http://fhir.ch/ig/ch-idmp/Bundle/200f39aa-ddd8-48a2-a05e-8e4b4e6ac847
type: Bundle
node role: treeRoot
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-bundle
    l: ch-idmp-bundle
language:
  v: de-CH
type:
  v: collection
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Comprehensive-Sample-Combipack
    l: Comprehensive-Sample-Combipack
  resource: Comprehensive-Sample-Combipack
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Comprehensive
    l: DocRef-FI-Comprehensive
  resource: DocRef-FI-Comprehensive
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Comprehensive
    l: DocRef-PI-Comprehensive
  resource: DocRef-PI-Comprehensive
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-12345601
    l: MA-12345601
  resource: MA-12345601
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Comprehensive-Sample-Combipack
    l: PMP-Comprehensive-Sample-Combipack
  resource: PMP-Comprehensive-Sample-Combipack
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-123456002
    l: MA-123456002
  resource: MA-123456002
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalPessary
    l: MI-Comprehensive-Sample-VaginalPessary
  resource: MI-Comprehensive-Sample-VaginalPessary
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
    l: MI-Comprehensive-Sample-VaginalCream
  resource: MI-Comprehensive-Sample-VaginalCream
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalPessary
    l: PhP-Comprehensive-Sample-VaginalPessary
  resource: PhP-Comprehensive-Sample-VaginalPessary
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
    l: PhP-Comprehensive-Sample-VaginalCream
  resource: PhP-Comprehensive-Sample-VaginalCream
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/ClindamycinPhosphate100
    l: ClindamycinPhosphate100
  resource: ClindamycinPhosphate100
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/HardFat
    l: HardFat
  resource: HardFat
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/ClindamycinPhosphate20
    l: ClindamycinPhosphate20
  resource: ClindamycinPhosphate20
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/BenzylAlcohol
    l: BenzylAlcohol
  resource: BenzylAlcohol
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/SorbitanStearate
    l: SorbitanStearate
  resource: SorbitanStearate
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbate60
    l: Polysorbate60
  resource: Polysorbate60
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/PropyleneGlycol
    l: PropyleneGlycol
  resource: PropyleneGlycol
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/StearicAcid
    l: StearicAcid
  resource: StearicAcid
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/CetostaerylAlcohol
    l: CetostaerylAlcohol
  resource: CetostaerylAlcohol
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/CetylPalmitate
    l: CetylPalmitate
  resource: CetylPalmitate
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/LiquidParaffin
    l: LiquidParaffin
  resource: LiquidParaffin
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/Ingredient/Water
    l: Water
  resource: Water
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10004055
    l: IND-10004055
  resource: IND-10004055
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10046961
    l: IND-10046961
  resource: IND-10046961
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10079528
    l: IND-10079528
  resource: IND-10079528
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10046950
    l: IND-10046950
  resource: IND-10046950
entry:
  full url:
    v: http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10050348
    l: IND-10050348
  resource: IND-10050348

