{ "resourceType" : "Bundle", "id" : "asp-liste-8", "meta" : { "versionId" : "2.0.0+20240208", "lastUpdated" : "2025-06-25T17:17:45.024+02:00" }, "identifier" : { "value" : "1.2.40.0.34.4.16" }, "type" : "collection", "entry" : [{ "fullUrl" : "MedicinalProductDefinition/100406362", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "100406362", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicinalProductDefinition 100406362

identifier: https://www.ages.at/fhir/referenceNumber/100406362

domain: Human

combinedPharmaceuticalDoseForm: Injektionsdispersion

legalStatusOfSupply: Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung

classification: COVID-19-mRNA-Impfstoff

Names

-ProductName
*Comirnaty 30 Mikrogramm/Dosis Injektionsdispersion; COVID-19-mRNA-Impfstoff (Nukleosid-modifiziert)
" }, "identifier" : [{ "system" : "https://www.ages.at/fhir/referenceNumber", "value" : "100406362" }], "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" : "100000074068", "display" : "Injektionsdispersion" }] }, "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" : "200000030565", "display" : "COVID-19-mRNA-Impfstoff" }, { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/atcGroup", "valueString" : "???" }], "system" : "http://www.whocc.no/atc", "code" : "J07BX03", "display" : "COVID-19-mRNA-Impfstoff" }] }], "name" : [{ "productName" : "Comirnaty 30 Mikrogramm/Dosis Injektionsdispersion; COVID-19-mRNA-Impfstoff (Nukleosid-modifiziert)" }] } }, { "fullUrl" : "PackagedProductDefinition/5506359", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "5506359", "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition 5506359

identifier: http://ema.europa.eu/fhir/dataCarrierIdentifier/5506359

packageFor: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

containedItemQuantity: 1.0 Durchstechflasche (Details: unitsOfPresentation code200000002158 = '200000002158')

MarketingStatuses

-Status
*Keine Daten übermittelt

Packagings

-Type
*Durchstechflasche
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Generated Narrative: RegulatedAuthorization 002-003,013

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/EU/1/20/1528/002-003,013

subject: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

status: Surrendered

holder: Biontech Manufacturing GmbH

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/marketingAuthorizationNumber", "value" : "EU/1/20/1528/002-003,013" }], "subject" : [{ "reference" : "MedicinalProductDefinition/100406362" }], "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-100047650", "display" : "Biontech Manufacturing GmbH" } } }, { "fullUrl" : "AdministrableProductDefinition/2031677", "resource" : { "resourceType" : "AdministrableProductDefinition", "id" : "2031677", "text" : { "status" : "generated", "div" : "

Generated Narrative: AdministrableProductDefinition 2031677

identifier: http://ema.europa.eu/fhir/???/2031677

formOf: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

RouteOfAdministrations

-Code
*intramuskuläre Anwendung
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/???", "value" : "2031677" }], "formOf" : [{ "reference" : "MedicinalProductDefinition/100406362" }], "routeOfAdministration" : [{ "code" : { "coding" : [{ "code" : "100000073600", "display" : "intramuskuläre Anwendung" }] } }] } }, { "fullUrl" : "Ingredient/22582997", "resource" : { "resourceType" : "Ingredient", "id" : "22582997", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 22582997

identifier: http://ema.europa.eu/fhir/???/22582997

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*TOZINAMERAN

Strengths

-Presentation[x]
*30.0 µg (Details: Units Of Measurement code100000110656 = 'microgram(s)')/1.0 Durchstechflasche (Details: Units Of Presentation code200000002158 = 'Durchstechflasche')
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "22582997" }, "for" : [{ "reference" : "AdministrableProductDefinition/2031677" }], "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" : "101102201", "display" : "TOZINAMERAN" }] } }, "strength" : [{ "presentationRatio" : { "numerator" : { "value" : 30.0, "unit" : "µg", "system" : "https://spor.ema.europa.eu/v1/lists/100000110633", "code" : "100000110656" }, "denominator" : { "value" : 1.0, "unit" : "Durchstechflasche", "system" : "https://spor.ema.europa.eu/v1/lists/200000000014", "code" : "200000002158" } } }] } } }] }