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
{
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🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle"
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"language" : "de-CH",
"type" : "collection",
"entry" : [
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Padcev-20mg-Powder",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "Padcev-20mg-Powder",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"
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},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_Padcev-20mg-Powder\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Padcev-20mg-Powder</b></p><a name=\"Padcev-20mg-Powder\"> </a><a name=\"hcPadcev-20mg-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-medicinalproductdefinition.html\">MedicinalProductDefinition</a></p></div><p><b>CH SMC - Authorized Dose Form</b>: <span title=\"Codes:{http://standardterms.edqm.eu 11215000}\">Lyophilisate for solution for infusion</span></p><p><b>identifier</b>: <a href=\"NamingSystem-MPID.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Medical Product Identifier</a>/CH-01100869-0682910030000</p><p><b>indication</b>: </p><div><p>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.</p>\n</div><p><b>legalStatusOfSupply</b>: <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></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator 756005001003}\">No Warning</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator 756005003002}\">Not authorised for the treatment in children</span></p><p><b>classification</b>: <span title=\"Codes:{http://www.whocc.no/atc L01EX13}\">gilteritinib</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category 756005011000005}\">NA KAS art. 12 para. 5 TPLO</span>, <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory 756005039000003}\">Biologics</span></p><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-SMC-marketing-status 7560050074000003}\">No interruption of distribution reported</span></td><td>2011-09-11 --> (ongoing)</td></tr></table><p><b>attachedDocument</b>: <a href=\"DocumentReference-DocRef-FI-Padcev.html\">DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#123456989-initial submission-Example-xyz-321; status = current; type = Information for healthcare professionals; date = 2021-11-09 00:00:00+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung</p><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:{urn:iso:std:iso:3166 CH}\">Switzerland</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 de-CH}\">German (Switzerland)</span></td></tr></table></blockquote></div>"
},
"extension" : [
{
"url" : "http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "11215000",
"display" : "Lyophilisate for solution for infusion"
}
]
}
}
],
"identifier" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/sid/mpid",
"value" : "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" : {
"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"
}
]
},
"additionalMonitoringIndicator" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator",
"code" : "756005001003",
"display" : "No Warning"
}
]
},
"pediatricUseIndicator" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator",
"code" : "756005003002",
"display" : "Not authorised for the treatment in children"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "http://www.whocc.no/atc",
"code" : "L01EX13"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category",
"code" : "756005011000005",
"display" : "NA KAS art. 12 para. 5 TPLO"
}
]
},
{
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory",
"code" : "756005039000003",
"display" : "Biologics"
}
]
}
],
"marketingStatus" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "CH",
"display" : "Switzerland"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status",
"code" : "7560050074000003",
"display" : "No interruption of distribution reported"
}
]
},
"dateRange" : {
"start" : "2011-09-11"
}
}
],
"attachedDocument" : [
{
🔗 "reference" : "DocumentReference/DocRef-FI-Padcev"
}
],
"name" : [
{
"productName" : "Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung",
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "CH",
"display" : "Switzerland"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "de-CH"
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]
}
}
]
}
]
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Padcev",
"resource" : {
"resourceType" : "DocumentReference",
"id" : "DocRef-FI-Padcev",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DocumentReference_DocRef-FI-Padcev\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference DocRef-FI-Padcev</b></p><a name=\"DocRef-FI-Padcev\"> </a><a name=\"hcDocRef-FI-Padcev\"> </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-documentreference.html\">DocumentReference</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AttNo.html\" title=\"Temporary Namingsystem in this implementation guide until officially released by Swissmedic\">Application / Assessment Tracking Number</a>/123456989-initial submission-Example-xyz-321</p><p><b>status</b>: Current</p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type 756005040000001}\">Information for healthcare professionals</span></p><p><b>date</b>: 2021-11-09 00:00:00+0000</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Language</b></td><td><b>Url</b></td></tr><tr><td style=\"display: none\">*</td><td>German (Switzerland)</td><td><a href=\"https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1\">https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1</a></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/sid/attno",
"value" : "123456989-initial submission-Example-xyz-321"
}
],
