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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle
type:
  v: collection
entry:
  full url:
    v: http://example.org/MedicinalProductDefinition/Estalis-Transdermalpatch
  resource: Estalis-Transdermalpatch
entry:
  full url:
    v: http://example.org/DocumentReference/DocRef-FI-Estalis
  resource: DocRef-FI-Estalis
entry:
  full url:
    v: http://example.org/DocumentReference/DocRef-PI-Estalis
  resource: DocRef-PI-Estalis
entry:
  full url:
    v: http://example.org/RegulatedAuthorisation/MA-5470402
  resource: MA-5470402
entry:
  full url:
    v: http://example.org/PackagedProductDefinition/PMP-Estalis-Transdermalpatch
  resource: PMP-Estalis-Transdermalpatch
entry:
  full url:
    v: http://example.org/RegulatedAuthorisation/MA-54704089
  resource: MA-54704089
entry:
  full url:
    v: http://example.org/RegulatedAuthorisation/FOPH-17418
  resource: FOPH-17418
entry:
  full url:
    v: http://example.org/ManufacturedItemDefinition/MI-Estradiolum-Norethisteroni-Transdermalpatch
  resource: MI-Estradiolum-Norethisteroni-Transdermalpatch
entry:
  full url:
    v: http://example.org/AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
  resource: PhP-Estradiolum-Norethisteroni-Transdermalpatch
entry:
  full url:
    v: http://example.org/ClinicalUseDefinition/IND-10030247
  resource: IND-10030247
entry:
  full url:
    v: http://example.org/ClinicalUseDefinition/IND-10031285
  resource: IND-10031285
entry:
  full url:
    v: http://example.org/Ingredient/Estradiol-hemihydrate-0.512mg
  resource: Estradiol-hemihydrate-0.512mg
entry:
  full url:
    v: http://example.org/Ingredient/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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div: 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-7601001029439-5470402 domain: 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)
extension:
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
      code:
        v: 10519000
      display:
        v: Transdermal patch
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID
  value:
    v: CH-7601001029439-5470402
domain:
  coding:
    system:
      v: http://spor.ema.europa.eu/v1/lists/100000000004
    code:
      v: 100000000012
    display:
      v: Human
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
    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
    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
    code:
      v: 756005003002
    display:
      v: Not authorised for the treatment in children
classification:
  coding:
    system:
      v: http://www.whocc.no/atc
    code:
      v: G03FA01
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/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
    code:
      v: 756005004001
    display:
      v: Synthetic
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
    code:
      v: 756001003002
    display:
      v: Originator product
attached document:
  link: http://fhir.ch/ig/ch-epl/DocumentReference/DocRef-FI-Estalis
  reference:
    v: DocumentReference/DocRef-FI-Estalis
attached document:
  link: http://fhir.ch/ig/ch-epl/DocumentReference/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
      code:
        v: SMC
      display:
        v: Zugelassener Arzneimittelname

DocRef-FI-Estalis
type: DocumentReference
id:
  v: DocRef-FI-Estalis
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div: 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-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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber
  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
    code:
      v: 756005007001
    display:
      v: Fachinformation
date:
  v: 2021-10-01T00:00:00Z
content:
  attachment:
    url:
      v: 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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference
language:
  v: de-CH
text:
  status:
    v: generated
  div: 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-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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-AttachmentNumber
  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
    code:
      v: 756005007002
    display:
      v: Patienteninformation
date:
  v: 2021-10-01T00:00:00Z
content:
  attachment:
    url:
      v: 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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization MA-5470402 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/5470402 subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = 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 type: 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
contained: Organization
  id:
    v: holder-Sandoz-Pharmaceuticals-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100054743
  identifier:
    system:
      v: urn:oid: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-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber
  value:
    v: 5470402
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 1999-08-17
holder:
  reference:
    v: #holder-Sandoz-Pharmaceuticals-AG
regulator:
  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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div: Generated Narrative: PackagedProductDefinition PMP-Estalis-Transdermalpatch Profile: IDMP PackagedProductDefinition identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID/CH-7601001029439-5470402-097 packageFor: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = 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 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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID
  value:
    v: CH-7601001029439-5470402-097
package for:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
contained item quantity:
  value:
    v: 24
  unit:
    v: Patch
  system:
    v: http://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
      code:
        v: 756005022003
      display:
        v: Medicinal product subject to medical or veterinary prescription (B)
packaging:
  identifier:
    system:
      v: urn:oid:2.51.1.1
    value:
      v: 7680547040979
  type:
    coding:
      system:
        v: http://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
      code:
        v: mo

