http://fhir.ch/ig/ch-idmp/Bundle/a058182b-13dc-4797-9364-2cdb9a4c2bd4
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle
    l: ch-idmp-bundle
language:
  v: de-CH
type:
  v: collection
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Padcev-20mg-Powder
    l: Padcev-20mg-Powder
  resource: Padcev-20mg-Powder
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Padcev
    l: DocRef-FI-Padcev
  resource: DocRef-FI-Padcev
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-6829103
    l: MA-6829103
  resource: MA-6829103
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder
    l: PMP-Enfortumabum-vedotinum-20-Powder
  resource: PMP-Enfortumabum-vedotinum-20-Powder
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-68291001
    l: MA-68291001
  resource: MA-68291001
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder
    l: MI-Enfortumabum-vedotinum-20-Powder
  resource: MI-Enfortumabum-vedotinum-20-Powder
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution
    l: PhP-Enfortumabum-vedotinum-20-Solution
  resource: PhP-Enfortumabum-vedotinum-20-Solution
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/EnfortumabumVedotinum20
    l: EnfortumabumVedotinum20
  resource: EnfortumabumVedotinum20
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Histidinum
    l: Histidinum
  resource: Histidinum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/HistidiniHydrochloridumMonohydricum
    l: HistidiniHydrochloridumMonohydricum
  resource: HistidiniHydrochloridumMonohydricum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/TrehalosumDihydricum
    l: TrehalosumDihydricum
  resource: TrehalosumDihydricum
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbatum20
    l: Polysorbatum20
  resource: Polysorbatum20
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/AquaAdIniectabile
    l: AquaAdIniectabile
  resource: AquaAdIniectabile
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10057352
    l: IND-10057352
  resource: IND-10057352

Padcev-20mg-Powder
type: MedicinalProductDefinition
id:
  v: Padcev-20mg-Powder
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition
    l: ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: MedicinalProductDefinition Padcev-20mg-Powder Profile: MedicinalProductDefinition CH SMC - Authorized Dose Form: Lyophilisate for solution for infusion identifier: 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 MarketingStatuses - Country Status DateRange * Switzerland No interruption of distribution reported 2011-09-11 --> (ongoing) attachedDocument: 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 name productName: Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung Usages - Country Language * Switzerland German (Switzerland)
extension:
  url:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm
    l: authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 11215000
      display:
        v: Lyophilisate for solution for infusion
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/mpid
    l: mpid
  value:
    v: CH-01100869-0682910030000
indication:
  v: 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.
legal status of supply:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply
      l: ch-SMC-legal-status-of-supply
    code:
      v: 756005034000001
    display:
      v: A: Single dispensing requiring a medical or veterinary prescription
additional monitoring indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-additional-monitoring-indicator
      l: ch-SMC-additional-monitoring-indicator
    code:
      v: 756005001003
    display:
      v: No Warning
pediatric use indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-pediatric-use-indicator
      l: ch-SMC-pediatric-use-indicator
    code:
      v: 756005003002
    display:
      v: Not authorised for the treatment in children
classification:
  coding:
    system:
      v: http://www.whocc.no/atc
      l: atc
    code:
      v: L01EX13
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
      l: ch-SMC-authorisation-category
    code:
      v: 756005011000005
    display:
      v: NA KAS art. 12 para. 5 TPLO
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory
      l: ch-SMC-MedicinalProductCategory
    code:
      v: 756005039000003
    display:
      v: Biologics
marketing status:
  country:
    coding:
      system:
        v: urn:iso:std:iso:3166
        l: 3166
      code:
        v: CH
      display:
        v: Switzerland
  status:
    coding:
      system:
        v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-marketing-status
        l: ch-SMC-marketing-status
      code:
        v: 7560050074000003
      display:
        v: No interruption of distribution reported
  date range:
    start:
      v: 2011-09-11
attached document:
  l: DocRef-FI-Padcev
  reference:
    v: DocumentReference/DocRef-FI-Padcev
name:
  product name:
    v: Padcev 20 mg, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

