Generated Narrative

Resource "cfsb1316794754115" (Language "no")

status: final

type: Package Leaflet (#100000155538)

date: 2015-02-07T13:28:17Z

author: See above (Organization/cfsb6005885654359)

title: TEST PURPOSES ONLY - Suliqua Vulcan ePI

confidentiality: unrestricted

<section> <title value="B. PAKNINGSVEDLEGG" /> <code> <coding> <system value="https://spor.ema.europa.eu/" /> <code value="100000155538" /> </coding> <text value="B. PAKNINGSVEDLEGG" /> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <h1>Pakningsvedlegg: Informasjon til brukeren</h1> </div> </text> </section> <section> <title value="1. Hva Suliqua er og hva det brukes mot" /> <code> <coding> <system value="https://spor.ema.europa.eu/" /> <code value="100000155538-1" /> </coding> <text value="B. PAKNINGSVEDLEGG" /> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <span>1. Hva Suliqua er og hva det brukes mot</span> </div> </text> </section> <section> <title value="2. Hva du må vite før du bruker Suliqua" /> <code> <coding> <system value="https://spor.ema.europa.eu/" /> <code value="100000155538-2" /> </coding> <text value="B. PAKNINGSVEDLEGG" /> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <span>2. Hva du må vite før du bruker Suliqua</span> </div> </text> </section> <section> <title value="3. Hvordan du bruker Suliqua" /> <code> <coding> <system value="https://spor.ema.europa.eu/" /> <code value="100000155538-3" /> </coding> <text value="B. PAKNINGSVEDLEGG" /> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <span>3. Hvordan du bruker Suliqua</span> </div> </text> </section> <section> <title value="4. Mulige bivirkninger" /> <code> <coding> <system value="https://spor.ema.europa.eu/" /> <code value="100000155538-4" /> </coding> <text value="B. PAKNINGSVEDLEGG" /> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <span>4. Mulige bivirkninger</span> </div> </text> </section> <section> <title value="5. Hvordan du oppbevarer Suliqua" /> <code> <coding> <system value="https://spor.ema.europa.eu/" /> <code value="100000155538-2" /> </coding> <text value="B. PAKNINGSVEDLEGG" /> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <span>5. Hvordan du oppbevarer Suliqua</span> </div> </text> </section> <section> <title value="6. Innholdet i pakningen og ytterligere informasjon" /> <code> <coding> <system value="https://spor.ema.europa.eu/" /> <code value="100000155538-2" /> </coding> <text value="B. PAKNINGSVEDLEGG" /> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <span>6. Innholdet i pakningen og ytterligere informasjon</span> </div> </text> </section> </Composition> </resource> </entry> <entry> <resource> <Organization> <id value="cfsb6005885654359" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb6005885654359" </p> </div> <p> <b>identifier</b>: id: ORG-100000789 (OFFICIAL) </p> <p> <b>active</b>: true </p> <p> <b>type</b>: Marketing authorisation holder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#bus)</span></p> <p> <b>name</b>: Sanofi-Aventis Groupe </p> <p> <b>address</b>: 54 Rue La Boetie Paris 75008 France(WORK) </p> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/rmswi/#/" /> <value value="ORG-100000789" /> </identifier> <active value="true" /> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="bus" /> </coding> <text value="Marketing authorisation holder" /> </type> <name value="Sanofi-Aventis Groupe" /> <contact> <address> <use value="work" /> <type value="physical" /> <text value="54 Rue La Boetie Paris 75008 France" /> <line value="54 Rue La Boetie" /> <city value="Paris" /> <country value="fr" /> </address> </contact> </Organization> </resource> </entry> <entry> <resource> <Organization> <id value="cfsb2176224411725" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb2176224411725" </p> </div> <p> <b>identifier</b>: id: ORG-100001175 (OFFICIAL) </p> <p> <b>active</b>: true </p> <p> <b>type</b>: Manufacturer API <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#220000000033)</span></p> <p> <b>name</b>: Sanofi-Aventis Deutschland GmbH </p> <p> <b>address</b>: Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY(WORK) </p> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/omswi/#/" /> <value value="ORG-100001175" /> </identifier> <active value="true" /> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="220000000033" /> </coding> <text value="Manufacturer API" /> </type> <name value="Sanofi-Aventis Deutschland GmbH" /> <contact> <address> <use value="work" /> <type value="physical" /> <text value="Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY" /> <line value="Brueningstrasse 50, Industriepark Höchst" /> <city value="Frankfurt am Main" /> <postalCode value="65926" /> <country value="de" /> </address> </contact> </Organization> </resource> </entry> <entry> <resource> <Organization> <id value="cfsb7719260512249" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb7719260512249" </p> </div> <p> <b>identifier</b>: id: ORG-100001175 (OFFICIAL) </p> <p> <b>active</b>: true </p> <p> <b>type</b>: Manufacturer Batch release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#220000000033)</span></p> <p> <b>name</b>: Sanofi-Aventis Deutschland GmbH </p> <p> <b>address</b>: Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY(WORK) </p> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/omswi/#/" /> <value value="ORG-100001175" /> </identifier> <active value="true" /> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="220000000033" /> </coding> <text value="Manufacturer Batch release" /> </type> <name value="Sanofi-Aventis Deutschland GmbH" /> <contact> <address> <use value="work" /> <type value="physical" /> <text value="Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY" /> <line value="Brueningstrasse 50, Industriepark Höchst" /> <city value="Frankfurt am Main" /> <postalCode value="65926" /> <country value="de" /> </address> </contact> </Organization> </resource> </entry> <entry> <resource> <Organization> <id value="cfsb1639015880655" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb1639015880655" </p> </div> <p> <b>identifier</b>: id: ORG-100013412 (OFFICIAL) </p> <p> <b>active</b>: true </p> <p> <b>type</b>: Medicines Regulatory Authority <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#220000000033)</span></p> <p> <b>name</b>: European Medicines Agency </p> <p> <b>address</b>: Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands(WORK) </p> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/omswi/#/" /> <value value="ORG-100013412" /> </identifier> <active value="true" /> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="220000000033" /> </coding> <text value="Medicines Regulatory Authority" /> </type> <name value="European Medicines Agency" /> <contact> <address> <use value="work" /> <type value="physical" /> <text value="Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands" /> <line value="Carretera De Martorell 41 61, Poligono Industrial Nord-Est" /> <city value="Amsterdam" /> <postalCode value="1083 HS" /> <country value="nl" /> </address> </contact> </Organization> </resource> </entry> <entry> <resource> <RegulatedAuthorization> <id value="cfsb2023900992766" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb2023900992766" </p> </div> <p> <b>identifier</b>: id: EU/1/16/1157/003 (OFFICIAL) </p> <p> <b>subject</b>: <a href="#MedicinalProductDefinition_cfsb7123030148537">See above (MedicinalProductDefinition/cfsb7123030148537)</a></p> <p> <b>type</b>: Marketing Authorisation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072062)</span></p> <p> <b>description</b>: Suliqua 100 units/ml + 33 microgram/ml solution for injection in x3 pre-filled pens </p> <p> <b>region</b>: European Union <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#eu)</span></p> <p> <b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ( <a href="http://build.fhir.org/codesystem-publication-status.html">PublicationStatus</a>#active) </span></p> <p> <b>statusDate</b>: 2017-01-11T13:28:17Z </p> <p> <b>validityPeriod</b>: 2017-01-11T13:28:17Z --> (ongoing) </p> <p> <b>holder</b>: <a href="#Organization_cfsb6005885654359">See above (Organization/cfsb6005885654359)</a></p> <p> <b>regulator</b>: <a href="#Organization_cfsb1639015880655">See above (Organization/cfsb1639015880655)</a></p> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/rmswi/#/" /> <value value="EU/1/16/1157/003" /> </identifier> <subject> <reference value="MedicinalProductDefinition/cfsb7123030148537" /> </subject> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072062" /> </coding> <text value="Marketing Authorisation" /> </type> <description value="Suliqua 100 units/ml + 33 microgram/ml solution for injection in x3 pre-filled pens" /> <region> <coding> <system value="urn:iso:std:iso:3166" /> <code value="eu" /> </coding> <text value="European Union" /> </region> <status> <coding> <system value="http://hl7.org/fhir/publication-status" /> <code value="active" /> </coding> <text value="Active" /> </status> <statusDate value="2017-01-11T13:28:17Z" /> <validityPeriod> <start value="2017-01-11T13:28:17Z" /> </validityPeriod> <holder> <reference value="Organization/cfsb6005885654359" /> </holder> <regulator> <reference value="Organization/cfsb1639015880655" /> </regulator> </RegulatedAuthorization> </resource> </entry> <entry> <resource> <MedicinalProductDefinition> <id value="cfsb7123030148537" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb7123030148537" </p> </div> <p> <b>identifier</b>: id: EU/1/16/1157/003 (OFFICIAL) </p> <p> <b>type</b>: Marketing Authorisation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072062)</span></p> <p> <b>domain</b>: Human use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000000012)</span></p> <p> <b>version</b>: 1 </p> <p> <b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ( <a href="http://build.fhir.org/codesystem-publication-status.html">PublicationStatus</a>#active) </span></p> <p> <b>statusDate</b>: 2015-02-07T13:28:17Z </p> <p> <b>description</b>: Suliqua 100 units/ml + 33 microgram/ml solution for injection in a pre-filled pen: Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide </p> <p> <b>route</b>: Subcutaneous use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000073633)</span></p> <p> <b>indication</b>: Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors. </p> <p> <b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072084)</span></p> <p> <b>classification</b>: insulin glargine and lixisenatide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#A10AE54)</span>, Diabetes mellitus inadequate control <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000019249)</span></p> <blockquote> <p> <b>name</b> </p> <p> <b>productName</b>: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen </p> <p> <b>type</b>: Full name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#220000000001)</span></p> <h3>NameParts</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Part</b> </td> <td> <b>Type</b> </td> </tr> <tr> <td>*</td> <td>Solution for injection</td> <td>Pharmaceutical dose form part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#220000000005)</span></td> </tr> </table> <h3>CountryLanguages</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Country</b> </td> <td> <b>Jurisdiction</b> </td> <td> <b>Language</b> </td> </tr> <tr> <td>*</td> <td>European Union <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#eu)</span></td> <td>European Union <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#eu)</span></td> <td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ( <a href="http://terminology.hl7.org/3.0.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en) </span></td> </tr> </table> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/pmswi/#/" /> <value value="EU/1/16/1157/003" /> </identifier> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072062" /> </coding> <text value="Marketing Authorisation" /> </type> <domain> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000000012" /> </coding> <text value="Human use" /> </domain> <version value="1" /> <status> <coding> <system value="http://hl7.org/fhir/publication-status" /> <code value="active" /> <display value="Active" /> </coding> </status> <statusDate value="2015-02-07T13:28:17Z" /> <description value="Suliqua 100 units/ml + 33 microgram/ml solution for injection in a pre-filled pen: Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide" /> <route> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000073633" /> </coding> <text value="Subcutaneous use" /> </route> <indication value="Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors." /> <legalStatusOfSupply> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072084" /> </coding> <text value="Medicinal product subject to medical prescription" /> </legalStatusOfSupply> <classification> <coding> <!-- not the correct code system --> <!--system value="https://www.whocc.no/atc_ddd_index/"/--> <system value="http://www.whocc.no/atc" /> <code value="A10AE54" /> </coding> <text value="insulin glargine and lixisenatide" /> </classification> <classification> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000019249" /> </coding> <text value="Diabetes mellitus inadequate control" /> </classification> <name> <productName value="Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen" /> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="220000000001" /> </coding> <text value="Full name" /> </type> <part> <part value="Solution for injection" /> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="220000000005" /> </coding> <text value="Pharmaceutical dose form part" /> </type> </part> <usage> <country> <coding> <system value="urn:iso:std:iso:3166" /> <code value="eu" /> </coding> <text value="European Union" /> </country> <jurisdiction> <coding> <system value="urn:iso:std:iso:3166" /> <code value="eu" /> </coding> <text value="European Union" /> </jurisdiction> <language> <coding> <system value="urn:ietf:bcp:47" /> <code value="en" /> </coding> <text value="English" /> </language> </usage> </name> </MedicinalProductDefinition> </resource> </entry> <entry> <resource> <PackagedProductDefinition> <id value="cfsb5595996591065" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb5595996591065" </p> </div> <p> <b>identifier</b>: id: EU/1/16/1157/003 (OFFICIAL) </p> <p> <b>name</b>: 3 ml cartridge (glass) in a pre-filled pen </p> <p> <b>type</b>: Chemical Medicinal Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000155527)</span></p> <p> <b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ( <a href="http://build.fhir.org/codesystem-publication-status.html">PublicationStatus</a>#active) </span></p> <p> <b>statusDate</b>: 2015-02-07T13:28:17Z </p> <p> <b>containedItemQuantity</b>: 3 ml </p> <p> <b>description</b>: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen. </p> <p> <b>copackagedIndicator</b>: false </p> <p> <b>manufacturer</b>: <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a></p> <h3>Packages</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Identifier</b> </td> <td> <b>Type</b> </td> <td> <b>Quantity</b> </td> <td> <b>Material</b> </td> </tr> <tr> <td>*</td> <td>id: EU/1/16/1157/003 (OFFICIAL)</td> <td>Pre-filled pen <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000073543)</span></td> <td>3</td> <td>Glass type I <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#200000003204)</span></td> </tr> </table> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/pmswi/#/" /> <value