Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 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
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<div xmlns="http://www.w3.org/1999/xhtml"><p>DrugX 75 mg tablets</p><p>acetaminophen</p><b>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</b><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><ul><li>What DrugX is and what it is used for</li><li>What you need to know before you take DrugX</li><li>How to take DrugX</li><li>Possible side effects</li><li>How to store DrugX</li><li>Contents of the pack and other information</li></ul></div>
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<line value="54, Yonge Street"/>
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<country value="FR"/>
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<subject>🔗
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<code value="MarketingAuth"/>
<display value="Marketing Authorization"/>
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<system value="urn:iso:std:iso:3166"/>
<code value="FR"/>
</coding>
<text value="European Union"/>
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<code value="active"/>
<display value="Active"/>
</coding>
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<statusDate value="2015-02-07T13:28:17Z"/>
<holder>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</holder>
</RegulatedAuthorization>
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<entry>
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<resource>
<MedicinalProductDefinition>
<id value="800a51a2-d81d-49a4-a4eb-f2417d301837"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_800a51a2-d81d-49a4-a4eb-f2417d301837"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 800a51a2-d81d-49a4-a4eb-f2417d301837</b></p><a name="800a51a2-d81d-49a4-a4eb-f2417d301837"> </a><a name="hc800a51a2-d81d-49a4-a4eb-f2417d301837"> </a><a name="800a51a2-d81d-49a4-a4eb-f2417d301837-en-US"> </a><p><b>identifier</b>: <code>http://example.org/sid/product</code>/medicinalproduct75</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></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>statusDate</b>: 2018-06-23 08:38:00+0200</p><p><b>legalStatusOfSupply</b>: <span title="Codes:{http://hl7.org/fhir/legal-status-of-supply 100000072084}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: DrugX</p><h3>Parts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>tablet</td><td><span title="Codes:{http://example.org 220000000005}">Invented name part</span></td></tr></table><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 FR}">France</span></td><td><span title="Codes:{urn:iso:std:iso:3166 FR}">France</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td></tr></table></blockquote></div>
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<value value="medicinalproduct75"/>
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<type>
<coding>
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<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
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<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
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<statusDate value="2018-06-23T08:38:00+02:00"/>
<legalStatusOfSupply>
<coding>
<system value="http://hl7.org/fhir/legal-status-of-supply"/>
<code value="100000072084"/>
<display
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</legalStatusOfSupply>
<name>
<productName value="DrugX"/>
<part>
<part value="tablet"/>
<type>
<coding>
<system value="http://example.org"/>
<code value="220000000005"/>
<display value="Administrable dose form part"/>
</coding>
<text value="Invented name part"/>
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<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="FR"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="FR"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
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<entry>
<fullUrl value="urn:uuid:eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d"/>
<resource>
<PackagedProductDefinition>
