{ "resourceType" : "Bundle", "id" : "asp-liste-2", "meta" : { "versionId" : "2.0.0+20240208", "lastUpdated" : "2025-06-25T17:23:27.537+02:00" }, "identifier" : { "value" : "1.2.40.0.34.4.16" }, "type" : "collection", "entry" : [{ "fullUrl" : "MedicinalProductDefinition/128393", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "128393", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicinalProductDefinition 128393

identifier: https://www.ages.at/fhir/referenceNumber/128393

domain: Human

combinedPharmaceuticalDoseForm: Salbe

legalStatusOfSupply: Arzneimittel zur Abgabe ohne aerztliche Verschreibung

classification: Harnstoff, Kombinationen

Names

-ProductName
*Calmurid - Salbe
" }, "identifier" : [{ "system" : "https://www.ages.at/fhir/referenceNumber", "value" : "128393" }], "domain" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Domain" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000000004", "code" : "100000000012", "display" : "Human" }] }, "combinedPharmaceuticalDoseForm" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Combined Pharmaceutical Dose Form" }], "system" : "https://spor.ema.europa.eu/v1/lists/200000000006", "code" : "100000073713", "display" : "Salbe" }] }, "legalStatusOfSupply" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Legal Status for the Supply" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000072051", "code" : "200000017695", "display" : "Arzneimittel zur Abgabe ohne aerztliche Verschreibung" }] }, "classification" : [{ "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Anatomical Therapeutic Chemical classification system - Human" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000093533", "code" : "100000095288", "display" : "Harnstoff, Kombinationen" }, { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/atcGroup", "valueString" : "???" }], "system" : "http://www.whocc.no/atc", "code" : "D02AE51", "display" : "Harnstoff, Kombinationen" }] }], "name" : [{ "productName" : "Calmurid - Salbe" }] } }, { "fullUrl" : "PackagedProductDefinition/0066453", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "0066453", "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition 0066453

identifier: http://ema.europa.eu/fhir/dataCarrierIdentifier/0066453

packageFor: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

containedItemQuantity: 1.0 nicht definiert (Details: unitsOfPresentation code900000000001 = '900000000001')

MarketingStatuses

-Status
*Keine Daten übermittelt

Packagings

-Type
*Tube
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/dataCarrierIdentifier", "value" : "0066453" }], "packageFor" : [{ "reference" : "MedicinalProductDefinition/128393" }], "containedItemQuantity" : [{ "value" : 1.0, "unit" : "nicht definiert", "system" : "https://ema.europa.eu/fhir/vs/unitsOfPresentation", "code" : "900000000001" }], "marketingStatus" : [{ "status" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Marketing Status" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000072052", "code" : "100000072075", "display" : "Keine Daten übermittelt" }] } }], "packaging" : { "type" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Packaging" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000073346", "code" : "100000073561", "display" : "Tube" }] } } } }, { "fullUrl" : "RegulatedAuthorization/15010", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "15010", "text" : { "status" : "generated", "div" : "

Generated Narrative: RegulatedAuthorization 15010

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/15010

subject: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

status: Surrendered

holder: Galderma International

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/marketingAuthorizationNumber", "value" : "15010" }], "subject" : [{ "reference" : "MedicinalProductDefinition/128393" }], "status" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Regulatory Entitlement Status" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000072049", "code" : "200000010409", "display" : "Surrendered" }] }, "holder" : { "reference" : "LOC-100001500", "display" : "Galderma International" } } }, { "fullUrl" : "AdministrableProductDefinition/1877218", "resource" : { "resourceType" : "AdministrableProductDefinition", "id" : "1877218", "text" : { "status" : "generated", "div" : "

Generated Narrative: AdministrableProductDefinition 1877218

identifier: http://ema.europa.eu/fhir/???/1877218

formOf: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

RouteOfAdministrations

-Code
*Anwendung auf der Haut
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/???", "value" : "1877218" }], "formOf" : [{ "reference" : "MedicinalProductDefinition/128393" }], "routeOfAdministration" : [{ "code" : { "coding" : [{ "code" : "100000073566", "display" : "Anwendung auf der Haut" }] } }] } }, { "fullUrl" : "Ingredient/69405", "resource" : { "resourceType" : "Ingredient", "id" : "69405", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 69405

identifier: http://ema.europa.eu/fhir/???/69405

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*MILCHSÄURE

Strengths

-Presentation[x]
*5.0 g (Details: Units Of Measurement code100000110654 = 'gram(s)')/1.0 nicht definiert (Details: Units Of Presentation code900000000001 = '900000000001')
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "69405" }, "for" : [{ "reference" : "AdministrableProductDefinition/1877218" }], "role" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Ingredient Role" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000072050", "code" : "100000072072", "display" : "Wirkstoff" }] }, "substance" : { "code" : { "concept" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/v1/lists/substanceDefinition", "code" : "1707758", "display" : "MILCHSÄURE" }] } }, "strength" : [{ "presentationRatio" : { "numerator" : { "value" : 5.0, "unit" : "g", "system" : "https://spor.ema.europa.eu/v1/lists/100000110633", "code" : "100000110654" }, "denominator" : { "value" : 1.0, "unit" : "nicht definiert", "system" : "https://spor.ema.europa.eu/v1/lists/200000000014", "code" : "900000000001" } } }] } } }, { "fullUrl" : "Ingredient/1029231", "resource" : { "resourceType" : "Ingredient", "id" : "1029231", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 1029231

identifier: http://ema.europa.eu/fhir/???/1029231

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*HARNSTOFF

Strengths

-Presentation[x]
*10.0 g (Details: Units Of Measurement code100000110654 = 'gram(s)')/1.0 nicht definiert (Details: Units Of Presentation code900000000001 = '900000000001')
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "1029231" }, "for" : [{ "reference" : "AdministrableProductDefinition/1877218" }], "role" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Ingredient Role" }], "system" : "https://spor.ema.europa.eu/v1/lists/100000072050", "code" : "100000072072", "display" : "Wirkstoff" }] }, "substance" : { "code" : { "concept" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/v1/lists/substanceDefinition", "code" : "1709102", "display" : "HARNSTOFF" }] } }, "strength" : [{ "presentationRatio" : { "numerator" : { "value" : 10.0, "unit" : "g", "system" : "https://spor.ema.europa.eu/v1/lists/100000110633", "code" : "100000110654" }, "denominator" : { "value" : 1.0, "unit" : "nicht definiert", "system" : "https://spor.ema.europa.eu/v1/lists/200000000014", "code" : "900000000001" } } }] } } }] }