MA-54704089
type: RegulatedAuthorization
id:
  v: MA-54704089
meta:
  profile:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div: Generated Narrative: RegulatedAuthorization MA-54704089 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/54704089 subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = 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 type: 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
contained: Organization
  id:
    v: holder-Sandoz-Pharmaceuticals-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100054743
  identifier:
    system:
      v: urn:oid: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-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100010911
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001398511
  name:
    v: SMC
identifier:
  system:
    v: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber
  value:
    v: 54704089
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
    code:
      v: 756000002001
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: CH
    display:
      v: Switzerland
status:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
    code:
      v: 756005023007
    display:
      v: valid
status date:
  v: 1999-08-17
holder:
  reference:
    v: #holder-Sandoz-Pharmaceuticals-AG
regulator:
  reference:
    v: #regulator-SMC

FOPH-17418
type: RegulatedAuthorization
id:
  v: FOPH-17418
text:
  status:
    v: extensions
  div: 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 subject: PackagedProductDefinition: identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-PCID#CH-7601001029439-5470402-097; 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: CH EPL Organization identifier: 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-epl-organization
      link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-epl-organization
  identifier:
    system:
      v: urn:oid:1.2.276.0.76
    value:
      v: 100054743
  identifier:
    system:
      v: urn:oid:2.51.1.3
    value:
      v: 7601001029439
  name:
    v: Sandoz Pharmaceuticals AG
extension:
  extension:
    url:
      v: FOPHDossierNumber
    value: Identifier
      system:
        v: urn:oid:2.16.756.1
      value:
        v: 17418
  extension:
    url:
      v: status
    value: CodeableConcept
  extension:
    url:
      v: statusDate
    value: date
      v: 2000-04-15
  extension:
    url:
      v: listingStatus
    value: CodeableConcept
  extension:
    url:
      v: listingPeriod
    value: Period
      start:
        v: 2000-04-15
  extension:
    url:
      v: firstListingDate
    value: date
      v: 2000-04-15
  extension:
    url:
      v: costShare
    value: integer
      v: 10
  extension:
    url:
      v: gamme
    value: CodeableConcept
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL
extension:
  extension:
    url:
      v: value
    value: Money
      value:
        v: 32.44
      currency:
        v: CHF
  extension:
    url:
      v: type
    value: CodeableConcept
  extension:
    url:
      v: changeType
    value: CodeableConcept
  extension:
    url:
      v: changeDate
    value: date
      v: 2014-11-01
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
extension:
  extension:
    url:
      v: value
    value: Money
      value:
        v: 53.65
      currency:
        v: CHF
  extension:
    url:
      v: type
    value: CodeableConcept
  extension:
    url:
      v: changeType
    value: CodeableConcept
  extension:
    url:
      v: changeDate
    value: date
      v: 2024-01-01
  url:
    v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
subject:
  link: http://fhir.ch/ig/ch-epl/PackagedProductDefinition/PMP-Estalis-Transdermalpatch
  reference:
    v: PackagedProductDefinition/PMP-Estalis-Transdermalpatch
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
    code:
      v: 756000002003
    display:
      v: Reimbursement SL
indication:
  extension:
    extension:
      url:
        v: status
      value: CodeableConcept
    extension:
      url:
        v: statusDate
      value: date
        v: 2000-04-15
    extension:
      url:
        v: period
      value: Period
    extension:
      url:
        v: 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
    extension:
      extension:
        value: Money
      extension:
        value: CodeableConcept
      extension:
        value: CodeableConcept
      extension:
        value: date
      url:
        v: http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice
    url:
      v: http://fhir.ch/ig/ch-epl/StructureDefinition/regulatedAuthorization-limitation
  reference:
    link: http://fhir.ch/ig/ch-epl/ClinicalUseDefinition/IND-10031285
    reference:
      v: ClinicalUseDefinition/IND-10031285
holder:
  reference:
    v: #holder-Sandoz-Pharmaceuticals-AG

