http://fhir.ch/ig/ch-epl/Bundle/5bb930aa-f30d-4f10-aeef-e85f6b5f8d59
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle
    l: ch-idmp-bundle
type:
  v: collection
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/MedicinalProductDefinition/Estalis-Transdermalpatch
    l: Estalis-Transdermalpatch
  resource: Estalis-Transdermalpatch
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/DocumentReference/DocRef-FI-Estalis
    l: DocRef-FI-Estalis
  resource: DocRef-FI-Estalis
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/DocumentReference/DocRef-PI-Estalis
    l: DocRef-PI-Estalis
  resource: DocRef-PI-Estalis
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/MA-5470402
    l: MA-5470402
  resource: MA-5470402
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/PackagedProductDefinition/PMP-Estalis-Transdermalpatch
    l: PMP-Estalis-Transdermalpatch
  resource: PMP-Estalis-Transdermalpatch
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/MA-54704089
    l: MA-54704089
  resource: MA-54704089
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/FOPH-17418
    l: FOPH-17418
  resource: FOPH-17418
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch
    l: MI-Estradiolum-Norethisteroni-Transdermalpatch
  resource: MI-Estradiolum-Norethisteroni-Transdermalpatch
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
    l: PhP-Estradiolum-Norethisteroni-Transdermalpatch
  resource: PhP-Estradiolum-Norethisteroni-Transdermalpatch
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/ClinicalUseDefinition/IND-10030247
    l: IND-10030247
  resource: IND-10030247
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/ClinicalUseDefinition/IND-10031285
    l: IND-10031285
  resource: IND-10031285
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/Ingredient/Estradiol-hemihydrate-0.512mg
    l: Estradiol-hemihydrate-0.512mg
  resource: Estradiol-hemihydrate-0.512mg
entry:
  full url:
    v: http://fhir.epl.bag.admin.ch/CHIDMP/Ingredient/Norethisteroni-acetas-0.496mg
    l: Norethisteroni-acetas-0.496mg
  resource: Norethisteroni-acetas-0.496mg

Estalis-Transdermalpatch
type: MedicinalProductDefinition
id:
  v: Estalis-Transdermalpatch
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition
    l: ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div:
    v: 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. 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, 07. STOFFWECHSEL, 07.08. Geschlechtshormone, 07.08.60. Kombinationen 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: FOPH Medicinal Product Name Usages - Country Language * Switzerland German (Switzerland)
extension:
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
    l: authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 10519000
      display:
        v: Transdermal patch
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/mpid
    l: mpid
  value:
    v: CH-01006431-0547040020000
indication:
  v: 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.
legal status of supply:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
      l: ch-SMC-legal-status-of-supply
    code:
      v: 756005022003
    display:
      v: Medicinal product subject to medical or veterinary prescription (B)
additional monitoring indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator
      l: ch-SMC-additional-monitoring-indicator
    code:
      v: 756005001003
    display:
      v: No Warning
pediatric use indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator
      l: ch-SMC-pediatric-use-indicator
    code:
      v: 756005003002
    display:
      v: Not authorised for the treatment in children
classification:
  coding:
    system:
      v: http://www.whocc.no/atc
      l: atc
    code:
      v: G03FA01
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category
      l: ch-SMC-authorisation-category
    code:
      v: 756005021001
    display:
      v: NA KAS art. 12 para. 5 TPLO
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
      l: ch-SMC-therapeuticproductcode
    code:
      v: 756005004001
    display:
      v: Synthetic
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
      l: ch-epl-foph-product-type
    code:
      v: 756001003002
    display:
      v: Originator product
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus
      l: ch-epl-foph-index-therapeuticus
    code:
      v: 070000
    display:
      v: 07. STOFFWECHSEL
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus
      l: ch-epl-foph-index-therapeuticus
    code:
      v: 070800
    display:
      v: 07.08. Geschlechtshormone
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus
      l: ch-epl-foph-index-therapeuticus
    code:
      v: 070860
    display:
      v: 07.08.60. Kombinationen
attached document:
  l: DocRef-FI-Estalis
  reference:
    v: DocumentReference/DocRef-FI-Estalis
attached document:
  l: DocRef-PI-Estalis
  reference:
    v: DocumentReference/DocRef-PI-Estalis
name:
  product name:
    v: ESTALIS Matrixpfl 50/250 24 Stk
  type:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type
        l: ch-medicinal-product-name-type
      code:
        v: FOPH
      display:
        v: FOPH Medicinal Product Name

