SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="LantusInjectionLabelBundle"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionBundle"/>
</meta>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:4e455ace-94f4-4fa3-85eb-0152e5a06239"/>
</identifier>
<type value="document"/>
<timestamp value="2021-01-27T00:00:00.0000Z"/>
<entry>
<fullUrl
value="http://example.org/Composition/LantusInjectionLabelComposition"/>
<resource>
<Composition>
<id value="LantusInjectionLabelComposition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_LantusInjectionLabelComposition"> </a><p><b>Generated Narrative: Composition</b><a name="LantusInjectionLabelComposition"> </a><a name="hcLantusInjectionLabelComposition"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceComposition "LantusInjectionLabelComposition" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ProductSubmissionDocument.html">ProductSubmissionDocument</a></p></div><p><b>VersionNumber</b>: 11</p><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6</p><p><b>status</b>: final</p><p><b>type</b>: HUMAN PRESCRIPTION DRUG LABEL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#34391-3)</span></p><p><b>date</b>: 2021-01-27</p><p><b>author</b>: See on this page: Organization/SanofiAventisUS</p><p><b>title</b>: These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>
<br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/versionNumber">
<valueString value="11"/>
</extension>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="http://loinc.org"/>
<code value="34391-3"/>
<display value="HUMAN PRESCRIPTION DRUG LABEL"/>
</coding>
</type>
<date value="2021-01-27"/>
<author>🔗
<reference value="Organization/SanofiAventisUS"/>
</author>
<title
value="These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>
<br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000"/>
<section id="68224803-d32c-4438-9439-9c210668e295">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId">
<valueString value="S1"/>
</extension>
<title value="1 INDICATIONS AND USAGE"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="34067-9"/>
<display value="INDICATIONS &amp; USAGE SECTION"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="highlights"><p>LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (<a href="#S1">1</a>)</p><p><span style="text-decoration: underline">Limitations of Use</span></p><p>Not recommended for treating diabetic ketoacidosis. (<a href="#S1">1</a>)</p></div><div style="narrative"><a name="S1"/><p>LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.</p></div></div>
</text>
<section id="0230cfa8-ff67-4666-ba57-bbad268ac6fe">
<code>
<coding>
<system value="http://loinc.org"/>
<code value="42229-5"/>
<display value="SPL UNCLASSIFIED SECTION"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p><span style="text-decoration: underline">Limitations of Use</span></p><p>LANTUS is not recommended for the treatment of diabetic ketoacidosis.</p></div></div>
</text>
</section>
</section>
<section id="f65bb254-5018-4af5-b02a-38d5d51ed901">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="48780-1"/>
<display value="SPL LISTING DATA ELEMENTS SECTION"/>
</coding>
</code>
<entry>🔗
<reference
value="MedicinalProductDefinition/LantusSyringeDefinition"/>
</entry>
<entry>🔗
<reference
value="MedicinalProductDefinition/LantusVialDefinition"/>
</entry>
</section>
<section id="ff673a31-f676-444c-a009-8d4a2645fd19">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<title value="PRINCIPAL DISPLAY PANEL - 10 mL Vial Package"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="51945-4"/>
<display value="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p>NDC 0088-5021-01<br/>Rx only</p><p>Lantus<sup>®</sup><br/>insulin glargine<br/>injection</p><p>100 units/mL<br/>(U-100)<br/>For subcutaneous<br/>injection only</p><p>Do not mix with<br/>other insulins</p><p>Use only if solution<br/>is clear and colorless<br/>with no particles visible</p><p>Use with U-100<br/>syringe only</p><p>One 10 mL multiple-dose vial</p><p>novaplus <sub>™</sub></p><img src="lantusnova-20.jpg" alt="PRINCIPAL DISPLAY PANEL - 10 mL Vial Package"/></div></div>
</text>
</section>
<section id="8ce1b409-6067-4c9d-8e21-bdb6df850c24">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<title value="PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="51945-4"/>
<display value="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p>NDC 0088-5020-05<br/>Rx only</p><p>Lantus<sup>®</sup> SoloStar<sup>®</sup><br/>insulin glargine injection<br/>For Single Patient Use Only<br/>100 units/mL (U-100)<br/>Five 3 mL Prefilled Pens</p><p>Solution for injection in a disposable insulin delivery device<br/>Do not mix with other insulins<br/>For subcutaneous injection only<br/>Use only if solution is clear and colorless with no particles visible<br/>Use within 28 days after initial use *Needles not include (see back panel)</p><p>novaplus <sub>™</sub></p><img src="lantusnova-21.jpg" alt="PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package"/></div></div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Organization/SanofiAventisUS"/>
<resource>
<Organization>
<id value="SanofiAventisUS"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_SanofiAventisUS"> </a><p><b>Generated Narrative: Organization</b><a name="SanofiAventisUS"> </a><a name="hcSanofiAventisUS"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceOrganization "SanofiAventisUS" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-IdentifiedLabeler.html">IdentifiedLabeler</a></p></div><p><b>identifier</b>: <code>urn:oid:1.3.6.1.4.1.519.1</code>/783243835</p><p><b>type</b>: An organization that submits product labels. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-organizationTypes.html">SPL Organization Types</a>#Labeler)</span></p><p><b>name</b>: sanofi-aventis U.S. LLC</p></div>
</text>
<identifier>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="783243835"/>
</identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes"/>
<code value="Labeler"/>
</coding>
</type>
<name value="sanofi-aventis U.S. LLC"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/Organization/SanofiAventisDeutschland"/>
<resource>
<Organization>