Comprehensive-Sample-Combipack
type: MedicinalProductDefinition
id:
  v: Comprehensive-Sample-Combipack
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-medicinalproductdefinition
    l: ch-idmp-medicinalproductdefinition
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: MedicinalProductDefinition Comprehensive-Sample-Combipack Profile: MedicinalProductDefinition CH SMC - Authorized Dose Form: Cream + Pessary identifier: Medical Product Identifier/CH-11111111-1234560010000 combinedPharmaceuticalDoseForm: Cream + Pessary indication: Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose) legalStatusOfSupply: D: Dispensed following expert advice additionalMonitoringIndicator: No Warning pediatricUseIndicator: Not authorised for the treatment in children classification: nystatin, NA NAS, Synthetic MarketingStatuses - Country Status DateRange * Switzerland No interruption of distribution reported 2020-09-24 --> 2026-12-31 attachedDocument: DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#999999999-FI-123; status = current; type = Information for healthcare professionals; date = 2023-07-01 00:00:00+0000 DocumentReference: identifier = http://fhir.ch/ig/ch-idmp/sid/attno#Application / Assessment Tracking Number#999999999-PI-123; status = current; type = Patient Information; date = 2023-07-01 00:00:00+0000 name productName: Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten type: Authorised Medicinal Product Name Usages - Country Language * Switzerland German (Switzerland)
extension:
  url:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/authorizedDoseForm
    l: authorizedDoseForm
  value: CodeableConcept
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 14001000
      display:
        v: Cream + Pessary
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/mpid
    l: mpid
  value:
    v: CH-11111111-1234560010000
combined pharmaceutical dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 14001000
    display:
      v: Cream + Pessary
indication:
  v: Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose)
legal status of supply:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply
      l: ch-SMC-legal-status-of-supply
    code:
      v: 756005034000005
    display:
      v: D: Dispensed following expert advice
additional monitoring indicator:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/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-idmp/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: G01AA01
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
      l: ch-SMC-authorisation-category
    code:
      v: 756005011000015
    display:
      v: NA NAS
classification:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-MedicinalProductCategory
      l: ch-SMC-MedicinalProductCategory
    code:
      v: 756005039000001
    display:
      v: Synthetic
marketing status:
  country:
    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-idmp/CodeSystem/ch-SMC-marketing-status
        l: ch-SMC-marketing-status
      code:
        v: 7560050074000003
      display:
        v: No interruption of distribution reported
  date range:
    start:
      v: 2020-09-24
    end:
      v: 2026-12-31
attached document:
  l: DocRef-FI-Comprehensive
  reference:
    v: DocumentReference/DocRef-FI-Comprehensive
attached document:
  l: DocRef-PI-Comprehensive
  reference:
    v: DocumentReference/DocRef-PI-Comprehensive
name:
  product name:
    v: Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten
  type:
    coding:
      system:
        v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-medicinal-product-name-type
        l: ch-medicinal-product-name-type
      code:
        v: SMC
      display:
        v: Authorised Medicinal Product Name

DocRef-FI-Comprehensive
type: DocumentReference
id:
  v: DocRef-FI-Comprehensive
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DocumentReference DocRef-FI-Comprehensive Profile: DocumentReference identifier: Application / Assessment Tracking Number/999999999-FI-123 status: Current type: Information for healthcare professionals date: 2023-07-01 00:00:00+0000 content Attachments - Language Url * German (Switzerland) https://swissmedicinfo-pro.ch/showText.aspx?textType=FI&lang=DE&authNr=69093&supportMultipleResults=1
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/attno
    l: attno
  value:
    v: 999999999-FI-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005040000001
    display:
      v: Information for healthcare professionals
date:
  v: 2023-07-01T00:00:00Z
content:
  attachment:
    language:
      v: de-CH
    url:
      v: https://swissmedicinfo-pro.ch/showText.aspx
      l: https://swissmedicinfo-pro.ch/showText.aspx

DocRef-PI-Comprehensive
type: DocumentReference
id:
  v: DocRef-PI-Comprehensive
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-documentreference
    l: ch-idmp-documentreference
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DocumentReference DocRef-PI-Comprehensive Profile: DocumentReference identifier: Application / Assessment Tracking Number/999999999-PI-123 status: Current type: Patient Information date: 2023-07-01 00:00:00+0000 content Attachments - Language Url * German (Switzerland) https://swissmedicinfo.ch/detailpage/69093002
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/attno
    l: attno
  value:
    v: 999999999-PI-123
status:
  v: current
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-attached-document-type
      l: ch-SMC-attached-document-type
    code:
      v: 756005040000002
    display:
      v: Patient Information
date:
  v: 2023-07-01T00:00:00Z
content:
  attachment:
    language:
      v: de-CH
    url:
      v: https://swissmedicinfo.ch/detailpage/69093002
      l: https://swissmedicinfo.ch/detailpage/69093002

MA-12345601
type: RegulatedAuthorization
id:
  v: MA-12345601
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-12345601 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/12345601 subject: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic type: Marketing Authorisation region: Switzerland status: approved statusDate: 2023-11-07 validityPeriod: 2023-11-07 --> 2028-11-06 holder: Organization Example AG regulator: Organization SMC Generated Narrative: Organization #holder-Example-AG Profile: Organization identifier: Swissmedic Location Identifier/12345678, LOC Identifier/0123456789, GLN Identifier/7601123456789 name: Example AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Example-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 12345678
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 0123456789
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601123456789
  name:
    v: Example AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/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: SMC
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/authno
    l: authno
  value:
    v: 12345601
subject:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs
      l: ch-authorisation-type-cs
    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-idmp/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005010000001
    display:
      v: approved
status date:
  v: 2023-11-07
validity period:
  start:
    v: 2023-11-07
  end:
    v: 2028-11-06
holder:
  l: holder-Example-AG
  reference:
    v: #holder-Example-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

