SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
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
{
"resourceType" : "Bundle",
"id" : "LantusInjectionLabelBundle",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionBundle"
]
},
"identifier" : {
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:4e455ace-94f4-4fa3-85eb-0152e5a06239"
},
"type" : "document",
"timestamp" : "2021-01-27T00:00:00.0000Z",
"entry" : [
{
"fullUrl" : "http://example.org/Composition/LantusInjectionLabelComposition",
"resource" : {
"resourceType" : "Composition",
"id" : "LantusInjectionLabelComposition",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"
]
},
"text" : {
"status" : "extensions",
"div" : "<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 \r\n\r\nThis 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: \r\n\r\nNote 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.\r\n\r\nThis 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/>\n <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000</p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/spl/StructureDefinition/versionNumber",
"valueString" : "11"
}
],
"identifier" : {
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6"
},
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "34391-3",
"display" : "HUMAN PRESCRIPTION DRUG LABEL"
}
]
},
"date" : "2021-01-27",
"author" : [
{
🔗 "reference" : "Organization/SanofiAventisUS"
}
],
"title" : "These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>\n <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" : "2021-01-27"
},
{
"url" : "http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId",
"valueString" : "S1"
}
],
"title" : "1 INDICATIONS AND USAGE",
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "34067-9",
"display" : "INDICATIONS & USAGE SECTION"
}
]
},
"text" : {
"status" : "additional",
"div" : "<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>"
},
"section" : [
{
"id" : "0230cfa8-ff67-4666-ba57-bbad268ac6fe",
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "42229-5",
"display" : "SPL UNCLASSIFIED SECTION"
}
]
},
"text" : {
"status" : "additional",
"div" : "<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>"
}
}
]
},
{
"id" : "f65bb254-5018-4af5-b02a-38d5d51ed901",
"extension" : [
{
"url" : "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime",
"valueDateTime" : "2021-01-27"
}
],
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "48780-1",
"display" : "SPL LISTING DATA ELEMENTS SECTION"
}
]
},
"entry" : [
{
🔗 "reference" : "MedicinalProductDefinition/LantusSyringeDefinition"
},
{
🔗 "reference" : "MedicinalProductDefinition/LantusVialDefinition"
}
]
},
{
"id" : "ff673a31-f676-444c-a009-8d4a2645fd19",
"extension" : [
{
"url" : "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime",
"valueDateTime" : "2021-01-27"
}
],
"title" : "PRINCIPAL DISPLAY PANEL - 10 mL Vial Package",
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "51945-4",
"display" : "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"
}
]
},
"text" : {
"status" : "additional",
"div" : "<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>"
}
},
{
"id" : "8ce1b409-6067-4c9d-8e21-bdb6df850c24",
"extension" : [
{
"url" : "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime",
"valueDateTime" : "2021-01-27"
}
],
"title" : "PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package",
"code" : {
"coding" : [
{
"system" : "http://loinc.org",
"code" : "51945-4",
"display" : "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"
}
]
},
"text" : {
"status" : "additional",
"div" : "<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>"
}
}
]
}
},
{
"fullUrl" : "http://example.org/Organization/SanofiAventisUS",
"resource" : {
"resourceType" : "Organization",
"id" : "SanofiAventisUS",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "783243835"
}
],
"type" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes",
"code" : "Labeler"
}
]
}
],
"name" : "sanofi-aventis U.S. LLC"
}
},
{
"fullUrl" : "http://example.org/Organization/SanofiAventisDeutschland",
"resource" : {
"resourceType" : "Organization",
"id" : "SanofiAventisDeutschland",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "313218430"
}
],
"type" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes",
"code" : "Establishment"
}
]
}
],
"name" : "Sanofi-Aventis Deutschland GmbH"
}
},
{
"fullUrl" : "http://example.org/Organization/SanofiAventisSRL",
"resource" : {
"resourceType" : "Organization",
"id" : "SanofiAventisSRL",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "338454274"
}
],
"type" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-organizationTypes",
"code" : "Establishment"
}
]
}
],
"name" : "Sanofi S.r.l."