<id value="eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d</b></p><a name="eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d"> </a><a name="hceb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d"> </a><a name="eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d-en-US"> </a><p><b>identifier</b>: <code>http://example.org/sid/product</code>/EU/1/97/049/001 (use: official, )</p><p><b>name</b>: DrugX 75 mg tablet blister x28 tablets</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-800a51a2-d81d-49a4-a4eb-f2417d301837.html">MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2018-06-23 08:38:00+0200</p><p><b>containedItemQuantity</b>: 75 mg</p><p><b>manufacturer</b>: <a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></p><h3>Packagings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td style="display: none">*</td><td><code>http://example.org/sid/product</code>/123456</td><td><span title="Codes:{http://hl7.org/fhir/medicinal-product-package-type 100000073496}">Blister</span></td><td>28</td><td><span title="Codes:{http://hl7.org/fhir/package-material 200000003222}">PolyVinyl Chloride</span></td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="http://example.org/sid/product"/>
<value value="EU/1/97/049/001"/>
</identifier>
<name value="DrugX 75 mg tablet blister x28 tablets"/>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<packageFor>🔗
<reference
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</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2018-06-23T08:38:00+02:00"/>
<containedItemQuantity>
<value value="75"/>
<unit value="mg"/>
</containedItemQuantity>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
<packaging>
<identifier>
<system value="http://example.org/sid/product"/>
<value value="123456"/>
</identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-package-type"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="28"/>
<material>
<coding>
<system value="http://hl7.org/fhir/package-material"/>
<code value="200000003222"/>
<display value="PolyVinyl Chloride"/>
</coding>
</material>
</packaging>
</PackagedProductDefinition>
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</entry>
<entry>
<fullUrl value="urn:uuid:373b9bf3-1fae-47a1-a7cd-230106def069"/>
<resource>
<AdministrableProductDefinition>
<id value="373b9bf3-1fae-47a1-a7cd-230106def069"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_373b9bf3-1fae-47a1-a7cd-230106def069"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition 373b9bf3-1fae-47a1-a7cd-230106def069</b></p><a name="373b9bf3-1fae-47a1-a7cd-230106def069"> </a><a name="hc373b9bf3-1fae-47a1-a7cd-230106def069"> </a><a name="373b9bf3-1fae-47a1-a7cd-230106def069-en-US"> </a><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/DrugXphpidplaceholder</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-800a51a2-d81d-49a4-a4eb-f2417d301837.html">MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{http://hl7.org/fhir/administrable-dose-form 100000073664}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://hl7.org/fhir/unit-of-presentation 200000002152}">Tablet</span></p><p><b>producedFrom</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); 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:{http://snomed.info/sct 26643006}">Oral route</span></td></tr></table></div>
</text>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="DrugXphpidplaceholder"/>
</identifier>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="http://hl7.org/fhir/administrable-dose-form"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="http://hl7.org/fhir/unit-of-presentation"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="26643006"/>
<display value="Oral route"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
<resource>
<ManufacturedItemDefinition>
<id value="3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_3214f286-b8ec-4ef5-bc8d-0aec39d97468"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition 3214f286-b8ec-4ef5-bc8d-0aec39d97468</b></p><a name="3214f286-b8ec-4ef5-bc8d-0aec39d97468"> </a><a name="hc3214f286-b8ec-4ef5-bc8d-0aec39d97468"> </a><a name="3214f286-b8ec-4ef5-bc8d-0aec39d97468-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi/#/</code>/EU/1/96/007/035 (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{http://hl7.org/fhir/manufactured-dose-form 100000073664}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{http://hl7.org/fhir/unit-of-presentation 200000002152}">Tablet</span></p><p><b>manufacturer</b>: <a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi/#/"/>
<value value="EU/1/96/007/035"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="http://hl7.org/fhir/manufactured-dose-form"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="http://hl7.org/fhir/unit-of-presentation"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:745c01bc-936e-45ca-9880-57e97608f43e"/>
<resource>
<Ingredient>
