Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-epi-type2-example-acetaminophen"/>
<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-500MG-BUNDLE"/>
</identifier>
<type value="document"/>
<timestamp value="2023-01-25T12:00:00Z"/>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-epi-type2-example-acetaminophen"/>
<resource>
<Composition>
<id value="composition-epi-type2-example-acetaminophen"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_composition-epi-type2-example-acetaminophen"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-epi-type2-example-acetaminophen</b></p><a name="composition-epi-type2-example-acetaminophen"> </a><a name="hccomposition-epi-type2-example-acetaminophen"> </a><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}">Package Leaflet</span></p><p><b>date</b>: 2023-01-25</p><p><b>author</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#Organization_org-epi-type2-example-acme">Organization Acme Pharma Inc.</a></p><p><b>title</b>: Package Leaflet: Information for the user - WonderDrug 500 mg tablets</p></div>
</text>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<subject>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen"/>
</subject>
<subject>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-100mg"/>
</subject>
<subject>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-200mg"/>
</subject>
<date value="2023-01-25"/>
<author>
<reference value="Organization/org-epi-type2-example-acme"/>
</author>
<title
value="Package Leaflet: Information for the user - WonderDrug 500 mg tablets"/>
<section>
<title value="1. What is in this leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="1. What is in this leaflet"/>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><h2>1. What is in this leaflet</h2><p>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</p></div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type2-example-acme"/>
<resource>
<Organization>
<id value="org-epi-type2-example-acme"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_org-epi-type2-example-acme"> </a><p class="res-header-id"><b>Generated Narrative: Organization org-epi-type2-example-acme</b></p><a name="org-epi-type2-example-acme"> </a><a name="hcorg-epi-type2-example-acme"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/omswi</code>/LOC-100000000</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000034}">Marketing authorisation holder</span></p><p><b>name</b>: Acme Pharma Inc.</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>123 Pharma Way, 102 37 Prague 10, Czech Republic</td></tr></table></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="LOC-100000000"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
</coding>
</type>
<name value="Acme Pharma Inc."/>
<contact>
<address>
<text value="123 Pharma Way, 102 37 Prague 10, Czech Republic"/>
<line value="123 Pharma Way"/>
<city value="Prague"/>
<postalCode value="102 37"/>
<country value="Czech Republic"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen"/>
<resource>
<MedicinalProductDefinition>
<id value="mpd-epi-type2-example-acetaminophen"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-acetaminophen</b></p><a name="mpd-epi-type2-example-acetaminophen"> </a><a name="hcmpd-epi-type2-example-acetaminophen"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-500MG</p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Contact</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#Organization_org-epi-type2-example-acme">Organization Acme Pharma Inc.</a></td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: WonderDrug 500 mg tablets</p><blockquote><p><b>part</b></p><p><b>part</b>: WonderDrug</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type INV}">Invented Name Part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 500 mg</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type STR}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablets</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type FRM}">Form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/country EE}">Estonia</span></td><td><span title="Codes:{urn:ietf:bcp:47 et}">Estonian</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-500MG"/>
</identifier>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<contact>
<contact>
<reference value="Organization/org-epi-type2-example-acme"/>
</contact>
</contact>
<name>
<productName value="WonderDrug 500 mg tablets"/>
<part>
<part value="WonderDrug"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="INV"/>
<display value="Invented Name Part"/>
</coding>
</type>
</part>
<part>
<part value="500 mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="STR"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="FRM"/>
<display value="Form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="http://hl7.org/fhir/country"/>
<code value="EE"/>
<display value="Estonia"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="et"/>
<display value="Estonian"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/RegulatedAuthorization/ra-epi-type2-example-acetaminophen"/>
<resource>
<RegulatedAuthorization>
<id value="ra-epi-type2-example-acetaminophen"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_ra-epi-type2-example-acetaminophen"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization ra-epi-type2-example-acetaminophen</b></p><a name="ra-epi-type2-example-acetaminophen"> </a><a name="hcra-epi-type2-example-acetaminophen"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/MA-123456789</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{http://hl7.org/fhir/country EE}">Estonia</span></p><p><b>holder</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#Organization_org-epi-type2-example-acme">Organization Acme Pharma Inc.</a></p></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="MA-123456789"/>
