CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5) - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
<PackagedProductDefinition xmlns="http://hl7.org/fhir">
<id value="PMP-Enfortumabum-vedotinum-30-Powder"/>
<meta>
<profile
value="http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition PMP-Enfortumabum-vedotinum-30-Powder</b></p><a name="PMP-Enfortumabum-vedotinum-30-Powder"> </a><a name="hcPMP-Enfortumabum-vedotinum-30-Powder"> </a><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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ch-idmp-packagedproductdefinition.html">PackagedProductDefinition</a></p></div><p><b>identifier</b>: <a href="NamingSystem-PCID.html" title="Temporary Identifier in this implementation guide until officially released by Swissmedic">Clinical Product Identifier</a>/CH-01100869-0682910040000-0002</p><p><b>packageFor</b>: <a href="MedicinalProductDefinition-Padcev-30mg-Powder.html">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910040000; indication = Padcev ist indiziert zur Behandlung von Erwachsenen mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom (mUC), die eine platinhaltige Chemotherapie im neoadjuvanten/adjuvanten, lokal fortgeschrittenen oder metastasierten Setting erhalten haben und die während oder nach der Behandlung mit einem Inhibitor des programmierten Zelltodrezeptors-1 (PD-1) oder des programmierten Zelltod-Liganden 1 (PD-L1) einen Progress oder einen Rückfall der Erkrankung erlitten haben.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Biologics</a></p><p><b>containedItemQuantity</b>: 30 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span></p><p><b>description</b>: </p><div><p>Durchstechflasche 1 Stk</p>
</div><h3>LegalStatusOfSupplies</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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply 756005034000001}">A: Single dispensing requiring a medical or veterinary prescription</span></td></tr></table><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td><td><b>DateRange</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 CH}">Switzerland</span></td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status 756002026002}">Marketed</span></td><td>2011-09-11 --> (ongoing)</td></tr></table><blockquote><p><b>packaging</b></p><p><b>identifier</b>: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-gtin.html" title="The GS1 GTIN is a globally unique identifier of trade items. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. Note: GTINs may be used in both Codes (http://build.fhir.org/datatypes.html#Coding) and Identifiers (http://build.fhir.org/datatypes.html#Identifier).">GTIN Global Trade Item Number</a>/7680682910014</p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30009000}">Box</span></p><p><b>quantity</b>: 1</p><h3>ShelfLifeStorages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Period[x]</b></td><td><b>SpecialPrecautionsForStorage</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000073343 100000073405}">Shelf life after dilution or reconstitution according to directions</span></td><td>No display for Duration (value: 16; unit: hour; system: http://unitsofmeasure.org; code: h)</td><td><span title="Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000011}">Store in the original container</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{http://standardterms.edqm.eu 30069000}">Vial</span></p><p><b>quantity</b>: 1</p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></td></tr></table><p><b>amount</b>: 30 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM codemg = 'mg')</span></p></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://fhir.ch/ig/ch-idmp/sid/pcid"/>
<value value="CH-01100869-0682910040000-0002"/>
</identifier>
<packageFor>🔗
<reference value="MedicinalProductDefinition/Padcev-30mg-Powder"/>
</packageFor>
<containedItemQuantity>
<value value="30"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</containedItemQuantity>
<description value="Durchstechflasche 1 Stk"/>
<legalStatusOfSupply>
<code>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"/>
<code value="756005034000001"/>
<display
value="A: Single dispensing requiring a medical or veterinary prescription"/>
</coding>
</code>
</legalStatusOfSupply>
<marketingStatus>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="CH"/>
<display value="Switzerland"/>
</coding>
</country>
<status>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status"/>
<code value="756002026002"/>
<display value="Marketed"/>
</coding>
</status>
<dateRange>
<start value="2011-09-11"/>
</dateRange>
</marketingStatus>
<packaging>
<identifier>
<system value="https://www.gs1.org/gtin"/>
<value value="7680682910014"/>
</identifier>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="30009000"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<shelfLifeStorage>
<type>
<coding>
<system value="http://spor.ema.europa.eu/v1/lists/100000073343"/>
<code value="100000073405"/>
<display
value="Shelf life after dilution or reconstitution according to directions"/>
</coding>
</type>
<periodDuration>
<value value="16"/>
<unit value="hour"/>
<system value="http://unitsofmeasure.org"/>
<code value="h"/>
</periodDuration>
<specialPrecautionsForStorage>
<coding>
<system
value="http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"/>
<code value="756005041000011"/>
<display value="Store in the original container"/>
</coding>
</specialPrecautionsForStorage>
</shelfLifeStorage>
<packaging>
<type>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="30069000"/>
<display value="Vial"/>
</coding>
</type>
<quantity value="1"/>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"/>
</reference>
</item>
<amount>
<value value="30"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>