<id value="SanofiAventisDeutschland"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_SanofiAventisDeutschland"> </a><p><b>Generated Narrative: Organization</b><a name="SanofiAventisDeutschland"> </a><a name="hcSanofiAventisDeutschland"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceOrganization "SanofiAventisDeutschland" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-IdentifiedEstablishment.html">IdentifiedEstablishment</a></p></div><p><b>identifier</b>: <code>urn:oid:1.3.6.1.4.1.519.1</code>/313218430</p><p><b>type</b>: An organization that provides operations in the manufacturing of a product. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-organizationTypes.html">SPL Organization Types</a>#Establishment)</span></p><p><b>name</b>: Sanofi-Aventis Deutschland GmbH</p></div>
</text>
<identifier>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="313218430"/>
</identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes"/>
<code value="Establishment"/>
</coding>
</type>
<name value="Sanofi-Aventis Deutschland GmbH"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Organization/SanofiAventisSRL"/>
<resource>
<Organization>
<id value="SanofiAventisSRL"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_SanofiAventisSRL"> </a><p><b>Generated Narrative: Organization</b><a name="SanofiAventisSRL"> </a><a name="hcSanofiAventisSRL"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceOrganization "SanofiAventisSRL" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-IdentifiedEstablishment.html">IdentifiedEstablishment</a></p></div><p><b>identifier</b>: <code>urn:oid:1.3.6.1.4.1.519.1</code>/338454274</p><p><b>type</b>: An organization that provides operations in the manufacturing of a product. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-organizationTypes.html">SPL Organization Types</a>#Establishment)</span></p><p><b>name</b>: Sanofi S.r.l.</p></div>
</text>
<identifier>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="338454274"/>
</identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes"/>
<code value="Establishment"/>
</coding>
</type>
<name value="Sanofi S.r.l."/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/MedicinalProductDefinition/LantusSyringeDefinition"/>
<resource>
<MedicinalProductDefinition>
<id value="LantusSyringeDefinition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_LantusSyringeDefinition"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="LantusSyringeDefinition"> </a><a name="hcLantusSyringeDefinition"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceMedicinalProductDefinition "LantusSyringeDefinition" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProduct.html">SubmittedMedicinalProduct</a></p></div><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5020</p><p><b>route</b>: SUBCUTANEOUS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C38299)</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td>active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-splMarketingStatuses.html">SPL Marketing Statuses CodeSystem</a>#active)</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: Lantus Solostar</p><p><b>type</b>: Proprietary Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-submittedMedicinalProductNameTypes.html">Medicinal Product Name Types CodeSystem</a>#PROPRIETARY)</span></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: insulin glargine</p><p><b>type</b>: Generic Name (Non-Proprietary) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-submittedMedicinalProductNameTypes.html">Medicinal Product Name Types CodeSystem</a>#NONPROPRIETARY)</span></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>ANALYSIS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C25391)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>API MANUFACTURE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C82401)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>LABEL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C84732)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>MANUFACTURE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C43360)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>PACK <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C84731)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5020"/>
</identifier>
<route>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C38299"/>
<display value="SUBCUTANEOUS"/>
</coding>
</route>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<name>
<productName value="Lantus Solostar"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="PROPRIETARY"/>
</coding>
</type>
</name>
<name>
<productName value="insulin glargine"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="NONPROPRIETARY"/>
</coding>
</type>
</name>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C25391"/>
<display value="ANALYSIS"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C82401"/>
<display value="API MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84732"/>
<display value="LABEL"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43360"/>
<display value="MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84731"/>
<display value="PACK"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/MedicinalProductDefinition/LantusVialDefinition"/>
<resource>
<MedicinalProductDefinition>
<id value="LantusVialDefinition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_LantusVialDefinition"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="LantusVialDefinition"> </a><a name="hcLantusVialDefinition"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceMedicinalProductDefinition "LantusVialDefinition" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProduct.html">SubmittedMedicinalProduct</a></p></div><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5021</p><p><b>route</b>: SUBCUTANEOUS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C38299)</span></p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td>active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-splMarketingStatuses.html">SPL Marketing Statuses CodeSystem</a>#active)</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>name</b></p><p><b>productName</b>: Lantus</p><p><b>type</b>: Proprietary Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-submittedMedicinalProductNameTypes.html">Medicinal Product Name Types CodeSystem</a>#PROPRIETARY)</span></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: insulin glargine</p><p><b>type</b>: Generic Name (Non-Proprietary) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-submittedMedicinalProductNameTypes.html">Medicinal Product Name Types CodeSystem</a>#NONPROPRIETARY)</span></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>ANALYSIS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C25391)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>API