UnicomIG, published by UNICOM. This is not an authorized publication; it is the continuous build for version 0.1.0). This version is based on the current content of https://github.com/hl7-eu/unicom-ig and changes regularly. See the Directory of published versions
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<id value="Clexane-60mg-06ml-solinj-EE-MPD"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="Clexane-60mg-06ml-solinj-EE-MPD"> </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">Resource MedicinalProductDefinition "Clexane-60mg-06ml-solinj-EE-MPD" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLMedicinalProductDefinition.html">PPL Medicinal Product profile</a></p></div><p><b>identifier</b>: id: EE-100001368-34217</p><p><b>domain</b>: Human use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-domain-ema-cs.html">Domain EMA</a>#100000000012)</span></p><p><b>status</b>: Current <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-recordStatus-ema-cs.html">Record Status EMA SPOR</a>#200000005004)</span></p><p><b>combinedPharmaceuticalDoseForm</b>: Solution for injection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-dose-form-ema-cs.html">Pharmaceutical Dose Form EMA</a>#100000073863)</span></p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-legal-status-for-the-supply-ema-cs.html">Legal Status for the Supply EMA</a>#100000072084)</span></p><p><b>classification</b>: Enoxaparin <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-ATC-Human-EMA.html">ATC Human EMA</a>#100000094266)</span>, Enoxaparin <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-WC.html">WHO ATC</a>#B01AB05)</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>namePart</b></p><p><b>part</b>: Clexane</p><p><b>type</b>: Invented name part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000002)</span></p></blockquote><blockquote><p><b>namePart</b></p><p><b>part</b>: 6000 RÜ</p><p><b>type</b>: Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000004)</span></p></blockquote><blockquote><p><b>namePart</b></p><p><b>part</b>: süstelahus süstlis</p><p><b>type</b>: Pharmaceutical dose form part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000005)</span></p></blockquote><h3>CountryLanguages</h3><table class="grid"><tr><td>-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td>*</td><td>Republic of Estonia <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-country-ema-cs.html">Country EMA</a>#100000000388)</span></td><td>Estonian <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-language-ema-cs.html">Language EMA</a>#100000072172)</span></td></tr></table></blockquote></div>
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<coding>
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<code value="100000073863"/>
<display value="Solution for injection"/>
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<display value="Enoxaparin"/>
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<display value="Enoxaparin"/>
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<url
value="MedicinalProductDefinition/Clexane-60mg-06ml-solinj-EE-MPD"/>
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<id value="Clexane-60mg-06ml-solinj-EE-RA"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: RegulatedAuthorization</b><a name="Clexane-60mg-06ml-solinj-EE-RA"> </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">Resource RegulatedAuthorization "Clexane-60mg-06ml-solinj-EE-RA" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLRegulatedAuthorization.html">PPL Marketing Authorisation profile</a></p></div><p><b>identifier</b>: id: 940517</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-EE-MPD">See above (MedicinalProductDefinition/Clexane-60mg-06ml-solinj-EE-MPD)</a></p><p><b>type</b>: Marketing Authorisation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000060#220000000061)</span></p><p><b>region</b>: Republic of Estonia <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-country-ema-cs.html">Country EMA</a>#100000000388)</span></p><p><b>status</b>: Valid - Renewed/Varied <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-regulatoryStatus-ema-cs.html">Regulatory Entitlement Status EMA SPOR</a>#200000017708)</span></p><p><b>statusDate</b>: 2022-06-28</p><p><b>holder</b>: <a href="#Organization_LOC-100001368-Sanofi-Aventis">See above (Organization/LOC-100001368-Sanofi-Aventis)</a></p></div>
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<code value="100000000388"/>
<display value="Republic of Estonia"/>
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<statusDate value="2022-06-28"/>
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<reference value="Organization/LOC-100001368-Sanofi-Aventis"/>
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<url value="RegulatedAuthorization/Clexane-60mg-06ml-solinj-EE-RA"/>
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<id value="LOC-100001368-Sanofi-Aventis"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
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<text>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="LOC-100001368-Sanofi-Aventis"> </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">Resource Organization "LOC-100001368-Sanofi-Aventis" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLOrganization.html">PPL Organization</a></p></div><p><b>identifier</b>: id: LOC-100001368</p><p><b>name</b>: Sanofi-Aventis Groupe</p></div>
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<identifier>