</identifier>
<subject>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="http://hl7.org/fhir/country"/>
<code value="EE"/>
<display value="Estonia"/>
</coding>
</region>
<holder>
<reference value="Organization/org-epi-type2-example-acme"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/PackagedProductDefinition/ppd-epi-type2-example-acetaminophen"/>
<resource>
<PackagedProductDefinition>
<id value="ppd-epi-type2-example-acetaminophen"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-epi-type2-example-acetaminophen"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen</b></p><a name="ppd-epi-type2-example-acetaminophen"> </a><a name="hcppd-epi-type2-example-acetaminophen"> </a><p><b>packageFor</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073496}">Blister</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#ManufacturedItemDefinition_mid-epi-type2-example-acetaminophen">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 30 Tablet</p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen"/>
</packageFor>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen"/>
</reference>
</item>
<amount>
<value value="30"/>
<unit value="Tablet"/>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/unit-of-presentation"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen"/>
<resource>
<ManufacturedItemDefinition>
<id value="mid-epi-type2-example-acetaminophen"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_mid-epi-type2-example-acetaminophen"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition mid-epi-type2-example-acetaminophen</b></p><a name="mid-epi-type2-example-acetaminophen"> </a><a name="hcmid-epi-type2-example-acetaminophen"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073664}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002152}">Tablet</span></p><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">colour</span></td><td><span title="Codes:{http://hl7.org/fhir/colour white}">White</span></td></tr></table></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<property>
<type>
<coding>
<code value="colour"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system value="http://hl7.org/fhir/colour"/>
<code value="white"/>
<display value="White"/>
</coding>
</valueCodeableConcept>
</property>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/AdministrableProductDefinition/apd-epi-type2-example-acetaminophen"/>
<resource>
<AdministrableProductDefinition>
<id value="apd-epi-type2-example-acetaminophen"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_apd-epi-type2-example-acetaminophen"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition apd-epi-type2-example-acetaminophen</b></p><a name="apd-epi-type2-example-acetaminophen"> </a><a name="hcapd-epi-type2-example-acetaminophen"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073664}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 200000002152}">Tablet</span></p><p><b>producedFrom</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#ManufacturedItemDefinition_mid-epi-type2-example-acetaminophen">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><h3>RouteOfAdministrations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073619}">Oral use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<producedFrom>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073619"/>
<display value="Oral use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-active"/>
<resource>
<Ingredient>
<id value="ingredient-epi-type2-example-acetaminophen-active"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-epi-type2-example-acetaminophen-active"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-active</b></p><a name="ingredient-epi-type2-example-acetaminophen-active"> </a><a name="hcingredient-epi-type2-example-acetaminophen-active"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#ManufacturedItemDefinition_mid-epi-type2-example-acetaminophen">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#AdministrableProductDefinition_apd-epi-type2-example-acetaminophen">AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072072}">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/smswi 100000000000}">Paracetamol</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td></tr><tr><td style="display: none">*</td><td>500 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span>/1 tablet<span style="background: LightGoldenRodYellow"> (Details: unit-of-presentation codetablet = 'tablet')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/apd-epi-type2-example-acetaminophen"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://spor.ema.europa.eu/smswi"/>
<code value="100000000000"/>
<display value="Paracetamol"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="500"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/unit-of-presentation"/>
<code value="tablet"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-1"/>
<resource>
<Ingredient>
<id value="ingredient-epi-type2-example-acetaminophen-excipient-1"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-epi-type2-example-acetaminophen-excipient-1"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-excipient-1</b></p><a name="ingredient-epi-type2-example-acetaminophen-excipient-1"> </a><a name="hcingredient-epi-type2-example-acetaminophen-excipient-1"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#ManufacturedItemDefinition_mid-epi-type2-example-acetaminophen">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#AdministrableProductDefinition_apd-epi-type2-example-acetaminophen">AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/smswi 100000000001}">Pregelatinised starch</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
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value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen"/>
