{ "resourceType" : "Bundle", "id" : "asp-liste-1", "meta" : { "versionId" : "2.0.0+20240208", "lastUpdated" : "2025-06-25T17:22:44.606+02:00" }, "identifier" : { "value" : "1.2.40.0.34.4.16" }, "type" : "collection", "entry" : [{ "fullUrl" : "MedicinalProductDefinition/125128", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "125128", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicinalProductDefinition 125128

identifier: https://www.ages.at/fhir/referenceNumber/125128

domain: Human

combinedPharmaceuticalDoseForm: Salbe

legalStatusOfSupply: Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung

classification: Prednisolon

Names

-ProductName
*Scheriproct - Salbe
" }, "identifier" : [{ "system" : "https://www.ages.at/fhir/referenceNumber", "value" : "125128" }], "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" : "200000017698", "display" : "Arzneimittel zur einmaligen Abgabe auf 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" : "100000094928", "display" : "Prednisolon" }, { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/atcGroup", "valueString" : "???" }], "system" : "http://www.whocc.no/atc", "code" : "C05AA04", "display" : "Prednisolon" }] }], "name" : [{ "productName" : "Scheriproct - Salbe" }] } }, { "fullUrl" : "PackagedProductDefinition/0050989", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "0050989", "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition 0050989

identifier: http://ema.europa.eu/fhir/dataCarrierIdentifier/0050989

packageFor: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

containedItemQuantity: 1.0 Tube (Details: unitsOfPresentation code200000002156 = '200000002156')

MarketingStatuses

-Status
*Keine Daten übermittelt

Packagings

-Type
*Tube
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/dataCarrierIdentifier", "value" : "0050989" }], "packageFor" : [{ "reference" : "MedicinalProductDefinition/125128" }], "containedItemQuantity" : [{ "value" : 1.0, "unit" : "Tube", "system" : "https://ema.europa.eu/fhir/vs/unitsOfPresentation", "code" : "200000002156" }], "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/10260", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "10260", "text" : { "status" : "generated", "div" : "

Generated Narrative: RegulatedAuthorization 10260

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/10260

subject: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

status: Valid

holder: KARO Pharma AB

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/marketingAuthorizationNumber", "value" : "10260" }], "subject" : [{ "reference" : "MedicinalProductDefinition/125128" }], "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" : "100000072099", "display" : "Valid" }] }, "holder" : { "reference" : "LOC-100058736", "display" : "KARO Pharma AB" } } }, { "fullUrl" : "AdministrableProductDefinition/1949508", "resource" : { "resourceType" : "AdministrableProductDefinition", "id" : "1949508", "text" : { "status" : "generated", "div" : "

Generated Narrative: AdministrableProductDefinition 1949508

identifier: http://ema.europa.eu/fhir/???/1949508

formOf: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

RouteOfAdministrations

-Code
*rektale Anwendung
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/???", "value" : "1949508" }], "formOf" : [{ "reference" : "MedicinalProductDefinition/125128" }], "routeOfAdministration" : [{ "code" : { "coding" : [{ "code" : "100000073628", "display" : "rektale Anwendung" }] } }] } }, { "fullUrl" : "Ingredient/335310", "resource" : { "resourceType" : "Ingredient", "id" : "335310", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 335310

identifier: http://ema.europa.eu/fhir/???/335310

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*PREDNISOLON HEXANOAT
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "335310" }, "for" : [{ "reference" : "AdministrableProductDefinition/1949508" }], "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" : "1708748", "display" : "PREDNISOLON HEXANOAT" }] } } } } }, { "fullUrl" : "Ingredient/1354234", "resource" : { "resourceType" : "Ingredient", "id" : "1354234", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 1354234

identifier: http://ema.europa.eu/fhir/???/1354234

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*CINCHOCAIN HYDROCHLORID
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "1354234" }, "for" : [{ "reference" : "AdministrableProductDefinition/1949508" }], "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" : "1709205", "display" : "CINCHOCAIN HYDROCHLORID" }] } } } } }] }