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<value value="LOC-100001368"/>
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<name value="Sanofi-Aventis Groupe"/>
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<request>
<method value="PUT"/>
<url value="Organization/LOC-100001368-Sanofi-Aventis"/>
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</entry>
<entry>
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value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition/Clexane-60mg-06ml-solinj-EE-APD"/>
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<AdministrableProductDefinition>
<id value="Clexane-60mg-06ml-solinj-EE-APD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdministrableProductDefinition</b><a name="Clexane-60mg-06ml-solinj-EE-APD"> </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">Resource AdministrableProductDefinition "Clexane-60mg-06ml-solinj-EE-APD" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLAdministrableProductDefinition.html">PPL Administrable Product profile</a></p></div><p><b>status</b>: active</p><p><b>formOf</b>: <a href="#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-EE-MPD">See above (MedicinalProductDefinition/Clexane-60mg-06ml-solinj-EE-MPD)</a></p><p><b>administrableDoseForm</b>: Solution for injection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-dose-form-ema-cs.html">Pharmaceutical Dose Form EMA</a>#100000073863)</span></p><p><b>unitOfPresentation</b>: Syringe <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-unit-of-presentation-ema-cs.html">Unit of Presentation EMA</a>#200000002150)</span></p><p><b>producedFrom</b>: <a href="#ManufacturedItemDefinition_Clexane-60mg-06ml-solinj-EE-MID">See above (ManufacturedItemDefinition/Clexane-60mg-06ml-solinj-EE-MID)</a></p><h3>RouteOfAdministrations</h3><table class="grid"><tr><td>-</td><td><b>Code</b></td></tr><tr><td>*</td><td>Subcutaneous use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-routes-and-methods-of-administration-ema-cs.html">Routes and Methods of Administration EMA</a>#100000073633)</span></td></tr></table></div>
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<status value="active"/>
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<reference
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<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
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<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002150"/>
<display value="Syringe"/>
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<producedFrom>
<reference
value="ManufacturedItemDefinition/Clexane-60mg-06ml-solinj-EE-MID"/>
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<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073633"/>
<display value="Subcutaneous use"/>
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<method value="PUT"/>
<url
value="AdministrableProductDefinition/Clexane-60mg-06ml-solinj-EE-APD"/>
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<id value="Clexane-60mg-06ml-solinj-EE-MID"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name="Clexane-60mg-06ml-solinj-EE-MID"> </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">Resource ManufacturedItemDefinition "Clexane-60mg-06ml-solinj-EE-MID" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLManufacturedItemDefinition.html">PPL Manufactured Item profile</a></p></div><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Solution for injection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-dose-form-ema-cs.html">Pharmaceutical Dose Form EMA</a>#100000073863)</span></p><p><b>unitOfPresentation</b>: Syringe <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-unit-of-presentation-ema-cs.html">Unit of Presentation EMA</a>#200000002150)</span></p></div>
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<status value="active"/>
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<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
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<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002150"/>
<display value="Syringe"/>
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<method value="PUT"/>
<url
value="ManufacturedItemDefinition/Clexane-60mg-06ml-solinj-EE-MID"/>
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<entry>
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value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/Clexane-60mg-06ml-solinj-EE-I"/>
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<Ingredient>
<id value="Clexane-60mg-06ml-solinj-EE-I"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="Clexane-60mg-06ml-solinj-EE-I"> </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">Resource Ingredient "Clexane-60mg-06ml-solinj-EE-I" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLIngredient.html">PPL Ingredient profile</a></p></div><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-EE-MPD">See above (MedicinalProductDefinition/Clexane-60mg-06ml-solinj-EE-MPD)</a></li><li><a href="#ManufacturedItemDefinition_Clexane-60mg-06ml-solinj-EE-MID">See above (ManufacturedItemDefinition/Clexane-60mg-06ml-solinj-EE-MID)</a></li><li><a href="#AdministrableProductDefinition_Clexane-60mg-06ml-solinj-EE-APD">See above (AdministrableProductDefinition/Clexane-60mg-06ml-solinj-EE-APD)</a></li></ul><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (100000072050#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td>-</td><td><b>Concept</b></td></tr><tr><td>*</td><td>Enoxaparin sodium <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-substance-sms-cs.html">Substances EMA SPOR SMS</a>#100000090152)</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td>-</td><td><b>Concentration[x]</b></td></tr><tr><td>*</td><td>60 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110655 = 'milligram(s)')</span>/0.6 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/100000110633 code 100000110662 = 'millilitre(s)')</span></td></tr></table></blockquote></div>
