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
{
"resourceType" : "PackagedProductDefinition",
"id" : "PMP-Enfortumabum-vedotinum-20-Powder",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition PMP-Enfortumabum-vedotinum-20-Powder</b></p><a name=\"PMP-Enfortumabum-vedotinum-20-Powder\"> </a><a name=\"hcPMP-Enfortumabum-vedotinum-20-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-01100869-0682910030000-0001</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Padcev-20mg-Powder.html\">MedicinalProductDefinition: extension = Lyophilisate for solution for infusion; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0682910030000; 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>: 20 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>/7680682910021</p><p><b>type</b>: <span title=\"Codes:{http://standardterms.edqm.eu 30009000}\">Box</span></p><p><b>quantity</b>: 6</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>: 20 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span></p></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/sid/pcid",
"value" : "CH-01100869-0682910030000-0001"
}
],
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/Padcev-20mg-Powder"
}
],
"containedItemQuantity" : [
{
"value" : 20,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
}
],
"description" : "Durchstechflasche 1 Stk",
"legalStatusOfSupply" : [
{
"code" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply",
"code" : "756005034000001",
"display" : "A: Single dispensing requiring a medical or veterinary prescription"
}
]
}
}
],
"marketingStatus" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "CH",
"display" : "Switzerland"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status",
"code" : "756002026002",
"display" : "Marketed"
}
]
},
"dateRange" : {
"start" : "2011-09-11"
}
}
],
"packaging" : {
"identifier" : [
{
"system" : "https://www.gs1.org/gtin",
"value" : "7680682910021"
}
],
"type" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "30009000",
"display" : "Box"
}
]
},
"quantity" : 6,
"shelfLifeStorage" : [
{
"type" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000073343",
"code" : "100000073405",
"display" : "Shelf life after dilution or reconstitution according to directions"
}
]
},
"periodDuration" : {
"value" : 16,
"unit" : "hour",
"system" : "http://unitsofmeasure.org",
"code" : "h"
},
"specialPrecautionsForStorage" : [
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage",
"code" : "756005041000011",
"display" : "Store in the original container"
}
]
}
]
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "30069000",
"display" : "Vial"
}
]
},
"quantity" : 1,
"containedItem" : [
{
"item" : {
"reference" : {
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"
}
},
"amount" : {
"value" : 20,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
}
}
]
}
]
}
}