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
{
"resourceType" : "Bundle",
"id" : "CLDBundleTemplate",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"
]
},
"language" : "en",
"identifier" : {
"system" : "https://www.mhra.gov.uk/",
"value" : "CLDBundleTemplateUniqueIdentifier"
},
"type" : "document",
"timestamp" : "2022-03-04T00:00:00Z",
"entry" : [
{
"fullUrl" : "Composition/CLDTemplate",
"resource" : {
"resourceType" : "Composition",
"id" : "CLDTemplate",
"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\"><a name=\"Composition_CLDTemplate\"> </a><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>"
},
"identifier" : [
{
"system" : "https://www.mhra.gov.uk/",
"value" : "6e1f47ac-76c7-11ee-b962-0242ac120002"
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "100000155538"
}
],
"text" : "Package Leaflet"
},
"date" : "2023-08-24T00:00:00Z",
"author" : [
{
🔗 "reference" : "Organization/PfEUMA"
}
],
"title" : "SmPCtemplate",
"section" : [
{
"title" : "Cover Page",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929791"
}
],
"text" : "Cover Page"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "1. INDICATIONS AND USAGE",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929792"
}
],
"text" : "1. INDICATIONS AND USAGE"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "2. DOSAGE AND ADMINISTRATION",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929793"
}
],
"text" : "2. DOSAGE AND ADMINISTRATION"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "2.1 Recommended Dose and Schedule",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929794"
}
],
"text" : "2.1 Recommended Dose and Schedule"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "2.2 Dose Modification",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929795"
}
],
"text" : "2.2 Dose Modification"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "3. DOSAGE FORMS AND STRENGTHS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929796"
}
],
"text" : "3. PHARMACEUTICAL FORM"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "5. WARNINGS AND PRECAUTIONS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929798"
}
],
"text" : "5. WARNINGS AND PRECAUTIONS"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "5.1\tNeutropenia",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929799"
}
],
"text" : "5.1\tNeutropenia"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "5.3\tEmbryo-Fetal Toxicity",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929800"
}
],
"text" : "5.3\tEmbryo-Fetal Toxicity"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "6. ADVERSE REACTIONS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929801"
}
],
"text" : "6. ADVERSE REACTIONS"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "6.1\tClinical Studies Experience",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929802"
}
],
"text" : "6.1\tClinical Studies Experience"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "6.2 Postmarketing Experience",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929803"
}
],
"text" : "6.2 Postmarketing Experience"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "7.\tDRUG INTERACTIONS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929804"
}
],
"text" : "7.\tDRUG INTERACTIONS"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "7.1\tAgents that may Increase Palbociclib Plasma Concentrations",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929805"
}
],
"text" : "7.1\tAgents that may Increase Palbociclib Plasma Concentrations"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "7.2\tAgents that may Decrease Palbociclib Plasma Concentrations",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929806"
}
],
"text" : "7.2\tAgents that may Decrease Palbociclib Plasma Concentrations"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "7.3\tDrugs that may have Their Plasma Concentrations Altered by Palbociclib",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929807"
}
],
"text" : "7.3\tDrugs that may have Their Plasma Concentrations Altered by Palbociclib"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "8.\tUSE IN SPECIFIC POPULATIONS",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929808"
}
],
"text" : "8.\tUSE IN SPECIFIC POPULATIONS"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "8.1\tPregnancy",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929809"
}
],
"text" : "8.1\tPregnancy"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.2\tLactation",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929810"
}
],
"text" : "8.2\tLactation"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.3\tFemales and Males of Reproductive Potential",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929811"
}
],
"text" : "8.3\tFemales and Males of Reproductive Potential"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.4\tPediatric Use",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929812"
}
],
"text" : "8.4\tPediatric Use"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.5\tGeriatric Use",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929813"
}
],
"text" : "8.5\tGeriatric Use"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.6\tHepatic Impairment",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929814"
}
],
"text" : "8.6\tHepatic Impairment"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "8.7\tRenal Impairment",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929815"
}
],
"text" : "8.7\tRenal Impairment"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "9.\tOVERDOSAGE",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929816"
}
],
"text" : "9.\tOVERDOSAGE"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "10.\tDESCRIPTION",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929817"
}
],
"text" : "10.\tDESCRIPTION"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "11.\tCLINICAL PHARMACOLOGY",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929818"
}
],
"text" : "11.\tCLINICAL PHARMACOLOGY"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "11.1\tMechanism of Action",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929819"
}
],
"text" : "11.1\tMechanism of Action"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "11.2\tPharmacodynamics",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929820"
}
],
"text" : "11.2\tPharmacodynamics"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "11.3\tPharmacokinetics",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929821"
}
],
"text" : "11.3\tPharmacokinetics"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "12\tNONCLINICAL TOXICOLOGY",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929822"
}
],
"text" : "12\tNONCLINICAL TOXICOLOGY"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
},
"section" : [
{
"title" : "12.1\tCarcinogenesis, Mutagenesis, Impairment of Fertility",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929823"
}
],
"text" : "12.1\tCarcinogenesis, Mutagenesis, Impairment of Fertility"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
},
{
"title" : "13\tCLINICAL STUDIES",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929824"
}
],
"text" : "13\tCLINICAL STUDIES"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "14\tHOW SUPPLIED/STORAGE AND HANDLING",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929825"
}
],
"text" : "14\tHOW SUPPLIED/STORAGE AND HANDLING"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
},
{
"title" : "15\tPATIENT COUNSELING INFORMATION",
"code" : {
"coding" : [
{
"system" : "https://www.mhra.gov.uk/",
"code" : "999999929826"
}
],
"text" : "15\tPATIENT COUNSELING INFORMATION"
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
}
}
]
}
},
{
"fullUrl" : "Organization/OrgTemplate",
"resource" : {
"resourceType" : "Organization",
"id" : "OrgTemplate",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_OrgTemplate\"> </a><p><b>Generated Narrative: Organization</b><a name=\"OrgTemplate\"> </a><a name=\"hcOrgTemplate\"> </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 Organization "OrgTemplate" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/OrgTemplate\u00a0(use:\u00a0official)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (rmswi#220000000034)</span></p><p><b>name</b>: Orgname OrgTemplate</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Boulevard de la Plaine 17, 1050 Bruxelles, Belgium(work)</td></tr></table></div>"
},
"identifier" : [
{
"use" : "official",
"system" : "https://spor.ema.europa.eu/omswi",
"value" : "OrgTemplate"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "220000000034",
"display" : "Marketing authorisation holder"
}
],
"text" : "Marketing authorisation holder"
}
],
"name" : "Orgname OrgTemplate",
"contact" : [
{
"address" : {
"use" : "work",
"type" : "physical",
"text" : "Boulevard de la Plaine 17, 1050 Bruxelles, Belgium",
"line" : [
"Boulevard de la Plaine 17"
],
"city" : "1050 Bruxelles",
"country" : "Belgium"
}
}
]
}
}
]
}
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.
