ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk (Bundle)

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 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://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
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, 04. GASTROENTEROLOGICA, 04.99. Varia
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
subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#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,04. GASTROENTEROLOGICA,04.99. Varia
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
packageFor: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#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,04. GASTROENTEROLOGICA,04.99. Varia
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
subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#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,04. GASTROENTEROLOGICA,04.99. Varia
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
url
FOPHDossierNumber
value: FOPH Dossier Number/17973
url
status
value: Reimbursed
url
statusDate
value: 2004-02-01
url
listingStatus
value: Listed
url
listingPeriod
value: 2004-02-01 --> (ongoing)
url
firstListingDate
value: 2004-02-01
url
costShare
value: 10
url
gamme
value: Rectal Vaginal
value: CHF40.89 (CHF)
type: Ex-factory price
changeType: Price mutation after triennal review of pharmaceuticals
changeDate: 2023-12-01
url
CH - EPL Product Price
value: CHF63.40 (CHF)
type: Retail price
changeType: VAT-change
changeDate: 2024-01-01
url
CH - EPL Product Price
subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-7601001346451-5204201-011; containedItemQuantity = 7 Tablet,7 Bottle; description = ENTOCORT Enema Klistier Lösung + Tabletten 7 Stk
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:

Profile: CH IDMP AdministrableProductDefinition
status: Active
formOf: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#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,04. GASTROENTEROLOGICA,04.99. Varia
administrableDoseForm: Rectal suspension
unitOfPresentation: Bottle
RouteOfAdministrations
- Code
* Rectal use

Entry 11 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10009900

Resource ClinicalUseDefinition:

Profile: CH IDMP ClinicalUseDefinition Indication
type: Indication
subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#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,04. GASTROENTEROLOGICA,04.99. Varia
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
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://fhir.epl.bag.admin.ch/CHIDMPIngredient/Budesonidum2.0

Resource Ingredient:

Profile: IDMP 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')