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
<Bundle xmlns="http://hl7.org/fhir">
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD-BBDL"/>
<type value="collection"/>
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<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/MedicinalProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"/>
<resource>
<MedicinalProductDefinition>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-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_Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-MPD"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-MPD-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100023206-00015002, <code>http://ema.europa.eu/fhir/eurdId</code>/3146</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/200000000004~200000000006~200000000007~200000000008 100000073868}">Powder and solvent for solution for injection</span></p><p><b>indication</b>: </p><div><p>Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt.</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 100000097488}">ziprasidone</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Zeldox 20 mg/ml pulver och vätska till injektionsvätska, lösning</p><blockquote><p><b>part</b></p><p><b>part</b>: Zeldox</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 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>: pulver och vätska till injektionsvätska, 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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<value value="SE-100023206-00015002"/>
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<system value="http://ema.europa.eu/fhir/eurdId"/>
<value value="3146"/>
</identifier>
<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/200000000004~200000000006~200000000007~200000000008"/>
<code value="100000073868"/>
<display value="Powder and solvent for solution for injection"/>
</coding>
</combinedPharmaceuticalDoseForm>
<indication
value="Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt."/>
<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="100000097488"/>
<display value="ziprasidone"/>
</coding>
</classification>
<name>
<productName
value="Zeldox 20 mg/ml pulver och vätska till injektionsvätska, lösning"/>
<part>
<part value="Zeldox"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="20 mg/ml"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="pulver och vätska till injektionsvätska, lösning"/>
<type>
<coding>
<system
value="http://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="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="sv"/>
<display value="Swedish"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/RegulatedAuthorization/Zeldox20mgmlpulvervatskainjek-SE-PLC-RA"/>
<resource>
<RegulatedAuthorization>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-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_Zeldox20mgmlpulvervatskainjek-SE-PLC-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization Zeldox20mgmlpulvervatskainjek-SE-PLC-RA</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-RA"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-RA"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-RA-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/15002</p><p><b>subject</b>: <a href="MedicinalProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100023206-00015002,http://ema.europa.eu/fhir/eurdId#3146; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder and solvent for solution for injection; indication = Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = ziprasidone</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>: 2000-08-17</p><p><b>holder</b>: <a href="Organization-LOC-100032008.html">Organization Upjohn EESV</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>2000-08-17</td></tr></table></div>
</text>
<identifier>
<system
value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
<value value="15002"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"/>
</subject>
<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"/>
</coding>
</status>
<statusDate value="2000-08-17"/>
<holder>🔗
<reference value="Organization/LOC-100032008"/>
</holder>
<case>
<type>
<coding>
<system
value="https://ema.europa.eu/fhir/authorisationDateType"/>
<code value="dateOfFirstAuthorisation"/>
<display value="First Authorisation"/>
</coding>
</type>
<dateDateTime value="2000-08-17"/>
</case>
</RegulatedAuthorization>
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</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-PPD"/>
<resource>
<PackagedProductDefinition>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-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_Zeldox20mgmlpulvervatskainjek-SE-PLC-PPD"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition Zeldox20mgmlpulvervatskainjek-SE-PLC-PPD</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-PPD"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-PPD"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-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-Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100023206-00015002,http://ema.europa.eu/fhir/eurdId#3146; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder and solvent for solution for injection; indication = Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = ziprasidone</a></p><p><b>containedItemQuantity</b>: 1 Ampoule<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002164 = '200000002164')</span></p><p><b>description</b>: </p><div><p>Injektionsflaska och ampull, 1 x (I+II)</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><p><b>packaging</b></p></blockquote></blockquote></div>
</text>
<extension
url="http://ema.europa.eu/fhir/extension/containedItemQuantity"/>
<extension
url="http://ema.europa.eu/fhir/extension/containedItemQuantity"/>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
</identifier>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="1"/>
<unit value="Ampoule"/>
<system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002164"/>
</containedItemQuantity>
<description value="Injektionsflaska och ampull, 1 x (I+II)"/>
<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="100000073563"/>
<display value="Vial"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003204"/>
<display value="Glass type I"/>
</coding>
</material>
<shelfLifeStorage>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073343"/>
<code value="100000073403"/>
<display
value="Shelf life of the medicinal product as packaged for sale"/>
</coding>
</type>
<periodDuration>
<value value="3"/>
<unit value="year"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="200000003434"/>
</periodDuration>
<specialPrecautionsForStorage>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073344"/>
<code value="100000073411"/>
<display value="Do not store above 30°C"/>
</coding>
</specialPrecautionsForStorage>
<specialPrecautionsForStorage>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073344"/>
<code value="100000073420"/>
<display value="Do not freeze"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"/>
</reference>
</item>
<amount>
<value value="1"/>
<unit value="Vial"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633~200000000014"/>
<code value="200000002158"/>
</amount>
</containedItem>
</packaging>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073490"/>
<display value="Ampoule"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003204"/>
<display value="Glass type I"/>
</coding>
</material>
<shelfLifeStorage>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073343"/>
<code value="100000073403"/>
<display
value="Shelf life of the medicinal product as packaged for sale"/>
</coding>
</type>
<periodDuration>
<value value="3"/>
<unit value="year"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="200000003434"/>
</periodDuration>
<specialPrecautionsForStorage>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073344"/>
<code value="100000073411"/>
<display value="Do not store above 30°C"/>
</coding>
</specialPrecautionsForStorage>
<specialPrecautionsForStorage>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073344"/>
<code value="100000073420"/>
<display value="Do not freeze"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02"/>
</reference>
</item>
<amount>
<value value="1"/>
<unit value="Ampoule"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633~200000000014"/>
<code value="200000002164"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"/>
<resource>
<ManufacturedItemDefinition>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"/>
<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_Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-MID01"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-MID01-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073866}">Powder for solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002158}">Vial</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073866"/>
