http://fhir.ch/ig/ch-epl/Bundle/c97d5d89-4467-4c1e-9954-9d1e1d1d46e2
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle
type:
  v: collection
entry:
  full url:
    v: http://example.org/MedicinalProductDefinition/Triogen-250mg-Capsule
  resource: Triogen-250mg-Capsule
entry:
  full url:
    v: http://example.org/DocumentReference/DocRef-FI-Triogen
  resource: DocRef-FI-Triogen
entry:
  full url:
    v: http://example.org/DocumentReference/DocRef-PI-Triogen
  resource: DocRef-PI-Triogen
entry:
  full url:
    v: http://example.org/RegulatedAuthorisation/MA-6743101
  resource: MA-6743101
entry:
  full url:
    v: http://example.org/PackagedProductDefinition/PMP-Triogen-250mg-Capsule
  resource: PMP-Triogen-250mg-Capsule
entry:
  full url:
    v: http://example.org/RegulatedAuthorisation/MA-67431001
  resource: MA-67431001
entry:
  full url:
    v: http://example.org/RegulatedAuthorisation/FOPH-21070
  resource: FOPH-21070
entry:
  full url:
    v: http://example.org/ManufacturedItemDefinition/MI-Trientinum-250mg-Capsule
  resource: MI-Trientinum-250mg-Capsule
entry:
  full url:
    v: http://example.org/AdministrableProductDefinition/PhP-Trientinum-250mg-Capsule
  resource: PhP-Trientinum-250mg-Capsule
entry:
  full url:
    v: http://example.org/Ingredient/Trientinum250
  resource: Trientinum250
entry:
  full url:
    v: http://example.org/ClinicalUseDefinition/IND-10061091
  resource: IND-10061091
entry:
  full url:
    v: http://example.org/ClinicalUseDefinition/LIM-79886009
  resource: LIM-79886009

Triogen-250mg-Capsule
type: MedicinalProductDefinition
id:
  v: Triogen-250mg-Capsule
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div: Generated Narrative: MedicinalProductDefinition Triogen-250mg-Capsule Profile: IDMP MedicinalProductDefinition CH - SMC Authorized Dose Form: Capsule, hard CH - EPL Full Limitation Text: TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden. identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID/CH-7601001403062-6743101 domain: Human indication: Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. legalStatusOfSupply: Medicinal product subject to medical or veterinary prescription (B) additionalMonitoringIndicator: No Warning pediatricUseIndicator: Authorised for the treatment in children classification: trientine, NA KAS art. 12 para. 5 TPLO, Synthetic, Originator product attachedDocument: DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-qrs-123; status = current; type = Fachinformation; date = 2019-12-01 00:00:00+0000 DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-qrs-321; status = current; type = Patienteninformation; date = 2019-12-01 00:00:00+0000 name productName: Triogen 250 mg, Kapseln type: Zugelassener Arzneimittelname Usages - Country Language * Switzerland German (Switzerland)
extension:
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
      code:
        v: 10210000
      display:
        v: Capsule, hard
extension:
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
  value: string
    v: TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID
  value:
    v: CH-7601001403062-6743101
domain:
  coding:
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000000004
    code:
      v: 100000000012
    display:
      v: Human
indication:
  v: Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.
legal status of supply:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
    code:
      v: 756005022003
    display:
      v: Medicinal product subject to medical or veterinary prescription (B)
additional monitoring indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator
    code:
      v: 756005001003
    display:
      v: No Warning
pediatric use indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator
    code:
      v: 756005003001
    display:
      v: Authorised for the treatment in children
classification:
  coding:
    system:
      v: http://www.whocc.no/atc
    code:
      v: A16AX12
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category
    code:
      v: 756005021001
    display:
      v: NA KAS art. 12 para. 5 TPLO
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
    code:
      v: 756005004001
    display:
      v: Synthetic
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
    code:
      v: 756001003002
    display:
      v: Originator product
attached document:
  link: http://fhir.ch/ig/ch-epl/DocumentReference/DocRef-FI-Triogen
  reference:
    v: DocumentReference/DocRef-FI-Triogen
attached document:
  link: http://fhir.ch/ig/ch-epl/DocumentReference/DocRef-PI-Triogen
  reference:
    v: DocumentReference/DocRef-PI-Triogen
name:
  product name:
    v: Triogen 250 mg, Kapseln
  type:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type
      code:
        v: SMC
      display:
        v: Zugelassener Arzneimittelname

