CH EPL (R5)
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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

Example Bundle: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk (Bundle)

Profile: IDMP Bundle

Bundle 6722a9ee-ae3b-4c20-bcf0-9b7cb6f062db of type collection


Entry 1 - fullUrl = http://example.org/MedicinalProductDefinition/Entocort-Solvent-and-Tablet

Resource 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: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID/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:

name

productName: ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk

type: Zugelassener Arzneimittelname

Usages

-CountryLanguage
*SwitzerlandGerman (Switzerland)

Entry 2 - fullUrl = http://example.org/DocumentReference/DocRef-FI-Entocort

Resource DocumentReference:

Language: de-CH

Profile: CH IDMP DocumentReference

identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/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://example.org/DocumentReference/DocRef-PI-Entocort

Resource DocumentReference:

Language: de-CH

Profile: CH IDMP DocumentReference

identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/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://example.org/RegulatedAuthorisation/MA-5204201

Resource RegulatedAuthorization:

identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/5204201

subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; 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

type: Marketing Authorisation

region: Switzerland

status: valid

statusDate: 1993-06-18

holder: Organization Tillotts Pharma AG

regulator: Organization SMC


identifier: LOC Identifier/100005174, GLN Identifier/7601001346451

name: Tillotts Pharma AG


identifier: LOC Identifier/100010911, GLN Identifier/7601001398511

name: SMC


Entry 5 - fullUrl = http://example.org/PackagedProductDefinition/PMP-Entocort-Solvent-and-Tablet

Resource PackagedProductDefinition:

identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7601001346451-5204201-011

packageFor: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; 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

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

-TypePeriod[x]SpecialPrecautionsForStorage
*Shelf life of the medicinal product as packaged for saleNo display for Duration (value: 60; unit: month; system: http://unitsofmeasure.org; code: mo)Do not store above 30°C

Entry 6 - fullUrl = http://example.org/RegulatedAuthorisation/MA-52042011

Resource RegulatedAuthorization:

identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/52042011

subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; 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

type: Marketing Authorisation

region: Switzerland

status: valid

statusDate: 1993-06-18

holder: Organization Tillotts Pharma AG

regulator: Organization SMC


identifier: LOC Identifier/100005174, GLN Identifier/7601001346451

name: Tillotts Pharma AG


identifier: LOC Identifier/100010911, GLN Identifier/7601001398511

name: SMC


Entry 7 - fullUrl = http://example.org/RegulatedAuthorisation/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

subject: PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001346451-5204201-011; containedItemQuantity = 7 Tablet,7 Bottle; description = ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk

type: Reimbursement SL

Indications

-ExtensionReference
*ClinicalUseDefinition: type = indication

holder: Organization Tillotts Pharma AG


identifier: LOC Identifier/100005174, GLN Identifier/7601001346451

name: Tillotts Pharma AG


Entry 8 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Budesonidum-2.3mg-Tablet

Resource ManufacturedItemDefinition:

status: Active

manufacturedDoseForm: Tablet for rectal suspension

unitOfPresentation: Tablet


Entry 9 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Solvent

Resource ManufacturedItemDefinition:

status: Active

manufacturedDoseForm: Solvent for...

unitOfPresentation: Bottle


Entry 10 - fullUrl = http://example.org/AdministrableProductDefinition/PhP-Budesonidum-Suspension

Resource AdministrableProductDefinition:

status: Active

formOf: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; 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

administrableDoseForm: Rectal suspension

unitOfPresentation: Bottle

RouteOfAdministrations

-Code
*Rectal use

Entry 11 - fullUrl = http://example.org/ClinicalUseDefinition/IND-10009900

Resource ClinicalUseDefinition:

type: Indication

subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; 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

indication

DiseaseSymptomProcedures

-Concept
*Colitis ulcerative

IntendedEffects

-Concept
*therapeutic

Entry 12 - fullUrl = http://example.org/Ingredient/Budesonidum2.3

Resource Ingredient:

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet for rectal suspension; unitOfPresentation = Tablet

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://example.org/Ingredient/Budesonidum2.0

Resource Ingredient:

status: Active

for: AdministrableProductDefinition: status = active; administrableDoseForm = Rectal suspension; unitOfPresentation = Bottle

role: Active

substance

Codes

-Concept
*Budesonide

Strengths

-Concentration[x]
*2 mg (Details: UCUM codemg = 'mg')/100 ml (Details: UCUM codeml = 'ml')