MANUFACTURE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C82401)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>LABEL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C84732)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>MANUFACTURE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C43360)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>PACK <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C84731)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisDeutschland</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>ANALYSIS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C25391)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisSRL</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>LABEL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C84732)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisSRL</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>MANUFACTURE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C43360)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisSRL</p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>PACK <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C84731)</span></td></tr></table><p><b>organization</b>: See on this page: Organization/SanofiAventisSRL</p></blockquote></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5021"/>
</identifier>
<route>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C38299"/>
<display value="SUBCUTANEOUS"/>
</coding>
</route>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<name>
<productName value="Lantus"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="PROPRIETARY"/>
</coding>
</type>
</name>
<name>
<productName value="insulin glargine"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes"/>
<code value="NONPROPRIETARY"/>
</coding>
</type>
</name>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C25391"/>
<display value="ANALYSIS"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C82401"/>
<display value="API MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84732"/>
<display value="LABEL"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43360"/>
<display value="MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84731"/>
<display value="PACK"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisDeutschland"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C25391"/>
<display value="ANALYSIS"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84732"/>
<display value="LABEL"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43360"/>
<display value="MANUFACTURE"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
<operation>
<type>
<concept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C84731"/>
<display value="PACK"/>
</coding>
</concept>
</type>
<organization>🔗
<reference value="Organization/SanofiAventisSRL"/>
</organization>
</operation>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/ManufacturedItemDefinition/LantusSolution"/>
<resource>
<ManufacturedItemDefinition>
<id value="LantusSolution"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_LantusSolution"> </a><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name="LantusSolution"> </a><a name="hcLantusSolution"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceManufacturedItemDefinition "LantusSolution" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedManufacturedItem.html">SubmittedManufacturedItem</a></p></div><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: INJECTION, SOLUTION <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C42945)</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C42945"/>
<display value="INJECTION, SOLUTION"/>
</coding>
</manufacturedDoseForm>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusActiveIngredient"/>
<resource>
<Ingredient>
<id value="LantusActiveIngredient"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusActiveIngredient"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusActiveIngredient"> </a><a name="hcLantusActiveIngredient"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusActiveIngredient" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#ACTIB)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td>See on this page: SubstanceDefinition/LantusIngredientDefinition</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>100 iU<span style="background: LightGoldenRodYellow"> (Details: UCUM code [iU] = '[iU]')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
</coding>
</role>
<substance>
<code>
<reference>🔗
<reference
value="SubstanceDefinition/LantusIngredientDefinition"/>
</reference>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="100"/>
<unit value="iU"/>
<system value="http://unitsofmeasure.org"/>
<code value="[iU]"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/SubstanceDefinition/LantusIngredientDefinition"/>
<resource>
<SubstanceDefinition>
<id value="LantusIngredientDefinition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_LantusIngredientDefinition"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="LantusIngredientDefinition"> </a><a name="hcLantusIngredientDefinition"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceSubstanceDefinition "LantusIngredientDefinition" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedIngredientDefinition.html">SubmittedIngredientDefinition</a></p></div><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>/2ZM8CX04RZ</p><h3>Moieties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Identifier</b></td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td><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>/2ZM8CX04RZ</td><td>INSULIN GLARGINE</td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>INSULIN GLARGINE</td></tr></table></div>
</text>
<identifier>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="2ZM8CX04RZ"/>
</identifier>
<moiety>
<identifier>
<system value="http://fdasis.nlm.nih.gov"/>
<value value="2ZM8CX04RZ"/>
</identifier>
<name value="INSULIN GLARGINE"/>
</moiety>
<name>
<name value="INSULIN GLARGINE"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient1"/>
<resource>
<Ingredient>
<id value="LantusIngredient1"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient1"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusIngredient1"> </a><a name="hcLantusIngredient1"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusIngredient1" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: inactive ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#IACT)</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>ZINC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#J41CSQ7QDS)</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>30 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM code ug = 'ug')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="J41CSQ7QDS"/>