value="EU/1/16/1157/003" /> </identifier> <name value="3 ml cartridge (glass) in a pre-filled pen" /> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000155527" /> </coding> <text value="Chemical Medicinal Product" /> </type> <packageFor> <reference value="MedicinalProductDefinition/cfsb7123030148537" /> </packageFor> <status> <coding> <system value="http://hl7.org/fhir/publication-status" /> <code value="active" /> <display value="Active" /> </coding> </status> <statusDate value="2015-02-07T13:28:17Z" /> <containedItemQuantity> <value value="3" /> <unit value="ml" /> </containedItemQuantity> <description value="Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen." /> <copackagedIndicator value="false" /> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> <packaging> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/rmswi/#/" /> <value value="EU/1/16/1157/003" /> </identifier> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000073543" /> </coding> <text value="Pre-filled pen" /> </type> <quantity value="3" /> <material> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="200000003204" /> </coding> <text value="Glass type I" /> </material> </packaging> </PackagedProductDefinition> </resource> </entry> <entry> <resource> <AdministrableProductDefinition> <id value="cfsb5880516529064" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb5880516529064" </p> </div> <p> <b>identifier</b>: id: TBD (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>formOf</b>: <a href="#MedicinalProductDefinition_cfsb7123030148537">See above (MedicinalProductDefinition/cfsb7123030148537)</a></p> <p> <b>administrableDoseForm</b>: Solution for injection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000073863)</span></p> <p> <b>unitOfPresentation</b>: Pen <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#200000002135)</span></p> <p> <b>producedFrom</b>: <a href="#ManufacturedItemDefinition_cfsb7089233601948">See above (ManufacturedItemDefinition/cfsb7089233601948)</a></p> <blockquote> <p> <b>routeOfAdministration</b> </p> <p> <b>code</b>: Subcutaneous use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000073633)</span></p> <h3>TargetSpecies</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Code</b> </td> </tr> <tr> <td>*</td> <td>Human <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000109093)</span></td> </tr> </table> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/pmswi/" /> <value value="TBD" /> </identifier> <status value="active" /> <formOf> <reference value="MedicinalProductDefinition/cfsb7123030148537" /> </formOf> <administrableDoseForm> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000073863" /> </coding> <text value="Solution for injection" /> </administrableDoseForm> <unitOfPresentation> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="200000002135" /> </coding> <text value="Pen" /> </unitOfPresentation> <producedFrom> <reference value="ManufacturedItemDefinition/cfsb7089233601948" /> </producedFrom> <routeOfAdministration> <code> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000073633" /> </coding> <text value="Subcutaneous use" /> </code> <targetSpecies> <code> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000109093" /> </coding> <text value="Human" /> </code> </targetSpecies> </routeOfAdministration> </AdministrableProductDefinition> </resource> </entry> <entry> <resource> <ManufacturedItemDefinition> <id value="cfsb7089233601948" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb7089233601948" </p> </div> <p> <b>identifier</b>: id: EU/1/16/1157/003 (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>manufacturedDoseForm</b>: Solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#200000002007)</span></p> <p> <b>unitOfPresentation</b>: Pen <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#200000002135)</span></p> <p> <b>manufacturer</b>: <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a></p> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/pmswi/#/" /> <value value="EU/1/16/1157/003" /> </identifier> <status value="active" /> <manufacturedDoseForm> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="200000002007" /> </coding> <text value="Solution" /> </manufacturedDoseForm> <unitOfPresentation> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="200000002135" /> </coding> <text value="Pen" /> </unitOfPresentation> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </ManufacturedItemDefinition> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb3768802370375" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb3768802370375" </p> </div> <p> <b>identifier</b>: id: 2ZM8CX04RZ (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#00000072072)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> <h3>Strengths</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Presentation[x]</b> </td> <td> <b>Basis</b> </td> </tr> <tr> <td>*</td> <td>100 units/ml</td> <td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (v3-RoleClassIngredientEntity#ACTIB)</span></td> </tr> </table> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="2ZM8CX04RZ" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="00000072072" /> </coding> <text