DocRef-FI-Padcev
type: DocumentReference
id:
  v: DocRef-FI-Padcev
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DocumentReference DocRef-FI-Padcev Profile: DocumentReference identifier: 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 content Attachments - Language Url * German (Switzerland) https://Swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=68291&supportMultipleResults=1
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/attno
    l: attno
  value:
    v: 123456989-initial submission-Example-xyz-321
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005040000001
    display:
      v: Information for healthcare professionals
date:
  v: 2021-11-09T00:00:00Z
content:
  attachment:
    language:
      v: de-CH
    url:
      v: https://Swissmedicinfo.ch/showText.aspx
      l: https://Swissmedicinfo.ch/showText.aspx

MA-6829103
type: RegulatedAuthorization
id:
  v: MA-6829103
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-6829103 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/6829103 subject: 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 type: Marketing Authorisation region: Switzerland status: approved statusDate: 2021-11-09 validityPeriod: 2021-11-09 --> 2026-11-08 holder: Organization Astellas Pharma AG regulator: Organization SMC Generated Narrative: Organization #holder-Astellas-Pharma-AG Profile: Organization identifier: Swissmedic Location Identifier/01100869, LOC Identifier/100010745, GLN Identifier/7601001000964 name: Astellas Pharma AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Astellas-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01100869
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010745
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001000964
  name:
    v: Astellas Pharma AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/authno
    l: authno
  value:
    v: 6829103
subject:
  l: Padcev-20mg-Powder
  reference:
    v: MedicinalProductDefinition/Padcev-20mg-Powder
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs
      l: ch-authorisation-type-cs
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005010000001
    display:
      v: approved
status date:
  v: 2021-11-09
validity period:
  start:
    v: 2021-11-09
  end:
    v: 2026-11-08
holder:
  l: holder-Astellas-Pharma-AG
  reference:
    v: #holder-Astellas-Pharma-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

PMP-Enfortumabum-vedotinum-20-Powder
type: PackagedProductDefinition
id:
  v: PMP-Enfortumabum-vedotinum-20-Powder
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition
    l: ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition PMP-Enfortumabum-vedotinum-20-Powder Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01100869-0682910030000-0001 packageFor: 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 containedItemQuantity: 20 mg (Details: UCUM codemg = 'mg') description: Durchstechflasche 1 Stk LegalStatusOfSupplies - Code * A: Single dispensing requiring a medical or veterinary prescription MarketingStatuses - Country Status DateRange * Switzerland Marketed 2011-09-11 --> (ongoing) packaging identifier: <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/7680682910021 type: Box quantity:…
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/pcid
    l: pcid
  value:
    v: CH-01100869-0682910030000-0001
package for:
  l: Padcev-20mg-Powder
  reference:
    v: MedicinalProductDefinition/Padcev-20mg-Powder
contained item quantity:
  value:
    v: 20
  unit:
    v: mg
  system:
    v: http://unitsofmeasure.org
    l: unitsofmeasure.org
  code:
    v: mg
description:
  v: Durchstechflasche 1 Stk
legal status of supply:
  code:
    coding:
      system:
        v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply
        l: ch-SMC-legal-status-of-supply
      code:
        v: 756005034000001
      display:
        v: A: Single dispensing requiring a medical or veterinary prescription
marketing status:
  country:
    coding:
      system:
        v: urn:iso:std:iso:3166
        l: 3166
      code:
        v: CH
      display:
        v: Switzerland
  status:
    coding:
      system:
        v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-Refdata-marketing-status
        l: ch-Refdata-marketing-status
      code:
        v: 756002026002
      display:
        v: Marketed
  date range:
    start:
      v: 2011-09-11
packaging:
  identifier:
    system:
      v: https://www.gs1.org/gtin
      l: gtin
    value:
      v: 7680682910021
  type:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 30009000
      display:
        v: Box
  quantity:
    v: 6
  shelf life storage:
    period: Duration
      value:
        v: 16
      unit:
        v: hour
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: h
  packaging:
    quantity:
      v: 1