<display value="ZINC"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="30"/>
<unit value="ug"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient2"/>
<resource>
<Ingredient>
<id value="LantusIngredient2"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient2"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusIngredient2"> </a><a name="hcLantusIngredient2"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusIngredient2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: inactive ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#IACT)</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>METACRESOL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#GGO4Y809LO)</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>2.7 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg = 'mg')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="GGO4Y809LO"/>
<display value="METACRESOL"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="2.7"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient3"/>
<resource>
<Ingredient>
<id value="LantusIngredient3"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient3"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusIngredient3"> </a><a name="hcLantusIngredient3"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusIngredient3" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: inactive ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#IACT)</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>GLYCERIN <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#PDC6A3C0OX)</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>20 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg = 'mg')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="PDC6A3C0OX"/>
<display value="GLYCERIN"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="20"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient4"/>
<resource>
<Ingredient>
<id value="LantusIngredient4"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient4"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusIngredient4"> </a><a name="hcLantusIngredient4"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusIngredient4" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: inactive ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#IACT)</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>POLYSORBATE 20 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#7T1F30V5YH)</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>20 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM code ug = 'ug')</span>/1 mL<span style="background: LightGoldenRodYellow"> (Details: UCUM code mL = 'mL')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="7T1F30V5YH"/>
<display value="POLYSORBATE 20"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="20"/>
<unit value="ug"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient5"/>
<resource>
<Ingredient>
<id value="LantusIngredient5"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient5"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusIngredient5"> </a><a name="hcLantusIngredient5"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusIngredient5" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: inactive ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#IACT)</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>WATER <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#059QF0KO0R)</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="059QF0KO0R"/>
<display value="WATER"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient6"/>
<resource>
<Ingredient>
<id value="LantusIngredient6"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient6"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusIngredient6"> </a><a name="hcLantusIngredient6"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusIngredient6" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: inactive ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#IACT)</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>HYDROCHLORIC ACID <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#QTT17582CB)</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="QTT17582CB"/>
<display value="HYDROCHLORIC ACID"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/Ingredient/LantusIngredient7"/>
<resource>
<Ingredient>
<id value="LantusIngredient7"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusIngredient7"> </a><p><b>Generated Narrative: Ingredient</b><a name="LantusIngredient7"> </a><a name="hcLantusIngredient7"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceIngredient "LantusIngredient7" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductIngredient.html">SubmittedMedicinalProductIngredient</a></p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: ManufacturedItemDefinition/LantusSolution</p><p><b>role</b>: inactive ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#IACT)</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>SODIUM HYDROXIDE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#55X04QC32I)</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference value="ManufacturedItemDefinition/LantusSolution"/>
</for>
<role>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="IACT"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="55X04QC32I"/>
<display value="SODIUM HYDROXIDE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/PackagedProductDefinition/LantusVialPackage"/>
<resource>
<PackagedProductDefinition>
<id value="LantusVialPackage"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_LantusVialPackage"> </a><p><b>Generated Narrative: PackagedProductDefinition</b><a name="LantusVialPackage"> </a><a name="hcLantusVialPackage"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourcePackagedProductDefinition "LantusVialPackage" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalPackaging.html">SubmittedMedicinalPackaging</a></p></div><p><b>packageFor</b>: See on this page: MedicinalProductDefinition/LantusVialDefinition</p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td>active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-splMarketingStatuses.html">SPL Marketing Statuses CodeSystem</a>#active)</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>package</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5021-01</p><p><b>type</b>: PACKAGE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C43233)</span></p><blockquote><p><b>package</b></p><p><b>type</b>: VIAL, GLASS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C43209)</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>containedItem</b></p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>🔗