<display value="Powder for solution for injection"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
<display value="Vial"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/Zeldox20mgmlpulvervatskainjek-SE-PLC-ING01"/>
<resource>
<Ingredient>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-ING01"/>
<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_Zeldox20mgmlpulvervatskainjek-SE-PLC-ING01"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Zeldox20mgmlpulvervatskainjek-SE-PLC-ING01</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-ING01"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-ING01"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-ING01-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100023206-00015002,http://ema.europa.eu/fhir/eurdId#3146; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder and solvent for solution for injection; indication = Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = ziprasidone</a></li><li><a href="ManufacturedItemDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial</a></li><li><a href="AdministrableProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-APD.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for injection</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 100000135817}">Ziprasidone mesilate trihydrate</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 32.7 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110655 = 'milligram(s)')</span>/1 Vial<span style="background: LightGoldenRodYellow"> (Details: Unit of Presentation EMA code200000002158 = 'Vial')</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 100000078790}">Ziprasidone</span></td></tr></table><p><b>strength</b>: 24 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110655 = 'milligram(s)')</span>/1 Vial<span style="background: LightGoldenRodYellow"> (Details: Unit of Presentation EMA code200000002158 = 'Vial')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="MedicinalProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-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.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000135817"/>
<display value="Ziprasidone mesilate trihydrate"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="32.7"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Vial"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000078790"/>
<display value="Ziprasidone"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="24"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="Vial"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/Zeldox20mgmlpulvervatskainjek-SE-PLC-ING02"/>
<resource>
<Ingredient>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-ING02"/>
<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_Zeldox20mgmlpulvervatskainjek-SE-PLC-ING02"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Zeldox20mgmlpulvervatskainjek-SE-PLC-ING02</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-ING02"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-ING02"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-ING02-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100023206-00015002,http://ema.europa.eu/fhir/eurdId#3146; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder and solvent for solution for injection; indication = Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = ziprasidone</a></li><li><a href="ManufacturedItemDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial</a></li><li><a href="AdministrableProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-APD.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for injection</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072082}">Excipient</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 100000085580}">BETADEX SULFOBUTYL ETHER SODIUM</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="MedicinalProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000085580"/>
<display value="BETADEX SULFOBUTYL ETHER SODIUM"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02"/>
<resource>
<ManufacturedItemDefinition>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02"/>
<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_Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-MID02"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-MID02-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000174029}">Solution for solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002164}">Ampoule</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000174029"/>
<display value="Solution for solution for injection"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002164"/>
<display value="Ampoule"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Ingredient/Zeldox20mgmlpulvervatskainjek-SE-PLC-ING03"/>
<resource>
<Ingredient>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-ING03"/>
<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_Zeldox20mgmlpulvervatskainjek-SE-PLC-ING03"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient Zeldox20mgmlpulvervatskainjek-SE-PLC-ING03</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-ING03"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-ING03"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-ING03-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="MedicinalProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100023206-00015002,http://ema.europa.eu/fhir/eurdId#3146; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder and solvent for solution for injection; indication = Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = ziprasidone</a></li><li><a href="ManufacturedItemDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for solution for injection; unitOfPresentation = Ampoule</a></li><li><a href="AdministrableProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-APD.html">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for injection</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072082}">Excipient</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 100000085825}">Water</span></td></tr></table></blockquote></div>
</text>
<status value="active"/>
<for>🔗
<reference
value="MedicinalProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"/>
</for>
<for>🔗
<reference
value="ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000085825"/>
<display value="Water"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-APD"/>
<resource>
<AdministrableProductDefinition>
<id value="Zeldox20mgmlpulvervatskainjek-SE-PLC-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_Zeldox20mgmlpulvervatskainjek-SE-PLC-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition Zeldox20mgmlpulvervatskainjek-SE-PLC-APD</b></p><a name="Zeldox20mgmlpulvervatskainjek-SE-PLC-APD"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-APD"> </a><a name="hcZeldox20mgmlpulvervatskainjek-SE-PLC-APD-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="MedicinalProductDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD.html">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100023206-00015002,http://ema.europa.eu/fhir/eurdId#3146; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder and solvent for solution for injection; indication = Ziprasidon injektionsvätska, lösning är indicerat för snabb kontroll av agiterade patienter med schizofreni, när peroral terapi inte är lämpligt, under maximalt tre på varandra följande dagar. Behandling med ziprasidon injektionsvätska, lösning bör upphöra och peroralt ziprasidon initieras så snart det är kliniskt lämpligt.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = ziprasidone</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>producedFrom</b>: </p><ul><li><a href="ManufacturedItemDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial</a></li><li><a href="ManufacturedItemDefinition-Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for solution for injection; unitOfPresentation = Ampoule</a></li></ul><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 100000073600}">Intramuscular use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MPD"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</administrableDoseForm>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID01"/>
</producedFrom>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/Zeldox20mgmlpulvervatskainjek-SE-PLC-MID02"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073600"/>
<display value="Intramuscular use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization/LOC-100032008"/>
<resource>
<Organization>
<id value="LOC-100032008"/>
<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-100032008"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100032008</b></p><a name="LOC-100032008"> </a><a name="hcLOC-100032008"> </a><a name="hcLOC-100032008-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100032008</p><p><b>name</b>: Upjohn EESV</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100032008"/>
</identifier>
<name value="Upjohn EESV"/>
</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.
