UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. 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-eu/unicom-ig/tree/master and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
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<MedicinalProductDefinition>
<id value="LantusSolostar-EE-MPD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_LantusSolostar-EE-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition LantusSolostar-EE-MPD</b></p><a name="LantusSolostar-EE-MPD"> </a><a name="hcLantusSolostar-EE-MPD"> </a><a name="LantusSolostar-EE-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/EE-100000869-3157</p><p><b>domain</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human use</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000005003 200000005004}">Current</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000007 100000074039}">Solution for injection in pre-filled pen</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 100000072084}">Medicinal product subject to medical prescription</span></p><p><b>classification</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 100000094023}">insulin glargine</span>, <span title="Codes:{http://www.whocc.no/atc A10AE04}">insulin glargine</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis</p><blockquote><p><b>part</b></p><p><b>part</b>: Lantus Solostar</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 100 ühikut/ml</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: süstelahus pen-süstlis</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}">Republic of Estonia</span></td><td><span title="Codes:{urn:ietf:bcp:47 et}">Estonian</span></td></tr></table></blockquote></div>
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<system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human use"/>
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<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005004"/>
<display value="Current"/>
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<combinedPharmaceuticalDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000007"/>
<code value="100000074039"/>
<display value="Solution for injection in pre-filled pen"/>
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</combinedPharmaceuticalDoseForm>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
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</legalStatusOfSupply>
<classification>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
<code value="100000094023"/>
<display value="insulin glargine"/>
</coding>
</classification>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="A10AE04"/>
<display value="insulin glargine"/>
</coding>
</classification>
<name>
<productName
value="Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis"/>
<part>
<part value="Lantus Solostar"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
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</part>
<part>
<part value="100 ühikut/ml"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
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</type>
</part>
<part>
<part value="süstelahus pen-süstlis"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
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</part>
<usage>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
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</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="et"/>
<display value="Estonian"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
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</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/RegulatedAuthorization-LantusSolostar-EE-RA"/>
<resource>
<RegulatedAuthorization>
<id value="LantusSolostar-EE-RA"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_LantusSolostar-EE-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization LantusSolostar-EE-RA</b></p><a name="LantusSolostar-EE-RA"> </a><a name="hcLantusSolostar-EE-RA"> </a><a name="LantusSolostar-EE-RA-en-US"> </a><p><b>identifier</b>: EU/1/00/134</p><p><b>subject</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000390}">European Union</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 200000017708}">Valid - Renewed/Varied</span></p><p><b>statusDate</b>: 2022-06-28</p><p><b>holder</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#Organization_LOC-100000869-Sanofi-Aventis-Deutchland">Bundle: type = collection</a></p></div>
</text>
<identifier>
<value value="EU/1/00/134"/>
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<subject>
<reference
value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
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<type>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
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</type>
<region>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000390"/>
<display value="European Union"/>
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</region>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="200000017708"/>
<display value="Valid - Renewed/Varied"/>
</coding>
</status>
<statusDate value="2022-06-28"/>
<holder>
<reference
value="Organization/LOC-100000869-Sanofi-Aventis-Deutchland"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization-LOC-100000869-Sanofi-Aventis-Deutchland"/>
<resource>
<Organization>
<id value="LOC-100000869-Sanofi-Aventis-Deutchland"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_LOC-100000869-Sanofi-Aventis-Deutchland"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100000869-Sanofi-Aventis-Deutchland</b></p><a name="LOC-100000869-Sanofi-Aventis-Deutchland"> </a><a name="hcLOC-100000869-Sanofi-Aventis-Deutchland"> </a><a name="LOC-100000869-Sanofi-Aventis-Deutchland-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100000869, <code>https://spor.ema.europa.eu/v1/organisations</code>/ORG-100001175</p><p><b>name</b>: Sanofi-Aventis Deutschland GmbH</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100000869"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/organisations"/>
<value value="ORG-100001175"/>
</identifier>
<name value="Sanofi-Aventis Deutschland GmbH"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition-LantusSolostar-EE-APD"/>
