CH EPL (R5)
0.1.0 - ci-build
CH EPL (R5)
0.1.0 - 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 0.1.0 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
Generated Narrative: Bundle 6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db
Bundle 6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db of type collection
Entry 1 - fullUrl = http://example.org/MedicinalProductDefinition/Entocort-Solvent-and-Tablet
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition Entocort-Solvent-and-Tablet
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:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID/CH-7601001346451-5204201domain: Human
combinedPharmaceuticalDoseForm: Tablet and solvent for rectal suspension
indication:
Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.
legalStatusOfSupply: Dispensation on medical or veterinary prescription (B)
classification: budesonide, Synthetika
attachedDocument:
- DocumentReference: status = current; type = Fachinformation
- DocumentReference: status = current; type = Patienteninformation
name
productName: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
type: Swissmedic
Usages
Country Language Switzerland German (Switzerland)
Entry 2 - fullUrl = http://example.org/DocumentReference/DocRef-FI-Entocort
Resource DocumentReference:
Generated Narrative: DocumentReference DocRef-FI-Entocort
status: Current
type: Fachinformation
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=52042&supportMultipleResults=1
Entry 3 - fullUrl = http://example.org/DocumentReference/DocRef-PI-Entocort
Resource DocumentReference:
Generated Narrative: DocumentReference DocRef-PI-Entocort
status: Current
type: Patienteninformation
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=52042&supportMultipleResults=1
Entry 4 - fullUrl = http://example.org/RegulatedAuthorisation/MA-5204201
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization MA-5204201
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/5204201type: Marketing Authorisation
region: Switzerland
status: zugelassen
statusDate: 1993-06-18
holder: Organization Tillotts Pharma AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Tillotts-Pharma-AG
identifier:
urn:oid:1.2.276.0.76/100005174, GLN/7601001346451name: Tillotts Pharma AG
Generated Narrative: Organization #regulator-SMC
identifier:
urn:oid:1.2.276.0.76/100010911, GLN/7601001398511name: SMC
Entry 5 - fullUrl = http://example.org/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition PMP-Entocort-Solvent-and-Tablet
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7601001346451-5204201-011description:
ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
LegalStatusOfSupplies
Code Dispensation on medical or veterinary prescription (B) packaging
identifier:
urn:oid:2.51.1.1/7680520420118type: Box
quantity: 6
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) Nicht über 30°C
Entry 6 - fullUrl = http://example.org/RegulatedAuthorisation/MA-52042011
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization MA-52042011
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/52042011type: Marketing Authorisation
region: Switzerland
status: zugelassen
statusDate: 1993-06-18
holder: Organization Tillotts Pharma AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Tillotts-Pharma-AG
identifier:
urn:oid:1.2.276.0.76/100005174, GLN/7601001346451name: Tillotts Pharma AG
Generated Narrative: Organization #regulator-SMC
identifier:
urn:oid:1.2.276.0.76/100010911, GLN/7601001398511name: SMC
Entry 7 - fullUrl = http://example.org/RegulatedAuthorisation/FOPH-17973
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization FOPH-17973
CH - EPL Reimbursement SL
- FOPHDossierNumber:
urn:oid:2.16.756.1/17973- status: Reimbursed
- statusDate: 2004-02-01
- listingStatus: Listed
- listingPeriod: 2004-02-01 --> (ongoing)
- firstListingDate: 2004-02-01
- costShare: 10
- gamme: RektalVaginal
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
Generated Narrative: Organization #holder-Tillotts-Pharma-AG
identifier:
urn:oid:1.2.276.0.76/100005174, GLN/7601001346451name: Tillotts Pharma AG
Entry 8 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet
Resource ManufacturedItemDefinition:
Generated Narrative: ManufacturedItemDefinition MI-Budesonidum-2.3mg-Tablet
status: Active
manufacturedDoseForm: Tablet for rectal suspension
unitOfPresentation: Tablet
Entry 9 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Solvent
Resource ManufacturedItemDefinition:
Generated Narrative: ManufacturedItemDefinition MI-Solvent
status: Active
manufacturedDoseForm: Solvent for...
unitOfPresentation: Bottle
Entry 10 - fullUrl = http://example.org/AdministrableProductDefinition/PhP-Budesonidum-Suspension
Resource AdministrableProductDefinition:
Generated Narrative: AdministrableProductDefinition PhP-Budesonidum-Suspension
status: Active
administrableDoseForm: Rectal suspension
unitOfPresentation: Bottle
RouteOfAdministrations
Code Rectal use
Entry 11 - fullUrl = http://example.org/ClinicalUseDefinition/IND-10009900
Resource ClinicalUseDefinition:
Generated Narrative: ClinicalUseDefinition IND-10009900
type: Indication
indication
DiseaseSymptomProcedures
Concept Colitis ulcerative IntendedEffects
Concept therapeutic
Entry 12 - fullUrl = http://example.org/Ingredient/Budesonidum2.3
Resource Ingredient:
Generated Narrative: Ingredient Budesonidum2.3
status: Active
role: Wirkstoff
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://example.org/Ingredient/Budesonidum2.0
Resource Ingredient:
Generated Narrative: Ingredient Budesonidum2.0
status: Active
role: Wirkstoff
substance
Codes
Concept Budesonide Strengths
Concentration[x] 2 mg (Details: UCUM codemg = 'mg')/100 ml (Details: UCUM codeml = 'ml')