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type",
"code" : "756005040000001",
"display" : "Information for healthcare professionals"
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]
},
"date" : "2021-11-09T00:00:00Z",
"content" : [
{
"attachment" : {
"language" : "de-CH",
"url" : "https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1"
}
}
]
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6829103",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-6829103",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-6829103\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-6829103</b></p><a name=\"MA-6829103\"> </a><a name=\"hcMA-6829103\"> </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-regulatedauthorization.html\">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AuthNo.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Marketing Authorisation Number</a>/6829103</p><p><b>subject</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>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 756000002001}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></p><p><b>status</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}\">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> 2026-11-08</p><p><b>holder</b>: <a href=\"#hcMA-6829103/holder-Astellas-Pharma-AG\">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-6829103/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name=\"MA-6829103/holder-Astellas-Pharma-AG\"> </a><a name=\"hcMA-6829103/holder-Astellas-Pharma-AG\"> </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-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-SMCLocID.html\" title=\"Temporary NamingSystem in this implementation guide until officially released by Swissmedic\">Swissmedic Location Identifier</a>/01100869, <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010745, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-6829103/regulator-SMC\"> </a><a name=\"hcMA-6829103/regulator-SMC\"> </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-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010911, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-Astellas-Pharma-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier" : [
{
"system" : "https://www.swissmedic.ch/fhir/identifier/locations",
"value" : "01100869"
},
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "100010745"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001000964"
}
],
"name" : "Astellas Pharma AG"
},
{
"resourceType" : "Organization",
"id" : "regulator-SMC",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "100010911"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001398511"
}
],
"name" : "SMC"
}
],
"identifier" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/sid/authno",
"value" : "6829103"
}
],
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Padcev-20mg-Powder"
}
],
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs",
"code" : "756000002001",
"display" : "Marketing Authorisation"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "CH",
"display" : "Switzerland"
}
]
}
],
"status" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status",
"code" : "756005010000001",
"display" : "approved"
}
]
},
"statusDate" : "2021-11-09",
"validityPeriod" : {
"start" : "2021-11-09",
"end" : "2026-11-08"
},
"holder" : {
"reference" : "#holder-Astellas-Pharma-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder",
"resource" : {
"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\"><a name=\"PackagedProductDefinition_PMP-Enfortumabum-vedotinum-20-Powder\"> </a><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"
}
}
]
}
]
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-68291001",
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "MA-68291001",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_MA-68291001\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-68291001</b></p><a name=\"MA-68291001\"> </a><a name=\"hcMA-68291001\"> </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-regulatedauthorization.html\">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AuthNo.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Marketing Authorisation Number</a>/68291001</p><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Enfortumabum-vedotinum-20-Powder.html\">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-01100869-0682910030000-0001; containedItemQuantity = 20 mg; description = Durchstechflasche 1 Stk</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 756000002001}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></p><p><b>status</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}\">approved</span></p><p><b>statusDate</b>: 2021-11-09</p><p><b>validityPeriod</b>: 2021-11-09 --> 2026-11-08</p><p><b>holder</b>: <a href=\"#hcMA-68291001/holder-Astellas-Pharma-AG\">Organization Astellas Pharma AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-68291001/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Astellas-Pharma-AG</b></p><a name=\"MA-68291001/holder-Astellas-Pharma-AG\"> </a><a name=\"hcMA-68291001/holder-Astellas-Pharma-AG\"> </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-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-SMCLocID.html\" title=\"Temporary NamingSystem in this implementation guide until officially released by Swissmedic\">Swissmedic Location Identifier</a>/01100869, <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010745, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001000964</p><p><b>name</b>: Astellas Pharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-68291001/regulator-SMC\"> </a><a name=\"hcMA-68291001/regulator-SMC\"> </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-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010911, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-Astellas-Pharma-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier" : [
