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 6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db of type collection
Entry 1 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPMedicinalProductDefinition/Entocort-Solvent-and-Tablet
Resource MedicinalProductDefinition:
Profile: IDMP MedicinalProductDefinition
CH - SMC Authorized Dose Form: Tablet and solvent for rectal suspension
CH - EPL Full Limitation Text: Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.
identifier: Medical Product Identifier/CH-7601001346451-5204201
combinedPharmaceuticalDoseForm: Tablet and solvent for rectal suspension
indication:
Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.
legalStatusOfSupply: Medicinal product subject to medical or veterinary prescription (B)
additionalMonitoringIndicator: No Warning
pediatricUseIndicator: Authorised for the treatment in children
classification: budesonide, NA KAS art. 12 para. 5 TPLO, Synthetic, Originator product
attachedDocument:
- DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-efg-123; status = current; type = Fachinformation; date = 2022-04-01 00:00:00+0000
- DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-efg-321; status = current; type = Patienteninformation; date = 2022-04-01 00:00:00+0000
name
productName: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
type: Zugelassener Arzneimittelname
Usages
Country Language Switzerland German (Switzerland)
Entry 2 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-FI-Entocort
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-efg-123
status: Current
type: Fachinformation
date: 2022-04-01 00:00:00+0000
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1
Entry 3 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-PI-Entocort
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-efg-321
status: Current
type: Patienteninformation
date: 2022-04-01 00:00:00+0000
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1
Entry 4 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-5204201
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier: Marketing Authorisation Number/5204201
type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1993-06-18
holder: Organization Tillotts Pharma AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100005174, GLN Identifier/7601001346451
name: Tillotts Pharma AG
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 5 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPPackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet
Resource PackagedProductDefinition:
Profile: IDMP PackagedProductDefinition
identifier: Clinical Product Identifier/CH-7601001346451-5204201-011
containedItemQuantity: 7 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet'), 7 Bottle (Details: EDQM - Standard Terms code30008000 = 'Bottle')
description:
ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
LegalStatusOfSupplies
Code Medicinal product subject to medical or veterinary prescription (B) packaging
identifier: Global Trade Item Number/7680520420118
type: Box
quantity: 1
ShelfLifeStorages
Type Period[x] SpecialPrecautionsForStorage Shelf life of the medicinal product as packaged for sale No display for Duration (value: 60; unit: month; system: http://unitsofmeasure.org; code: mo) Do not store above 30°C
Entry 6 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-52042011
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier: Marketing Authorisation Number/52042011
type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1993-06-18
holder: Organization Tillotts Pharma AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100005174, GLN Identifier/7601001346451
name: Tillotts Pharma AG
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 7 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/FOPH-17973
Resource RegulatedAuthorization:
CH - EPL Reimbursement SL
- FOPHDossierNumber: FOPH Dossier Number/17973
- status: Reimbursed
- statusDate: 2004-02-01
- listingStatus: Listed
- listingPeriod: 2004-02-01 --> (ongoing)
- firstListingDate: 2004-02-01
- costShare: 10
- gamme: Rectal Vaginal
CH - EPL Product Price
- value: CHF40.89 (CHF)
- type: Ex-factory price
- changeType: Price mutation after triennal review of pharmaceuticals
- changeDate: 2023-12-01
CH - EPL Product Price
- value: CHF63.40 (CHF)
- type: Retail price
- changeType: VAT-change
- changeDate: 2024-01-01
type: Reimbursement SL
Indications
Extension Reference ClinicalUseDefinition: type = indication holder: Organization Tillotts Pharma AG
Profile: CH EPL Organization
identifier: LOC Identifier/100005174, GLN Identifier/7601001346451
name: Tillotts Pharma AG
Entry 8 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet
Resource ManufacturedItemDefinition:
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Tablet for rectal suspension
unitOfPresentation: Tablet
Entry 9 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Solvent
Resource ManufacturedItemDefinition:
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Solvent for...
unitOfPresentation: Bottle
Entry 10 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPAdministrableProductDefinition/PhP-Budesonidum-Suspension
Resource AdministrableProductDefinition:
status: Active
administrableDoseForm: Rectal suspension
unitOfPresentation: Bottle
RouteOfAdministrations
Code Rectal use
Entry 11 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10009900
Resource ClinicalUseDefinition:
type: Indication
indication
DiseaseSymptomProcedures
Concept Colitis ulcerative IntendedEffects
Concept therapeutic
Entry 12 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPIngredient/Budesonidum2.3
Resource Ingredient:
Profile: IDMP Ingredient
status: Active
role: Active
substance
Codes
Concept Budesonide Strengths
Presentation[x] 2.3 mg (Details: UCUM codemg = 'mg')/1 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
Entry 13 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPIngredient/Budesonidum2.0
Resource Ingredient:
Profile: IDMP Ingredient
status: Active
role: Active
substance
Codes
Concept Budesonide Strengths
Concentration[x] 2 mg (Details: UCUM codemg = 'mg')/100 ml (Details: UCUM codeml = 'ml')