CH IDMP (R5)
1.0.0-ballot - ballot
CH IDMP (R5)
1.0.0-ballot - ballot
This page is part of the CH IDMP (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:PackagedProductDefinition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "PMP-Enfortumabum-vedotinum-30-Powder"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>\n</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>"^^rdf:XMLLiteral ]
] ; #
fhir:identifier ( [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/sid/pcid"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/sid/pcid> ] ;
fhir:value [ fhir:v "CH-01100869-0682910040000-0002" ]
] ) ; #
fhir:packageFor ( [
fhir:l fhir:MedicinalProductDefinition/Padcev-30mg-Powder ;
fhir:reference [ fhir:v "MedicinalProductDefinition/Padcev-30mg-Powder" ]
] ) ; #
fhir:containedItemQuantity ( [
fhir:value [ fhir:v "30"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org> ] ;
fhir:code [ fhir:v "mg" ]
] ) ; #
fhir:description [ fhir:v "Durchstechflasche 1 Stk"] ; #
fhir:legalStatusOfSupply ( [
fhir:code [
( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply> ] ;
fhir:code [ fhir:v "756005034000001" ] ;
fhir:display [ fhir:v "A: Single dispensing requiring a medical or veterinary prescription" ] ] ) ]
] ) ; #
fhir:marketingStatus ( [
fhir:country [
( fhir:coding [
fhir:system [
fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ;
fhir:l <urn:iso:std:iso:3166> ] ;
fhir:code [ fhir:v "CH" ] ;
fhir:display [ fhir:v "Switzerland" ] ] ) ] ;
fhir:status [
( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status> ] ;
fhir:code [ fhir:v "756002026002" ] ;
fhir:display [ fhir:v "Marketed" ] ] ) ] ;
fhir:dateRange [
fhir:start [ fhir:v "2011-09-11"^^xsd:date ] ]
] ) ; #
fhir:packaging [
( fhir:identifier [
fhir:system [
fhir:v "https://www.gs1.org/gtin"^^xsd:anyURI ;
fhir:l <https://www.gs1.org/gtin> ] ;
fhir:value [ fhir:v "7680682910014" ] ] ) ;
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu> ] ;
fhir:code [ fhir:v "30009000" ] ;
fhir:display [ fhir:v "Box" ] ] ) ] ;
fhir:quantity [ fhir:v 1 ] ;
( fhir:shelfLifeStorage [
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://spor.ema.europa.eu/v1/lists/100000073343"^^xsd:anyURI ;
fhir:l <http://spor.ema.europa.eu/v1/lists/100000073343> ] ;
fhir:code [ fhir:v "100000073405" ] ;
fhir:display [ fhir:v "Shelf life after dilution or reconstitution according to directions" ] ] ) ] ;
fhir:period [
a fhir:Duration ;
fhir:value [ fhir:v "16"^^xsd:decimal ] ;
fhir:unit [ fhir:v "hour" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org> ] ;
fhir:code [ fhir:v "h" ] ] ;
( fhir:specialPrecautionsForStorage [
( fhir:coding [
fhir:system [
fhir:v "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage"^^xsd:anyURI ;
fhir:l <http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage> ] ;
fhir:code [ fhir:v "756005041000011" ] ;
fhir:display [ fhir:v "Store in the original container" ] ] ) ] ) ] ) ;
( fhir:packaging [
fhir:type [
( fhir:coding [
fhir:system [
fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ;
fhir:l <http://standardterms.edqm.eu> ] ;
fhir:code [ fhir:v "30069000" ] ;
fhir:display [ fhir:v "Vial" ] ] ) ] ;
fhir:quantity [ fhir:v 1 ] ;
( fhir:containedItem [
fhir:item [
fhir:reference [
fhir:l fhir:ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder ;
fhir:reference [ fhir:v "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder" ] ] ] ;
fhir:amount [
fhir:value [ fhir:v "30"^^xsd:decimal ] ;
fhir:unit [ fhir:v "mg" ] ;
fhir:system [
fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ;
fhir:l <http://unitsofmeasure.org> ] ;
fhir:code [ fhir:v "mg" ] ] ] ) ] )
] . #
IG © 2026+ Refdata Foundation. Package ch.fhir.ig.ch-idmp#1.0.0-ballot based on FHIR 5.0.0. Generated 2026-06-12
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