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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div: Generated Narrative: ManufacturedItemDefinition MI-Estradiolum-Norethisteroni-Transdermalpatch Profile: CH IDMP ManufacturedItemDefinition status: Active manufacturedDoseForm: Transdermal patch unitOfPresentation: Patch
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 10519000
    display:
      v: Transdermal patch
unit of presentation:
  coding:
    system:
      v: http://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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div: Generated Narrative: AdministrableProductDefinition PhP-Estradiolum-Norethisteroni-Transdermalpatch Profile: CH IDMP AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = 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 administrableDoseForm: Transdermal patch unitOfPresentation: Patch RouteOfAdministrations - Code * Transdermal use
status:
  v: active
form of:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/Estalis-Transdermalpatch
  reference:
    v: MedicinalProductDefinition/Estalis-Transdermalpatch
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 10519000
    display:
      v: Transdermal patch
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 15036000
    display:
      v: Patch
route of administration:
  code:
    coding:
      system:
        v: http://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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div: Generated Narrative: ClinicalUseDefinition IND-10030247 Profile: CH IDMP ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = 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 indication DiseaseSymptomProcedures - Concept * Oestrogenmangel Comorbidities - Concept * Menopause IntendedEffects - Concept * preventive
type:
  v: indication
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div: Generated Narrative: ClinicalUseDefinition IND-10031285 Profile: CH IDMP ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Transdermal patch; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001029439-5470402; domain = 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 indication DiseaseSymptomProcedures - Concept * Osteoporose postmenopausal IntendedEffects - Concept * preventive
type:
  v: indication
subject:
  link: http://fhir.ch/ig/ch-epl/MedicinalProductDefinition/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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
text:
  status:
    v: generated
  div: 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')
status:
  v: active
for:
  link: http://fhir.ch/ig/ch-epl/AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
  reference:
    v: AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
for:
  link: http://fhir.ch/ig/ch-epl/ManufacturedItemDefinition/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
    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
    link: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient
text:
  status:
    v: generated
  div: 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')
status:
  v: active
for:
  link: http://fhir.ch/ig/ch-epl/AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
  reference:
    v: AdministrableProductDefinition/PhP-Estradiolum-Norethisteroni-Transdermalpatch
for:
  link: http://fhir.ch/ig/ch-epl/ManufacturedItemDefinition/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
    code:
      v: 756005051001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio

v: urn:iso:std:iso:3166

v: CH

v: Switzerland

v: urn:ietf:bcp: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: 756002004011

v: Transdermal

v: 756002005002

v: Ex-factory price

v: 756002006007

v: Price mutation after triennal review of pharmaceuticals

v: 756002005001

v: Retail price

v: 756002006005

v: VAT-change

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

v: 2000-04-15

v: value

Money
value:
  v: 32.44
currency:
  v: CHF

v: type

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

v: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  code:
    v: 756002006007
  display:
    v: Price mutation after triennal review of pharmaceuticals

v: changeDate

date
v: 2014-11-01

v: value

Money
value:
  v: 53.65
currency:
  v: CHF

v: type

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

v: changeType

CodeableConcept
coding:
  system:
    v: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change
  code:
    v: 756002006005
  display:
    v: VAT-change

v: changeDate

date
v: 2024-01-01

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