MA-68291001
type: RegulatedAuthorization
id:
  v: MA-68291001
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-68291001 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/68291001 subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-01100869-0682910030000-0001; containedItemQuantity = 20 mg; description = Durchstechflasche 1 Stk type: Marketing Authorisation region: Switzerland status: approved statusDate: 2021-11-09 validityPeriod: 2021-11-09 --> 2026-11-08 holder: Organization Astellas Pharma AG regulator: Organization SMC Generated Narrative: Organization #holder-Astellas-Pharma-AG Profile: Organization identifier: Swissmedic Location Identifier/01100869, LOC Identifier/100010745, GLN Identifier/7601001000964 name: Astellas Pharma AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Astellas-Pharma-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01100869
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010745
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001000964
  name:
    v: Astellas Pharma AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/authno
    l: authno
  value:
    v: 68291001
subject:
  l: PMP-Enfortumabum-vedotinum-20-Powder
  reference:
    v: PackagedProductDefinition/PMP-Enfortumabum-vedotinum-20-Powder
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs
      l: ch-authorisation-type-cs
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005010000001
    display:
      v: approved
status date:
  v: 2021-11-09
validity period:
  start:
    v: 2021-11-09
  end:
    v: 2026-11-08
holder:
  l: holder-Astellas-Pharma-AG
  reference:
    v: #holder-Astellas-Pharma-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

MI-Enfortumabum-vedotinum-20-Powder
type: ManufacturedItemDefinition
id:
  v: MI-Enfortumabum-vedotinum-20-Powder
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Enfortumabum-vedotinum-20-Powder Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Lyophilisate for solution for infusion unitOfPresentation: Vial
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 11215000
    display:
      v: Lyophilisate for solution for infusion
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15060000
    display:
      v: Vial

PhP-Enfortumabum-vedotinum-20-Solution
type: AdministrableProductDefinition
id:
  v: PhP-Enfortumabum-vedotinum-20-Solution
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition
    l: ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition PhP-Enfortumabum-vedotinum-20-Solution Profile: AdministrableProductDefinition status: Active formOf: 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 administrableDoseForm: Solution for Infusion unitOfPresentation: Vial RouteOfAdministrations - Code * Intravenous use
status:
  v: active
form of:
  l: Padcev-20mg-Powder
  reference:
    v: MedicinalProductDefinition/Padcev-20mg-Powder
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 11210000
    display:
      v: Solution for Infusion
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15060000
    display:
      v: Vial
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 20045000
      display:
        v: Intravenous use

EnfortumabumVedotinum20
type: Ingredient
id:
  v: EnfortumabumVedotinum20
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient EnfortumabumVedotinum20 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial role: Active substance Codes - Concept * Enfortumab vedotin strength presentation: 20 mg (Details: UCUM codemg = 'mg')/1 vial (Details: EDQM - Standard Terms code15060000 = 'Vial') referenceStrength Substances - Concept * Enfortumab vedotin strength: 20 mg (Details: UCUM codemg = 'mg')/1 vial (Details: EDQM - Standard Terms code15060000 = 'Vial')
status:
  v: active
for:
  l: PhP-Enfortumabum-vedotinum-20-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution
for:
  l: MI-Enfortumabum-vedotinum-20-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio
    reference strength:
      strength: Ratio

Histidinum
type: Ingredient
id:
  v: Histidinum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Histidinum Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial role: Excipient substance Codes - Concept * Histidine
status:
  v: active
for:
  l: PhP-Enfortumabum-vedotinum-20-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution
for:
  l: MI-Enfortumabum-vedotinum-20-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder
for:
  l: PhP-Enfortumabum-vedotinum-30-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution
for:
  l: MI-Enfortumabum-vedotinum-30-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

