http://fhir.ch/ig/ch-epl/Bundle/08f553cb-1404-4972-bf14-2023a5f59955
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle
    l: ch-idmp-bundle
type:
  v: collection
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPMedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet
    l: Cuprior-150mg-Filmcoatedtablet
  resource: Cuprior-150mg-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-FI-Cuprior
    l: DocRef-FI-Cuprior
  resource: DocRef-FI-Cuprior
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-PI-Cuprior
    l: DocRef-PI-Cuprior
  resource: DocRef-PI-Cuprior
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-6771901
    l: MA-6771901
  resource: MA-6771901
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPPackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet
    l: PMP-Cuprior-150mg-Filmcoatedtablet
  resource: PMP-Cuprior-150mg-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorization/MA-67719001
    l: MA-67719001
  resource: MA-67719001
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorization/FOPH-21208
    l: FOPH-21208
  resource: FOPH-21208
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Trientinum-150mg-Filmcoatedtablet
    l: MI-Trientinum-150mg-Filmcoatedtablet
  resource: MI-Trientinum-150mg-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPAdministrableProductDefinition/PhP-Trientinum-150mg-Filmcoatedtablet
    l: PhP-Trientinum-150mg-Filmcoatedtablet
  resource: PhP-Trientinum-150mg-Filmcoatedtablet
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPIngredient/Trientinum150
    l: Trientinum150
  resource: Trientinum150
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10061091
    l: IND-10061091
  resource: IND-10061091
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/LIM-79886009
    l: LIM-79886009
  resource: LIM-79886009

Cuprior-150mg-Filmcoatedtablet
type: MedicinalProductDefinition
id:
  v: Cuprior-150mg-Filmcoatedtablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition
    l: ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: MedicinalProductDefinition Cuprior-150mg-Filmcoatedtablet Profile: IDMP MedicinalProductDefinition CH - SMC Authorized Dose Form: Film-coated tablet CH - EPL Full Limitation Text: 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: Medical Product Identifier/CH-7640109110007-6771901 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, 07. STOFFWECHSEL attachedDocument: DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-abc-123; status = current; type = Fachinformation; date = 2020-09-01 00:00:00+0000 DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-abc-321; status = current; type = Patienteninformation; date = 2020-09-01 00:00:00+0000 name productName: Cuprior 150 mg, Filmtabletten type: Zugelassener Arzneimittelname Usages - Country Language * Switzerland German (Switzerland)
extension:
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
    l: authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 10221000
      display:
        v: Film-coated tablet
extension:
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
    l: fullLimitationText
  value: String
    v: 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:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/mpid
    l: mpid
  value:
    v: CH-7640109110007-6771901
indication:
  v: 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.
legal status of supply:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
      l: 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
      l: 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
      l: 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
      l: atc
    code:
      v: L01EX13
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category
      l: 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
      l: 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
      l: ch-epl-foph-product-type
    code:
      v: 756001003002
    display:
      v: Originator product
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus
      l: ch-epl-foph-index-therapeuticus
    code:
      v: 070000
    display:
      v: 07. STOFFWECHSEL
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus
      l: ch-epl-foph-index-therapeuticus
    code:
      v: 079900
    display:
      v: 07.99. Varia
attached document:
  l: DocRef-FI-Cuprior
  reference:
    v: DocumentReference/DocRef-FI-Cuprior
attached document:
  l: DocRef-PI-Cuprior
  reference:
    v: DocumentReference/DocRef-PI-Cuprior
name:
  product name:
    v: Cuprior 150 mg, Filmtabletten
  type:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type
        l: ch-medicinal-product-name-type
      code:
        v: SMC
      display:
        v: Zugelassener Arzneimittelname

DocRef-FI-Cuprior
type: DocumentReference
id:
  v: DocRef-FI-Cuprior
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DocumentReference DocRef-FI-Cuprior Language: de-CH Profile: CH IDMP DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-123 status: Current type: Fachinformation date: 2020-09-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67719&supportMultipleResults=1
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/attno
    l: attno
  value:
    v: 123456789-initial submission-Example-abc-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005007001
    display:
      v: Fachinformation
date:
  v: 2020-09-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showText.aspx
      l: https://swissmedicinfo.ch/showText.aspx