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<status value="active"/>
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<for>
<reference
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<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
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<coding>
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<display value="Enoxaparin sodium"/>
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<unit value="milligram(s)"/>
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<unit value="millilitre(s)"/>
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<code value="100000110662"/>
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<request>
<method value="PUT"/>
<url value="Ingredient/Clexane-60mg-06ml-solinj-EE-I"/>
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<entry>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b><a name="Clexane-60mg-06ml-solinj-EE-PPD-1065552"> </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">Resource PackagedProductDefinition "Clexane-60mg-06ml-solinj-EE-PPD-1065552" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PPLPackagedProductDefinition.html">PPL Packaged Product profile</a></p></div><p><b>identifier</b>: id: EE-100001368-34217-1065552</p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_Clexane-60mg-06ml-solinj-EE-MPD">See above (MedicinalProductDefinition/Clexane-60mg-06ml-solinj-EE-MPD)</a></p><p><b>containedItemQuantity</b>: 2 Syringe<span style="background: LightGoldenRodYellow"> (Details: https://spor.ema.europa.eu/v1/lists/200000000014 code 200000002150 = 'Syringe')</span></p><p><b>description</b>: 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><h3>MarketingStatuses</h3><table class="grid"><tr><td>-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td>*</td><td>Republic of Estonia <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-country-ema-cs.html">Country EMA</a>#100000000388)</span></td><td>Marketed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-Marketing-Status-ema-cs.html">Marketing Status EMA</a>#100000072083)</span></td></tr></table><blockquote><p><b>package</b></p><p><b>type</b>: Box <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-packaging-ema-cs.html">Packaging EMA SPOR</a>#100000073498)</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: Cardboard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-material-ema-cs.html">Material EMA</a>#200000003529)</span></p><blockquote><p><b>package</b></p><p><b>type</b>: Pre-filled syringe <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-packaging-ema-cs.html">Packaging EMA SPOR</a>#100000073544)</span></p><p><b>quantity</b>: 2</p><p><b>material</b>: Glass type I <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-material-ema-cs.html">Material EMA</a>#200000003204)</span></p></blockquote></blockquote></div>
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<containedItemQuantity>
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<unit value="Syringe"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002150"/>
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<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). "/>
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<country>
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<code value="100000000388"/>
<display value="Republic of Estonia"/>
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<system
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<code value="100000072083"/>
<display value="Marketed"/>
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<package>
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<system
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<code value="100000073498"/>
<display value="Box"/>
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<quantity value="1"/>
<material>
<coding>
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<code value="200000003529"/>
<display value="Cardboard"/>
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<code value="100000073544"/>
<display value="Pre-filled syringe"/>
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<quantity value="2"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003204"/>
<display value="Glass type I"/>
</coding>
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<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/Clexane-60mg-06ml-solinj-EE-MID"/>
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<amount>
<value value="0.6"/>
<unit value="millilitre(s)"/>
<system
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<code value="100000110662"/>
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<request>
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<url
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IG © 2022+ UNICOM. Package hl7.eu.fhir.unicom#0.1.0 based on FHIR 4.3.0. Generated 2023-02-03
research and innovation programme under grant agreement No. 875299.