DocRef-FI-Estalis
type: DocumentReference
id:
  v: DocRef-FI-Estalis
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div:
    v: 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
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/attno
    l: attno
  value:
    v: 123456789-initial submission-Example-hij-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005007001
    display:
      v: Fachinformation
date:
  v: 2021-10-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showTextAccepted.aspx
      l: https://swissmedicinfo.ch/showTextAccepted.aspx

DocRef-PI-Estalis
type: DocumentReference
id:
  v: DocRef-PI-Estalis
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div:
    v: 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
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/attno
    l: attno
  value:
    v: 123456789-initial submission-Example-hij-321
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005007002
    display:
      v: Patienteninformation
date:
  v: 2021-10-01T00:00:00Z
content:
  attachment:
    url:
      v: https://swissmedicinfo.ch/showTextAccepted.aspx
      l: https://swissmedicinfo.ch/showTextAccepted.aspx

MA-5470402
type: RegulatedAuthorization
id:
  v: MA-5470402
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-5470402 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/5470402 subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01006431-0547040020000; 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,07. STOFFWECHSEL,07.08. Geschlechtshormone,07.08.60. Kombinationen 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
contained: Organization
  id:
    v: holder-Sandoz-Pharmaceuticals-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01006431
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100054743
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001029439
  name:
    v: Sandoz Pharmaceuticals AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: Swissmedic Swiss Agency for Therapeutic Products
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/authno
    l: authno
  value:
    v: 5470402
subject:
  l: Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 1999-08-17
holder:
  l: holder-Sandoz-Pharmaceuticals-AG
  reference:
    v: #holder-Sandoz-Pharmaceuticals-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

PMP-Estalis-Transdermalpatch
type: PackagedProductDefinition
id:
  v: PMP-Estalis-Transdermalpatch
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition
    l: ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition PMP-Estalis-Transdermalpatch Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-01006431-0547040020000-0097 packageFor: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01006431-0547040020000; 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,07. STOFFWECHSEL,07.08. Geschlechtshormone,07.08.60. Kombinationen 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
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/pcid
    l: pcid
  value:
    v: CH-01006431-0547040020000-0097
package for:
  l: Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
contained item quantity:
  value:
    v: 24
  unit:
    v: Patch
  system:
    v: http://standardterms.edqm.eu
    l: standardterms.edqm.eu
  code:
    v: 15036000
description:
  v: ESTALIS Matrixpfl 50/250 24 Stk
legal status of supply:
  code:
    coding:
      system:
        v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply
        l: ch-SMC-legal-status-of-supply
      code:
        v: 756005022003
      display:
        v: Medicinal product subject to medical or veterinary prescription (B)
packaging:
  identifier:
    system:
      v: urn:oid:2.51.1.1
      l: 2.51.1.1
    value:
      v: 7680547040979
  type:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 30009000
      display:
        v: Box
  quantity:
    v: 1
  shelf life storage:
    period: Duration
      value:
        v: 6
      unit:
        v: month
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mo

MA-54704089
type: RegulatedAuthorization
id:
  v: MA-54704089
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-54704089 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/54704089 subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01006431-0547040020000; 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,07. STOFFWECHSEL,07.08. Geschlechtshormone,07.08.60. Kombinationen 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
contained: Organization
  id:
    v: holder-Sandoz-Pharmaceuticals-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01006431
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100054743
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001029439
  name:
    v: Sandoz Pharmaceuticals AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001398511
  name:
    v: Swissmedic Swiss Agency for Therapeutic Products
identifier:
  system:
    v: http://fhir.ch/ig/ch-epl/sid/authno
    l: authno
  value:
    v: 54704089
subject:
  l: Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 1999-08-17
holder:
  l: holder-Sandoz-Pharmaceuticals-AG
  reference:
    v: #holder-Sandoz-Pharmaceuticals-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

