CH EPL (R5)
1.0.0 - trial-use
CH EPL (R5)
1.0.0 - trial-use
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
Profile: IDMP Bundle
Bundle a69ea53d-79d4-46f4-bd2e-7a71439f148f of type collection
Entry 1 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPMedicinalProductDefinition/Paxlovid-Filmcoatedtablet
Resource MedicinalProductDefinition:
Profile: IDMP MedicinalProductDefinition
CH - SMC Authorized Dose Form: Film-coated tablet
identifier: Medical Product Identifier/CH-7601001010604-6879301
indication:
Paxlovid wird angewendet für die Behandlung der Coronavirus-Krankheit 2019 (COVID-19) bei Erwachsenen, die keine Sauerstofftherapie oder Hospitalisierung aufgrund von COVID-19 benötigen und bei denen ein erhöhtes Risiko für einen schweren Verlauf von COVID-19 besteht (siehe «Klinische Wirksamkeit»). Paxlovid ist nicht als Ersatz für eine Impfung gegen COVID-19 vorgesehen. Paxlovid sollte gemäss den offiziellen Empfehlungen und unter Berücksichtigung der lokalen epidemiologischen Daten zu zirkulierenden SARS-CoV-2-Varianten angewendet werden.
legalStatusOfSupply: Medicinal product subject to medical or veterinary prescription single dispensation (A+)
additionalMonitoringIndicator: Black Triangle Warning
pediatricUseIndicator: Not authorised for the treatment in children
classification: Protease inhibitors, NA KAS art. 12 para. 5 TPLO, Synthetic, Originator product, 08. INFEKTIONSKRANKHEITEN, 08.03. Mittel gegen Viren
attachedDocument:
- DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-nop-123; status = current; type = Fachinformation; date = 2024-07-01 00:00:00+0000
- DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-nop-321; status = current; type = Patienteninformation; date = 2024-07-01 00:00:00+0000
name
productName: PAXLOVID Filmtabl 4x150mg/2x100mg
type: Zugelassener Arzneimittelname
Usages
Country Language Switzerland German (Switzerland)
Entry 2 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-FI-Paxlovid
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-nop-123
status: Current
type: Fachinformation
date: 2024-07-01 00:00:00+0000
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=68793&supportMultipleResults=1
Entry 3 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-PI-Paxlovid
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-nop-321
status: Current
type: Patienteninformation
date: 2024-07-01 00:00:00+0000
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=68793&supportMultipleResults=1
Entry 4 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-6879301
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier: Marketing Authorisation Number/6879301
type: Marketing Authorisation
region: Switzerland
status: limited authorisation
statusDate: 2022-06-15
holder: Organization Pfizer AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100015286, GLN Identifier/7601001010604
name: Pfizer 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-Paxlovid-Filmcoatedtablet
Resource PackagedProductDefinition:
Profile: IDMP PackagedProductDefinition
identifier: Clinical Product Identifier/CH-7601001010604-6879301-001
containedItemQuantity: 30 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
description:
PAXLOVID Filmtabl 4x150mg/2x100mg
LegalStatusOfSupplies
Code Medicinal product subject to medical or veterinary prescription single dispensation (A+) packaging
identifier: Global Trade Item Number/7680687930017
type: Box
quantity: 1
ShelfLifeStorages
Type SpecialPrecautionsForStorage Shelf life of the medicinal product as packaged for sale Do not freeze
Entry 6 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-68793001
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier: Marketing Authorisation Number/68793001
type: Marketing Authorisation
region: Switzerland
status: limited authorisation
statusDate: 2022-06-15
holder: Organization Pfizer AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100015286, GLN Identifier/7601001010604
name: Pfizer 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-21529
Resource RegulatedAuthorization:
CH - EPL Reimbursement SL
url
FOPHDossierNumbervalue: FOPH Dossier Number/21529
url
statusvalue: Reimbursed
url
statusDatevalue: 2023-12-01
url
expiryDatevalue: 2026-03-31
url
listingStatusvalue: Listed
url
listingPeriodvalue: 2023-12-01 --> 2025-12-31
url
firstListingDatevalue: 2023-12-01
url
costSharevalue: 10
url
gammevalue: Oral
value: CHF958.62 (CHF)
type: Ex-factory price
changeType: Price mutation after triennal review of pharmaceuticals
changeDate: 2023-12-01
url
CH - EPL Product Pricevalue: CHF1,113.95 (CHF)
type: Retail price
changeType: VAT-change
changeDate: 2024-01-01
url
CH - EPL Product Pricetype: Reimbursement SL
Indications
Extension Reference ClinicalUseDefinition: type = indication holder: Organization Pfizer AG
Profile: CH EPL Organization
identifier: LOC Identifier/100015286, GLN Identifier/7601001010604
name: Pfizer AG
Entry 8 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Nirmatrelvir-150mg
Resource ManufacturedItemDefinition:
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Film-coated tablet
unitOfPresentation: Tablet
Entry 9 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Ritonavirum-100mg
Resource ManufacturedItemDefinition:
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Film-coated tablet
unitOfPresentation: Tablet
Entry 10 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPAdministrableProductDefinition/PhP-Nirmatrelvir-150mg-Filmcoatedtablet
Resource AdministrableProductDefinition:
status: Active
administrableDoseForm: Film-coated tablet
unitOfPresentation: Tablet
RouteOfAdministrations
Code Oral use
Entry 11 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPAdministrableProductDefinition/PhP-Ritonavirum-100mg-Filmcoatedtablet
Resource AdministrableProductDefinition:
status: Active
administrableDoseForm: Film-coated tablet
unitOfPresentation: Tablet
RouteOfAdministrations
Code Oral use
Entry 12 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPIngredient/Nirmatrelvir150
Resource Ingredient:
Profile: IDMP Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Active
substance
Codes
Concept Nirmatrelvir Strengths
Presentation[x] 150 mg (Details: UCUM codemg = 'mg')/1 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
Entry 13 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPIngredient/Ritonavirum100
Resource Ingredient:
Profile: IDMP Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
role: Active
substance
Codes
Concept Ritonavir Strengths
Presentation[x] 100 mg (Details: UCUM codemg = 'mg')/1 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
Entry 14 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10084529
Resource ClinicalUseDefinition:
type: Indication
indication
DiseaseSymptomProcedures
Concept Coronavirus-Krankheit 2019 (COVID-19) IntendedEffects
Concept therapeutic
Entry 15 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/LIM-840539006
Resource ClinicalUseDefinition:
type: Indication
indication
DiseaseSymptomProcedures
Concept Disease caused by severe acute respiratory syndrome coronavirus 2 (disorder) IntendedEffects
Concept therapeutic