CH EPL (R5)
1.0.1 - trial-use
CH EPL (R5)
1.0.1 - 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 1.0.1 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: 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: MedicinalProductDefinition
CH SMC - Authorized Dose Form: Film-coated tablet
identifier: Medical Product Identifier/CH-01001107-0687930010000
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: FOPH Medicinal Product Name
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: 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: 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: RegulatedAuthorization
identifier: Marketing Authorisation Number/6879301
type: Marketing Authorisation
region: Switzerland
status: limited authorisation
statusDate: 2022-06-15
holder: Organization Pfizer AG
regulator: Organization Swissmedic Swiss Agency for Therapeutic Products
Profile: Organization
identifier:
https://www.swissmedic.ch/fhir/identifier/locations/01001107, LOC Identifier/100015286, GLN Identifier/7601001010604name: Pfizer AG
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: Swissmedic Swiss Agency for Therapeutic Products
Entry 5 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPPackagedProductDefinition/PMP-Paxlovid-Filmcoatedtablet
Resource PackagedProductDefinition:
Profile: PackagedProductDefinition
identifier: Clinical Product Identifier/CH-01001107-0687930010000-0001
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: RegulatedAuthorization
identifier: Marketing Authorisation Number/68793001
type: Marketing Authorisation
region: Switzerland
status: limited authorisation
statusDate: 2022-06-15
holder: Organization Pfizer AG
regulator: Organization Swissmedic Swiss Agency for Therapeutic Products
Profile: Organization
identifier:
https://www.swissmedic.ch/fhir/identifier/locations/01001107, LOC Identifier/100015286, GLN Identifier/7601001010604name: Pfizer AG
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: Swissmedic Swiss Agency for Therapeutic Products
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: Organization
identifier:
https://www.swissmedic.ch/fhir/identifier/locations/01001107, LOC Identifier/100015286, GLN Identifier/7601001010604name: Pfizer AG
Entry 8 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Nirmatrelvir-150mg
Resource ManufacturedItemDefinition:
Profile: 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: 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:
Profile: 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:
Profile: 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: 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: 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:
Profile: ClinicalUseDefinition Indication
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 Befristete Limitation bis 31.12.2025. PAXLOVID wird als antivirale Monotherapie für die Behandlung einer bestätigten Covid-19 Infektion (Positiver Erregernachweis Antigen/PCR und vorhandener Covid-19-Symptome) in folgenden Fällen vergütet:
• in einer Dosierung von 300 mg Nirmatrelvir (zwei Tabletten zu je 150 mg) und 100 mg Ritonavir (eine Tablette zu 100 mg) zur gleichzeitigen Einnahme alle 12 Stunden, über einen Zeitraum von 5 Tagen
• zur Frühbehandlung (ausser bei immunsupprimierten Personen vorzugsweise innerhalb von 5 Tagen nach Symptombeginn) bei Erwachsenen, die keine Sauerstofftherapie oder Hospitalisierung aufgrund von COVID-19 benötigen und für welche gemäss der aktuell gültigen Kriterienliste der Schweizerischen Gesellschaft für Infektiologie (SSI) (https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/heilmittel/versorgung-covid-19-arzneimittel.html) ein erhöhtes Risiko für einen schweren COVID-19-Verlauf besteht.IntendedEffects
Concept therapeutic