HistidiniHydrochloridumMonohydricum
type: Ingredient
id:
  v: HistidiniHydrochloridumMonohydricum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient HistidiniHydrochloridumMonohydricum Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial role: Excipient substance Codes - Concept * Histidine hydrochloride monohydrate
status:
  v: active
for:
  l: PhP-Enfortumabum-vedotinum-20-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution
for:
  l: MI-Enfortumabum-vedotinum-20-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder
for:
  l: PhP-Enfortumabum-vedotinum-30-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution
for:
  l: MI-Enfortumabum-vedotinum-30-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

TrehalosumDihydricum
type: Ingredient
id:
  v: TrehalosumDihydricum
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient TrehalosumDihydricum Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial role: Excipient substance Codes - Concept * Trehalose dihydrate
status:
  v: active
for:
  l: PhP-Enfortumabum-vedotinum-20-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution
for:
  l: MI-Enfortumabum-vedotinum-20-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder
for:
  l: PhP-Enfortumabum-vedotinum-30-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution
for:
  l: MI-Enfortumabum-vedotinum-30-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

Polysorbatum20
type: Ingredient
id:
  v: Polysorbatum20
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Polysorbatum20 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial ManufacturedItemDefinition: status = active; manufacturedDoseForm = Lyophilisate for solution for infusion; unitOfPresentation = Vial role: Excipient substance Codes - Concept * Polysorbate 20
status:
  v: active
for:
  l: PhP-Enfortumabum-vedotinum-20-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution
for:
  l: MI-Enfortumabum-vedotinum-20-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-20-Powder
for:
  l: PhP-Enfortumabum-vedotinum-30-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution
for:
  l: MI-Enfortumabum-vedotinum-30-Powder
  reference:
    v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

AquaAdIniectabile
type: Ingredient
id:
  v: AquaAdIniectabile
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient AquaAdIniectabile Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial AdministrableProductDefinition: status = active; administrableDoseForm = Solution for Infusion; unitOfPresentation = Vial role: Excipient substance Codes - Concept * Water
status:
  v: active
for:
  l: PhP-Enfortumabum-vedotinum-20-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-20-Solution
for:
  l: PhP-Enfortumabum-vedotinum-30-Solution
  reference:
    v: AdministrableProductDefinition/PhP-Enfortumabum-vedotinum-30-Solution
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

IND-10057352
type: ClinicalUseDefinition
id:
  v: IND-10057352
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10057352 Profile: ClinicalUseDefinition Indication type: Indication subject: 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 indication DiseaseSymptomProcedures - Concept * Metastatic carcinoma of the bladder IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Padcev-20mg-Powder
  reference:
    v: MedicinalProductDefinition/Padcev-20mg-Powder

v: urn:iso:std:iso:3166
l: 3166

v: CH

v: Switzerland

v: urn:ietf:bcp:47
l: 47

v: de-CH

v: 100000073405

v: Shelf life after dilution or reconstitution according to directions

v: 756005041000011

v: Store in the original container

v: 30069000

v: Vial

l: MI-Enfortumabum-vedotinum-30-Powder
reference:
  v: ManufacturedItemDefinition/MI-Enfortumabum-vedotinum-30-Powder

v: 20

v: mg

v: mg

v: DLE8519RWM

v: Enfortumab vedotin

v: 20

v: mg

v: mg

v: 1

v: vial

v: 15060000

coding:
  system:
    v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance
    l: ch-SMC-substance
  code:
    v: DLE8519RWM
  display:
    v: Enfortumab vedotin

value:
  v: 20
unit:
  v: mg
system:
  v: http://unitsofmeasure.org
  l: unitsofmeasure.org
code:
  v: mg

value:
  v: 1
unit:
  v: vial
system:
  v: http://standardterms.edqm.eu
  l: standardterms.edqm.eu
code:
  v: 15060000

v: 4QD397987E

v: Histidine

v: X573657P6P

v: Histidine hydrochloride monohydrate

v: 7YIN7J07X4

v: Trehalose dihydrate

v: 7T1F30V5YH

v: Polysorbate 20

v: 059QF0KO0R

v: Water

v: 10057352

v: Metastatic carcinoma of the bladder

v: 756005042000002

v: therapeutic