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
{
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"id" : "SmPCtemplate",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
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"status" : "final",
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},
"date" : "2023-08-24T00:00:00Z",
"author" : [
{
🔗 "reference" : "Organization/PfEUMA"
}
],
"title" : "SmPCtemplate",
"section" : [
{
"title" : "SUMMARY OF PRODUCT CHARACTERISTICS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029791"
}
],
"text" : "SUMMARY OF PRODUCT CHARACTERISTICS"
},
"text" : {
"status" : "additional",
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}
},
{
"title" : "1. NAME OF THE MEDICINAL PRODUCT",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029792"
}
],
"text" : "1. NAME OF THE MEDICINAL PRODUCT"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
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},
{
"title" : "2. QUALITATIVE AND QUANTITATIVE COMPOSITION",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029793"
}
],
"text" : "2. QUALITATIVE AND QUANTITATIVE COMPOSITION"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "2.1 General description",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029794"
}
],
"text" : "2.1 General description"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "2.2 Qualitative and quantitative composition",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029795"
}
],
"text" : "2.2 Qualitative and quantitative composition"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Excipient(s) with known effect",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029796"
}
],
"text" : "Excipient(s) with known effect"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "3. PHARMACEUTICAL FORM",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029797"
}
],
"text" : "3. PHARMACEUTICAL FORM"
},
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}
},
{
"title" : "4. CLINICAL PARTICULARS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029798"
}
],
"text" : "4. CLINICAL PARTICULARS"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "4.1 Therapeutic indications",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029799"
}
],
"text" : "4.1 Therapeutic indications"
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}
},
{
"title" : "4.2 Posology and method of administration",
"code" : {
"coding" : [
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"system" : "https://www.mhra.gov.uk/",
"code" : "200000029800"
}
],
"text" : "4.2 Posology and method of administration"
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"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "Posology",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029801"
}
],
"text" : "Posology"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Paediatric population",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029802"
}
],
"text" : "Paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Method of administration",
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"system" : "https://www.mhra.gov.uk/",
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],
"text" : "Method of administration"
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"text" : {
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}
},
{
"title" : "Precautions to be taken before handling or administering the medicinal product",
"code" : {
"coding" : [
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"system" : "https://www.mhra.gov.uk/",
"code" : "200000029804"
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],
"text" : "Precautions to be taken before handling or administering the medicinal product"
},
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"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "4.3 Contraindications",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029805"
}
],
"text" : "4.3 Contraindications"
},
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"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "4.4 Special warnings and precautions for use",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029806"
}
],
"text" : "4.4 Special warnings and precautions for use"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
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"title" : "Traceability",
"code" : {
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"system" : "https://www.mhra.gov.uk/",
"code" : "200000029807"
}
],
"text" : "Traceability"
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}
},
{
"title" : "Paediatric population",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029808"
}
],
"text" : "Paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "4.5 Interaction with other medicinal products and other forms of interaction",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029809"
}
],
"text" : "4.5 Interaction with other medicinal products and other forms of interaction"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
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"title" : "Paediatric population",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029810"
}
],
"text" : "Paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "4.6 Fertility, pregnancy and lactation",
"code" : {
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"code" : "200000029811"
}
],
"text" : "4.6 Fertility, pregnancy and lactation"
},
"text" : {
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
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"title" : "Pregnancy",
"code" : {
"coding" : [
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"system" : "https://www.mhra.gov.uk/",
"code" : "200000029812"
}
],
"text" : "Pregnancy"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Breast-feeding",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029813"
}
],
"text" : "Breast-feeding"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Fertility",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029814"
}
],
"text" : "Fertility"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "4.7 Effects on ability to drive and use machines",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029815"
}
],
"text" : "4.7 Effects on ability to drive and use machines"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "4.8 Undesirable effects",
"code" : {
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"system" : "https://www.mhra.gov.uk/",
"code" : "200000029816"
}
],
"text" : "4.8 Undesirable effects"
},
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
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"title" : "Paediatric population",
"code" : {
"coding" : [
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"system" : "https://www.mhra.gov.uk/",
"code" : "200000029817"
}
],
"text" : "Paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Reporting of suspected adverse reactions",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029818"
}
],
"text" : "Reporting of suspected adverse reactions"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "4.9 Overdose",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029819"
}
],
"text" : "4.9 Overdose"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "Paediatric population",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029820"
}
],
"text" : "Paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
}
]
},
{
"title" : "5. PHARMACOLOGICAL PROPERTIES",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029821"
}
],
"text" : "5. PHARMACOLOGICAL PROPERTIES"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "5.1 Pharmacodynamic properties",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029822"
}
],
"text" : "5.1 Pharmacodynamic properties"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "Mechanism of action",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029823"
}
],
"text" : "Paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Pharmacodynamic effects",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029824"
}
],
"text" : "Pharmacodynamic effects"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Clinical efficacy and safety",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029825"
}
],
"text" : "Clinical efficacy and safety"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Paediatric population",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029826"
}
],
"text" : "Paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "5.2 Pharmacokinetic properties",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029827"
}
],
"text" : "5.2 Pharmacokinetic properties"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "Absorption",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029828"
}
],
"text" : "Absorption"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Distribution",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029829"
}
],
"text" : "Distribution"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "\tBiotransformation",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029830"
}
],
"text" : "Biotransformation"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Elimination",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029831"
}
],
"text" : "Elimination"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Linearity/non-linearity",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029832"
}
],
"text" : "Linearity/non-linearity"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "Pharmacokinetic/pharmacodynamic relationship(s)",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029833"
}
],
"text" : "Pharmacokinetic/pharmacodynamic relationship(s)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "5.3 Preclinical safety data",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029834"
}
],
"text" : "5.3 Preclinical safety data"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "Environmental risk assessment (ERA)",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029835"
}
],
"text" : "Environmental risk assessment (ERA)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
}
]
},
{
"title" : "6. PHARMACEUTICAL PARTICULARS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029836"
}
],
"text" : "6. PHARMACEUTICAL PARTICULARS"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "6.1 List of excipients",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029837"
}
],
"text" : "6.1 List of excipients"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "6.2 Incompatibilities",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029838"
}
],
"text" : "6.2 Incompatibilities"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "6.3 Shelf life",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029839"
}
],
"text" : "6.3 Shelf life"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "6.4 Special precautions for storage",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029840"
}
],
"text" : "6.4 Special precautions for storage"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "6.5 Nature and contents of container <and special equipment for use, administration or implantation>",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029841"
}
],
"text" : "6.5 Nature and contents of container <and special equipment for use, administration or implantation>"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "6.6 Special precautions for disposal <and other handling>>",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029842"
}
],
"text" : "6.6 Special precautions for disposal <and other handling>"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "Use in the paediatric population",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029843"
}
],
"text" : "Use in the paediatric population"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
}
]
},
{
"title" : "7. MARKETING AUTHORISATION HOLDER",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029844"
}
],
"text" : "7. MARKETING AUTHORISATION HOLDER"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8. MARKETING AUTHORISATION NUMBER(S)",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029845"
}
],
"text" : "8. MARKETING AUTHORISATION NUMBER(S)"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029846"
}
],
"text" : "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "10. DATE OF REVISION OF THE TEXT",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "200000029847"
}
],
"text" : "10. DATE OF REVISION OF THE TEXT"
},
"text" : {
"status" : "additional",
"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
Links: Table of Contents |
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.
