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
{
"resourceType" : "PackagedProductDefinition",
"id" : "PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet",
"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-Gilteritinibi-hemifumaras-40-Filmcoatedtablet</b></p><a name=\"PMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </a><a name=\"hcPMP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet\"> </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-01100869-0672110010000-0001</p><p><b>packageFor</b>: <a href=\"MedicinalProductDefinition-Xospata-Filmcoatedtablet.html\">MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-01100869-0672110010000; indication = Xospata wird angewendet für die Behandlung von erwachsenen Patienten, die an rezidivierter oder refraktärer akuter myeloider Leukämie (AML) mit FMS-ähnlichen Tyrosinkinase 3 (FLT3)-Mutationen leiden.; legalStatusOfSupply = A: Single dispensing requiring a medical or veterinary prescription; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = gilteritinib,Synthetic</a></p><p><b>containedItemQuantity</b>: 48 Tablet<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15054000 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>4 Blister zu 7 Tabletten in 1 Box</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>2020-09-24 --> (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>/7680672110011</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 100000073403}\">Shelf life of the medicinal product as packaged for sale</span></td><td>No display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo)</td><td><span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage 756005041000009}\">Do not store above 30°C</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{http://standardterms.edqm.eu 30007000}\">Blister</span></p><p><b>quantity</b>: 4</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-Gilteritinibi-hemifumaras-40-Filmcoatedtablet.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 12 countable unit(s)<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code1 = '1')</span></p></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/sid/pcid",
"value" : "CH-01100869-0672110010000-0001"
}
],
"packageFor" : [
{
🔗 "reference" : "MedicinalProductDefinition/Xospata-Filmcoatedtablet"
}
],
"containedItemQuantity" : [
{
"value" : 48,
"unit" : "Tablet",
"system" : "http://standardterms.edqm.eu",
"code" : "15054000"
}
],
"description" : "4 Blister zu 7 Tabletten in 1 Box",
"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" : "2020-09-24"
}
}
],
"packaging" : {
"identifier" : [
{
"system" : "https://www.gs1.org/gtin",
"value" : "7680672110011"
}
],
"type" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "30009000",
"display" : "Box"
}
]
},
"quantity" : 1,
"shelfLifeStorage" : [
{
"type" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/100000073343",
"code" : "100000073403",
"display" : "Shelf life of the medicinal product as packaged for sale"
}
]
},
"periodDuration" : {
"value" : 36,
"unit" : "month",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"specialPrecautionsForStorage" : [
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-special-precautions-for-storage",
"code" : "756005041000009",
"display" : "Do not store above 30°C"
}
]
}
]
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "30007000",
"display" : "Blister"
}
]
},
"quantity" : 4,
"containedItem" : [
{
"item" : {
"reference" : {
🔗 "reference" : "ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet"
}
},
"amount" : {
"value" : 12,
"unit" : "countable unit(s)",
"system" : "http://unitsofmeasure.org",
"code" : "1"
}
}
]
}
]
}
}