CH EPL (R5)
1.0.0-ballot - ballot
CH EPL (R5)
1.0.0-ballot - ballot
This page is part of the CH EPL (R5) (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
Generated Narrative: Bundle a69ea53d-79d4-46f4-bd2e-7a71439f148f
Profile: IDMP Bundle
Bundle a69ea53d-79d4-46f4-bd2e-7a71439f148f of type collection
Entry 1 - fullUrl = http://example.org/MedicinalProductDefinition/Paxlovid-Filmcoatedtablet
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition Paxlovid-Filmcoatedtablet
Profile: IDMP MedicinalProductDefinition
CH - SMC Authorized Dose Form: Film-coated tablet
CH - EPL Full Limitation Text: 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.
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID/CH-7601001010604-6879301domain: Human
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
attachedDocument:
- DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-nop-123; status = current; type = Fachinformation; date = 2024-07-01 00:00:00+0000
- DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#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://example.org/DocumentReference/DocRef-FI-Paxlovid
Resource DocumentReference:
Generated Narrative: DocumentReference DocRef-FI-Paxlovid
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-nop-123status: 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://example.org/DocumentReference/DocRef-PI-Paxlovid
Resource DocumentReference:
Generated Narrative: DocumentReference DocRef-PI-Paxlovid
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-nop-321status: 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://example.org/RegulatedAuthorisation/MA-6879301
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization MA-6879301
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/6879301type: Marketing Authorisation
region: Switzerland
status: limited authorisation
statusDate: 2022-06-15
holder: Organization Pfizer AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Pfizer-AG
Profile: CH EPL Organization
identifier: LOC Identifier/100015286, GLN Identifier/7601001010604
name: Pfizer AG
Generated Narrative: Organization #regulator-SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 5 - fullUrl = http://example.org/PackagedProductDefinition/PMP-Paxlovid-Filmcoatedtablet
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition PMP-Paxlovid-Filmcoatedtablet
Profile: IDMP PackagedProductDefinition
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7601001010604-6879301-001containedItemQuantity: 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://example.org/RegulatedAuthorisation/MA-68793001
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization MA-68793001
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/68793001type: Marketing Authorisation
region: Switzerland
status: limited authorisation
statusDate: 2022-06-15
holder: Organization Pfizer AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Pfizer-AG
Profile: CH EPL Organization
identifier: LOC Identifier/100015286, GLN Identifier/7601001010604
name: Pfizer AG
Generated Narrative: Organization #regulator-SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 7 - fullUrl = http://example.org/RegulatedAuthorisation/FOPH-21529
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization FOPH-21529
CH - EPL Reimbursement SL
- FOPHDossierNumber: FOPH Dossier Number/21529
- status: Reimbursed
- statusDate: 2023-12-01
- expiryDate: 2026-03-31
- listingStatus: Listed
- listingPeriod: 2023-12-01 --> 2025-12-31
- firstListingDate: 2023-12-01
- costShare: 10
- gamme: Oral
CH - EPL Product Price
- value: CHF958.62 (CHF)
- type: Ex-factory price
- changeType: Price mutation after triennal review of pharmaceuticals
- changeDate: 2023-12-01
CH - EPL Product Price
- value: CHF1,113.95 (CHF)
- type: Retail price
- changeType: VAT-change
- changeDate: 2024-01-01
type: Reimbursement SL
Indications
Extension Reference ClinicalUseDefinition: type = indication holder: Organization Pfizer AG
Generated Narrative: Organization #holder-Pfizer-AG
Profile: CH EPL Organization
identifier: LOC Identifier/100015286, GLN Identifier/7601001010604
name: Pfizer AG
Entry 8 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Nirmatrelvir-150mg
Resource ManufacturedItemDefinition:
Generated Narrative: ManufacturedItemDefinition MI-Nirmatrelvir-150mg
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Film-coated tablet
unitOfPresentation: Tablet
Entry 9 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Ritonavirum-100mg
Resource ManufacturedItemDefinition:
Generated Narrative: ManufacturedItemDefinition MI-Ritonavirum-100mg
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Film-coated tablet
unitOfPresentation: Tablet
Entry 10 - fullUrl = http://example.org/AdministrableProductDefinition/PhP-Nirmatrelvir-150mg-Filmcoatedtablet
Resource AdministrableProductDefinition:
Generated Narrative: AdministrableProductDefinition PhP-Nirmatrelvir-150mg-Filmcoatedtablet
status: Active
administrableDoseForm: Film-coated tablet
unitOfPresentation: Tablet
RouteOfAdministrations
Code Oral use
Entry 11 - fullUrl = http://example.org/AdministrableProductDefinition/PhP-Ritonavirum-100mg-Filmcoatedtablet
Resource AdministrableProductDefinition:
Generated Narrative: AdministrableProductDefinition PhP-Ritonavirum-100mg-Filmcoatedtablet
status: Active
administrableDoseForm: Film-coated tablet
unitOfPresentation: Tablet
RouteOfAdministrations
Code Oral use
Entry 12 - fullUrl = http://example.org/Ingredient/Nirmatrelvir150
Resource Ingredient:
Generated Narrative: Ingredient Nirmatrelvir150
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://example.org/Ingredient/Ritonavirum100
Resource Ingredient:
Generated Narrative: Ingredient Ritonavirum100
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://example.org/ClinicalUseDefinition/IND-10084529
Resource ClinicalUseDefinition:
Generated Narrative: ClinicalUseDefinition IND-10084529
type: Indication
indication
DiseaseSymptomProcedures
Concept Coronavirus-Krankheit 2019 (COVID-19) IntendedEffects
Concept therapeutic
Entry 15 - fullUrl = http://example.org/ClinicalUseDefinition/LIM-840539006
Resource ClinicalUseDefinition:
Generated Narrative: ClinicalUseDefinition LIM-840539006
type: Indication
indication
DiseaseSymptomProcedures
Concept Disease caused by severe acute respiratory syndrome coronavirus 2 (disorder) IntendedEffects
Concept therapeutic