UFIS-SWE-IG
0.1.0 - ci-build
UFIS-SWE-IG, 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/joofio/ufis-swe-ig/ and changes regularly. See the Directory of published versions
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<id value="Sporanox-10mgml-Solution-SE-IS-MPD-BBDL"/>
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value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/MedicinalProductDefinition/Sporanox-10mgml-Solution-SE-IS-MPD"/>
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<MedicinalProductDefinition>
<id value="Sporanox-10mgml-Solution-SE-IS-MPD"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Sporanox-10mgml-Solution-SE-IS-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Sporanox-10mgml-Solution-SE-IS-MPD</b></p><a name="Sporanox-10mgml-Solution-SE-IS-MPD"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-MPD"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100003163-00013358, <code>http://ema.europa.eu/fhir/eurdId</code>/1798</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 100000073646}">Oral solution</span></p><p><b>indication</b>: </p><div><p>Sporanox oral lösning är indicerad: - för behandling av oral och/eller esofageal candidiasis hos HIV-positiva patienter eller andra patienter med nedsatt immunförsvar. - som profylax, mot djupa svampinfektioner som förutses vara itrakonazolkänsliga, hos patienter med hematologisk malignitet eller som genomgår benmärgstransplantation och som förväntas bli neutropena (dvs. <0,5 x 109 /l) när standardterapi anses olämplig. För närvarande är data över klinisk effekt vid aspergillosprofylax otillräckliga. Hänsyn ska tas till nationella och/eller lokala behandlingsrekommendationer för antimykotika.</p>
</div><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/100000116677 100000093533}">J02AC02</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Sporanox 10 mg/ml Oral lösning</p><blockquote><p><b>part</b></p><p><b>part</b>: Sporanox</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 10 mg/ml</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Oral lösning</p><p><b>type</b>: <span title="Codes:{http://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 100000000535}">Kingdom of Sweden</span></td><td><span title="Codes:{urn:ietf:bcp:47 sv}">Swedish</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/200000000004"/>
<code value="100000073646"/>
<display value="Oral solution"/>
</coding>
</combinedPharmaceuticalDoseForm>
<indication
value="Sporanox oral lösning är indicerad: - för behandling av oral och/eller esofageal candidiasis hos HIV-positiva patienter eller andra patienter med nedsatt immunförsvar. - som profylax, mot djupa svampinfektioner som förutses vara itrakonazolkänsliga, hos patienter med hematologisk malignitet eller som genomgår benmärgstransplantation och som förväntas bli neutropena (dvs. <0,5 x 109 /l) när standardterapi anses olämplig. För närvarande är data över klinisk effekt vid aspergillosprofylax otillräckliga. Hänsyn ska tas till nationella och/eller lokala behandlingsrekommendationer för antimykotika."/>
<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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<classification>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000116677"/>
<code value="100000093533"/>
<display value="J02AC02"/>
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<name>
<productName value="Sporanox 10 mg/ml Oral lösning"/>
<part>
<part value="Sporanox"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
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<part>
<part value="10 mg/ml"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
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<part>
<part value="Oral lösning"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
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<usage>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="sv"/>
<display value="Swedish"/>
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</language>
</usage>
</name>
</MedicinalProductDefinition>
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<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/RegulatedAuthorization/Sporanox-10mgml-Solution-SE-IS-RA"/>
<resource>
<RegulatedAuthorization>
<id value="Sporanox-10mgml-Solution-SE-IS-RA"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"/>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_Sporanox-10mgml-Solution-SE-IS-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization Sporanox-10mgml-Solution-SE-IS-RA</b></p><a name="Sporanox-10mgml-Solution-SE-IS-RA"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-RA"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-RA-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/13358</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Sporanox-10mgml-Solution-SE-IS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100003163-00013358,http://ema.europa.eu/fhir/eurdId#1798; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Oral solution; indication = Sporanox oral lösning är indicerad: - för behandling av oral och/eller esofageal candidiasis hos HIV-positiva patienter eller andra patienter med nedsatt immunförsvar. - som profylax, mot djupa svampinfektioner som förutses vara itrakonazolkänsliga, hos patienter med hematologisk malignitet eller som genomgår benmärgstransplantation och som förväntas bli neutropena (dvs. <0,5 x 109 /l) när standardterapi anses olämplig. För närvarande är data över klinisk effekt vid aspergillosprofylax otillräckliga. Hänsyn ska tas till nationella och/eller lokala behandlingsrekommendationer för antimykotika.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = J02AC02</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 100000000535}">Kingdom of Sweden</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 100000072099}">Valid</span></p><p><b>statusDate</b>: 1997-09-10</p><p><b>holder</b>: <a href="Organization-LOC-100061163.html">Organization Janssen-Cilag AB</a></p><h3>Cases</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://ema.europa.eu/fhir/authorisationDateType dateOfFirstAuthorisation}">First Authorisation</span></td><td>1997-09-10</td></tr></table></div>
</text>
<identifier>
<system
value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
<value value="13358"/>
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<subject>🔗
<reference
value="MedicinalProductDefinition/Sporanox-10mgml-Solution-SE-IS-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="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</region>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="100000072099"/>
<display value="Valid"/>
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<statusDate value="1997-09-10"/>
<holder>🔗
<reference value="Organization/LOC-100061163"/>
</holder>
<case>
<type>
<coding>
<system
value="https://ema.europa.eu/fhir/authorisationDateType"/>
<code value="dateOfFirstAuthorisation"/>
<display value="First Authorisation"/>
</coding>
</type>
<dateDateTime value="1997-09-10"/>
</case>
</RegulatedAuthorization>
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</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition/Sporanox-10mgml-Solution-SE-IS-PPD"/>
<resource>