DocRef-FI-Triogen
type: DocumentReference
id:
  v: DocRef-FI-Triogen
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div: Generated Narrative: DocumentReference DocRef-FI-Triogen Language: de-CH Profile: CH IDMP DocumentReference identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-qrs-123 status: Current type: Fachinformation date: 2019-12-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=67431&supportMultipleResults=1
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber
  value:
    v: 123456789-initial submission-Example-qrs-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
    code:
      v: 756005007001
    display:
      v: Fachinformation
date:
  v: 2019-12-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showTextAccepted.aspx

DocRef-PI-Triogen
type: DocumentReference
id:
  v: DocRef-PI-Triogen
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div: Generated Narrative: DocumentReference DocRef-PI-Triogen Language: de-CH Profile: CH IDMP DocumentReference identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-qrs-321 status: Current type: Patienteninformation date: 2019-12-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=67431&supportMultipleResults=1
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber
  value:
    v: 123456789-initial submission-Example-qrs-321
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
    code:
      v: 756005007002
    display:
      v: Patienteninformation
date:
  v: 2019-12-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showTextAccepted.aspx

MA-6743101
type: RegulatedAuthorization
id:
  v: MA-6743101
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization MA-6743101 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/6743101 subject: MedicinalProductDefinition: extension = Capsule, hard,TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001403062-6743101; domain = Human; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product type: Marketing Authorisation region: Switzerland status: valid statusDate: 2020-05-28 holder: Organization IDEOGEN AG regulator: Organization SMC Generated Narrative: Organization #holder-Ideogen-AG Profile: CH EPL Organization identifier: LOC Identifier/100012910, GLN Identifier/7601001403062 name: IDEOGEN AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Ideogen-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100012910
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001403062
  name:
    v: IDEOGEN AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber
  value:
    v: 6743101
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Triogen-250mg-Capsule
  reference:
    v: MedicinalProductDefinition/Triogen-250mg-Capsule
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 2020-05-28
holder:
  reference:
    v: #holder-Ideogen-AG
regulator:
  reference:
    v: #regulator-SMC

PMP-Triogen-250mg-Capsule
type: PackagedProductDefinition
id:
  v: PMP-Triogen-250mg-Capsule
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div: Generated Narrative: PackagedProductDefinition PMP-Triogen-250mg-Capsule Profile: IDMP PackagedProductDefinition identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7601001403062-6743101-001 packageFor: MedicinalProductDefinition: extension = Capsule, hard,TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001403062-6743101; domain = Human; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product containedItemQuantity: 100 Capsule (Details: EDQM - Standard Terms code15012000 = 'Capsule') description: TRIOGEN Kaps 250 mg Ds 100 Stk LegalStatusOfSupplies - Code * Medicinal product subject to medical or veterinary prescription (B) packaging identifier: Global Trade Item Number/7680674310013 type: Box quantity: 1 ShelfLifeStorages - Type SpecialPrecautionsForStorage * Shelf life of the medicinal product as packaged for sale Do not store above 30°C
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID
  value:
    v: CH-7601001403062-6743101-001
package for:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Triogen-250mg-Capsule
  reference:
    v: MedicinalProductDefinition/Triogen-250mg-Capsule
contained item quantity:
  value:
    v: 100
  unit:
    v: Capsule
  system:
    v: http://standardterms.edqm.eu
  code:
    v: 15012000
description:
  v: TRIOGEN Kaps 250 mg Ds 100 Stk
legal status of supply:
  code:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
      code:
        v: 756005022003
      display:
        v: Medicinal product subject to medical or veterinary prescription (B)
packaging:
  identifier:
    system:
      v: urn:oid:2.51.1.1
    value:
      v: 7680674310013
  type:
    coding:
      system:
        v: http://standardterms.edqm.eu
      code:
        v: 30009000
      display:
        v: Box
  quantity:
    v: 1

MA-67431001
type: RegulatedAuthorization
id:
  v: MA-67431001
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization MA-67431001 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/67431001 subject: MedicinalProductDefinition: extension = Capsule, hard,TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001403062-6743101; domain = Human; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product type: Marketing Authorisation region: Switzerland status: valid statusDate: 2020-05-28 holder: Organization IDEOGEN AG regulator: Organization SMC Generated Narrative: Organization #holder-Ideogen-AG Profile: CH EPL Organization identifier: LOC Identifier/100012910, GLN Identifier/7601001403062 name: IDEOGEN AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Ideogen-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100012910
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001403062
  name:
    v: IDEOGEN AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber
  value:
    v: 67431001
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Triogen-250mg-Capsule
  reference:
    v: MedicinalProductDefinition/Triogen-250mg-Capsule
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 2020-05-28
holder:
  reference:
    v: #holder-Ideogen-AG
regulator:
  reference:
    v: #regulator-SMC

