CH EPL (R5)
0.1.0 - ci-build
CH EPL (R5)
0.1.0 - ci-build
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 0.1.0 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
Generated Narrative: Bundle 5bb930aa-f30d-4f10-aeef-e85f6b5f8d59
Bundle 5bb930aa-f30d-4f10-aeef-e85f6b5f8d59 of type collection
Entry 1 - fullUrl = http://example.org/MedicinalProductDefinition/Estalis-Transdermalpatch
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition Estalis-Transdermalpatch
CH - SMC Authorized Dose Form: Transdermal patch
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID/CH-7601001029439-5470402domain: Human
indication:
Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen. Osteoporoseprophylaxe: Vorbeugung oder Verzögerung einer durch Östrogenmangel induzierten Osteoporose bei postmenopausalen Frauen mit hohem Frakturrisiko, für die eine Behandlung mit anderen zur Prävention der Osteoporose zugelassenen Arzneimitteln nicht in Frage kommt, oder bei Frauen die gleichzeitig an behandlungsbedürftigen Symptomen des Östrogenmangels leiden.
legalStatusOfSupply: Abgabe auf ärztliche oder tierärztliche Verschreibung (B)
additionalMonitoringIndicator: No Warning
pediatricUseIndicator: Nicht zugelassen für die Anwendung bei Kindern
classification: norethisterone and estrogen, NA BWS Art 12. Abs. 5 VAZV, Synthetika, Originalpräparat
attachedDocument:
- DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-hij-123; status = current; type = Fachinformation; date = 2021-10-01 00:00:00+0000
- DocumentReference: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber#123456789-initial submission-Example-hij-321; status = current; type = Patienteninformation; date = 2021-10-01 00:00:00+0000
name
productName: ESTALIS Matrixpfl 50/250 24 Stk
type: Zugelassener Arzneimittelname
Usages
Country Language Switzerland German (Switzerland)
Entry 2 - fullUrl = http://example.org/DocumentReference/DocRef-FI-Estalis
Resource DocumentReference:
Generated Narrative: DocumentReference DocRef-FI-Estalis
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-hij-123status: Current
type: Fachinformation
date: 2021-10-01 00:00:00+0000
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=FI&lang=DE&authNr=54704&supportMultipleResults=1
Entry 3 - fullUrl = http://example.org/DocumentReference/DocRef-PI-Estalis
Resource DocumentReference:
Generated Narrative: DocumentReference DocRef-PI-Estalis
Language: de-CH
Profile: CH IDMP DocumentReference
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber/123456789-initial submission-Example-hij-321status: Current
type: Patienteninformation
date: 2021-10-01 00:00:00+0000
content
Attachments
Url https://swissmedicinfo.ch/showTextAccepted.aspx?textType=PI&lang=DE&authNr=54704&supportMultipleResults=1
Entry 4 - fullUrl = http://example.org/RegulatedAuthorisation/MA-5470402
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization MA-5470402
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/5470402type: Marketing Authorisation
region: Switzerland
status: zugelassen
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
identifier:
urn:oid:1.2.276.0.76/100054743, GLN/7601001029439name: Sandoz Pharmaceuticals AG
Generated Narrative: Organization #regulator-SMC
identifier:
urn:oid:1.2.276.0.76/100010911, GLN/7601001398511name: SMC
Entry 5 - fullUrl = http://example.org/PackagedProductDefinition/PMP-Estalis-Transdermalpatch
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition PMP-Estalis-Transdermalpatch
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7601001029439-5470402-097containedItemQuantity: 24 Patch (Details: EDQM - Standard Terms code15036000 = 'Patch')
description:
ESTALIS Matrixpfl 50/250 24 Stk
LegalStatusOfSupplies
Code Abgabe auf ärztliche oder tierärztliche Verschreibung (B) packaging
identifier:
urn:oid:2.51.1.1/7680547040979type: Box