PMP-Comprehensive-Sample-Combipack
type: PackagedProductDefinition
id:
  v: PMP-Comprehensive-Sample-Combipack
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-packagedproductdefinition
    l: ch-idmp-packagedproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition PMP-Comprehensive-Sample-Combipack Profile: PackagedProductDefinition identifier: Clinical Product Identifier/CH-11111111-1234560010000-0002 packageFor: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic containedItemQuantity: 1 Tube (Details: EDQM - Standard Terms code15058000 = 'Tube'), 6 Vaginal Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet') description: Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen LegalStatusOfSupplies - Code * D: Dispensed following expert advice MarketingStatuses - Country Status DateRange * Switzerland Marketed 2020-09-24 --> 2026-12-31 packaging identifier: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-gtin.html" title="The GS1 GTIN is a globally unique identifier of trade items. A trade item is any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. Note: GTINs may be used in both Codes (http://build.fhir.org/datatypes.html#Coding) and Identifiers (http://build.fhir.org/datatypes.html#Identifier).">GTIN Global Trade Item Number/7680612345678 type: Box quantity: 1 ShelfLifeStorages - Type Period[x] SpecialPrecautionsForStorage * Shelf life of the medicinal product as packaged for sale No display for Duration (value: 24; u…
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/pcid
    l: pcid
  value:
    v: CH-11111111-1234560010000-0002
package for:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack
contained item quantity:
  value:
    v: 1
  unit:
    v: Tube
  system:
    v: http://standardterms.edqm.eu
    l: standardterms.edqm.eu
  code:
    v: 15058000
contained item quantity:
  value:
    v: 6
  unit:
    v: Vaginal Tablet
  system:
    v: http://standardterms.edqm.eu
    l: standardterms.edqm.eu
  code:
    v: 15054000
description:
  v: Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen
legal status of supply:
  code:
    coding:
      system:
        v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-legal-status-of-supply
        l: ch-SMC-legal-status-of-supply
      code:
        v: 756005034000005
      display:
        v: D: Dispensed following expert advice
marketing status:
  country:
    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-idmp/CodeSystem/ch-Refdata-marketing-status
        l: ch-Refdata-marketing-status
      code:
        v: 756002026002
      display:
        v: Marketed
  date range:
    start:
      v: 2020-09-24
    end:
      v: 2026-12-31
packaging:
  identifier:
    system:
      v: https://www.gs1.org/gtin
      l: gtin
    value:
      v: 7680612345678
  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: 24
      unit:
        v: month
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mo
  shelf life storage:
    period: Duration
      value:
        v: 6
      unit:
        v: month
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mo
  packaging:
    quantity:
      v: 3
    packaging:
      quantity:
        v: 1
  packaging:
    quantity:
      v: 1

MA-123456002
type: RegulatedAuthorization
id:
  v: MA-123456002
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization
    l: ch-idmp-regulatedauthorization
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization MA-123456002 Profile: RegulatedAuthorization identifier: Marketing Authorisation Number/123456002 subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-11111111-1234560010000-0002; containedItemQuantity = 1 Tube,6 Vaginal Tablet; description = Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen type: Marketing Authorisation region: Switzerland status: approved statusDate: 2023-11-07 validityPeriod: 2023-11-07 --> 2028-11-06 holder: Organization Example AG regulator: Organization SMC Generated Narrative: Organization #holder-Example-AG Profile: Organization identifier: Swissmedic Location Identifier/12345678, LOC Identifier/0123456789, GLN Identifier/7601123456789 name: Example AG Generated Narrative: Organization #regulator-SMC Profile: Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC
contained: Organization
  id:
    v: holder-Example-AG
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization
      l: ch-idmp-organization
  identifier:
    system:
      v: https://www.swissmedic.ch/fhir/identifier/locations
      l: locations
    value:
      v: 12345678
  identifier:
    system:
      v: https://spor.ema.europa.eu/v1/locations
      l: locations
    value:
      v: 0123456789
  identifier:
    system:
      v: urn:oid:2.51.1.3
      l: 2.51.1.3
    value:
      v: 7601123456789
  name:
    v: Example AG
contained: Organization
  id:
    v: regulator-SMC
  meta:
    profile:
      v: http://fhir.ch/ig/ch-idmp/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: SMC
identifier:
  system:
    v: http://fhir.ch/ig/ch-idmp/sid/authno
    l: authno
  value:
    v: 123456002
subject:
  l: PMP-Comprehensive-Sample-Combipack
  reference:
    v: PackagedProductDefinition/PMP-Comprehensive-Sample-Combipack
type:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs
      l: ch-authorisation-type-cs
    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-idmp/CodeSystem/ch-SMC-authorisation-status
      l: ch-SMC-authorisation-status
    code:
      v: 756005010000001
    display:
      v: approved
status date:
  v: 2023-11-07
validity period:
  start:
    v: 2023-11-07
  end:
    v: 2028-11-06
holder:
  l: holder-Example-AG
  reference:
    v: #holder-Example-AG
regulator:
  l: regulator-SMC
  reference:
    v: #regulator-SMC