FOPH-21070
type: RegulatedAuthorization
id:
  v: FOPH-21070
text:
  status:
    v: extensions
  div: Generated Narrative: RegulatedAuthorization FOPH-21070 CH - EPL Reimbursement SL FOPHDossierNumber: FOPH Dossier Number/21070 status: Reimbursed statusDate: 2020-09-01 listingStatus: Listed listingPeriod: 2020-09-01 --> (ongoing) firstListingDate: 2020-09-01 costShare: 10 gamme: Oral CH - EPL Product Price value: CHF4,117.12 (CHF) type: Ex-factory price changeType: Price mutation at first listing changeDate: 2020-09-01 CH - EPL Product Price value: CHF4,470.40 (CHF) type: Retail price changeType: VAT-change changeDate: 2024-01-01 subject: PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001403062-6743101-001; containedItemQuantity = 100 Capsule; description = TRIOGEN Kaps 250 mg Ds 100 Stk type: Reimbursement SL Indications - Extension Reference * ClinicalUseDefinition: type = indication holder: Organization IDEOGEN AG Generated Narrative: Organization #holder-Ideogen-AG Profile: CH EPL Organization identifier: LOC Identifier/100012910, GLN Identifier/7601001403062 name: IDEOGEN AG
contained: Organization
  id:
    v: holder-Ideogen-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100012910
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001403062
  name:
    v: IDEOGEN AG
extension:
  extension:
    url:
      v: FOPHDossierNumber
    value: Identifier
      system:
        v: urn:oid:2.16.756.1
      value:
        v: 21070
  extension:
    url:
      v: status
    value: CodeableConcept
  extension:
    url:
      v: statusDate
    value: date
      v: 2020-09-01
  extension:
    url:
      v: listingStatus
    value: CodeableConcept
  extension:
    url:
      v: listingPeriod
    value: Period
      start:
        v: 2020-09-01
  extension:
    url:
      v: firstListingDate
    value: date
      v: 2020-09-01
  extension:
    url:
      v: costShare
    value: integer
      v: 10
  extension:
    url:
      v: gamme
    value: CodeableConcept
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL
extension:
  extension:
    url:
      v: value
    value: Money
      value:
        v: 4117.12
      currency:
        v: CHF
  extension:
    url:
      v: type
    value: CodeableConcept
  extension:
    url:
      v: changeType
    value: CodeableConcept
  extension:
    url:
      v: changeDate
    value: date
      v: 2020-09-01
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
extension:
  extension:
    url:
      v: value
    value: Money
      value:
        v: 4470.4
      currency:
        v: CHF
  extension:
    url:
      v: type
    value: CodeableConcept
  extension:
    url:
      v: changeType
    value: CodeableConcept
  extension:
    url:
      v: changeDate
    value: date
      v: 2024-01-01
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
subject:
  link: http://fhir.ch/ig/ch-epl/PackagedProductDefinition/PMP-Triogen-250mg-Capsule
  reference:
    v: PackagedProductDefinition/PMP-Triogen-250mg-Capsule
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
    code:
      v: 756000002003
    display:
      v: Reimbursement SL
indication:
  extension:
    extension:
      url:
        v: status
      value: CodeableConcept
    extension:
      url:
        v: statusDate
      value: date
        v: 2020-09-01
    extension:
      url:
        v: period
      value: Period
    extension:
      url:
        v: firstLimitationDate
      value: date
        v: 2020-09-01
    extension:
      url:
        v: limitationIndication
      value: Reference
        link: http://fhir.ch/ig/ch-epl/ClinicalUseDefinition/LIM-79886009
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: date
      url:
        v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: date
      url:
        v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
    url:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation
  reference:
    link: http://fhir.ch/ig/ch-epl/ClinicalUseDefinition/IND-10061091
    reference:
      v: ClinicalUseDefinition/IND-10061091
holder:
  reference:
    v: #holder-Ideogen-AG

MI-Trientinum-250mg-Capsule
type: ManufacturedItemDefinition
id:
  v: MI-Trientinum-250mg-Capsule
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div: Generated Narrative: ManufacturedItemDefinition MI-Trientinum-250mg-Capsule Profile: CH IDMP ManufacturedItemDefinition status: Active manufacturedDoseForm: Capsule, hard unitOfPresentation: Capsule
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 10210000
    display:
      v: Capsule, hard
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 15012000
    display:
      v: Capsule

