Reporting of suspected adverse reactions" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029818" ] ] ) ; fhir:text [ fhir:v "Reporting of suspected adverse reactions" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "4.9 Overdose" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029819" ] ] ) ; fhir:text [ fhir:v "4.9 Overdose" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Paediatric population" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029820" ] ] ) ; fhir:text [ fhir:v "Paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] ) ] [ fhir:title [ fhir:v "5. PHARMACOLOGICAL PROPERTIES" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029821" ] ] ) ; fhir:text [ fhir:v "5. PHARMACOLOGICAL PROPERTIES" ] ] ; 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 Pharmacodynamic properties" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029822" ] ] ) ; fhir:text [ fhir:v "5.1 Pharmacodynamic properties" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Mechanism of action" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029823" ] ] ) ; fhir:text [ fhir:v "Paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Pharmacodynamic effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029824" ] ] ) ; fhir:text [ fhir:v "Pharmacodynamic effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Clinical efficacy and safety" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029825" ] ] ) ; fhir:text [ fhir:v "Clinical efficacy and safety" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Paediatric population" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029826" ] ] ) ; fhir:text [ fhir:v "Paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "5.2 Pharmacokinetic properties" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029827" ] ] ) ; fhir:text [ fhir:v "5.2 Pharmacokinetic properties" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Absorption" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029828" ] ] ) ; fhir:text [ fhir:v "Absorption" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Distribution" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029829" ] ] ) ; fhir:text [ fhir:v "Distribution" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v " Biotransformation" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029830" ] ] ) ; fhir:text [ fhir:v "Biotransformation" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Elimination" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029831" ] ] ) ; fhir:text [ fhir:v "Elimination" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Linearity/non-linearity" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029832" ] ] ) ; fhir:text [ fhir:v "Linearity/non-linearity" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "Pharmacokinetic/pharmacodynamic relationship(s)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029833" ] ] ) ; fhir:text [ fhir:v "Pharmacokinetic/pharmacodynamic relationship(s)" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] [ fhir:title [ fhir:v "5.3 Preclinical safety data" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029834" ] ] ) ; fhir:text [ fhir:v "5.3 Preclinical safety data" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Environmental risk assessment (ERA)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029835" ] ] ) ; fhir:text [ fhir:v "Environmental risk assessment (ERA)" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] ) ] [ fhir:title [ fhir:v "6. PHARMACEUTICAL PARTICULARS" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029836" ] ] ) ; fhir:text [ fhir:v "6. PHARMACEUTICAL PARTICULARS" ] ] ; 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 List of excipients" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029837" ] ] ) ; fhir:text [ fhir:v "6.1 List of excipients" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "6.2 Incompatibilities" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029838" ] ] ) ; fhir:text [ fhir:v "6.2 Incompatibilities" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "6.3 Shelf life" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029839" ] ] ) ; fhir:text [ fhir:v "6.3 Shelf life" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "6.4 Special precautions for storage" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029840" ] ] ) ; fhir:text [ fhir:v "6.4 Special precautions for storage" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "6.5 Nature and contents of container <and special equipment for use, administration or implantation>" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029841" ] ] ) ; fhir:text [ fhir:v "6.5 Nature and contents of container <and special equipment for use, administration or implantation>" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "6.6 Special precautions for disposal <and other handling>>" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029842" ] ] ) ; fhir:text [ fhir:v "6.6 Special precautions for disposal <and other handling>" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ; ( fhir:section [ fhir:title [ fhir:v "Use in the paediatric population" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029843" ] ] ) ; fhir:text [ fhir:v "Use in the paediatric population" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] ) ] ) ] [ fhir:title [ fhir:v "7. MARKETING AUTHORISATION HOLDER" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029844" ] ] ) ; fhir:text [ fhir:v "7. MARKETING AUTHORISATION HOLDER" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "8. MARKETING AUTHORISATION NUMBER(S)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029845" ] ] ) ; fhir:text [ fhir:v "8. MARKETING AUTHORISATION NUMBER(S)" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029846" ] ] ) ; fhir:text [ fhir:v "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "10. DATE OF REVISION OF THE TEXT" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://www.mhra.gov.uk/"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000029847" ] ] ) ; fhir:text [ fhir:v "10. DATE OF REVISION OF THE TEXT" ] ] ; 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
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.