<id value="745c01bc-936e-45ca-9880-57e97608f43e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_745c01bc-936e-45ca-9880-57e97608f43e"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 745c01bc-936e-45ca-9880-57e97608f43e</b></p><a name="745c01bc-936e-45ca-9880-57e97608f43e"> </a><a name="hc745c01bc-936e-45ca-9880-57e97608f43e"> </a><a name="745c01bc-936e-45ca-9880-57e97608f43e-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/362O9ITL9D (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072072}">Active</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov 362O9ITL9D}">acetaminophen</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>75 mg</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="362O9ITL9D"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="362O9ITL9D"/>
<display value="acetaminophen"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="75"/>
<unit value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
</coding>
<text value="active ingredient - basis of strength"/>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:09c13040-8fd5-4818-972d-f01d4ee169b6"/>
<resource>
<Ingredient>
<id value="09c13040-8fd5-4818-972d-f01d4ee169b6"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_09c13040-8fd5-4818-972d-f01d4ee169b6"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 09c13040-8fd5-4818-972d-f01d4ee169b6</b></p><a name="09c13040-8fd5-4818-972d-f01d4ee169b6"> </a><a name="hc09c13040-8fd5-4818-972d-f01d4ee169b6"> </a><a name="09c13040-8fd5-4818-972d-f01d4ee169b6-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/ETJ7Z6XBU4 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov ETJ7Z6XBU4}">Silicon dioxide</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="ETJ7Z6XBU4"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="ETJ7Z6XBU4"/>
<display value="Silicon dioxide"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a4b7b60c-998f-4f93-89c7-860396af0fe3"/>
<resource>
<Ingredient>
<id value="a4b7b60c-998f-4f93-89c7-860396af0fe3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_a4b7b60c-998f-4f93-89c7-860396af0fe3"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient a4b7b60c-998f-4f93-89c7-860396af0fe3</b></p><a name="a4b7b60c-998f-4f93-89c7-860396af0fe3"> </a><a name="hca4b7b60c-998f-4f93-89c7-860396af0fe3"> </a><a name="a4b7b60c-998f-4f93-89c7-860396af0fe3-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/R12CBM0EIZ (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov R12CBM0EIZ}">Carnauba wax</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="R12CBM0EIZ"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="R12CBM0EIZ"/>
<display value="Carnauba wax"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fbf58407-83d3-42db-be3d-506b2006d431"/>
<resource>
<Ingredient>
<id value="fbf58407-83d3-42db-be3d-506b2006d431"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_fbf58407-83d3-42db-be3d-506b2006d431"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient fbf58407-83d3-42db-be3d-506b2006d431</b></p><a name="fbf58407-83d3-42db-be3d-506b2006d431"> </a><a name="hcfbf58407-83d3-42db-be3d-506b2006d431"> </a><a name="fbf58407-83d3-42db-be3d-506b2006d431-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/M28OL1HH48 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov M28OL1HH48}">Croscarmellose sodium</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="M28OL1HH48"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="M28OL1HH48"/>
<display value="Croscarmellose sodium"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1c10b441-6bd3-40b8-b14b-514e7c2f79d0"/>
<resource>
<Ingredient>
<id value="1c10b441-6bd3-40b8-b14b-514e7c2f79d0"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_1c10b441-6bd3-40b8-b14b-514e7c2f79d0"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 1c10b441-6bd3-40b8-b14b-514e7c2f79d0</b></p><a name="1c10b441-6bd3-40b8-b14b-514e7c2f79d0"> </a><a name="hc1c10b441-6bd3-40b8-b14b-514e7c2f79d0"> </a><a name="1c10b441-6bd3-40b8-b14b-514e7c2f79d0-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/3NXW29V3WO (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov 3NXW29V3WO}">Hypromellose</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="3NXW29V3WO"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="3NXW29V3WO"/>
<display value="Hypromellose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:7a3c0b14-2473-4541-9e45-a24d24cceddf"/>
<resource>
<Ingredient>
<id value="7a3c0b14-2473-4541-9e45-a24d24cceddf"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_7a3c0b14-2473-4541-9e45-a24d24cceddf"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 7a3c0b14-2473-4541-9e45-a24d24cceddf</b></p><a name="7a3c0b14-2473-4541-9e45-a24d24cceddf"> </a><a name="hc7a3c0b14-2473-4541-9e45-a24d24cceddf"> </a><a name="7a3c0b14-2473-4541-9e45-a24d24cceddf-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/EWQ57Q8I5X (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov EWQ57Q8I5X}">Lactose Monohydrate</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="EWQ57Q8I5X"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="EWQ57Q8I5X"/>