{
"system" : "https://www.swissmedic.ch/fhir/identifier/locations",
"value" : "01100869"
},
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "100010745"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001000964"
}
],
"name" : "Astellas Pharma AG"
},
{
"resourceType" : "Organization",
"id" : "regulator-SMC",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "100010911"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001398511"
}
],
"name" : "SMC"
}
],
"identifier" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/sid/authno",
"value" : "68291001"
}
],
"subject" : [
{
🔗 "reference" : "PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder"
}
],
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs",
"code" : "756000002001",
"display" : "Marketing Authorisation"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "CH",
"display" : "Switzerland"
}
]
}
],
"status" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status",
"code" : "756005010000001",
"display" : "approved"
}
]
},
"statusDate" : "2021-11-09",
"validityPeriod" : {
"start" : "2021-11-09",
"end" : "2026-11-08"
},
"holder" : {
"reference" : "#holder-Astellas-Pharma-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder",
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "MI-Enfortumabum-vedotinum-20-Powder",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_MI-Enfortumabum-vedotinum-20-Powder\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition MI-Enfortumabum-vedotinum-20-Powder</b></p><a name=\"MI-Enfortumabum-vedotinum-20-Powder\"> </a><a name=\"hcMI-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-manufactureditemdefinition.html\">ManufacturedItemDefinition</a></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 11215000}\">Lyophilisate for solution for infusion</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15060000}\">Vial</span></p></div>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "11215000",
"display" : "Lyophilisate for solution for infusion"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "15060000",
"display" : "Vial"
}
]
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution",
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "PhP-Enfortumabum-vedotinum-20-Solution",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_PhP-Enfortumabum-vedotinum-20-Solution\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition PhP-Enfortumabum-vedotinum-20-Solution</b></p><a name=\"PhP-Enfortumabum-vedotinum-20-Solution\"> </a><a name=\"hcPhP-Enfortumabum-vedotinum-20-Solution\"> </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-administrableproductdefinition.html\">AdministrableProductDefinition</a></p></div><p><b>status</b>: Active</p><p><b>formOf</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>administrableDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 11210000}\">Solution for Infusion</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{http://standardterms.edqm.eu 15060000}\">Vial</span></p><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:{http://standardterms.edqm.eu 20045000}\">Intravenous use</span></td></tr></table></div>"
},
"status" : "active",
"formOf" : [
{
🔗 "reference" : "MedicinalProductDefinition/Padcev-20mg-Powder"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "11210000",
"display" : "Solution for Infusion"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "15060000",
"display" : "Vial"
}
]
},
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20045000",
"display" : "Intravenous use"
}
]
}
}
]
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/Ingredient/EnfortumabumVedotinum20",
"resource" : {
"resourceType" : "Ingredient",
"id" : "EnfortumabumVedotinum20",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_EnfortumabumVedotinum20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient EnfortumabumVedotinum20</b></p><a name=\"EnfortumabumVedotinum20\"> </a><a name=\"hcEnfortumabumVedotinum20\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000001}\">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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance DLE8519RWM}\">Enfortumab vedotin</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 20 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 vial<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15060000 = '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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance DLE8519RWM}\">Enfortumab vedotin</span></td></tr></table><p><b>strength</b>: 20 mg<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codemg = 'mg')</span>/1 vial<span style=\"background: LightGoldenRodYellow\"> (Details: EDQM - Standard Terms code15060000 = 'Vial')</span></p></blockquote></blockquote></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005035000001",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code" : "DLE8519RWM",
"display" : "Enfortumab vedotin"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 20,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "vial",
"system" : "http://standardterms.edqm.eu",
"code" : "15060000"
}
},
"referenceStrength" : [
{
"substance" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code" : "DLE8519RWM",
"display" : "Enfortumab vedotin"
}
]
}
},
"strengthRatio" : {
"numerator" : {
"value" : 20,
"unit" : "mg",
"system" : "http://unitsofmeasure.org",
"code" : "mg"
},
"denominator" : {
"value" : 1,
"unit" : "vial",
"system" : "http://standardterms.edqm.eu",
"code" : "15060000"
}
}
}
]
}
]
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Histidinum",
"resource" : {
