{ "resourceType" : "Bundle", "id" : "asp-liste-4", "meta" : { "versionId" : "2.0.0+20240208", "lastUpdated" : "2025-06-25T17:16:31.964+02:00" }, "identifier" : { "value" : "1.2.40.0.34.4.16" }, "type" : "collection", "entry" : [{ "fullUrl" : "MedicinalProductDefinition/942778", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "942778", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicinalProductDefinition 942778

identifier: https://www.ages.at/fhir/referenceNumber/942778

domain: Human

combinedPharmaceuticalDoseForm: Injektionssuspension

legalStatusOfSupply: Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung

classification: Influenza, gereinigtes Antigen

Names

-ProductName
*VAXIGRIP Injektionssupension in einer Fertigspritze
" }, "identifier" : [{ "system" : "https://www.ages.at/fhir/referenceNumber", "value" : "942778" }], "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" : "100000073864", "display" : "Injektionssuspension" }] }, "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" : "100000096563", "display" : "Influenza, gereinigtes Antigen" }, { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/atcGroup", "valueString" : "???" }], "system" : "http://www.whocc.no/atc", "code" : "J07BB02", "display" : "Influenza, gereinigtes Antigen" }] }], "name" : [{ "productName" : "VAXIGRIP Injektionssupension in einer Fertigspritze" }] } }, { "fullUrl" : "PackagedProductDefinition/1076502", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "1076502", "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition 1076502

identifier: http://ema.europa.eu/fhir/dataCarrierIdentifier/1076502

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
*Fertigspritze
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/dataCarrierIdentifier", "value" : "1076502" }], "packageFor" : [{ "reference" : "MedicinalProductDefinition/942778" }], "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" : "100000073544", "display" : "Fertigspritze" }] } } } }, { "fullUrl" : "RegulatedAuthorization/2-00215", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "2-00215", "text" : { "status" : "generated", "div" : "

Generated Narrative: RegulatedAuthorization 2-00215

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/2-00215

subject: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

status: Surrendered

holder: Sanofi Pasteur Europe

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/marketingAuthorizationNumber", "value" : "2-00215" }], "subject" : [{ "reference" : "MedicinalProductDefinition/942778" }], "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-100010588", "display" : "Sanofi Pasteur Europe" } } }, { "fullUrl" : "AdministrableProductDefinition/2198207", "resource" : { "resourceType" : "AdministrableProductDefinition", "id" : "2198207", "text" : { "status" : "generated", "div" : "

Generated Narrative: AdministrableProductDefinition 2198207

identifier: http://ema.europa.eu/fhir/???/2198207, http://ema.europa.eu/fhir/???/2198207

formOf: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

routeOfAdministration

code: subkutane Anwendung

routeOfAdministration

code: intramuskuläre Anwendung

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/???", "value" : "2198207" }, { "system" : "http://ema.europa.eu/fhir/???", "value" : "2198207" }], "formOf" : [{ "reference" : "MedicinalProductDefinition/942778" }], "routeOfAdministration" : [{ "code" : { "coding" : [{ "code" : "100000073633", "display" : "subkutane Anwendung" }] } }, { "code" : { "coding" : [{ "code" : "100000073600", "display" : "intramuskuläre Anwendung" }] } }] } }, { "fullUrl" : "Ingredient/1040389", "resource" : { "resourceType" : "Ingredient", "id" : "1040389", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 1040389

identifier: http://ema.europa.eu/fhir/???/1040389

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*INFLUENZAVIRUS (AUSZUG, PRODUKTE)
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "1040389" }, "for" : [{ "reference" : "AdministrableProductDefinition/2198207" }], "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" : "1708839", "display" : "INFLUENZAVIRUS (AUSZUG, PRODUKTE)" }] } } } } }] }