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 5bb930aa-f30d-4f10-aeef-e85f6b5f8d59 of type collection
Entry 1 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPMedicinalProductDefinition/Estalis-Transdermalpatch
Resource MedicinalProductDefinition:
Profile: IDMP MedicinalProductDefinition
CH - SMC Authorized Dose Form: Transdermal patch
identifier: Medical Product Identifier/CH-7601001029439-5470402
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: Medicinal product subject to medical or veterinary prescription (B)
additionalMonitoringIndicator: No Warning
pediatricUseIndicator: Not authorised for the treatment in children
classification: norethisterone and estrogen, NA KAS art. 12 para. 5 TPLO, Synthetic, Originator product
attachedDocument:
- DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#123456789-initial submission-Example-hij-123; status = current; type = Fachinformation; date = 2021-10-01 00:00:00+0000
- DocumentReference: identifier = http://fhir.ch/ig/ch-epl/sid/attno#Application / Assessment Tracking Number#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://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-FI-Estalis
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-hij-123
status: 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://fhir.epl.bag.admin.ch/CHIDMPDocumentReference/DocRef-PI-Estalis
Resource DocumentReference:
Language: de-CH
Profile: CH IDMP DocumentReference
identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-hij-321
status: 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://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-5470402
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier: Marketing Authorisation Number/5470402
type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals 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-Estalis-Transdermalpatch
Resource PackagedProductDefinition:
Profile: IDMP PackagedProductDefinition
identifier: Clinical Product Identifier/CH-7601001029439-5470402-097
containedItemQuantity: 24 Patch (Details: EDQM - Standard Terms code15036000 = 'Patch')
description:
ESTALIS Matrixpfl 50/250 24 Stk
LegalStatusOfSupplies
Code Medicinal product subject to medical or veterinary prescription (B) packaging
identifier: Global Trade Item Number/7680547040979
type: 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) protect from light
Entry 6 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPRegulatedAuthorisation/MA-54704089
Resource RegulatedAuthorization:
Profile: IDMP RegulatedAuthorization
identifier: Marketing Authorisation Number/54704089
type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization SMC
Profile: CH EPL Organization
identifier: LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals 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-17418
Resource RegulatedAuthorization:
CH - EPL Reimbursement SL
url
FOPHDossierNumbervalue: FOPH Dossier Number/17418
url
statusvalue: Reimbursed
url
statusDatevalue: 2000-04-15
url
listingStatusvalue: Listed
url
listingPeriodvalue: 2000-04-15 --> (ongoing)
url
firstListingDatevalue: 2000-04-15
url
costSharevalue: 10
url
gammevalue: Transdermal
value: CHF32.44 (CHF)
type: Ex-factory price
changeType: Price mutation after triennal review of pharmaceuticals
changeDate: 2014-11-01
url
CH - EPL Product Pricevalue: CHF53.65 (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 Sandoz Pharmaceuticals AG
Profile: CH EPL Organization
identifier: LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals AG
Entry 8 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch
Resource ManufacturedItemDefinition:
Profile: CH IDMP ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Transdermal patch
unitOfPresentation: Patch
Entry 9 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPAdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
Resource AdministrableProductDefinition:
status: Active
administrableDoseForm: Transdermal patch
unitOfPresentation: Patch
RouteOfAdministrations
Code Transdermal use
Entry 10 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10030247
Resource ClinicalUseDefinition:
type: Indication
indication
DiseaseSymptomProcedures
Concept Oestrogenmangel Comorbidities
Concept Menopause IntendedEffects
Concept preventive
Entry 11 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPClinicalUseDefinition/IND-10031285
Resource ClinicalUseDefinition:
type: Indication
indication
DiseaseSymptomProcedures
Concept Osteoporose postmenopausal IntendedEffects
Concept preventive
Entry 12 - fullUrl = http://fhir.epl.bag.admin.ch/CHIDMPIngredient/Estradiol-hemihydrate-0.512mg
Resource Ingredient:
Profile: IDMP Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch
role: Active
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://fhir.epl.bag.admin.ch/CHIDMPIngredient/Norethisteroni-acetas-0.496mg
Resource Ingredient:
Profile: IDMP Ingredient
status: Active
for:
- AdministrableProductDefinition: status = active; administrableDoseForm = Transdermal patch; unitOfPresentation = Patch
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Transdermal patch; unitOfPresentation = Patch
role: Active
substance
Codes
Concept Norethisterone acetate Strengths
Presentation[x] 0.496 mg (Details: UCUM codemg = 'mg')/1 Patch (Details: EDQM - Standard Terms code15036000 = 'Patch')