value="active" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="2ZM8CX04RZ" /> <display value="Insulin glargine" /> </coding> </concept> </code> <strength> <presentationQuantity> <value value="100" /> <unit value="units/ml" /> </presentationQuantity> <basis> <coding> <system value="http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity" /> <code value="ACTIB" /> </coding> <text value="active ingredient - basis of strength" /> </basis> </strength> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb8724428384435" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb8724428384435" </p> </div> <p> <b>identifier</b>: id: 74O62BB01U (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#00000072072)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> <h3>Strengths</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Presentation[x]</b> </td> <td> <b>Basis</b> </td> </tr> <tr> <td>*</td> <td>50 ug/ml</td> <td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (v3-RoleClassIngredientEntity#ACTIB)</span></td> </tr> </table> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="74O62BB01U" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="00000072072" /> </coding> <text value="active" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="74O62BB01U" /> <display value="Lixisenatide" /> </coding> </concept> </code> <strength> <presentationQuantity> <value value="50" /> <unit value="ug/ml" /> </presentationQuantity> <basis> <coding> <system value="http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity" /> <code value="ACTIB" /> </coding> <text value="active ingredient - basis of strength" /> </basis> </strength> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb8364716455502" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb8364716455502" </p> </div> <p> <b>identifier</b>: id: 74O62BB01U (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#00000072072)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> <h3>Strengths</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Presentation[x]</b> </td> <td> <b>Basis</b> </td> </tr> <tr> <td>*</td> <td>33 ug/ml</td> <td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (v3-RoleClassIngredientEntity#ACTIB)</span></td> </tr> </table> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="74O62BB01U" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="00000072072" /> </coding> <text value="active" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="74O62BB01U" /> <display value="Lixisenatide" /> </coding> </concept> </code> <strength> <presentationQuantity> <value value="33" /> <unit value="ug/ml" /> </presentationQuantity> <basis> <coding> <system value="http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity" /> <code value="ACTIB" /> </coding> <text value="active ingredient - basis of strength" /> </basis> </strength> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb7644964356957" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb7644964356957" </p> </div> <p> <b>identifier</b>: id: PDC6A3C0OX (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072082)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="PDC6A3C0OX" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072082" /> </coding> <text value="Excipient" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="PDC6A3C0OX" /> <display value="Glycerol" /> </coding> </concept> </code> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb8873568628101" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb8873568628101" </p> </div> <p> <b>identifier</b>: id: AE28F7PNPL (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072082)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="AE28F7PNPL" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072082" /> </coding> <text value="Excipient" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="AE28F7PNPL" /> <display value="Methionine" /> </coding> </concept> </code> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb7194634205639" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb7194634205639" </p> </div> <p> <b>identifier</b>: id: GGO4Y809LO (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072082)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="GGO4Y809LO" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072082" /> </coding> <text value="Excipient" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="GGO4Y809LO" /> <display value="Metacresol" /> </coding> </concept> </code> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb9561966749493" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb9561966749493" </p> </div> <p> <b>identifier</b>: id: 86Q357L16B (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072082)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="86Q357L16B" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072082" /> </coding> <text value="Excipient" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="86Q357L16B" /> <display value="Zinc chloride" /> </coding> </concept> </code> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb1268193754623" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb1268193754623" </p> </div> <p> <b>identifier</b>: id: QTT17582CB (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072082)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="QTT17582CB" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072082" /> </coding> <text value="Excipient" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="QTT17582CB" /> <display value="Concentrated hydrochloric acid" /> </coding> </concept> </code> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb3286639616821" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb3286639616821" </p> </div> <p> <b>identifier</b>: id: 55X04QC32I (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072082)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="55X04QC32I" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072082" /> </coding> <text value="Excipient" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="55X04QC32I" /> <display value="Sodium hydroxide" /> </coding> </concept> </code> </substance> </Ingredient> </resource> </entry> <entry> <resource> <Ingredient> <id value="cfsb7034777237464" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb7034777237464" </p> </div> <p> <b>identifier</b>: id: 059QF0KO0R (OFFICIAL) </p> <p> <b>status</b>: active </p> <p> <b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#/#100000072082)</span></p> <p> <b>allergenicIndicator</b>: false </p> <h3>Manufacturers</h3> <table class="grid"> <tr> <td>-</td> <td> <b>Manufacturer</b> </td> </tr> <tr> <td>*</td> <td> <a href="#Organization_cfsb2176224411725">See above (Organization/cfsb2176224411725)</a> </td> </tr> </table> <blockquote> <p> <b>substance</b> </p> </blockquote> </div> </text> <identifier> <use value="official" /> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <value value="059QF0KO0R" /> </identifier> <status value="active" /> <role> <coding> <system value="https://spor.ema.europa.eu/rmswi/" /> <code value="100000072082" /> </coding> <text value="Excipient" /> </role> <allergenicIndicator value="false" /> <manufacturer> <manufacturer> <reference value="Organization/cfsb2176224411725" /> </manufacturer> </manufacturer> <substance> <code> <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/" /> <code value="059QF0KO0R" /> <display value="Water for injections" /> </coding> </concept> </code> </substance> </Ingredient> </resource> </entry> <entry> <resource> <ClinicalUseDefinition> <id value="cfsb4325643431772" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb4325643431772" </p> </div> <p> <b>identifier</b>: id: Hypersensitivity reaction (OFFICIAL) </p> <p> <b>type</b>: contraindication </p> <p> <b>subject</b>: </p> <ul> <li> <a href="MedicinalProductDefinition-cfsb1151803027115.html">MedicinalProductDefinition/cfsb1151803027115</a> </li> <li> <a href="#MedicinalProductDefinition_cfsb7123030148537">See above (MedicinalProductDefinition/cfsb7123030148537)</a> </li> </ul> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/rmswi/#/" /> <value value="Hypersensitivity reaction" /> </identifier> <type value="contraindication" /> <subject> <reference value="MedicinalProductDefinition/cfsb1151803027115" /> </subject> <subject> <reference value="MedicinalProductDefinition/cfsb7123030148537" /> </subject> </ClinicalUseDefinition> </resource> </entry> <entry> <resource> <ClinicalUseDefinition> <id value="cfsb8699684597483" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p> <b>Generated Narrative</b> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"> <p style="margin-bottom: 0px">Resource "cfsb8699684597483" </p> </div> <p> <b>identifier</b>: id: Type 2 diabetes mellitus (OFFICIAL) </p> <p> <b>type</b>: indication </p> <p> <b>subject</b>: </p> <ul> <li> <a href="MedicinalProductDefinition-cfsb1151803027115.html">MedicinalProductDefinition/cfsb1151803027115</a> </li> <li> <a href="#MedicinalProductDefinition_cfsb7123030148537">See above (MedicinalProductDefinition/cfsb7123030148537)</a> </li> </ul> </div> </text> <identifier> <use value="official" /> <system value="https://spor.ema.europa.eu/rmswi/#/" /> <value value="Type 2 diabetes mellitus" /> </identifier> <type value="indication" /> <subject> <reference value="MedicinalProductDefinition/cfsb1151803027115" /> </subject> <subject> <reference value="MedicinalProductDefinition/cfsb7123030148537" /> </subject> </ClinicalUseDefinition> </resource> </entry> <entry> <resource> <DocumentReference> <id value="cfsb5671063821622" /> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <!-- Rik added xhtml --> <!-- Rik video is not allowed --> <!--video width="720" height="404" controls="controls"> <source src="https://www.felleskatalogen.no/medisin/film/suliqua-ferdigfylt-penn.mp4" type="video/mp4"/> </video--> </div> </text> <status value="current" /> <description value="Instruksjonsfilm for bruk av ferdigfylt penn." /> <content> <attachment> <contentType value="video/mp4" /> <language value="no" /> <url value="https://www.felleskatalogen.no/medisin/film/suliqua-ferdigfylt-penn.mp4" /> <title value="Suliqua ferdigfylt penn" /> <creation value="2018-09-28" /> <height value="404" /> <width value="720" /> <duration value="366" /> </attachment> </content> </DocumentReference> </resource> </entry> </Bundle>