"resourceType" : "Ingredient",
"id" : "Histidinum",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Histidinum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Histidinum</b></p><a name=\"Histidinum\"> </a><a name=\"hcHistidinum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 4QD397987E}\">Histidine</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"
},
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005035000002",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code" : "4QD397987E",
"display" : "Histidine"
}
]
}
}
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/Ingredient/HistidiniHydrochloridumMonohydricum",
"resource" : {
"resourceType" : "Ingredient",
"id" : "HistidiniHydrochloridumMonohydricum",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_HistidiniHydrochloridumMonohydricum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient HistidiniHydrochloridumMonohydricum</b></p><a name=\"HistidiniHydrochloridumMonohydricum\"> </a><a name=\"hcHistidiniHydrochloridumMonohydricum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance X573657P6P}\">Histidine hydrochloride monohydrate</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"
},
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005035000002",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code" : "X573657P6P",
"display" : "Histidine hydrochloride monohydrate"
}
]
}
}
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/Ingredient/TrehalosumDihydricum",
"resource" : {
"resourceType" : "Ingredient",
"id" : "TrehalosumDihydricum",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_TrehalosumDihydricum\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient TrehalosumDihydricum</b></p><a name=\"TrehalosumDihydricum\"> </a><a name=\"hcTrehalosumDihydricum\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 7YIN7J07X4}\">Trehalose dihydrate</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"
},
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005035000002",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code" : "7YIN7J07X4",
"display" : "Trehalose dihydrate"
}
]
}
}
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbatum20",
"resource" : {
"resourceType" : "Ingredient",
"id" : "Polysorbatum20",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_Polysorbatum20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient Polysorbatum20</b></p><a name=\"Polysorbatum20\"> </a><a name=\"hcPolysorbatum20\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-20-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"ManufacturedItemDefinition-MI-Enfortumabum-vedotinum-30-Powder.html\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 7T1F30V5YH}\">Polysorbate 20</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder"
},
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"
},
{
🔗 "reference" : "ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005035000002",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code" : "7T1F30V5YH",
"display" : "Polysorbate 20"
}
]
}
}
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/Ingredient/AquaAdIniectabile",
"resource" : {
"resourceType" : "Ingredient",
"id" : "AquaAdIniectabile",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_AquaAdIniectabile\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient AquaAdIniectabile</b></p><a name=\"AquaAdIniectabile\"> </a><a name=\"hcAquaAdIniectabile\"> </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-ingredient.html\">Ingredient</a></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-20-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li><li><a href=\"AdministrableProductDefinition-PhP-Enfortumabum-vedotinum-30-Solution.html\">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial</a></li></ul><p><b>role</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role 756005035000002}\">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:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance 059QF0KO0R}\">Water</span></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution"
},
{
🔗 "reference" : "AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution"
}
],
"role" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role",
"code" : "756005035000002",
"display" : "Excipient"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance",
"code" : "059QF0KO0R",
"display" : "Water"
}
]
}
}
}
}
},
{
"fullUrl" : "http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10057352",
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "IND-10057352",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_IND-10057352\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition IND-10057352</b></p><a name=\"IND-10057352\"> </a><a name=\"hcIND-10057352\"> </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-clinicalusedefinition-indication.html\">ClinicalUseDefinition Indication</a></p></div><p><b>type</b>: Indication</p><p><b>subject</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><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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://www.meddra.org 10057352}\">Metastatic carcinoma of the bladder</span></td></tr></table><h3>IntendedEffects</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:{http://spor.ema.europa.eu/v1/lists/200000003186 756005042000002}\">therapeutic</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
🔗 "reference" : "MedicinalProductDefinition/Padcev-20mg-Powder"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10057352",
"display" : "Metastatic carcinoma of the bladder"
}
]
}
},
"intendedEffect" : {
"concept" : {
"coding" : [
{
"system" : "http://spor.ema.europa.eu/v1/lists/200000003186",
"code" : "756005042000002",
"display" : "therapeutic"
}
]
}
}
}
}
}
]
}