quantity: 1
ShelfLifeStorages
Type Period[x] SpecialPrecautionsForStorage Shelf life of the medicinal product as packaged for sale No display for Duration (value: 6; unit: month; system: http://unitsofmeasure.org; code: mo) vor Licht Schützen
Entry 6 - fullUrl = http://example.org/RegulatedAuthorisation/MA-54704089
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization MA-54704089
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/54704089type: Marketing Authorisation
region: Switzerland
status: zugelassen
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
identifier:
urn:oid:1.2.276.0.76/100054743, GLN/7601001029439name: Sandoz Pharmaceuticals AG
Generated Narrative: Organization #regulator-SMC
identifier:
urn:oid:1.2.276.0.76/100010911, GLN/7601001398511name: SMC
Entry 7 - fullUrl = http://example.org/RegulatedAuthorisation/FOPH-17418
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization FOPH-17418
CH - EPL Reimbursement SL
- FOPHDossierNumber:
urn:oid:2.16.756.1/17418- status: Reimbursed
- statusDate: 2000-04-15
- listingStatus: Listed
- listingPeriod: 2000-04-15 --> (ongoing)
- firstListingDate: 2000-04-15
- costShare: 10
- gamme: Transdermal
CH - EPL Product Price
- value: CHF32.44 (CHF)
- type: Ex-factory price
- changeType: Price mutation after triennal review of pharmaceuticals
- changeDate: 2014-11-01
CH - EPL Product Price
- value: CHF53.65 (CHF)
- type: Retail price
- changeType: VAT-change
- changeDate: 2024-01-01
type: Reimbursement SL
Indications
Extension Reference ClinicalUseDefinition: type = indication holder: Organization Sandoz Pharmaceuticals AG
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
identifier:
urn:oid:1.2.276.0.76/100054743, GLN/7601001029439name: Sandoz Pharmaceuticals AG
Entry 8 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch
Resource ManufacturedItemDefinition:
Generated Narrative: ManufacturedItemDefinition MI-Estradiolum-Norethisteroni-Transdermalpatch
status: Active
manufacturedDoseForm: Transdermal patch
unitOfPresentation: Patch
Entry 9 - fullUrl = http://example.org/AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
Resource AdministrableProductDefinition:
Generated Narrative: AdministrableProductDefinition PhP-Estradiolum-Norethisteroni-Transdermalpatch
status: Active
administrableDoseForm: Transdermal patch
unitOfPresentation: Patch
RouteOfAdministrations
Code Transdermal use
Entry 10 - fullUrl = http://example.org/ClinicalUseDefinition/IND-10030247
Resource ClinicalUseDefinition:
Generated Narrative: ClinicalUseDefinition IND-10030247
type: Indication
indication
DiseaseSymptomProcedures
Concept Oestrogenmangel Comorbidities
Concept Menopause IntendedEffects
Concept preventive
Entry 11 - fullUrl = http://example.org/ClinicalUseDefinition/IND-10031285
Resource ClinicalUseDefinition:
Generated Narrative: ClinicalUseDefinition IND-10031285
type: Indication
indication
DiseaseSymptomProcedures
Concept Osteoporose postmenopausal IntendedEffects
Concept preventive
Entry 12 - fullUrl = http://example.org/Ingredient/Estradiol-hemihydrate-0.512mg
Resource Ingredient:
Generated Narrative: Ingredient Estradiol-hemihydrate-0.512mg
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch
role: Wirkstoff
substance
Codes
Concept Estradiol-hemihydrate Strengths
Presentation[x] 0.512 mg (Details: UCUM codemg = 'mg')/1 Patch (Details: EDQM - Standard Terms code15036000 = 'Patch')
Entry 13 - fullUrl = http://example.org/Ingredient/Norethisteroni-acetas-0.496mg
Resource Ingredient:
Generated Narrative: Ingredient Norethisteroni-acetas-0.496mg
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch
role: Wirkstoff
substance
Codes
Concept Norethisterone acetate Strengths
Presentation[x] 0.496 mg (Details: UCUM codemg = 'mg')/1 Patch (Details: EDQM - Standard Terms code15036000 = 'Patch')