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" : "MedicinalProductDefinition",
"id" : "Padcev-30mg-Powder",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition Padcev-30mg-Powder</b></p><a name=\"Padcev-30mg-Powder\"> </a><a name=\"hcPadcev-30mg-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-01100869-0682910040000</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 30 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-01100869-0682910040000"
}
],
"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" : {
"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 30 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"
}
]
}
}
]
}
]
}