CH EPL (R5)
1.0.0-ci-build - ci-build
CH EPL (R5)
1.0.0-ci-build - ci-build
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 1.0.0-ci-build 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
Profile: IDMP Bundle
Bundle 08f553cb-1404-4972-bf14-2023a5f59955 of type collection
Entry 1 - fullUrl = http://example.org/MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet
Resource MedicinalProductDefinition:
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:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID/CH-7640109110007-6771901indication:
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
attachedDocument:
- DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-abc-123; status = current; type = Fachinformation; date = 2020-09-01 00:00:00+0000
- DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#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)
Entry 2 - fullUrl = http://example.org/DocumentReference/DocRef-FI-Cuprior
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-abc-123status: 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
Entry 3 - fullUrl = http://example.org/DocumentReference/DocRef-PI-Cuprior
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-abc-321status: 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
Entry 4 - fullUrl = http://example.org/RegulatedAuthorisation/MA-6771901
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/6771901type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 2021-01-21
holder: Organization Curatis AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100082791, GLN Identifier/7640109110007
name: Curatis AG
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 5 - fullUrl = http://example.org/PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet
Resource PackagedProductDefinition:
Profile: IDMP PackagedProductDefinition
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7640109110007-6771901-001containedItemQuantity: 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://example.org/RegulatedAuthorisation/MA-67719001
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/67719001type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 2021-01-21
holder: Organization Curatis AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100082791, GLN Identifier/7640109110007
name: Curatis AG
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 7 - fullUrl = http://example.org/RegulatedAuthorisation/FOPH-21208
Resource 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
type: Reimbursement SL
Indications
Extension Reference ClinicalUseDefinition: type = indication holder: Organization Curatis AG
Profile: CH EPL Organization
identifier: LOC Identifier/100082791, GLN Identifier/7640109110007
name: Curatis AG
Entry 8 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Trientinum-150mg-Filmcoatedtablet
Resource ManufacturedItemDefinition:
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Film-coated tablet
unitOfPresentation: Tablet
Entry 9 - fullUrl = http://example.org/AdministrableProductDefinition/PhP-Trientinum-150mg-Filmcoatedtablet
Resource AdministrableProductDefinition:
status: Active
administrableDoseForm: Film-coated tablet
unitOfPresentation: Tablet
RouteOfAdministrations
Code Oral use
Entry 10 - fullUrl = http://example.org/Ingredient/Trientinum150
Resource Ingredient:
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')
Entry 11 - fullUrl = http://example.org/ClinicalUseDefinition/IND-10061091
Resource ClinicalUseDefinition:
type: Indication
indication
DiseaseSymptomProcedures
Concept Wilson's disease IntendedEffects
Concept therapeutic
Entry 12 - fullUrl = http://example.org/ClinicalUseDefinition/LIM-79886009
Resource ClinicalUseDefinition:
type: Indication
indication
DiseaseSymptomProcedures
Concept Disorder of copper metabolism IntendedEffects
Concept therapeutic