<display value="Lactose Monohydrate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ceba5cd1-321f-4bc3-b203-92d97fcf472e"/>
<resource>
<Ingredient>
<id value="ceba5cd1-321f-4bc3-b203-92d97fcf472e"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_ceba5cd1-321f-4bc3-b203-92d97fcf472e"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient ceba5cd1-321f-4bc3-b203-92d97fcf472e</b></p><a name="ceba5cd1-321f-4bc3-b203-92d97fcf472e"> </a><a name="hcceba5cd1-321f-4bc3-b203-92d97fcf472e"> </a><a name="ceba5cd1-321f-4bc3-b203-92d97fcf472e-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/SA1B764746 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov SA1B764746}">Macrogol 3000</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="SA1B764746"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="SA1B764746"/>
<display value="Macrogol 3000"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:eee155e8-e442-491d-9a82-7af3cefac57f"/>
<resource>
<Ingredient>
<id value="eee155e8-e442-491d-9a82-7af3cefac57f"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_eee155e8-e442-491d-9a82-7af3cefac57f"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient eee155e8-e442-491d-9a82-7af3cefac57f</b></p><a name="eee155e8-e442-491d-9a82-7af3cefac57f"> </a><a name="hceee155e8-e442-491d-9a82-7af3cefac57f"> </a><a name="eee155e8-e442-491d-9a82-7af3cefac57f-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/70097M6I30 (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov 70097M6I30}">Magnesium stearate</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="70097M6I30"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="70097M6I30"/>
<display value="Magnesium stearate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd"/>
<resource>
<Ingredient>
<id value="1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient 1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd</b></p><a name="1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd"> </a><a name="hc1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd"> </a><a name="1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/OP1R32D61U (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov OP1R32D61U}">Microcrystalline cellulose</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="OP1R32D61U"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="OP1R32D61U"/>
<display value="Microcrystalline cellulose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a88891dc-7e9e-4d84-b462-95e53de3b6a6"/>
<resource>
<Ingredient>
<id value="a88891dc-7e9e-4d84-b462-95e53de3b6a6"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_a88891dc-7e9e-4d84-b462-95e53de3b6a6"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient a88891dc-7e9e-4d84-b462-95e53de3b6a6</b></p><a name="a88891dc-7e9e-4d84-b462-95e53de3b6a6"> </a><a name="hca88891dc-7e9e-4d84-b462-95e53de3b6a6"> </a><a name="a88891dc-7e9e-4d84-b462-95e53de3b6a6-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/15FIX9V2JP (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="ManufacturedItemDefinition-3214f286-b8ec-4ef5-bc8d-0aec39d97468.html">ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/96/007/035 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet</a></p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/ingredient-role 100000072082}">Excipient</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></td></tr></table><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:{http://fdasis.nlm.nih.gov 15FIX9V2JP}">Titanium Dioxide</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="15FIX9V2JP"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/3214f286-b8ec-4ef5-bc8d-0aec39d97468"/>
</for>
<role>
<coding>
<system value="http://hl7.org/fhir/ingredient-role"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<manufacturer>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
</manufacturer>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="15FIX9V2JP"/>
<display value="Titanium Dioxide"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:83f4a22f-9e5e-4941-9fdb-339a0f1f2055"/>
<resource>
<ClinicalUseDefinition>