<resource>
<AdministrableProductDefinition>
<id value="LantusSolostar-EE-APD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_LantusSolostar-EE-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition LantusSolostar-EE-APD</b></p><a name="LantusSolostar-EE-APD"> </a><a name="hcLantusSolostar-EE-APD"> </a><a name="LantusSolostar-EE-APD-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002135}">Pen</span></p><p><b>producedFrom</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#ManufacturedItemDefinition_LantusSolostar-EE-MID">Bundle: type = collection</a></p><h3>RouteOfAdministrations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073633}">Subcutaneous use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>
<reference
value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002135"/>
<display value="Pen"/>
</coding>
</unitOfPresentation>
<producedFrom>
<reference
value="ManufacturedItemDefinition/LantusSolostar-EE-MID"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073633"/>
<display value="Subcutaneous use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/ManufacturedItemDefinition-LantusSolostar-EE-MID"/>
<resource>
<ManufacturedItemDefinition>
<id value="LantusSolostar-EE-MID"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_LantusSolostar-EE-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition LantusSolostar-EE-MID</b></p><a name="LantusSolostar-EE-MID"> </a><a name="hcLantusSolostar-EE-MID"> </a><a name="LantusSolostar-EE-MID-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002135}">Pen</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002135"/>
<display value="Pen"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient-LantusSolostar-EE-I"/>
<resource>
<Ingredient>
<id value="LantusSolostar-EE-I"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_LantusSolostar-EE-I"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient LantusSolostar-EE-I</b></p><a name="LantusSolostar-EE-I"> </a><a name="hcLantusSolostar-EE-I"> </a><a name="LantusSolostar-EE-I-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></li><li><a href="Bundle-013-LantusSolostar-EE-FullProduct.html#ManufacturedItemDefinition_LantusSolostar-EE-MID">Bundle: type = collection</a></li><li><a href="Bundle-013-LantusSolostar-EE-FullProduct.html#AdministrableProductDefinition_LantusSolostar-EE-APD">Bundle: type = collection</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v2/SubstanceDefinition 100000085460}">Insulin glargine</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concentration[x]</b></td></tr><tr><td style="display: none">*</td><td>100 unit(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110756 = 'unit(s)')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110662 = 'millilitre(s)')</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>
<reference
value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/LantusSolostar-EE-MID"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/LantusSolostar-EE-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000085460"/>
<display value="Insulin glargine"/>
</coding>
</concept>
</code>
<strength>
<concentrationRatio>
<numerator>
<value value="100"/>
<unit value="unit(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110756"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="millilitre(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</denominator>
</concentrationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition-LantusSolostar-EE-PPD-1265778"/>
<resource>
<PackagedProductDefinition>
<id value="LantusSolostar-EE-PPD-1265778"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_LantusSolostar-EE-PPD-1265778"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition LantusSolostar-EE-PPD-1265778</b></p><a name="LantusSolostar-EE-PPD-1265778"> </a><a name="hcLantusSolostar-EE-PPD-1265778"> </a><a name="LantusSolostar-EE-PPD-1265778-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/EE-100000869-3157-1265778</p><p><b>packageFor</b>: <a href="Bundle-013-LantusSolostar-EE-FullProduct.html#MedicinalProductDefinition_LantusSolostar-EE-MPD">Bundle: type = collection</a></p><p><b>containedItemQuantity</b>: 5 Pen<span style="background: LightGoldenRodYellow"> (Details: Unit of Presentation EMA code200000002135 = 'Pen')</span></p><p><b>description</b>: </p><div><p>Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis. I tüüpi värvitust klaasist kolbampull musta värvi kolvi (broombutüülkumm), äärikkattega
(alumiinium) ja korgiga (broombutüülkumm või polüisopreenlaminaat ja broombutüülkumm);
sisaldab 3 ml süstelahust. Kolbampull on paigaldatud mittetäidetavasse pen-süstlisse. Nõelad ei sisaldu pakendis.
Pakendis on 5 pen-süstlit.</p>
</div><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}">Republic of Estonia</span></td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003529}">Cardboard</span></p><blockquote><p><b>packaging</b></p></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
<value value="EE-100000869-3157-1265778"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/LantusSolostar-EE-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="5"/>
<unit value="Pen"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002135"/>
</containedItemQuantity>
<description
value="Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis. I tüüpi värvitust klaasist kolbampull musta värvi kolvi (broombutüülkumm), äärikkattega
(alumiinium) ja korgiga (broombutüülkumm või polüisopreenlaminaat ja broombutüülkumm);
sisaldab 3 ml süstelahust. Kolbampull on paigaldatud mittetäidetavasse pen-süstlisse. Nõelad ei sisaldu pakendis.
Pakendis on 5 pen-süstlit."/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072083"/>
<display value="Marketed"/>
</coding>
</status>
</marketingStatus>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073543"/>
<display value="Pre-filled pen"/>
</coding>
</type>
<quantity value="5"/>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/LantusSolostar-EE-MID"/>
</reference>
</item>
<amount>
<value value="3"/>
<unit value="millilitre(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
</Bundle>