{ "resourceType" : "Bundle", "id" : "5bb930aa-f30d-4f10-aeef-e85f6b5f8d59", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"] }, "type" : "collection", "entry" : [{ "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/MedicinalProductDefinition/Estalis-Transdermalpatch", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "Estalis-Transdermalpatch", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"] }, "text" : { "status" : "extensions", "div" : "
Generated Narrative: MedicinalProductDefinition Estalis-Transdermalpatch
Profile: MedicinalProductDefinition
CH SMC - Authorized Dose Form: Transdermal patch
identifier: Medical Product Identifier/CH-01006431-0547040020000
indication:
Klimakterische Beschwerden: Behandlung der Symptome des Östrogenmangels infolge der natürlichen oder künstlichen Menopause bei nicht-hysterektomierten Frauen.\nOsteoporoseprophylaxe: 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.
\nlegalStatusOfSupply: 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, 07. STOFFWECHSEL, 07.08. Geschlechtshormone, 07.08.60. Kombinationen
attachedDocument:
name
productName: ESTALIS Matrixpfl 50/250 24 Stk
type: FOPH Medicinal Product Name
Usages
- Country Language * Switzerland German (Switzerland)
Generated Narrative: DocumentReference DocRef-FI-Estalis
Language: de-CH
Profile: 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
Generated Narrative: DocumentReference DocRef-PI-Estalis
Language: de-CH
Profile: 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
Generated Narrative: RegulatedAuthorization MA-5470402
Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/5470402
type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization Swissmedic Swiss Agency for Therapeutic Products
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
Profile: Organization
identifier: Swissmedic Location Identifier/01006431, LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals AG
Generated Narrative: Organization #regulator-SMC
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: Swissmedic Swiss Agency for Therapeutic Products
Generated Narrative: PackagedProductDefinition PMP-Estalis-Transdermalpatch
Profile: PackagedProductDefinition
identifier: Clinical Product Identifier/CH-01006431-0547040020000-0097
containedItemQuantity: 24 Patch (Details: EDQM - Standard Terms code15036000 = 'Patch')
description:
ESTALIS Matrixpfl 50/250 24 Stk
\n| - | 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
Generated Narrative: RegulatedAuthorization MA-54704089
Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/54704089
type: Marketing Authorisation
region: Switzerland
status: valid
statusDate: 1999-08-17
holder: Organization Sandoz Pharmaceuticals AG
regulator: Organization Swissmedic Swiss Agency for Therapeutic Products
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
Profile: Organization
identifier: Swissmedic Location Identifier/01006431, LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals AG
Generated Narrative: Organization #regulator-SMC
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: Swissmedic Swiss Agency for Therapeutic Products
Generated Narrative: RegulatedAuthorization FOPH-17418
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 Price
type: Reimbursement SL
| - | Extension | Reference |
| * | ClinicalUseDefinition: type = indication |
holder: Organization Sandoz Pharmaceuticals AG
Generated Narrative: Organization #holder-Sandoz-Pharmaceuticals-AG
Profile: Organization
identifier: Swissmedic Location Identifier/01006431, LOC Identifier/100054743, GLN Identifier/7601001029439
name: Sandoz Pharmaceuticals AG
Generated Narrative: ManufacturedItemDefinition MI-Estradiolum-Norethisteroni-Transdermalpatch
Profile: ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Transdermal patch
unitOfPresentation: Patch
Generated Narrative: AdministrableProductDefinition PhP-Estradiolum-Norethisteroni-Transdermalpatch
Profile: AdministrableProductDefinition
status: Active
administrableDoseForm: Transdermal patch
unitOfPresentation: Patch
| - | Code |
| * | Transdermal use |
Generated Narrative: ClinicalUseDefinition IND-10030247
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
- Concept * Oestrogenmangel Comorbidities
- Concept * Menopause IntendedEffects
- Concept * preventive
Generated Narrative: ClinicalUseDefinition IND-10031285
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
- Concept * Osteoporose postmenopausal IntendedEffects
- Concept * preventive
Generated Narrative: Ingredient Estradiol-hemihydrate-0.512mg
Profile: Ingredient
status: Active
for:
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')
Generated Narrative: Ingredient Norethisteroni-acetas-0.496mg
Profile: Ingredient
status: Active
for:
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')