CUPRIOR Filmtabl 150 mg (Bundle)

CH EPL (R5)
1.0.1 - trial-use Switzerland flag

CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions

Example Bundle: CUPRIOR Filmtabl 150 mg (Bundle)

Profile: Bundle

Bundle 08f553cb-1404-4972-bf14-2023a5f59955 of type collection

Entry 1 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPMedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet

Resource MedicinalProductDefinition:

Profile: MedicinalProductDefinition
CH SMC - Authorized Dose Form: Film-coated tablet
identifier: Medical Product Identifier/CH-01100726-0677190010000
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, 07.99. Varia
attachedDocument:
DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-abc-123; status = current; type = Information for healthcare professionals; 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 = Patient Information; date = 2020-09-01 00:00:00+0000
name
productName: Cuprior 150 mg, Filmtabletten
type: FOPH Medicinal Product Name
Usages
- Country Language
* Switzerland German (Switzerland)

Entry 2 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-FI-Cuprior

Resource DocumentReference:

Language: de-CH
Profile: DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-123
status: Current
type: Information for healthcare professionals
date: 2020-09-01 00:00:00+0000
content
Attachments
- Url
* https://swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67719&supportMultipleResults=1

Entry 3 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-PI-Cuprior

Resource DocumentReference:

Language: de-CH
Profile: DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-321
status: Current
type: Patient Information
date: 2020-09-01 00:00:00+0000
content
Attachments
- Url
* https://swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67719&supportMultipleResults=1

Entry 4 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-6771901

Resource RegulatedAuthorization:

Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/6771901
subject: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; 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,07.99. Varia
type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 2021-01-21
holder: Organization Curatis AG
regulator: Organization Swissmedic Swiss Agency for Therapeutic Products

Profile: Organization
identifier: https://www.swissmedic.ch/fhir/identifier/locations/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007
name: Curatis AG

Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: Swissmedic Swiss Agency for Therapeutic Products

Entry 5 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPPackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet

Resource PackagedProductDefinition:

Profile: PackagedProductDefinition
identifier: Clinical Product Identifier/CH-01100726-0677190010000-0001
packageFor: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; 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,07.99. Varia
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

Entry 6 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorization/MA-67719001

Resource RegulatedAuthorization:

Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/67719001
subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01100726-0677190010000-0001; 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 Swissmedic Swiss Agency for Therapeutic Products

Profile: Organization
identifier: https://www.swissmedic.ch/fhir/identifier/locations/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007
name: Curatis AG

Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: Swissmedic Swiss Agency for Therapeutic Products

Entry 7 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorization/FOPH-21208

Resource RegulatedAuthorization:

Profile: RegulatedAuthorization
CH EPL - Reimbursement SL
url
FOPHDossierNumber
value: FOPH Dossier Number/21208
url
status
value: Reimbursed
url
statusDate
value: 2021-08-01
url
listingStatus
value: Listed
url
listingPeriod
value: 2021-08-01 --> (ongoing)
url
firstListingDate
value: 2021-08-01
url
costShare
value: 10
url
gamme
value: Oral
value: CHF3,022.10 (CHF)
type: Ex-factory price
changeType: Price mutation after triennal review of pharmaceuticals
changeDate: 2024-01-01
url
CH EPL - Product Price
value: CHF3,347.10 (CHF)
type: Retail price
changeType: VAT-change
changeDate: 2024-01-01
url
CH EPL - Product Price
subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01100726-0677190010000-0001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk
type: Reimbursement SL
Indications
- Extension Reference
* ClinicalUseDefinition: type = indication
holder: Organization Curatis AG

Profile: Organization
identifier: https://www.swissmedic.ch/fhir/identifier/locations/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007
name: Curatis AG

Entry 8 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Trientinum-150mg-Filmcoatedtablet

Resource ManufacturedItemDefinition:

Profile: ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Film-coated tablet
unitOfPresentation: Tablet

Entry 9 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPAdministrableProductDefinition/PhP-Trientinum-150mg-Filmcoatedtablet

Resource AdministrableProductDefinition:

Profile: AdministrableProductDefinition
status: Active
formOf: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; 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,07.99. Varia
administrableDoseForm: Film-coated tablet
unitOfPresentation: Tablet
RouteOfAdministrations
- Code
* Oral use

Entry 10 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPIngredient/Trientinum150

Resource Ingredient:

Profile: 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')

Entry 11 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10061091

Resource ClinicalUseDefinition:

Profile: ClinicalUseDefinition Indication
type: Indication
subject: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; 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,07.99. Varia
indication
DiseaseSymptomProcedures
- Concept
* Wilson's disease
IntendedEffects
- Concept
* therapeutic

Entry 12 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/LIM-79886009-CUPRIOR

Resource ClinicalUseDefinition:

type: Indication
indication
DiseaseSymptomProcedures
- Concept
* 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.
IntendedEffects
- Concept
* therapeutic

IG © 2023+ Federal Office of Public Health FOPH. Package ch.fhir.ig.ch-epl#1.0.1 based on FHIR 5.0.0. Generated 2026-03-30
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