FOPH-17418
type: RegulatedAuthorization
id:
  v: FOPH-17418
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: RegulatedAuthorization FOPH-17418 CH EPL - Reimbursement SL url FOPHDossierNumber value: FOPH Dossier Number/17418 url status value: Reimbursed url statusDate value: 2000-04-15 url listingStatus value: Listed url listingPeriod value: 2000-04-15 --> (ongoing) url firstListingDate value: 2000-04-15 url costShare value: 10 url gamme value: 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 Price value: CHF53.65 (CHF) type: Retail price changeType: VAT-change changeDate: 2024-01-01 url CH EPL - Product Price subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01006431-0547040020000-0097; containedItemQuantity = 24 Patch; description = ESTALIS Matrixpfl 50/250 24 Stk type: Reimbursement SL Indications - 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
contained: Organization
  id:
    v: holder-Sandoz-Pharmaceuticals-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 01006431
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 100054743
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601001029439
  name:
    v: Sandoz Pharmaceuticals AG
extension:
  extension:
    url:
      v: FOPHDossierNumber
      l: FOPHDossierNumber
    value: Identifier
      system:
        v: urn:oid:2.16.756.1
        l: 2.16.756.1
      value:
        v: 17418
  extension:
    url:
      v: status
      l: status
    value: CodeableConcept
  extension:
    url:
      v: statusDate
      l: statusDate
    value: Date
      v: 2000-04-15
  extension:
    url:
      v: listingStatus
      l: listingStatus
    value: CodeableConcept
  extension:
    url:
      v: listingPeriod
      l: listingPeriod
    value: Period
      start:
        v: 2000-04-15
  extension:
    url:
      v: firstListingDate
      l: firstListingDate
    value: Date
      v: 2000-04-15
  extension:
    url:
      v: costShare
      l: costShare
    value: Integer
      v: 10
  extension:
    url:
      v: gamme
      l: gamme
    value: CodeableConcept
  extension:
    extension:
      url:
        v: value
        l: value
      value: Money
    extension:
      url:
        v: type
        l: type
      value: CodeableConcept
    extension:
      url:
        v: changeType
        l: changeType
      value: CodeableConcept
    extension:
      url:
        v: changeDate
        l: changeDate
      value: Date
        v: 2014-11-01
    url:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
      l: productPrice
  extension:
    extension:
      url:
        v: value
        l: value
      value: Money
    extension:
      url:
        v: type
        l: type
      value: CodeableConcept
    extension:
      url:
        v: changeType
        l: changeType
      value: CodeableConcept
    extension:
      url:
        v: changeDate
        l: changeDate
      value: Date
        v: 2024-01-01
    url:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
      l: productPrice
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL
    l: reimbursementSL
subject:
  l: PMP-Estalis-Transdermalpatch
  reference:
    v: PackagedProductDefinition/PMP-Estalis-Transdermalpatch
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
      l: ch-authorisation-type
    code:
      v: 756000002003
    display:
      v: Reimbursement SL
indication:
  extension:
    extension:
      url:
        v: status
        l: status
      value: CodeableConcept
    extension:
      url:
        v: statusDate
        l: statusDate
      value: Date
        v: 2000-04-15
    extension:
      url:
        v: period
        l: period
      value: Period
    extension:
      url:
        v: firstLimitationDate
        l: firstLimitationDate
      value: Date
        v: 2000-04-15
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: Date
      url:
        v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
        l: productPrice
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: Date
      url:
        v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
        l: productPrice
    url:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation
      l: regulatedAuthorization-limitation

MI-Estradiolum-Norethisteroni-Transdermalpatch
type: ManufacturedItemDefinition
id:
  v: MI-Estradiolum-Norethisteroni-Transdermalpatch
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Estradiolum-Norethisteroni-Transdermalpatch Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Transdermal patch unitOfPresentation: Patch
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10519000
    display:
      v: Transdermal patch
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15036000
    display:
      v: Patch

PhP-Estradiolum-Norethisteroni-Transdermalpatch
type: AdministrableProductDefinition
id:
  v: PhP-Estradiolum-Norethisteroni-Transdermalpatch
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition
    l: ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition PhP-Estradiolum-Norethisteroni-Transdermalpatch Profile: AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01006431-0547040020000; 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,07. STOFFWECHSEL,07.08. Geschlechtshormone,07.08.60. Kombinationen administrableDoseForm: Transdermal patch unitOfPresentation: Patch RouteOfAdministrations - Code * Transdermal use
status:
  v: active
form of:
  l: Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10519000
    display:
      v: Transdermal patch
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15036000
    display:
      v: Patch
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 20070000
      display:
        v: Transdermal use