<id value="83f4a22f-9e5e-4941-9fdb-339a0f1f2055"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-contraindication-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_83f4a22f-9e5e-4941-9fdb-339a0f1f2055"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition 83f4a22f-9e5e-4941-9fdb-339a0f1f2055</b></p><a name="83f4a22f-9e5e-4941-9fdb-339a0f1f2055"> </a><a name="hc83f4a22f-9e5e-4941-9fdb-339a0f1f2055"> </a><a name="83f4a22f-9e5e-4941-9fdb-339a0f1f2055-en-US"> </a><p><b>identifier</b>: <code>http://example.org/sid</code>/contra-example-1</p><p><b>type</b>: Contraindication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-800a51a2-d81d-49a4-a4eb-f2417d301837.html">MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><blockquote><p><b>contraindication</b></p><h3>DiseaseSymptomProcedures</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:{http://terminology.hl7.org/CodeSystem/mdr 10017947}">Gastrointestinal disorders</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://example.org/sid"/>
<value value="contra-example-1"/>
</identifier>
<type value="contraindication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"/>
</subject>
<contraindication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/mdr"/>
<code value="10017947"/>
<display value="Gastrointestinal disorders"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</contraindication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:bac1d528-6430-4310-bde6-b8b3471ce35a"/>
<resource>
<ClinicalUseDefinition>
<id value="bac1d528-6430-4310-bde6-b8b3471ce35a"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_bac1d528-6430-4310-bde6-b8b3471ce35a"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition bac1d528-6430-4310-bde6-b8b3471ce35a</b></p><a name="bac1d528-6430-4310-bde6-b8b3471ce35a"> </a><a name="hcbac1d528-6430-4310-bde6-b8b3471ce35a"> </a><a name="bac1d528-6430-4310-bde6-b8b3471ce35a-en-US"> </a><p><b>identifier</b>: <code>http://example.org/sid</code>/indication-example-1</p><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="MedicinalProductDefinition-800a51a2-d81d-49a4-a4eb-f2417d301837.html">MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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:{http://terminology.hl7.org/CodeSystem/mdr 10037156}">Psoriasis</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://example.org/sid"/>
<value value="indication-example-1"/>
</identifier>
<type value="indication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/mdr"/>
<code value="10037156"/>
<display value="Psoriasis"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e60575aa-e7b3-4461-a456-d310514f4041"/>
<resource>
<ClinicalUseDefinition>
<id value="e60575aa-e7b3-4461-a456-d310514f4041"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-interaction-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_e60575aa-e7b3-4461-a456-d310514f4041"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition e60575aa-e7b3-4461-a456-d310514f4041</b></p><a name="e60575aa-e7b3-4461-a456-d310514f4041"> </a><a name="hce60575aa-e7b3-4461-a456-d310514f4041"> </a><a name="e60575aa-e7b3-4461-a456-d310514f4041-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/YL5FZ2Y5U1 (use: official, )</p><p><b>type</b>: Interaction</p><p><b>subject</b>: <a href="MedicinalProductDefinition-800a51a2-d81d-49a4-a4eb-f2417d301837.html">MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><blockquote><p><b>interaction</b></p><h3>Interactants</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov YL5FZ2Y5U1}">METHOTREXATE</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="YL5FZ2Y5U1"/>
</identifier>
<type value="interaction"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"/>
</subject>
<interaction>
<interactant>
<itemCodeableConcept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="YL5FZ2Y5U1"/>
<display value="METHOTREXATE"/>
</coding>
</itemCodeableConcept>
</interactant>
</interaction>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4312f8ec-43b6-4b25-9fca-d61a1188bfea"/>
<resource>
<ClinicalUseDefinition>
<id value="4312f8ec-43b6-4b25-9fca-d61a1188bfea"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-undesirableEffect-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_4312f8ec-43b6-4b25-9fca-d61a1188bfea"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition 4312f8ec-43b6-4b25-9fca-d61a1188bfea</b></p><a name="4312f8ec-43b6-4b25-9fca-d61a1188bfea"> </a><a name="hc4312f8ec-43b6-4b25-9fca-d61a1188bfea"> </a><a name="4312f8ec-43b6-4b25-9fca-d61a1188bfea-en-US"> </a><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)</a>/YL5FZ2Y5U1 (use: official, )</p><p><b>type</b>: Undesirable Effect</p><p><b>subject</b>: <a href="MedicinalProductDefinition-800a51a2-d81d-49a4-a4eb-f2417d301837.html">MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><blockquote><p><b>undesirableEffect</b></p><h3>SymptomConditionEffects</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:{http://snomed.info/sct 2767007}">Dysergia</span></td></tr></table><p><b>frequencyOfOccurrence</b>: <span title="Codes:{http://hl7.org/fhir/undesirable-effect-frequency Rare}">Rare</span></p></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="YL5FZ2Y5U1"/>
