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">
<id value="010-Clexane-60mg-06ml-EE-FullProduct"/>
<type value="collection"/>
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<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/MedicinalProductDefinition-Clexane-60mg-06ml-solinj-EE-MPD"/>
<resource>
<MedicinalProductDefinition>
<id value="Clexane-60mg-06ml-solinj-EE-MPD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Clexane-60mg-06ml-solinj-EE-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Clexane-60mg-06ml-solinj-EE-MPD</b></p><a name="Clexane-60mg-06ml-solinj-EE-MPD"> </a><a name="hcClexane-60mg-06ml-solinj-EE-MPD"> </a><a name="Clexane-60mg-06ml-solinj-EE-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/EE-100001368-34217</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/200000000004 100000073863}">Solution for injection</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 100000094266}">Enoxaparin</span>, <span title="Codes:{http://www.whocc.no/atc B01AB05}">Enoxaparin</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Clexane, 6000 RÜ (60 mg)/0,6 ml süstelahus süstlis</p><blockquote><p><b>part</b></p><p><b>part</b>: Clexane</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>: 6000 RÜ</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 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="http://ema.europa.eu/fhir/mpId"/>
<value value="EE-100001368-34217"/>
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<domain>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005004"/>
<display value="Current"/>
</coding>
</status>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</combinedPharmaceuticalDoseForm>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<classification>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
<code value="100000094266"/>
<display value="Enoxaparin"/>
</coding>
</classification>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="B01AB05"/>
<display value="Enoxaparin"/>
</coding>
</classification>
<name>
<productName
value="Clexane, 6000 RÜ (60 mg)/0,6 ml süstelahus süstlis"/>
<part>
<part value="Clexane"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="6000 RÜ"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="süstelahus süstlis"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="et"/>
<display value="Estonian"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/RegulatedAuthorization-Clexane-60mg-06ml-solinj-EE-RA"/>
<resource>
<RegulatedAuthorization>
<id value="Clexane-60mg-06ml-solinj-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_Clexane-60mg-06ml-solinj-EE-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization Clexane-60mg-06ml-solinj-EE-RA</b></p><a name="Clexane-60mg-06ml-solinj-EE-RA"> </a><a name="hcClexane-60mg-06ml-solinj-EE-RA"> </a><a name="Clexane-60mg-06ml-solinj-EE-RA-en-US"> </a><p><b>identifier</b>: 940517</p><p><b>subject</b>: <a href="Bundle-010-Clexane-60mg-06ml-EE-FullProduct.html#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-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 100000000388}">Republic of Estonia</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-010-Clexane-60mg-06ml-EE-FullProduct.html#Organization_LOC-100001368-Sanofi-Aventis">Bundle: type = collection</a></p></div>
</text>
<identifier>
<value value="940517"/>
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<subject>
<reference
value="MedicinalProductDefinition/Clexane-60mg-06ml-solinj-EE-MPD"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</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-100001368-Sanofi-Aventis"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization-LOC-100001368-Sanofi-Aventis"/>
<resource>
<Organization>
<id value="LOC-100001368-Sanofi-Aventis"/>
<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-100001368-Sanofi-Aventis"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100001368-Sanofi-Aventis</b></p><a name="LOC-100001368-Sanofi-Aventis"> </a><a name="hcLOC-100001368-Sanofi-Aventis"> </a><a name="LOC-100001368-Sanofi-Aventis-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100001368</p><p><b>name</b>: Sanofi-Aventis Groupe</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100001368"/>
</identifier>
<name value="Sanofi-Aventis Groupe"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition-Clexane-60mg-06ml-solinj-EE-APD"/>
<resource>
<AdministrableProductDefinition>
<id value="Clexane-60mg-06ml-solinj-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_Clexane-60mg-06ml-solinj-EE-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition Clexane-60mg-06ml-solinj-EE-APD</b></p><a name="Clexane-60mg-06ml-solinj-EE-APD"> </a><a name="hcClexane-60mg-06ml-solinj-EE-APD"> </a><a name="Clexane-60mg-06ml-solinj-EE-APD-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-010-Clexane-60mg-06ml-EE-FullProduct.html#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-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 200000002150}">Syringe</span></p><p><b>producedFrom</b>: <a href="Bundle-010-Clexane-60mg-06ml-EE-FullProduct.html#ManufacturedItemDefinition_Clexane-60mg-06ml-solinj-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/Clexane-60mg-06ml-solinj-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="200000002150"/>