IND-10030247
type: ClinicalUseDefinition
id:
  v: IND-10030247
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10030247 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01006431-0547040020000; 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,07. STOFFWECHSEL,07.08. Geschlechtshormone,07.08.60. Kombinationen indication DiseaseSymptomProcedures - Concept * Oestrogenmangel Comorbidities - Concept * Menopause IntendedEffects - Concept * preventive
type:
  v: indication
subject:
  l: Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch

IND-10031285
type: ClinicalUseDefinition
id:
  v: IND-10031285
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10031285 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01006431-0547040020000; 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,07. STOFFWECHSEL,07.08. Geschlechtshormone,07.08.60. Kombinationen indication DiseaseSymptomProcedures - Concept * Osteoporose postmenopausal IntendedEffects - Concept * preventive
type:
  v: indication
subject:
  l: Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch

Estradiol-hemihydrate-0.512mg
type: Ingredient
id:
  v: Estradiol-hemihydrate-0.512mg
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Estradiol-hemihydrate-0.512mg Profile: 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')
status:
  v: active
for:
  l: PhP-Estradiolum-Norethisteroni-Transdermalpatch
  reference:
    v: AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
for:
  l: MI-Estradiolum-Norethisteroni-Transdermalpatch
  reference:
    v: ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005051001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio

Norethisteroni-acetas-0.496mg
type: Ingredient
id:
  v: Norethisteroni-acetas-0.496mg
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Norethisteroni-acetas-0.496mg Profile: 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')
status:
  v: active
for:
  l: PhP-Estradiolum-Norethisteroni-Transdermalpatch
  reference:
    v: AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
for:
  l: MI-Estradiolum-Norethisteroni-Transdermalpatch
  reference:
    v: ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005051001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio

v: urn:iso:std:iso:3166
l: 3166

v: CH

v: Switzerland

v: urn:ietf:bcp:47
l: 47

v: de-CH

v: German (Switzerland)

v: 100000073403

v: Shelf life of the medicinal product as packaged for sale

v: 756005042004

v: protect from light

v: 756001021001

v: Reimbursed

v: 756001002001

v: Listed

v: 756002004012

v: Transdermal

v: 32.44

v: CHF

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
  l: ch-epl-foph-price-type
code:
  v: 756002005002
display:
  v: Ex-factory price

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  l: ch-epl-foph-type-of-price-change
code:
  v: 756002006010
display:
  v: Price mutation after triennal review of pharmaceuticals

v: 53.65

v: CHF

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
  l: ch-epl-foph-price-type
code:
  v: 756002005001
display:
  v: Retail price

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  l: ch-epl-foph-type-of-price-change
code:
  v: 756002006008
display:
  v: VAT-change

system:
  v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus
  l: ch-epl-foph-limitationstatus
code:
  v: 756002071001
display:
  v: Limitation Reimbursed

v: 2000-04-15

v: value
l: value

Money
value:
  v: 32.44
currency:
  v: CHF

v: type
l: type

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
    l: ch-epl-foph-price-type
  code:
    v: 756002005002
  display:
    v: Ex-factory price

v: changeType
l: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
    l: ch-epl-foph-type-of-price-change
  code:
    v: 756002006010
  display:
    v: Price mutation after triennal review of pharmaceuticals

v: changeDate
l: changeDate

Date
v: 2014-11-01

v: value
l: value

Money
value:
  v: 53.65
currency:
  v: CHF

v: type
l: type

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type
    l: ch-epl-foph-price-type
  code:
    v: 756002005001
  display:
    v: Retail price

v: changeType
l: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
    l: ch-epl-foph-type-of-price-change
  code:
    v: 756002006008
  display:
    v: VAT-change

v: changeDate
l: changeDate

Date
v: 2024-01-01

l: IND-10031285
reference:
  v: ClinicalUseDefinition/IND-10031285

l: holder-Sandoz-Pharmaceuticals-AG
reference:
  v: #holder-Sandoz-Pharmaceuticals-AG

v: 10030247

v: Oestrogenmangel

v: 10027308

v: Menopause

v: 200000003192

v: preventive

v: 10031285

v: Osteoporose postmenopausal

v: 200000003192

v: preventive

v: CXY7B3Q98Z

v: Estradiol-hemihydrate

v: 0.512

v: mg

v: mg

v: 1

v: Patch

v: 15036000

v: 9S44LIC7OJ

v: Norethisterone acetate

v: 0.496

v: mg

v: mg

v: 1

v: Patch

v: 15036000