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 5bb930aa-f30d-4f10-aeef-e85f6b5f8d59
Profile: IDMP Bundle
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
Profile: IDMP MedicinalProductDefinition
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: 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://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
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/5470402type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
Profile: CH EPL Organization
identifier: LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals 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-Estalis-Transdermalpatch
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition PMP-Estalis-Transdermalpatch
Profile: IDMP PackagedProductDefinition
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 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://example.org/RegulatedAuthorisation/MA-54704089
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization MA-54704089
Profile: IDMP RegulatedAuthorization
identifier:
http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/54704089type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization SMC
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
Profile: CH EPL Organization
identifier: LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals 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-17418
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization FOPH-17418
CH - EPL Reimbursement SL
- FOPHDossierNumber: FOPH Dossier Number/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
Profile: CH EPL Organization
identifier: LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals AG
Entry 8 - fullUrl = http://example.org/ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch
Resource ManufacturedItemDefinition:
Generated Narrative: ManufacturedItemDefinition MI-Estradiolum-Norethisteroni-Transdermalpatch
Profile: CH IDMP ManufacturedItemDefinition
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
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://example.org/Ingredient/Norethisteroni-acetas-0.496mg
Resource Ingredient:
Generated Narrative: Ingredient Norethisteroni-acetas-0.496mg
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')