CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5)
1.0.0-ballot - trial-use
CH IDMP (R5) - Local Development build (v1.0.0-ballot) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Language: de-CH
Profile: Bundle
Bundle 200f39aa-ddd8-48a2-a05e-8e4b4e6ac847 of type collection
Entry 1 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/MedicinalProductDefinition/Comprehensive-Sample-Combipack
Resso}:
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)
Entry 2 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Comprehensive
Resso}:
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 de-CH https://swissmedicinfo-pro.ch/showText.aspx?textType=FI&lang=DE&authNr=69093&supportMultipleResults=1
Entry 3 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-PI-Comprehensive
Resso}:
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 de-CH https://swissmedicinfo.ch/detailpage/69093002
Entry 4 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-12345601
Resso}:
Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/12345601
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
Profile: Organization
identifier: Swissmedic Location Identifier/12345678, LOC Identifier/0123456789, GLN Identifier/7601123456789
name: Example AG
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 5 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/PackagedProductDefinition/PMP-Comprehensive-Sample-Combipack
Resso}:
Profile: PackagedProductDefinition
identifier: Clinical Product Identifier/CH-11111111-1234560010000-0002
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: 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; unit: month; system: http://unitsofmeasure.org; code: mo) at room temperature (15 - 25°C) protect from light Store in the original container Shelf life after first opening the immediate packaging No display for Duration (value: 6; unit: month; system: http://unitsofmeasure.org; code: mo) packaging
type: Blister
quantity: 3
containedItem
Items
Reference ManufacturedItemDefinition: status = active; manufacturedDoseForm = Pessary; unitOfPresentation = Pessary amount: 2 countable unit(s) (Details: UCUM code1 = '1')
packaging
type: Tube
quantity: 1
containedItem
Items
Reference ManufacturedItemDefinition: status = active; manufacturedDoseForm = Vaginal Cream; unitOfPresentation = Tube amount: 10 mg (Details: UCUM codemg = 'mg')
packaging
type: Sachet
quantity: 1
Entry 6 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-123456002
Resso}:
Profile: RegulatedAuthorization
identifier: Marketing Authorisation Number/123456002
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
Profile: Organization
identifier: Swissmedic Location Identifier/12345678, LOC Identifier/0123456789, GLN Identifier/7601123456789
name: Example AG
Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC
Entry 7 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalPessary
Resso}:
Profile: ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Pessary
unitOfPresentation: Pessary
Entry 8 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream
Resso}:
Profile: ManufacturedItemDefinition
status: Active
manufacturedDoseForm: Vaginal Cream
unitOfPresentation: Tube
Entry 9 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalPessary
Resso}:
Profile: AdministrableProductDefinition
status: Active
administrableDoseForm: Pessary
unitOfPresentation: Pessary
RouteOfAdministrations
Code Vaginal use
Entry 10 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream
Resso}:
Profile: AdministrableProductDefinition
status: Active
administrableDoseForm: Vaginal Cream
unitOfPresentation: Tube
RouteOfAdministrations
Code Vaginal use
Entry 11 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/ClindamycinPhosphate100
Resso}:
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')
Entry 12 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/HardFat
Resso}:
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
Entry 13 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/ClindamycinPhosphate20
Resso}:
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')
Entry 14 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/BenzylAlcohol
Resso}:
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
Entry 15 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/SorbitanStearate
Resso}:
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
Entry 16 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbate60
Resso}:
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
Entry 17 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/PropyleneGlycol
Resso}:
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
Entry 18 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/StearicAcid
Resso}:
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
Entry 19 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/CetostaerylAlcohol
Resso}:
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
Entry 20 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/CetylPalmitate
Resso}:
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
Entry 21 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/LiquidParaffin
Resso}:
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
Entry 22 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Water
Resso}:
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
Entry 23 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10004055
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Bacterial vaginosis Comorbidities
Concept Recurrent UTI IntendedEffects
Concept therapeutic
Entry 24 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10046961
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Vaginosis bacterial NOS Comorbidities
Concept Obesity IntendedEffects
Concept therapeutic
Entry 25 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10079528
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Bacterial vulvovaginitis Comorbidities
Concept Diabetes mellitus IntendedEffects
Concept therapeutic
Entry 26 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10046950
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Vaginitis Comorbidities
Concept HIV infection IntendedEffects
Concept therapeutic
Entry 27 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10050348
Resso}:
Profile: ClinicalUseDefinition Indication
type: Indication
indication
DiseaseSymptomProcedures
Concept Genital infection NOS, female Comorbidities
Concept Diabetes mellitus IntendedEffects
Concept therapeutic