}
},
{
"fullUrl" : "http://example.org/MedicinalProductDefinition/LantusSyringeDefinition",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "LantusSyringeDefinition",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/ndc",
"value" : "0088-5020"
}
],
"route" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C38299",
"display" : "SUBCUTANEOUS"
}
]
}
],
"marketingStatus" : [
{
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses",
"code" : "active"
}
]
},
"dateRange" : {
"start" : "2017-06-04"
}
}
],
"name" : [
{
"productName" : "Lantus Solostar",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes",
"code" : "PROPRIETARY"
}
]
}
},
{
"productName" : "insulin glargine",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes",
"code" : "NONPROPRIETARY"
}
]
}
}
],
"operation" : [
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C25391",
"display" : "ANALYSIS"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C82401",
"display" : "API MANUFACTURE"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84732",
"display" : "LABEL"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C43360",
"display" : "MANUFACTURE"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84731",
"display" : "PACK"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
}
]
}
},
{
"fullUrl" : "http://example.org/MedicinalProductDefinition/LantusVialDefinition",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "LantusVialDefinition",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/ndc",
"value" : "0088-5021"
}
],
"route" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C38299",
"display" : "SUBCUTANEOUS"
}
]
}
],
"marketingStatus" : [
{
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses",
"code" : "active"
}
]
},
"dateRange" : {
"start" : "2017-06-04"
}
}
],
"name" : [
{
"productName" : "Lantus",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes",
"code" : "PROPRIETARY"
}
]
}
},
{
"productName" : "insulin glargine",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes",
"code" : "NONPROPRIETARY"
}
]
}
}
],
"operation" : [
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C25391",
"display" : "ANALYSIS"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C82401",
"display" : "API MANUFACTURE"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84732",
"display" : "LABEL"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C43360",
"display" : "MANUFACTURE"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84731",
"display" : "PACK"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisDeutschland"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C25391",
"display" : "ANALYSIS"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisSRL"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84732",
"display" : "LABEL"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisSRL"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C43360",
"display" : "MANUFACTURE"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisSRL"
}
]
},
{
"type" : {
"concept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C84731",
"display" : "PACK"
}
]
}
},
"organization" : [
{
🔗 "reference" : "Organization/SanofiAventisSRL"
}
]
}
]
}
},
{
"fullUrl" : "http://example.org/ManufacturedItemDefinition/LantusSolution",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "LantusSolution",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42945",
"display" : "INJECTION, SOLUTION"
}
]
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusActiveIngredient",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusActiveIngredient",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "ACTIB"
}
]
},
"substance" : {
"code" : {
"reference" : {
🔗 "reference" : "SubstanceDefinition/LantusIngredientDefinition"
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 100,
"unit" : "iU",
"system" : "http://unitsofmeasure.org",
"code" : "[iU]"
},
"denominator" : {
"value" : 1,
"unit" : "mL",
"system" : "http://unitsofmeasure.org",
"code" : "mL"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/SubstanceDefinition/LantusIngredientDefinition",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "LantusIngredientDefinition",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"value" : "2ZM8CX04RZ"
}
],
"moiety" : [
{
"identifier" : {
"system" : "http://fdasis.nlm.nih.gov",
"value" : "2ZM8CX04RZ"
},
"name" : "INSULIN GLARGINE"
}
],
"name" : [
{
"name" : "INSULIN GLARGINE"
}
]
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusIngredient1",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusIngredient1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "IACT"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "J41CSQ7QDS",
"display" : "ZINC"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 30,
"unit" : "ug",
"system" : "http://unitsofmeasure.org",
"code" : "ug"
},
"denominator" : {
"value" : 1,
"unit" : "mL",
"system" : "http://unitsofmeasure.org",
"code" : "mL"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusIngredient2",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusIngredient2",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "IACT"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "GGO4Y809LO",
"display" : "METACRESOL"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 2.7,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "mL",
"system" : "http://unitsofmeasure.org",
