UFIS-SWE-IG
0.1.0 - ci-build
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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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_Instillagel-209-Gel-SE-AJ-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Instillagel-209-Gel-SE-AJ-MPD</b></p><a name="Instillagel-209-Gel-SE-AJ-MPD"> </a><a name="hcInstillagel-209-Gel-SE-AJ-MPD"> </a><a name="hcInstillagel-209-Gel-SE-AJ-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100003544-00010132, <code>http://ema.europa.eu/fhir/eurdId</code>/10933</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 100000073726}">Gel</span></p><p><b>indication</b>: </p><div><p>Kateterisering, sondering och andra endouretrala ingrepp på män. Vissa typer av cystoskopering. Alla uretrala ingrepp och manipulationer på kvinnor. Lokalbehandling av smärtsamma cystiter. Instillagel är avsett för vuxna och barn från och med 2 års ålder (se avsnitt 4.2 och 4.3).</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/100000093533 100000097196}">lidocaine</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Instillagel 20,9 mg/ml Gel</p><blockquote><p><b>part</b></p><p><b>part</b>: Instillagel</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>: 20,9 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>: Gel</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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<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_Instillagel-209-Gel-SE-AJ-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization Instillagel-209-Gel-SE-AJ-RA</b></p><a name="Instillagel-209-Gel-SE-AJ-RA"> </a><a name="hcInstillagel-209-Gel-SE-AJ-RA"> </a><a name="hcInstillagel-209-Gel-SE-AJ-RA-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/10132</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Instillagel-209-Gel-SE-AJ-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100003544-00010132,http://ema.europa.eu/fhir/eurdId#10933; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Gel; indication = Kateterisering, sondering och andra endouretrala ingrepp på män. Vissa typer av cystoskopering. Alla uretrala ingrepp och manipulationer på kvinnor. Lokalbehandling av smärtsamma cystiter. Instillagel är avsett för vuxna och barn från och med 2 års ålder (se avsnitt 4.2 och 4.3).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = lidocaine</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>: 1984-11-01</p><p><b>holder</b>: <a href="Organization-LOC-100009206.html">Organization Farco-Pharma GmbH</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>1984-11-01</td></tr></table></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_Instillagel-209-Gel-SE-AJ-PPD"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition Instillagel-209-Gel-SE-AJ-PPD</b></p><a name="Instillagel-209-Gel-SE-AJ-PPD"> </a><a name="hcInstillagel-209-Gel-SE-AJ-PPD"> </a><a name="hcInstillagel-209-Gel-SE-AJ-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-Instillagel-209-Gel-SE-AJ-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100003544-00010132,http://ema.europa.eu/fhir/eurdId#10933; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Gel; indication = Kateterisering, sondering och andra endouretrala ingrepp på män. Vissa typer av cystoskopering. Alla uretrala ingrepp och manipulationer på kvinnor. Lokalbehandling av smärtsamma cystiter. Instillagel är avsett för vuxna och barn från och med 2 års ålder (se avsnitt 4.2 och 4.3).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = lidocaine</a></p><p><b>containedItemQuantity</b>: 10 Syringe<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002150 = '200000002150')</span></p><p><b>description</b>: </p><div><p>Engångsspruta, 10 x 11 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>
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<unit value="Syringe"/>
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<code value="200000002150"/>
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<description value="Engångsspruta, 10 x 11 ml"/>
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<packaging>
<type>
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<system
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<display value="Unit-dose blister"/>
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<quantity value="10"/>
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<code value="200000003207"/>
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<material>
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<code value="200000003219"/>
<display value="PolyPropylene"/>
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<type>
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<system
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<display value="Pre-filled syringe"/>
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<quantity value="1"/>
<material>
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<code value="200000003219"/>
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<item>
<reference>🔗
<reference
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_Instillagel-209-Gel-SE-AJ-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition Instillagel-209-Gel-SE-AJ-MID</b></p><a name="Instillagel-209-Gel-SE-AJ-MID"> </a><a name="hcInstillagel-209-Gel-SE-AJ-MID"> </a><a name="hcInstillagel-209-Gel-SE-AJ-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 100000073726}">Gel</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002150}">Syringe</span></p></div>