DocRef-PI-Cuprior
type: DocumentReference
id:
  v: DocRef-PI-Cuprior
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DocumentReference DocRef-PI-Cuprior Language: de-CH Profile: CH IDMP DocumentReference identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-321 status: Current type: Patienteninformation date: 2020-09-01 00:00:00+0000 content Attachments - Url * https://swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67719&supportMultipleResults=1
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/attno
    l: attno
  value:
    v: 123456789-initial submission-Example-abc-321
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005007002
    display:
      v: Patienteninformation
date:
  v: 2020-09-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showText.aspx
      l: https://swissmedicinfo.ch/showText.aspx

MA-6771901
type: RegulatedAuthorization
id:
  v: MA-6771901
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-6771901 Profile: IDMP RegulatedAuthorization identifier: Marketing Authorisation Number/6771901 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://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; 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,07. STOFFWECHSEL type: Marketing Authorisation region: Switzerland status: valid statusDate: 2021-01-21 holder: Organization Curatis AG regulator: Organization SMC Generated Narrative: Organization #holder-Curatis-AG Profile: CH EPL Organization identifier: LOC Identifier/100082791, GLN Identifier/7640109110007 name: Curatis AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Curatis-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      l: ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
      l: 1.2.276.0.76
    value:
      v: 100082791
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7640109110007
  name:
    v: Curatis AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      l: ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
      l: 1.2.276.0.76
    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-epl/sid/authno
    l: authno
  value:
    v: 6771901
subject:
  l: Cuprior-150mg-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    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-epl/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 2021-01-21
holder:
  l: holder-Curatis-AG
  reference:
    v: #holder-Curatis-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

PMP-Cuprior-150mg-Filmcoatedtablet
type: PackagedProductDefinition
id:
  v: PMP-Cuprior-150mg-Filmcoatedtablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition
    l: ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition PMP-Cuprior-150mg-Filmcoatedtablet Profile: IDMP PackagedProductDefinition identifier: Clinical Product Identifier/CH-7640109110007-6771901-001 packageFor: 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://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; 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,07. STOFFWECHSEL containedItemQuantity: 72 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet') description: CUPRIOR Filmtabl 150 mg 72 Stk LegalStatusOfSupplies - Code * Medicinal product subject to medical or veterinary prescription (B) packaging identifier: Global Trade Item Number/7680677190018 type: Box quantity: 1 ShelfLifeStorages - Type Period[x] SpecialPrecautionsForStorage * Shelf life of the medicinal product as packaged for sale No display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo) Do not store above 30°C Characteristics - Type Value[x] * Package Size Type Modal pack
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/pcid
    l: pcid
  value:
    v: CH-7640109110007-6771901-001
package for:
  l: Cuprior-150mg-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet
contained item quantity:
  value:
    v: 72
  unit:
    v: Tablet
  system:
    v: http://standardterms.edqm.eu
    l: standardterms.edqm.eu
  code:
    v: 15054000
description:
  v: CUPRIOR Filmtabl 150 mg 72 Stk
legal status of supply:
  code:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
        l: 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
      l: 2.51.1.1
    value:
      v: 7680677190018
  type:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 30009000
      display:
        v: Box
  quantity:
    v: 1
  shelf life storage:
    period: Duration
      value:
        v: 36
      unit:
        v: month
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mo
characteristic:
  type:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-other-characteristics-type
        l: ch-other-characteristics-type
      code:
        v: 756000003001
      display:
        v: Package Size Type
  value: CodeableConcept
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-other-characteristics-packaged-item
        l: ch-epl-foph-other-characteristics-packaged-item
      code:
        v: 756005041001
      display:
        v: Modal pack