MI-Comprehensive-Sample-VaginalPessary
type: ManufacturedItemDefinition
id:
  v: MI-Comprehensive-Sample-VaginalPessary
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Comprehensive-Sample-VaginalPessary Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Pessary unitOfPresentation: Pessary
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10909000
    display:
      v: Pessary
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15039000
    display:
      v: Pessary

MI-Comprehensive-Sample-VaginalCream
type: ManufacturedItemDefinition
id:
  v: MI-Comprehensive-Sample-VaginalCream
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-manufactureditemdefinition
    l: ch-idmp-manufactureditemdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition MI-Comprehensive-Sample-VaginalCream Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Vaginal Cream unitOfPresentation: Tube
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10901000
    display:
      v: Vaginal Cream
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15058000
    display:
      v: Tube

PhP-Comprehensive-Sample-VaginalPessary
type: AdministrableProductDefinition
id:
  v: PhP-Comprehensive-Sample-VaginalPessary
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition
    l: ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition PhP-Comprehensive-Sample-VaginalPessary Profile: AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic administrableDoseForm: Pessary unitOfPresentation: Pessary RouteOfAdministrations - Code * Vaginal use
status:
  v: active
form of:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10909000
    display:
      v: Pessary
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15039000
    display:
      v: Pessary
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 20072000
      display:
        v: Vaginal use

PhP-Comprehensive-Sample-VaginalCream
type: AdministrableProductDefinition
id:
  v: PhP-Comprehensive-Sample-VaginalCream
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-administrableproductdefinition
    l: ch-idmp-administrableproductdefinition
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition PhP-Comprehensive-Sample-VaginalCream Profile: AdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic administrableDoseForm: Vaginal Cream unitOfPresentation: Tube RouteOfAdministrations - Code * Vaginal use
status:
  v: active
form of:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack
administrable dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10901000
    display:
      v: Vaginal Cream
unit of presentation:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 15058000
    display:
      v: Tube
route of administration:
  code:
    coding:
      system:
        v: http://standardterms.edqm.eu
        l: standardterms.edqm.eu
      code:
        v: 20072000
      display:
        v: Vaginal use

ClindamycinPhosphate100
type: Ingredient
id:
  v: ClindamycinPhosphate100
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ClindamycinPhosphate100 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Pessary; unitOfPresentation = Pessary ManufacturedItemDefinition: status = active; manufacturedDoseForm = Pessary; unitOfPresentation = Pessary role: Active substance Codes - Concept * Clindamycin phosphate strength referenceStrength Substances - Concept * Clindamycin strength: 100 mg (Details: UCUM codemg = 'mg')/1 Pessary (Details: EDQM - Standard Terms code15039000 = 'Pessary')
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalPessary
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalPessary
for:
  l: MI-Comprehensive-Sample-VaginalPessary
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalPessary
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000001
    display:
      v: Active
substance:
  strength:
    reference strength:
      strength: Ratio

HardFat
type: Ingredient
id:
  v: HardFat
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient HardFat Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Pessary; unitOfPresentation = Pessary ManufacturedItemDefinition: status = active; manufacturedDoseForm = Pessary; unitOfPresentation = Pessary role: Excipient substance Codes - Concept * Hard Fat
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalPessary
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalPessary
for:
  l: MI-Comprehensive-Sample-VaginalPessary
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalPessary
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