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<for>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen"/>
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<for>
<reference
value="AdministrableProductDefinition/apd-epi-type2-example-acetaminophen"/>
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<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://spor.ema.europa.eu/smswi"/>
<code value="100000000001"/>
<display value="Pregelatinised starch"/>
</coding>
</concept>
</code>
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</Ingredient>
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<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-2"/>
<resource>
<Ingredient>
<id value="ingredient-epi-type2-example-acetaminophen-excipient-2"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-epi-type2-example-acetaminophen-excipient-2"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-excipient-2</b></p><a name="ingredient-epi-type2-example-acetaminophen-excipient-2"> </a><a name="hcingredient-epi-type2-example-acetaminophen-excipient-2"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#ManufacturedItemDefinition_mid-epi-type2-example-acetaminophen">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#AdministrableProductDefinition_apd-epi-type2-example-acetaminophen">AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/smswi 100000000002}">Maize starch</span></td></tr></table></blockquote></div>
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value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/apd-epi-type2-example-acetaminophen"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://spor.ema.europa.eu/smswi"/>
<code value="100000000002"/>
<display value="Maize starch"/>
</coding>
</concept>
</code>
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<entry>
<fullUrl
value="http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-3"/>
<resource>
<Ingredient>
<id value="ingredient-epi-type2-example-acetaminophen-excipient-3"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ingredient-epi-type2-example-acetaminophen-excipient-3"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-excipient-3</b></p><a name="ingredient-epi-type2-example-acetaminophen-excipient-3"> </a><a name="hcingredient-epi-type2-example-acetaminophen-excipient-3"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#ManufacturedItemDefinition_mid-epi-type2-example-acetaminophen">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></li><li><a href="Bundle-bundle-epi-type2-example-acetaminophen.html#AdministrableProductDefinition_apd-epi-type2-example-acetaminophen">AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072082}">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/smswi 100000000003}">Magnesium stearate</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
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<for>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/apd-epi-type2-example-acetaminophen"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://spor.ema.europa.eu/smswi"/>
<code value="100000000003"/>
<display value="Magnesium stearate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<MedicinalProductDefinition>
<id value="mpd-epi-type2-example-acetaminophen-100mg"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen-100mg"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-acetaminophen-100mg</b></p><a name="mpd-epi-type2-example-acetaminophen-100mg"> </a><a name="hcmpd-epi-type2-example-acetaminophen-100mg"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-100MG</p><blockquote><p><b>name</b></p><p><b>productName</b>: WonderDrug 100 mg tablets</p><blockquote><p><b>part</b></p><p><b>part</b>: WonderDrug</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type INV}">Invented Name Part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 100 mg</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type STR}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablets</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type FRM}">Form part</span></p></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-100MG"/>
</identifier>
<name>
<productName value="WonderDrug 100 mg tablets"/>
<part>
<part value="WonderDrug"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="INV"/>
<display value="Invented Name Part"/>
</coding>
</type>
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<part>
<part value="100 mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="STR"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="FRM"/>
<display value="Form part"/>
</coding>
</type>
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</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="ppd-epi-type2-example-acetaminophen-100mg-1"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-epi-type2-example-acetaminophen-100mg-1"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-100mg-1</b></p><a name="ppd-epi-type2-example-acetaminophen-100mg-1"> </a><a name="hcppd-epi-type2-example-acetaminophen-100mg-1"> </a><p><b>packageFor</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen-100mg">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-100MG</a></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073496}">Blister</span></p><p><b>quantity</b>: 2</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg">ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg</a></td></tr></table><p><b>amount</b>: 60 Tablet</p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>
<reference
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</packageFor>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="2"/>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg"/>
</reference>
</item>
<amount>
<value value="60"/>
