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)
Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose)
Not authorised for the treatment in children
No interruption of distribution reported
Comprehensive Sample Combipack 20 mg Vaginal Salbe und 100 mg Vaginaltabletten
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
Information for healthcare professionals
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
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
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; 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
Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen
Shelf life of the medicinal product as packaged for sale
Shelf life after first opening the immediate packaging
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
Generated Narrative: ManufacturedItemDefinition MI-Comprehensive-Sample-VaginalPessary Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Pessary unitOfPresentation: Pessary
Generated Narrative: ManufacturedItemDefinition MI-Comprehensive-Sample-VaginalCream Profile: ManufacturedItemDefinition status: Active manufacturedDoseForm: Vaginal Cream unitOfPresentation: Tube
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
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
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')
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
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')
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
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
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
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
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
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
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
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
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
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
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
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
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
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