CH IDMP (R5)
1.0.0-ballot - ballot Switzerland flag

This page is part of the CH IDMP (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Example Bundle: Comprehensive Sample Product, Creme and Pessary (Bundle)

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

Resource 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

-CountryStatusDateRange
*SwitzerlandNo interruption of distribution reported2020-09-24 --> 2026-12-31

attachedDocument:

name

productName: Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten

type: Authorised Medicinal Product Name

Usages

-CountryLanguage
*SwitzerlandGerman (Switzerland)

Entry 2 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/DocumentReference/DocRef-FI-Comprehensive

Resource 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

-LanguageUrl
*de-CHhttps://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

Resource DocumentReference:

identifier: Application / Assessment Tracking Number/999999999-PI-123

status: Current

type: Patient Information

date: 2023-07-01 00:00:00+0000

content

Attachments

-LanguageUrl
*de-CHhttps://swissmedicinfo.ch/detailpage/69093002

Entry 4 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/RegulatedAuthorisation/MA-12345601

Resource 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

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

Resource 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

-CountryStatusDateRange
*SwitzerlandMarketed2020-09-24 --> 2026-12-31

packaging

identifier: GTIN Global Trade Item Number/7680612345678

type: Box

quantity: 1

ShelfLifeStorages

-TypePeriod[x]SpecialPrecautionsForStorage
*Shelf life of the medicinal product as packaged for saleNo 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 packagingNo 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

Resource 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

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

Resource ManufacturedItemDefinition:

status: Active

manufacturedDoseForm: Pessary

unitOfPresentation: Pessary

Entry 8 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ManufacturedItemDefinition/MI-Comprehensive-Sample-VaginalCream

Resource ManufacturedItemDefinition:

status: Active

manufacturedDoseForm: Vaginal Cream

unitOfPresentation: Tube

Entry 9 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalPessary

Resource 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

Entry 10 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/AdministrableProductDefinition/PhP-Comprehensive-Sample-VaginalCream

Resource 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

Entry 11 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/ClindamycinPhosphate100

Resource Ingredient:

Profile: Ingredient

status: Active

for:

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

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Hard Fat

Entry 13 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/ClindamycinPhosphate20

Resource Ingredient:

Profile: Ingredient

status: Active

for:

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

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Benzyl Alcohol

Entry 15 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/SorbitanStearate

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Sorbitan monostearate

Entry 16 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Polysorbate60

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Polysorbate 60

Entry 17 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/PropyleneGlycol

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Propylene Glycol

Entry 18 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/StearicAcid

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Stearic Acid

Entry 19 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/CetostaerylAlcohol

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*CETOSTEARYL ALCOHOL

Entry 20 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/CetylPalmitate

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*CETYL PALMITATE

Entry 21 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/LiquidParaffin

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*LIQUID PARAFFIN

Entry 22 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/Ingredient/Water

Resource Ingredient:

Profile: Ingredient

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Water

Entry 23 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10004055

Resource ClinicalUseDefinition:

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

Entry 24 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10046961

Resource ClinicalUseDefinition:

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

Entry 25 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10079528

Resource ClinicalUseDefinition:

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

Entry 26 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10046950

Resource ClinicalUseDefinition:

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

Entry 27 - fullUrl = http://fhir.ch-idmp.smc.admin.ch/ClinicalUseDefinition/IND-10050348

Resource ClinicalUseDefinition:

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