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<unitOfPresentation>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_Instillagel-209-Gel-SE-AJ-ING"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Instillagel-209-Gel-SE-AJ-ING</b></p><a name="Instillagel-209-Gel-SE-AJ-ING"> </a><a name="hcInstillagel-209-Gel-SE-AJ-ING"> </a><a name="hcInstillagel-209-Gel-SE-AJ-ING-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-Instillagel-209-Gel-SE-AJ-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100003544-00010132,http://ema.europa.eu/fhir/eurdId#10933; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Gel; indication = Kateterisering, sondering och andra endouretrala ingrepp på män. Vissa typer av cystoskopering. Alla uretrala ingrepp och manipulationer på kvinnor. Lokalbehandling av smärtsamma cystiter. Instillagel är avsett för vuxna och barn från och med 2 års ålder (se avsnitt 4.2 och 4.3).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = lidocaine</a></li><li><a href="ManufacturedItemDefinition-Instillagel-209-Gel-SE-AJ-MID.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Gel; unitOfPresentation = Syringe</a></li><li><a href="AdministrableProductDefinition-Instillagel-209-Gel-SE-AJ-APD.html">AdministrableProductDefinition: status = active; administrableDoseForm = Gel</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 100000090563}">Lidocaine hydrochloride monohydrate</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 22.9 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 100000139489}">Lidocaine hydrochloride</span></td></tr></table><p><b>strength</b>: 20.9 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110655 = 'milligram(s)')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110662 = 'millilitre(s)')</span></p></blockquote><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 100000091713}">Lidocaine</span></td></tr></table><p><b>strength</b>: 18.09 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110655 = 'milligram(s)')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110662 = 'millilitre(s)')</span></p></blockquote></blockquote></blockquote></div>
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<denominator>
<value value="1"/>
<unit value="millilitre(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</denominator>
</concentrationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000139489"/>
<display value="Lidocaine hydrochloride"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="20.9"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
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<denominator>
<value value="1"/>
<unit value="millilitre(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</denominator>
</strengthRatio>
</referenceStrength>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000091713"/>
<display value="Lidocaine"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="18.09"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="millilitre(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition/Instillagel-209-Gel-SE-AJ-APD"/>
<resource>
<AdministrableProductDefinition>
<id value="Instillagel-209-Gel-SE-AJ-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_Instillagel-209-Gel-SE-AJ-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition Instillagel-209-Gel-SE-AJ-APD</b></p><a name="Instillagel-209-Gel-SE-AJ-APD"> </a><a name="hcInstillagel-209-Gel-SE-AJ-APD"> </a><a name="hcInstillagel-209-Gel-SE-AJ-APD-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-Instillagel-209-Gel-SE-AJ-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100003544-00010132,http://ema.europa.eu/fhir/eurdId#10933; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Gel; indication = Kateterisering, sondering och andra endouretrala ingrepp på män. Vissa typer av cystoskopering. Alla uretrala ingrepp och manipulationer på kvinnor. Lokalbehandling av smärtsamma cystiter. Instillagel är avsett för vuxna och barn från och med 2 års ålder (se avsnitt 4.2 och 4.3).; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = lidocaine</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073726}">Gel</span></p><p><b>producedFrom</b>: <a href="ManufacturedItemDefinition-Instillagel-209-Gel-SE-AJ-MID.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Gel; unitOfPresentation = Syringe</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 100000073638}">Urethral use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/Instillagel-209-Gel-SE-AJ-MPD"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073726"/>
<display value="Gel"/>
</coding>
</administrableDoseForm>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/Instillagel-209-Gel-SE-AJ-MID"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073638"/>
<display value="Urethral use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization/LOC-100009206"/>
<resource>
<Organization>
<id value="LOC-100009206"/>
<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-100009206"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100009206</b></p><a name="LOC-100009206"> </a><a name="hcLOC-100009206"> </a><a name="hcLOC-100009206-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100009206</p><p><b>name</b>: Farco-Pharma GmbH</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100009206"/>
</identifier>
<name value="Farco-Pharma GmbH"/>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2022+ UNICOM. Package hl7.eu.fhir.ufis-swe-unicom#0.1.0 based on FHIR 5.0.0. Generated 2024-06-28
Links: Table of Contents |
QA Report
The UNICOM Innovation Action has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 875299.