PhP-Trientinum-250mg-Capsule
type: AdministrableProductDefinition
id:
  v: PhP-Trientinum-250mg-Capsule
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div: Generated Narrative: AdministrableProductDefinition PhP-Trientinum-250mg-Capsule Profile: CH IDMP AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Capsule, hard,TRIOGEN wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001403062-6743101; domain = Human; indication = Zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Patienten, die eine Behandlung mit D-Penicillamin nicht vertragen.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = trientine,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product administrableDoseForm: Capsule, hard unitOfPresentation: Capsule RouteOfAdministrations - Code * Oral use
status:
  v: active
form of:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Triogen-250mg-Capsule
  reference:
    v: MedicinalProductDefinition/Triogen-250mg-Capsule
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 10210000
    display:
      v: Capsule, hard
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 15012000
    display:
      v: Capsule
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
      code:
        v: 20053000
      display:
        v: Oral use

Trientinum250
type: Ingredient
id:
  v: Trientinum250
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient Trientinum250 Profile: IDMP Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Capsule, hard; unitOfPresentation = Capsule ManufacturedItemDefinition: status = active; manufacturedDoseForm = Capsule, hard; unitOfPresentation = Capsule role: Active substance Codes - Concept * Trientine Strengths - Presentation[x] * 250 mg (Details: UCUM codemg = 'mg')/1 Capsule (Details: EDQM - Standard Terms code15012000 = 'Capsule')
status:
  v: active
for:
  link: http://fhir.ch/ig/ch-epl/AdministrableProductDefinition/PhP-Trientinum-250mg-Capsule
  reference:
    v: AdministrableProductDefinition/PhP-Trientinum-250mg-Capsule
for:
  link: http://fhir.ch/ig/ch-epl/ManufacturedItemDefinition/MI-Trientinum-250mg-Capsule
  reference:
    v: ManufacturedItemDefinition/MI-Trientinum-250mg-Capsule
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role
    code:
      v: 756005051001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio

IND-10061091
type: ClinicalUseDefinition
id:
  v: IND-10061091
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div: Generated Narrative: ClinicalUseDefinition IND-10061091 Profile: CH IDMP ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Film-coated tablet,CUPRIOR wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7640109110007-6771901; domain = Human; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product indication DiseaseSymptomProcedures - Concept * Wilson's disease IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet

LIM-79886009
type: ClinicalUseDefinition
id:
  v: LIM-79886009
text:
  status:
    v: generated
  div: Generated Narrative: ClinicalUseDefinition LIM-79886009 type: Indication indication DiseaseSymptomProcedures - Concept * Disorder of copper metabolism IntendedEffects - Concept * therapeutic
type:
  v: indication
indication:
  disease symptom procedure:
    concept:
      coding: http://snomed.info/id/79886009

v: urn:iso:std:iso:3166

v: CH

v: Switzerland

v: urn:ietf:bcp:47

v: de-CH

v: German (Switzerland)

v: 100000073403

v: Shelf life of the medicinal product as packaged for sale

v: 756005042009

v: Do not store above 30°C

v: 756001021001

v: Reimbursed

v: 756001002001

v: Listed

v: 756002004001

v: Oral

v: 756002005002

v: Ex-factory price

v: 756002006010

v: Price mutation at first listing

v: 756002005001

v: Retail price

v: 756002006005

v: VAT-change

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus
code:
  v: 756002071001
display:
  v: Limitation Reimbursed

v: 2020-09-01

v: ClinicalUseDefinition/LIM-79886009

v: value

Money
value:
  v: 4117.12
currency:
  v: CHF

v: type

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
  code:
    v: 756002005002
  display:
    v: Ex-factory price

v: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  code:
    v: 756002006007
  display:
    v: Price mutation after triennal review of pharmaceuticals

v: changeDate

date
v: 2020-09-01

v: value

Money
value:
  v: 4470.4
currency:
  v: CHF

v: type

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
  code:
    v: 756002005001
  display:
    v: Retail price

v: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  code:
    v: 756002006005
  display:
    v: VAT-change

v: changeDate

date
v: 2024-01-01

v: SJ76Y07H5F

v: Trientine

v: 250

v: mg

v: mg

v: 1

v: Capsule

v: 15012000

v: 10061091

v: Wilson's disease

v: 200000003194

v: therapeutic

v: 79886009

v: Disorder of copper metabolism

v: 200000003194

v: therapeutic