<display value="Syringe"/>
</coding>
</unitOfPresentation>
<producedFrom>
<reference
value="ManufacturedItemDefinition/Clexane-60mg-06ml-solinj-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-Clexane-60mg-06ml-solinj-EE-MID"/>
<resource>
<ManufacturedItemDefinition>
<id value="Clexane-60mg-06ml-solinj-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_Clexane-60mg-06ml-solinj-EE-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition Clexane-60mg-06ml-solinj-EE-MID</b></p><a name="Clexane-60mg-06ml-solinj-EE-MID"> </a><a name="hcClexane-60mg-06ml-solinj-EE-MID"> </a><a name="Clexane-60mg-06ml-solinj-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 200000002150}">Syringe</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="200000002150"/>
<display value="Syringe"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient-Clexane-60mg-06ml-solinj-EE-I"/>
<resource>
<Ingredient>
<id value="Clexane-60mg-06ml-solinj-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_Clexane-60mg-06ml-solinj-EE-I"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Clexane-60mg-06ml-solinj-EE-I</b></p><a name="Clexane-60mg-06ml-solinj-EE-I"> </a><a name="hcClexane-60mg-06ml-solinj-EE-I"> </a><a name="Clexane-60mg-06ml-solinj-EE-I-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-010-Clexane-60mg-06ml-EE-FullProduct.html#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-EE-MPD">Bundle: type = collection</a></li><li><a href="Bundle-010-Clexane-60mg-06ml-EE-FullProduct.html#ManufacturedItemDefinition_Clexane-60mg-06ml-solinj-EE-MID">Bundle: type = collection</a></li><li><a href="Bundle-010-Clexane-60mg-06ml-EE-FullProduct.html#AdministrableProductDefinition_Clexane-60mg-06ml-solinj-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 100000090152}">Enoxaparin sodium</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>60 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110655 = 'milligram(s)')</span>/0.6 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/Clexane-60mg-06ml-solinj-EE-MPD"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/Clexane-60mg-06ml-solinj-EE-MID"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/Clexane-60mg-06ml-solinj-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="100000090152"/>
<display value="Enoxaparin sodium"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="60"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="0.6"/>
<unit value="millilitre(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</denominator>
</presentationRatio>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition-Clexane-60mg-06ml-solinj-EE-PPD-1065552"/>
<resource>
<PackagedProductDefinition>
<id value="Clexane-60mg-06ml-solinj-EE-PPD-1065552"/>
<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_Clexane-60mg-06ml-solinj-EE-PPD-1065552"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition Clexane-60mg-06ml-solinj-EE-PPD-1065552</b></p><a name="Clexane-60mg-06ml-solinj-EE-PPD-1065552"> </a><a name="hcClexane-60mg-06ml-solinj-EE-PPD-1065552"> </a><a name="Clexane-60mg-06ml-solinj-EE-PPD-1065552-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/EE-100001368-34217-1065552</p><p><b>packageFor</b>: <a href="Bundle-010-Clexane-60mg-06ml-EE-FullProduct.html#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-EE-MPD">Bundle: type = collection</a></p><p><b>containedItemQuantity</b>: 2 Syringe<span style="background: LightGoldenRodYellow"> (Details: Unit of Presentation EMA code200000002150 = 'Syringe')</span></p><p><b>description</b>: </p><div><p>CLEXANE 6000 RÜ (60 mg)/0,6 ml: süstelahus süstlites (I tüüpi klaas), mis on varustatud kummikorgiga (klorobutüül ja bromobutüül) ning süstimisnõelaga (automaatse ohutussüsteemiga ERIS või PREVENTIS või ilma).</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-100001368-34217-1065552"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/Clexane-60mg-06ml-solinj-EE-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="2"/>
<unit value="Syringe"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002150"/>
</containedItemQuantity>
<description
value="CLEXANE 6000 RÜ (60 mg)/0,6 ml: süstelahus süstlites (I tüüpi klaas), mis on varustatud kummikorgiga (klorobutüül ja bromobutüül) ning süstimisnõelaga (automaatse ohutussüsteemiga ERIS või PREVENTIS või ilma). "/>
<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>
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