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 c97d5d89-4467-4c1e-9954-9d1e1d1d46e2 of type collection
Entry 1 - fullUrl = http://example.org/MedicinalProductDefinition/Triogen-250mg-Capsule
Resource MedicinalProductDefinition:
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-7601001403062-6743101indication:
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)
Entry 2 - fullUrl = http://example.org/DocumentReference/DocRef-FI-Triogen
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-qrs-123status: 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
Entry 3 - fullUrl = http://example.org/DocumentReference/DocRef-PI-Triogen
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-qrs-321status: 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
Entry 4 - fullUrl = http://example.org/RegulatedAuthorisation/MA-6743101
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/6743101type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 2020-05-28
holder: Organization IDEOGEN AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100012910, GLN Identifier/7601001403062
name: IDEOGEN AG
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 5 - fullUrl = http://example.org/PackagedProductDefinition/PMP-Triogen-250mg-Capsule
Resource PackagedProductDefinition:
Profile: IDMP PackagedProductDefinition
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7601001403062-6743101-001containedItemQuantity: 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
Entry 6 - fullUrl = http://example.org/RegulatedAuthorisation/MA-67431001
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/67431001type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 2020-05-28
holder: Organization IDEOGEN AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100012910, GLN Identifier/7601001403062
name: IDEOGEN AG
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 7 - fullUrl = http://example.org/RegulatedAuthorisation/FOPH-21070
Resource RegulatedAuthorization:
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
type: Reimbursement SL
Indications
Extension Reference ClinicalUseDefinition: type = indication holder: Organization IDEOGEN AG
Profile: CH EPL Organization
identifier: LOC Identifier/100012910, GLN Identifier/7601001403062
name: IDEOGEN AG
Entry 8 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Trientinum-250mg-Capsule
Resource ManufacturedItemDefinition:
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Capsule, hard
unitOfPresentation: Capsule
Entry 9 - fullUrl = http://example.org/AdministrableProductDefinition/PhP-Trientinum-250mg-Capsule
Resource AdministrableProductDefinition:
status: Active
administrableDoseForm: Capsule, hard
unitOfPresentation: Capsule
RouteOfAdministrations
Code Oral use
Entry 10 - fullUrl = http://example.org/Ingredient/Trientinum250
Resource Ingredient:
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')
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