ClindamycinPhosphate20
type: Ingredient
id:
  v: ClindamycinPhosphate20
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ClindamycinPhosphate20 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Active substance Codes - Concept * Clindamycin phosphate strength presentation: 950.4 mg (Details: UCUM codemg = 'mg')/1 Tube (Details: EDQM - Standard Terms code15058000 = 'Tube') concentration: 23.76 mg (Details: UCUM codemg = 'mg')/1 g (Details: UCUM codeg = 'g') referenceStrength Substances - Concept * Clindamycin strength: 800 mg (Details: UCUM codemg = 'mg')/1 Tube (Details: EDQM - Standard Terms code15058000 = 'Tube') referenceStrength Substances - Concept * Clindamycin strength: 20 mg (Details: UCUM codemg = 'mg')/1 g (Details: UCUM codeg = 'g')
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000001
    display:
      v: Active
substance:
  strength:
    presentation: Ratio
    concentration: Ratio
    reference strength:
      strength: Ratio
    reference strength:
      strength: Ratio

BenzylAlcohol
type: Ingredient
id:
  v: BenzylAlcohol
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient BenzylAlcohol Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Excipient substance Codes - Concept * Benzyl Alcohol
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

SorbitanStearate
type: Ingredient
id:
  v: SorbitanStearate
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient SorbitanStearate Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Excipient substance Codes - Concept * Sorbitan monostearate
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

Polysorbate60
type: Ingredient
id:
  v: Polysorbate60
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Polysorbate60 Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Excipient substance Codes - Concept * Polysorbate 60
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

PropyleneGlycol
type: Ingredient
id:
  v: PropyleneGlycol
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient PropyleneGlycol Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Excipient substance Codes - Concept * Propylene Glycol
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

StearicAcid
type: Ingredient
id:
  v: StearicAcid
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient StearicAcid Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Excipient substance Codes - Concept * Stearic Acid
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

CetostaerylAlcohol
type: Ingredient
id:
  v: CetostaerylAlcohol
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient CetostaerylAlcohol Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Excipient substance Codes - Concept * CETOSTEARYL ALCOHOL
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

CetylPalmitate
type: Ingredient
id:
  v: CetylPalmitate
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient CetylPalmitate Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Vaginal Cream; unitOfPresentation = Tube ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube role: Excipient substance Codes - Concept * CETYL PALMITATE
status:
  v: active
for:
  l: PhP-Comprehensive-Sample-VaginalCream
  reference:
    v: AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
for:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

LiquidParaffin
type: Ingredient
id:
  v: LiquidParaffin
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient LiquidParaffin Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * LIQUID PARAFFIN
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

Water
type: Ingredient
id:
  v: Water
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-ingredient
    l: ch-idmp-ingredient
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient Water Profile: Ingredient status: Active for: AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Water
status:
  v: active
for:
  l: PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: AdministrableProductDefinition/PhP-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
for:
  l: MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
  reference:
    v: ManufacturedItemDefinition/MI-Gilteritinibi-hemifumaras-40-Filmcoatedtablet
role:
  coding:
    system:
      v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-ingredient-role
      l: ch-SMC-ingredient-role
    code:
      v: 756005035000002
    display:
      v: Excipient

IND-10004055
type: ClinicalUseDefinition
id:
  v: IND-10004055
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10004055 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic indication DiseaseSymptomProcedures - Concept * Bacterial vaginosis Comorbidities - Concept * Recurrent UTI IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack

IND-10046961
type: ClinicalUseDefinition
id:
  v: IND-10046961
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10046961 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic indication DiseaseSymptomProcedures - Concept * Vaginosis bacterial NOS Comorbidities - Concept * Obesity IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack

IND-10079528
type: ClinicalUseDefinition
id:
  v: IND-10079528
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10079528 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic indication DiseaseSymptomProcedures - Concept * Bacterial vulvovaginitis Comorbidities - Concept * Diabetes mellitus IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack

IND-10046950
type: ClinicalUseDefinition
id:
  v: IND-10046950
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10046950 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic indication DiseaseSymptomProcedures - Concept * Vaginitis Comorbidities - Concept * HIV infection IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack

IND-10050348
type: ClinicalUseDefinition
id:
  v: IND-10050348
meta:
  profile:
    v: http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-clinicalusedefinition-indication
    l: ch-idmp-clinicalusedefinition-indication
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition IND-10050348 Profile: ClinicalUseDefinition Indication type: Indication subject: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic indication DiseaseSymptomProcedures - Concept * Genital infection NOS, female Comorbidities - Concept * Diabetes mellitus IntendedEffects - Concept * therapeutic
type:
  v: indication
subject:
  l: Comprehensive-Sample-Combipack
  reference:
    v: MedicinalProductDefinition/Comprehensive-Sample-Combipack

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

v: CH

v: Switzerland

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

v: de-CH

v: 100000073403

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

v: 756005041000006

v: at room temperature (15 - 25°C)

v: 756005041000004

v: protect from light

v: 756005041000011

v: Store in the original container

v: 100000073404

v: Shelf life after first opening the immediate packaging

v: 15007000

v: Blister

l: MI-Comprehensive-Sample-VaginalPessary
reference:
  v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalPessary

v: 2

v: countable unit(s)

v: 1

system:
  v: http://standardterms.edqm.eu
  l: standardterms.edqm.eu
code:
  v: 15058000
display:
  v: Tube

reference:
  l: MI-Comprehensive-Sample-VaginalCream
  reference:
    v: ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream

value:
  v: 10
unit:
  v: mg
system:
  v: http://unitsofmeasure.org
  l: unitsofmeasure.org
code:
  v: mg

v: 30054000

v: Sachet

v: EH6D7113I8

v: Clindamycin phosphate

coding:
  system:
    v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance
    l: ch-SMC-substance
  code:
    v: 3U02EL437C
  display:
    v: Clindamycin

value:
  v: 100
unit:
  v: mg
system:
  v: http://unitsofmeasure.org
  l: unitsofmeasure.org
code:
  v: mg

value:
  v: 1
unit:
  v: Pessary
system:
  v: http://standardterms.edqm.eu
  l: standardterms.edqm.eu
code:
  v: 15039000

v: 8334LX7S21

v: Hard Fat

v: EH6D7113I8

v: Clindamycin phosphate

v: 950.4

v: mg

v: mg

v: 1

v: Tube

v: 15058000

v: 23.76

v: mg

v: mg

v: 1

v: g

v: g

coding:
  system:
    v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance
    l: ch-SMC-substance
  code:
    v: 3U02EL437C
  display:
    v: Clindamycin

value:
  v: 800
unit:
  v: mg
system:
  v: http://unitsofmeasure.org
  l: unitsofmeasure.org
code:
  v: mg

value:
  v: 1
unit:
  v: Tube
system:
  v: http://standardterms.edqm.eu
  l: standardterms.edqm.eu
code:
  v: 15058000

coding:
  system:
    v: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-substance
    l: ch-SMC-substance
  code:
    v: 3U02EL437C
  display:
    v: Clindamycin

value:
  v: 20
unit:
  v: mg
system:
  v: http://unitsofmeasure.org
  l: unitsofmeasure.org
code:
  v: mg

value:
  v: 1
unit:
  v: g
system:
  v: http://unitsofmeasure.org
  l: unitsofmeasure.org
code:
  v: g

v: LKG8494WBH

v: Benzyl Alcohol

v: NVZ4I0H58X

v: Sorbitan monostearate

v: CAL22UVI4M

v: Polysorbate 60

v: 6DC9Q167V3

v: Propylene Glycol

v: 4ELV7Z65AP

v: Stearic Acid

v: 2DMT128M1S

v: CETOSTEARYL ALCOHOL

v: 5ZA2S6B08X

v: CETYL PALMITATE

v: T5L8T28FGP

v: LIQUID PARAFFIN

v: 059QF0KO0R

v: Water

v: 10004055

v: Bacterial vaginosis

v: 10038141

v: Recurrent UTI

v: 756005042000002

v: therapeutic

v: 10046961

v: Vaginosis bacterial NOS

v: 10029883

v: Obesity

v: 756005042000002

v: therapeutic

v: IND-10079528

v: Bacterial vulvovaginitis

v: 10012601

v: Diabetes mellitus

v: 756005042000002

v: therapeutic

v: 10046950

v: Vaginitis

v: 10020161

v: HIV infection

v: 756005042000002

v: therapeutic

v: 10050348

v: Genital infection NOS, female

v: 10012601

v: Diabetes mellitus

v: 756005042000002

v: therapeutic