"code" : "mL"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusIngredient3",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusIngredient3",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "IACT"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "PDC6A3C0OX",
"display" : "GLYCERIN"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 20,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "mL",
"system" : "http://unitsofmeasure.org",
"code" : "mL"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusIngredient4",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusIngredient4",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "IACT"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "7T1F30V5YH",
"display" : "POLYSORBATE 20"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 20,
"unit" : "ug",
"system" : "http://unitsofmeasure.org",
"code" : "ug"
},
"denominator" : {
"value" : 1,
"unit" : "mL",
"system" : "http://unitsofmeasure.org",
"code" : "mL"
}
}
}
]
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusIngredient5",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusIngredient5",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "IACT"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "059QF0KO0R",
"display" : "WATER"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusIngredient6",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusIngredient6",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "IACT"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "QTT17582CB",
"display" : "HYDROCHLORIC ACID"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/Ingredient/LantusIngredient7",
"resource" : {
"resourceType" : "Ingredient",
"id" : "LantusIngredient7",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
],
"role" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
"code" : "IACT"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "55X04QC32I",
"display" : "SODIUM HYDROXIDE"
}
]
}
}
}
}
},
{
"fullUrl" : "http://example.org/PackagedProductDefinition/LantusVialPackage",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "LantusVialPackage",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/LantusVialDefinition"
}
],
"marketingStatus" : [
{
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses",
"code" : "active"
}
]
},
"dateRange" : {
"start" : "2017-06-04"
}
}
],
"package" : {
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/ndc",
"value" : "0088-5021-01"
}
],
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C43233",
"display" : "PACKAGE"
}
]
},
"package" : [
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C43209",
"display" : "VIAL, GLASS"
}
]
},
"quantity" : 1,
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
"code" : "SPLCMBPRDTP"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C112160",
"display" : "Type 0: Not a Combination Product"
}
]
}
}
],
"containedItem" : [
{
"item" : {
"reference" : {
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
},
"amount" : {
"value" : 10,
"unit" : "mL",
"system" : "http://unitsofmeasure.org",
"code" : "mL"
}
}
]
}
]
}
}
},
{
"fullUrl" : "http://example.org/PackagedProductDefinition/LantusSyringePackage",
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "LantusSyringePackage",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/LantusSyringeDefinition"
}
],
"marketingStatus" : [
{
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-splMarketingStatuses",
"code" : "active"
}
]
},
"dateRange" : {
"start" : "2017-06-04"
}
}
],
"package" : {
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/ndc",
"value" : "0088-5020-05"
}
],
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C43233",
"display" : "PACKAGE"
}
]
},
"package" : [
{
"identifier" : [
{
"system" : "http://hl7.org/fhir/sid/ndc",
"value" : "0088-5020-01"
}
],
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C43202",
"display" : "SYRINGE"
}
]
},
"quantity" : 5,
"property" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
"code" : "SPLCMBPRDTP"
}
]
},
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C112160",
"display" : "Type 0: Not a Combination Product"
}
]
}
}
],
"containedItem" : [
{
"item" : {
"reference" : {
🔗 "reference" : "ManufacturedItemDefinition/LantusSolution"
}
},
"amount" : {
"value" : 3,
"unit" : "mL",
"system" : "http://unitsofmeasure.org",
"code" : "mL"
}
}
]
}
]
}
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorization/LantusVialMarketing",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "LantusVialMarketing",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.150",
"value" : "BLA021081"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/LantusVialDefinition"
}
],
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C73585",
"display" : "BLA"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "USA"
}
]
}
]
}
},
{
"fullUrl" : "http://example.org/RegulatedAuthorization/LantusSyringeMarketing",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "LantusSyringeMarketing",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing"
]
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.150",
"value" : "BLA021081"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/LantusSyringeDefinition"
}
],
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C73585",
"display" : "BLA"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "USA"
}
]
}
]
}
}
]
}
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.1.0 based on FHIR 4.3.0. Generated 2024-05-16
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