<unit value="Tablet"/>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/unit-of-presentation"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="ppd-epi-type2-example-acetaminophen-100mg-2"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-epi-type2-example-acetaminophen-100mg-2"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-100mg-2</b></p><a name="ppd-epi-type2-example-acetaminophen-100mg-2"> </a><a name="hcppd-epi-type2-example-acetaminophen-100mg-2"> </a><p><b>packageFor</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen-100mg">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-100MG</a></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073497}">Bottle</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg">ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg</a></td></tr></table><p><b>amount</b>: 30 Tablet</p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-100mg"/>
</packageFor>
<packaging>
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<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
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<quantity value="1"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073497"/>
<display value="Bottle"/>
</coding>
</type>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg"/>
</reference>
</item>
<amount>
<value value="30"/>
<unit value="Tablet"/>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/unit-of-presentation"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<MedicinalProductDefinition>
<id value="mpd-epi-type2-example-acetaminophen-200mg"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen-200mg"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-acetaminophen-200mg</b></p><a name="mpd-epi-type2-example-acetaminophen-200mg"> </a><a name="hcmpd-epi-type2-example-acetaminophen-200mg"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/WONDERDRUG-200MG</p><blockquote><p><b>name</b></p><p><b>productName</b>: WonderDrug 200 mg tablets</p><blockquote><p><b>part</b></p><p><b>part</b>: WonderDrug</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type INV}">Invented Name Part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 200 mg</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type STR}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablets</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-name-part-type FRM}">Form part</span></p></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="WONDERDRUG-200MG"/>
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<name>
<productName value="WonderDrug 200 mg tablets"/>
<part>
<part value="WonderDrug"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="INV"/>
<display value="Invented Name Part"/>
</coding>
</type>
</part>
<part>
<part value="200 mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="STR"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="FRM"/>
<display value="Form part"/>
</coding>
</type>
</part>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="ppd-epi-type2-example-acetaminophen-200mg-1"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-epi-type2-example-acetaminophen-200mg-1"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-200mg-1</b></p><a name="ppd-epi-type2-example-acetaminophen-200mg-1"> </a><a name="hcppd-epi-type2-example-acetaminophen-200mg-1"> </a><p><b>packageFor</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen-200mg">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-200MG</a></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073496}">Blister</span></p><p><b>quantity</b>: 2</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg">ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg</a></td></tr></table><p><b>amount</b>: 20 Tablet</p></blockquote></blockquote></blockquote></div>
</text>
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<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
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<quantity value="1"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="2"/>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg"/>
</reference>
</item>
<amount>
<value value="20"/>
<unit value="Tablet"/>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/unit-of-presentation"/>
</amount>
</containedItem>
</packaging>
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</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="ppd-epi-type2-example-acetaminophen-200mg-2"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_ppd-epi-type2-example-acetaminophen-200mg-2"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-200mg-2</b></p><a name="ppd-epi-type2-example-acetaminophen-200mg-2"> </a><a name="hcppd-epi-type2-example-acetaminophen-200mg-2"> </a><p><b>packageFor</b>: <a href="Bundle-bundle-epi-type2-example-acetaminophen.html#MedicinalProductDefinition_mpd-epi-type2-example-acetaminophen-200mg">MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-200MG</a></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073497}">Bottle</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg">ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg</a></td></tr></table><p><b>amount</b>: 40 Tablet</p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>
<reference
value="MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-200mg"/>
</packageFor>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073497"/>
<display value="Bottle"/>
</coding>
</type>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg"/>
</reference>
</item>
<amount>
<value value="40"/>
<unit value="Tablet"/>
<system
value="http://hl7.org/fhir/uv/emedicinal-product-info/CodeSystem/unit-of-presentation"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
</Bundle>
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-01-02
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