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
<Bundle xmlns="http://hl7.org/fhir">
<id value="CLDBundleTemplate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="https://www.mhra.gov.uk/"/>
<value value="CLDBundleTemplateUniqueIdentifier"/>
</identifier>
<type value="document"/>
<timestamp value="2022-03-04T00:00:00Z"/>
<entry>
<fullUrl value="Composition/CLDTemplate"/>
<resource>
<Composition>
<id value="CLDTemplate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="https://www.mhra.gov.uk/"/>
<value value="6e1f47ac-76c7-11ee-b962-0242ac120002"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<date value="2023-08-24T00:00:00Z"/>
<author>🔗
<reference value="Organization/PfEUMA"/>
</author>
<title value="SmPCtemplate"/>
<section>
<title value="Cover Page"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929791"/>
</coding>
<text value="Cover Page"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="1. INDICATIONS AND USAGE"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929792"/>
</coding>
<text value="1. INDICATIONS AND USAGE"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="2. DOSAGE AND ADMINISTRATION"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929793"/>
</coding>
<text value="2. DOSAGE AND ADMINISTRATION"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title value="2.1 Recommended Dose and Schedule"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929794"/>
</coding>
<text value="2.1 Recommended Dose and Schedule"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="2.2 Dose Modification"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929795"/>
</coding>
<text value="2.2 Dose Modification"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</section>
<section>
<title value="3. DOSAGE FORMS AND STRENGTHS"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929796"/>
</coding>
<text value="3. PHARMACEUTICAL FORM"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="5. WARNINGS AND PRECAUTIONS"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929798"/>
</coding>
<text value="5. WARNINGS AND PRECAUTIONS"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title value="5.1 Neutropenia"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929799"/>
</coding>
<text value="5.1 Neutropenia"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="5.3 Embryo-Fetal Toxicity"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929800"/>
</coding>
<text value="5.3 Embryo-Fetal Toxicity"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</section>
<section>
<title value="6. ADVERSE REACTIONS"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929801"/>
</coding>
<text value="6. ADVERSE REACTIONS"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title value="6.1 Clinical Studies Experience"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929802"/>
</coding>
<text value="6.1 Clinical Studies Experience"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="6.2 Postmarketing Experience"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929803"/>
</coding>
<text value="6.2 Postmarketing Experience"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</section>
<section>
<title value="7. DRUG INTERACTIONS"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929804"/>
</coding>
<text value="7. DRUG INTERACTIONS"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title
value="7.1 Agents that may Increase Palbociclib Plasma Concentrations"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929805"/>
</coding>
<text
value="7.1 Agents that may Increase Palbociclib Plasma Concentrations"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title
value="7.2 Agents that may Decrease Palbociclib Plasma Concentrations"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929806"/>
</coding>
<text
value="7.2 Agents that may Decrease Palbociclib Plasma Concentrations"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title
value="7.3 Drugs that may have Their Plasma Concentrations Altered by Palbociclib"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929807"/>
</coding>
<text
value="7.3 Drugs that may have Their Plasma Concentrations Altered by Palbociclib"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</section>
<section>
<title value="8. USE IN SPECIFIC POPULATIONS"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929808"/>
</coding>
<text value="8. USE IN SPECIFIC POPULATIONS"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title value="8.1 Pregnancy"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929809"/>
</coding>
<text value="8.1 Pregnancy"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="8.2 Lactation"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929810"/>
</coding>
<text value="8.2 Lactation"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="8.3 Females and Males of Reproductive Potential"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929811"/>
</coding>
<text value="8.3 Females and Males of Reproductive Potential"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="8.4 Pediatric Use"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929812"/>
</coding>
<text value="8.4 Pediatric Use"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="8.5 Geriatric Use"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929813"/>
</coding>
<text value="8.5 Geriatric Use"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="8.6 Hepatic Impairment"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929814"/>
</coding>
<text value="8.6 Hepatic Impairment"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="8.7 Renal Impairment"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929815"/>
</coding>
<text value="8.7 Renal Impairment"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</section>
<section>
<title value="9. OVERDOSAGE"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929816"/>
</coding>
<text value="9. OVERDOSAGE"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="10. DESCRIPTION"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929817"/>
</coding>
<text value="10. DESCRIPTION"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="11. CLINICAL PHARMACOLOGY"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929818"/>
</coding>
<text value="11. CLINICAL PHARMACOLOGY"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title value="11.1 Mechanism of Action"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929819"/>
</coding>
<text value="11.1 Mechanism of Action"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="11.2 Pharmacodynamics"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929820"/>
</coding>
<text value="11.2 Pharmacodynamics"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="11.3 Pharmacokinetics"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929821"/>
</coding>
<text value="11.3 Pharmacokinetics"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</section>
<section>
<title value="12 NONCLINICAL TOXICOLOGY"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929822"/>
</coding>
<text value="12 NONCLINICAL TOXICOLOGY"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
<section>
<title
value="12.1 Carcinogenesis, Mutagenesis, Impairment of Fertility"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929823"/>
</coding>
<text
value="12.1 Carcinogenesis, Mutagenesis, Impairment of Fertility"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</section>
<section>
<title value="13 CLINICAL STUDIES"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929824"/>
</coding>
<text value="13 CLINICAL STUDIES"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="14 HOW SUPPLIED/STORAGE AND HANDLING"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929825"/>
</coding>
<text value="14 HOW SUPPLIED/STORAGE AND HANDLING"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="15 PATIENT COUNSELING INFORMATION"/>
<code>
<coding>
<system value="https://www.mhra.gov.uk/"/>
<code value="999999929826"/>
</coding>
<text value="15 PATIENT COUNSELING INFORMATION"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="Organization/OrgTemplate"/>
<resource>
<Organization>
<id value="OrgTemplate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<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 (use: official)</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>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="OrgTemplate"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
</coding>
<text value="Marketing authorisation holder"/>
</type>
<name value="Orgname OrgTemplate"/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text value="Boulevard de la Plaine 17, 1050 Bruxelles, Belgium"/>
<line value="Boulevard de la Plaine 17"/>
<city value="1050 Bruxelles"/>
<country value="Belgium"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>