MA-67719001
type: RegulatedAuthorization
id:
  v: MA-67719001
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-67719001 Profile: IDMP RegulatedAuthorization identifier: Marketing Authorisation Number/67719001 subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7640109110007-6771901-001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk type: Marketing Authorisation region: Switzerland status: valid statusDate: 2021-01-21 holder: Organization Curatis AG regulator: Organization SMC Generated Narrative: Organization #holder-Curatis-AG Profile: CH EPL Organization identifier: LOC Identifier/100082791, GLN Identifier/7640109110007 name: Curatis AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Curatis-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      l: ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
      l: 1.2.276.0.76
    value:
      v: 100082791
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7640109110007
  name:
    v: Curatis AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      l: ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
      l: 1.2.276.0.76
    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-epl/sid/authno
    l: authno
  value:
    v: 67719001
subject:
  l: PMP-Cuprior-150mg-Filmcoatedtablet
  reference:
    v: PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    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-epl/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 2021-01-21
holder:
  l: holder-Curatis-AG
  reference:
    v: #holder-Curatis-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

FOPH-21208
type: RegulatedAuthorization
id:
  v: FOPH-21208
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: RegulatedAuthorization FOPH-21208 Profile: IDMP RegulatedAuthorization CH - EPL Reimbursement SL FOPHDossierNumber: FOPH Dossier Number/21208 status: Reimbursed statusDate: 2021-08-01 listingStatus: Listed listingPeriod: 2021-08-01 --> (ongoing) firstListingDate: 2021-08-01 costShare: 10 gamme: Oral CH - EPL Product Price value: CHF3,022.10 (CHF) type: Ex-factory price changeType: Price mutation after triennal review of pharmaceuticals changeDate: 2024-01-01 CH - EPL Product Price value: CHF3,347.10 (CHF) type: Retail price changeType: VAT-change changeDate: 2024-01-01 subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7640109110007-6771901-001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk type: Reimbursement SL Indications - Extension Reference * ClinicalUseDefinition: type = indication holder: Organization Curatis AG Generated Narrative: Organization #holder-Curatis-AG Profile: CH EPL Organization identifier: LOC Identifier/100082791, GLN Identifier/7640109110007 name: Curatis AG
contained: Organization
  id:
    v: holder-Curatis-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      l: ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
      l: 1.2.276.0.76
    value:
      v: 100082791
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7640109110007
  name:
    v: Curatis AG
extension:
  extension:
    url:
      v: FOPHDossierNumber
      l: FOPHDossierNumber
    value: Identifier
      system:
        v: urn:oid:2.16.756.1
        l: 2.16.756.1
      value:
        v: 21208
  extension:
    url:
      v: status
      l: status
    value: CodeableConcept
  extension:
    url:
      v: statusDate
      l: statusDate
    value: Date
      v: 2021-08-01
  extension:
    url:
      v: listingStatus
      l: listingStatus
    value: CodeableConcept
  extension:
    url:
      v: listingPeriod
      l: listingPeriod
    value: Period
      start:
        v: 2021-08-01
  extension:
    url:
      v: firstListingDate
      l: firstListingDate
    value: Date
      v: 2021-08-01
  extension:
    url:
      v: costShare
      l: costShare
    value: Integer
      v: 10
  extension:
    url:
      v: gamme
      l: gamme
    value: CodeableConcept
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL
    l: reimbursementSL
extension:
  extension:
    url:
      v: value
      l: value
    value: Money
      value:
        v: 3022.1
      currency:
        v: CHF
  extension:
    url:
      v: type
      l: type
    value: CodeableConcept
  extension:
    url:
      v: changeType
      l: changeType
    value: CodeableConcept
  extension:
    url:
      v: changeDate
      l: changeDate
    value: Date
      v: 2024-01-01
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
    l: productPrice
extension:
  extension:
    url:
      v: value
      l: value
    value: Money
      value:
        v: 3347.1
      currency:
        v: CHF
  extension:
    url:
      v: type
      l: type
    value: CodeableConcept
  extension:
    url:
      v: changeType
      l: changeType
    value: CodeableConcept
  extension:
    url:
      v: changeDate
      l: changeDate
    value: Date
      v: 2024-01-01
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
    l: productPrice
subject:
  l: PMP-Cuprior-150mg-Filmcoatedtablet
  reference:
    v: PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    code:
      v: 756000002003
    display:
      v: Reimbursement SL
indication:
  extension:
    extension:
      url:
        v: status
        l: status
      value: CodeableConcept
    extension:
      url:
        v: statusDate
        l: statusDate
      value: Date
        v: 2021-08-01
    extension:
      url:
        v: period
        l: period
      value: Period
    extension:
      url:
        v: firstLimitationDate
        l: firstLimitationDate
      value: Date
        v: 2021-08-01
    extension:
      url:
        v: indicationCode
        l: indicationCode
      value: String
        v: ABCDE.XX
    extension:
      url:
        v: limitationIndication
        l: limitationIndication
      value: Reference
        l: LIM-79886009
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: Date