<reference value="MedicinalProductDefinition/LantusVialDefinition"/>
</packageFor>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<package>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5021-01"/>
</identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43233"/>
<display value="PACKAGE"/>
</coding>
</type>
<package>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43209"/>
<display value="VIAL, GLASS"/>
</coding>
</type>
<quantity value="1"/>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes"/>
<code value="SPLCMBPRDTP"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C112160"/>
<display value="Type 0: Not a Combination Product"/>
</coding>
</valueCodeableConcept>
</property>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/LantusSolution"/>
</reference>
</item>
<amount>
<value value="10"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</amount>
</containedItem>
</package>
</package>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/PackagedProductDefinition/LantusSyringePackage"/>
<resource>
<PackagedProductDefinition>
<id value="LantusSyringePackage"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_LantusSyringePackage"> </a><p><b>Generated Narrative: PackagedProductDefinition</b><a name="LantusSyringePackage"> </a><a name="hcLantusSyringePackage"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourcePackagedProductDefinition "LantusSyringePackage" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalPackaging.html">SubmittedMedicinalPackaging</a></p></div><p><b>packageFor</b>: See on this page: MedicinalProductDefinition/LantusSyringeDefinition</p><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td>active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-codesystem-splMarketingStatuses.html">SPL Marketing Statuses CodeSystem</a>#active)</span></td><td>2017-06-04 --> (ongoing)</td></tr></table><blockquote><p><b>package</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5020-05</p><p><b>type</b>: PACKAGE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C43233)</span></p><blockquote><p><b>package</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/5.5.0/NamingSystem-v3-ndc.html" title="National drug codes">National drug codes</a>/0088-5020-01</p><p><b>type</b>: SYRINGE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C43202)</span></p><p><b>quantity</b>: 5</p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>containedItem</b></p></blockquote></blockquote></blockquote></div>
</text>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/LantusSyringeDefinition"/>
</packageFor>
<marketingStatus>
<status>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses"/>
<code value="active"/>
</coding>
</status>
<dateRange>
<start value="2017-06-04"/>
</dateRange>
</marketingStatus>
<package>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5020-05"/>
</identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43233"/>
<display value="PACKAGE"/>
</coding>
</type>
<package>
<identifier>
<system value="http://hl7.org/fhir/sid/ndc"/>
<value value="0088-5020-01"/>
</identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C43202"/>
<display value="SYRINGE"/>
</coding>
</type>
<quantity value="5"/>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes"/>
<code value="SPLCMBPRDTP"/>
</coding>
</type>
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C112160"/>
<display value="Type 0: Not a Combination Product"/>
</coding>
</valueCodeableConcept>
</property>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/LantusSolution"/>
</reference>
</item>
<amount>
<value value="3"/>
<unit value="mL"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</amount>
</containedItem>
</package>
</package>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/RegulatedAuthorization/LantusVialMarketing"/>
<resource>
<RegulatedAuthorization>
<id value="LantusVialMarketing"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_LantusVialMarketing"> </a><p><b>Generated Narrative: RegulatedAuthorization</b><a name="LantusVialMarketing"> </a><a name="hcLantusVialMarketing"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceRegulatedAuthorization "LantusVialMarketing" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductMarketing.html">SubmittedMedicinalProductMarketing</a></p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.3.150</code>/BLA021081</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/LantusVialDefinition</p><p><b>type</b>: BLA <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C73585)</span></p><p><b>region</b>: United States of America <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></p></div>
</text>
<identifier>
<system value="urn:oid:2.16.840.1.113883.3.150"/>
<value value="BLA021081"/>
</identifier>
<subject>🔗
<reference value="MedicinalProductDefinition/LantusVialDefinition"/>
</subject>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C73585"/>
<display value="BLA"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="USA"/>
</coding>
</region>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://example.org/RegulatedAuthorization/LantusSyringeMarketing"/>
<resource>
<RegulatedAuthorization>
<id value="LantusSyringeMarketing"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_LantusSyringeMarketing"> </a><p><b>Generated Narrative: RegulatedAuthorization</b><a name="LantusSyringeMarketing"> </a><a name="hcLantusSyringeMarketing"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceRegulatedAuthorization "LantusSyringeMarketing" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubmittedMedicinalProductMarketing.html">SubmittedMedicinalProductMarketing</a></p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.3.150</code>/BLA021081</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/LantusSyringeDefinition</p><p><b>type</b>: BLA <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C73585)</span></p><p><b>region</b>: United States of America <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></p></div>
</text>
<identifier>
<system value="urn:oid:2.16.840.1.113883.3.150"/>
<value value="BLA021081"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/LantusSyringeDefinition"/>
</subject>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C73585"/>
<display value="BLA"/>
</coding>
</type>
<region>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="USA"/>
</coding>
</region>
</RegulatedAuthorization>
</resource>
</entry>
</Bundle>