</identifier>
<type value="undesirable-effect"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"/>
</subject>
<undesirableEffect>
<symptomConditionEffect>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="2767007"/>
<display value="Dysergia"/>
</coding>
</concept>
</symptomConditionEffect>
<frequencyOfOccurrence>
<coding>
<system
value="http://hl7.org/fhir/undesirable-effect-frequency"/>
<code value="Rare"/>
<display value="Rare"/>
</coding>
</frequencyOfOccurrence>
</undesirableEffect>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ac21a804-cafa-41ff-b644-a14c8003edeb"/>
<resource>
<ClinicalUseDefinition>
<id value="ac21a804-cafa-41ff-b644-a14c8003edeb"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-warning-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_ac21a804-cafa-41ff-b644-a14c8003edeb"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition ac21a804-cafa-41ff-b644-a14c8003edeb</b></p><a name="ac21a804-cafa-41ff-b644-a14c8003edeb"> </a><a name="hcac21a804-cafa-41ff-b644-a14c8003edeb"> </a><a name="ac21a804-cafa-41ff-b644-a14c8003edeb-en-US"> </a><p><b>identifier</b>: <code>http://example.org/sid</code>/warning-example-1</p><p><b>type</b>: Warning</p><p><b>subject</b>: <a href="MedicinalProductDefinition-800a51a2-d81d-49a4-a4eb-f2417d301837.html">MedicinalProductDefinition: identifier = http://example.org/sid/product#medicinalproduct75; type = Medicinal Product; domain = Human use; status = Active; statusDate = 2018-06-23 08:38:00+0200; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><h3>Warnings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Description</b></td></tr><tr><td style="display: none">*</td><td><div><p>Symptomatic hypotension, especially after the first dose, may occur in patients.</p>
</div></td></tr></table></div>
</text>
<identifier>
<system value="http://example.org/sid"/>
<value value="warning-example-1"/>
</identifier>
<type value="warning"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837"/>
</subject>
<warning>
<description
value="Symptomatic hypotension, especially after the first dose, may occur in patients."/>
</warning>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:da33bd51-a726-4232-aaa0-4168b9bfe249"/>
<resource>
<SubstanceDefinition>
<id value="da33bd51-a726-4232-aaa0-4168b9bfe249"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_da33bd51-a726-4232-aaa0-4168b9bfe249"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition da33bd51-a726-4232-aaa0-4168b9bfe249</b></p><a name="da33bd51-a726-4232-aaa0-4168b9bfe249"> </a><a name="hcda33bd51-a726-4232-aaa0-4168b9bfe249"> </a><a name="da33bd51-a726-4232-aaa0-4168b9bfe249-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/362O9ITL9D (use: official, )</p><p><b>version</b>: 1</p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>description</b>: </p><div><p>White to off-white, biconvex, and oval-shaped with the number 1234 engraved on the other side.</p>
</div><p><b>manufacturer</b>: <a href="Organization-d71bf884-90eb-47f9-81b7-fa81ecec7e75.html">Organization acme inc</a></p><h3>MolecularWeights</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Amount</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">exact</span></td><td>151.6</td></tr></table><h3>Structures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>MolecularFormula</b></td></tr><tr><td style="display: none">*</td><td>C8H9NO2</td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>acetaminophen</td><td><span title="Codes:{http://hl7.org/fhir/substance-name-type Scientific}">Scientific</span></td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="362O9ITL9D"/>
</identifier>
<version value="1"/>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<description
value="White to off-white, biconvex, and oval-shaped with the number 1234 engraved on the other side."/>
<manufacturer>🔗
<reference
value="Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75"/>
</manufacturer>
<molecularWeight>
<type>
<text value="exact"/>
</type>
<amount>
<value value="151.6"/>
</amount>
</molecularWeight>
<structure>
<molecularFormula value="C8H9NO2"/>
</structure>
<name>
<name value="acetaminophen"/>
<type>
<coding>
<system value="http://hl7.org/fhir/substance-name-type"/>
<code value="Scientific"/>
</coding>
<text value="Scientific"/>
</type>
</name>
</SubstanceDefinition>
</resource>
</entry>
</Bundle>
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2024-07-15
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