MI-Trientinum-150mg-Filmcoatedtablet
type: ManufacturedItemDefinition
id:
  v: MI-Trientinum-150mg-Filmcoatedtablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Trientinum-150mg-Filmcoatedtablet Profile: CH IDMP ManufacturedItemDefinition status: Active manufacturedDoseForm: Film-coated tablet unitOfPresentation: Tablet
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10221000
    display:
      v: Film-coated tablet
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15054000
    display:
      v: Tablet

PhP-Trientinum-150mg-Filmcoatedtablet
type: AdministrableProductDefinition
id:
  v: PhP-Trientinum-150mg-Filmcoatedtablet
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition
    l: ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition PhP-Trientinum-150mg-Filmcoatedtablet Profile: CH IDMP AdministrableProductDefinition status: Active formOf: 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://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; 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,07. STOFFWECHSEL administrableDoseForm: Film-coated tablet unitOfPresentation: Tablet RouteOfAdministrations - Code * Oral use
status:
  v: active
form of:
  l: Cuprior-150mg-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10221000
    display:
      v: Film-coated tablet
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15054000
    display:
      v: Tablet
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 20053000
      display:
        v: Oral use

Trientinum150
type: Ingredient
id:
  v: Trientinum150
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Trientinum150 Profile: IDMP Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * Trientine Strengths - Presentation[x] * 150 mg (Details: UCUM codemg = 'mg')/1 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
status:
  v: active
for:
  l: PhP-Trientinum-150mg-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Trientinum-150mg-Filmcoatedtablet
for:
  l: MI-Trientinum-150mg-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Trientinum-150mg-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role
      l: 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
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: 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://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-7640109110007-6771901; 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,07. STOFFWECHSEL indication DiseaseSymptomProcedures - Concept * Wilson's disease IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Cuprior-150mg-Filmcoatedtablet
  reference:
    v: MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet

LIM-79886009
type: ClinicalUseDefinition
id:
  v: LIM-79886009
text:
  status:
    v: generated
  div:
    v: 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
l: 3166

v: CH

v: Switzerland

v: urn:ietf:bcp:47
l: 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: 756002006007

v: Price mutation after triennal review of pharmaceuticals

v: 756002005001

v: Retail price

v: 756002006005

v: VAT-change

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

v: 2021-08-01

v: ClinicalUseDefinition/LIM-79886009

v: value
l: value

Money
value:
  v: 3022.1
currency:
  v: CHF

v: type
l: type

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

v: changeType
l: changeType

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

v: changeDate
l: changeDate

Date
v: 2024-01-01

extension:
  url:
    v: value
    l: value
  value: Money
    value:
      v: 3347.1
    currency:
      v: CHF
extension:
  url:
    v: type
    l: type
  value: CodeableConcept
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
        l: ch-epl-foph-price-type
      code:
        v: 756002005001
      display:
        v: Retail price
extension:
  url:
    v: changeType
    l: changeType
  value: CodeableConcept
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
        l: ch-epl-foph-type-of-price-change
      code:
        v: 756002006005
      display:
        v: VAT-change
extension:
  url:
    v: changeDate
    l: changeDate
  value: Date
    v: 2024-01-01
url:
  v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
  l: productPrice

l: IND-10061091
reference:
  v: ClinicalUseDefinition/IND-10061091

l: holder-Curatis-AG
reference:
  v: #holder-Curatis-AG

v: SJ76Y07H5F

v: Trientine

v: 150

v: mg

v: mg

v: 1

v: Tablet

v: 15054000

v: 10061091

v: Wilson's disease

v: 200000003194

v: therapeutic

v: 79886009

v: Disorder of copper metabolism

v: 200000003194

v: therapeutic