<PackagedProductDefinition>
<id value="Sporanox-10mgml-Solution-SE-IS-PPD"/>
<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_Sporanox-10mgml-Solution-SE-IS-PPD"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition Sporanox-10mgml-Solution-SE-IS-PPD</b></p><a name="Sporanox-10mgml-Solution-SE-IS-PPD"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-PPD"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-PPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/?ngen-9?</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-Sporanox-10mgml-Solution-SE-IS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100003163-00013358,http://ema.europa.eu/fhir/eurdId#1798; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Oral solution; indication = Sporanox oral lösning är indicerad: - för behandling av oral och/eller esofageal candidiasis hos HIV-positiva patienter eller andra patienter med nedsatt immunförsvar. - som profylax, mot djupa svampinfektioner som förutses vara itrakonazolkänsliga, hos patienter med hematologisk malignitet eller som genomgår benmärgstransplantation och som förväntas bli neutropena (dvs. <0,5 x 109 /l) när standardterapi anses olämplig. För närvarande är data över klinisk effekt vid aspergillosprofylax otillräckliga. Hänsyn ska tas till nationella och/eller lokala behandlingsrekommendationer för antimykotika.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = J02AC02</a></p><p><b>containedItemQuantity</b>: 1 Bottle<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002111 = '200000002111')</span></p><p><b>description</b>: </p><div><p>Flaska, 1 x 150 ml</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 100000000535}">Kingdom of Sweden</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"/>
</identifier>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/Sporanox-10mgml-Solution-SE-IS-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="1"/>
<unit value="Bottle"/>
<system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002111"/>
</containedItemQuantity>
<description value="Flaska, 1 x 150 ml"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
</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="100000073497"/>
<display value="Bottle"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003203"/>
<display value="Glass"/>
</coding>
</material>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003219"/>
<display value="PolyPropylene"/>
</coding>
</material>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/Sporanox-10mgml-Solution-SE-IS-MID"/>
</reference>
</item>
<amount>
<value value="150"/>
<unit value="millilitre(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/ManufacturedItemDefinition/Sporanox-10mgml-Solution-SE-IS-MID"/>
<resource>
<ManufacturedItemDefinition>
<id value="Sporanox-10mgml-Solution-SE-IS-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_Sporanox-10mgml-Solution-SE-IS-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition Sporanox-10mgml-Solution-SE-IS-MID</b></p><a name="Sporanox-10mgml-Solution-SE-IS-MID"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-MID"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-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 100000073646}">Oral solution</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002111}">Bottle</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073646"/>
<display value="Oral solution"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002111"/>
<display value="Bottle"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/Sporanox-10mgml-Solution-SE-IS-ING"/>
<resource>
<Ingredient>
<id value="Sporanox-10mgml-Solution-SE-IS-ING"/>
<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_Sporanox-10mgml-Solution-SE-IS-ING"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Sporanox-10mgml-Solution-SE-IS-ING</b></p><a name="Sporanox-10mgml-Solution-SE-IS-ING"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-ING"> </a><a name="hcSporanox-10mgml-Solution-SE-IS-ING-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-Sporanox-10mgml-Solution-SE-IS-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100003163-00013358,http://ema.europa.eu/fhir/eurdId#1798; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Oral solution; indication = Sporanox oral lösning är indicerad: - för behandling av oral och/eller esofageal candidiasis hos HIV-positiva patienter eller andra patienter med nedsatt immunförsvar. - som profylax, mot djupa svampinfektioner som förutses vara itrakonazolkänsliga, hos patienter med hematologisk malignitet eller som genomgår benmärgstransplantation och som förväntas bli neutropena (dvs. <0,5 x 109 /l) när standardterapi anses olämplig. För närvarande är data över klinisk effekt vid aspergillosprofylax otillräckliga. Hänsyn ska tas till nationella och/eller lokala behandlingsrekommendationer för antimykotika.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = J02AC02</a></li><li><a href="ManufacturedItemDefinition-Sporanox-10mgml-Solution-SE-IS-MID.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Oral solution; unitOfPresentation = Bottle</a></li><li><a href="AdministrableProductDefinition-Sporanox-10mgml-Solution-SE-IS-APD.html">AdministrableProductDefinition: status = active; administrableDoseForm = Oral solution</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.azure-api.net/sms/api/v2/SubstanceDefinition 100000091697}">Itraconazole</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 10 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110662 = '100000110662')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</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.azure-api.net/sms/api/v2/SubstanceDefinition 100000091697}">Itraconazole</span></td></tr></table><p><b>strength</b>: 10 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110662 = '100000110662')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="MedicinalProductDefinition/Sporanox-10mgml-Solution-SE-IS-MPD"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/Sporanox-10mgml-Solution-SE-IS-MID"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/Sporanox-10mgml-Solution-SE-IS-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="Active"/>
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<substance>
<code>
<concept>
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<display value="Itraconazole"/>
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<code value="100000110655"/>
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<code value="100000073646"/>
<display value="Oral solution"/>
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<producedFrom>🔗
<reference
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<display value="Oral use"/>
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<meta>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_LOC-100061163"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100061163</b></p><a name="LOC-100061163"> </a><a name="hcLOC-100061163"> </a><a name="hcLOC-100061163-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100061163</p><p><b>name</b>: Janssen-Cilag AB</p></div>
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<name value="Janssen-Cilag AB"/>
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