{ "resourceType" : "Bundle", "id" : "asp-liste-5", "meta" : { "versionId" : "2.0.0+20240208", "lastUpdated" : "2025-06-25T17:14:26.409+02:00" }, "identifier" : { "value" : "1.2.40.0.34.4.16" }, "type" : "collection", "entry" : [{ "fullUrl" : "MedicinalProductDefinition/946126", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "946126", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicinalProductDefinition 946126

identifier: https://www.ages.at/fhir/referenceNumber/946126

domain: Human

combinedPharmaceuticalDoseForm: Suspension for injection in pre-filled syringe

legalStatusOfSupply: Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung

classification: Diphtherie-Pertussis-Poliomyelitis-Tetanus

Names

-ProductName
*Repevax Injektionssuspension in einer Fertigspritze
" }, "identifier" : [{ "system" : "https://www.ages.at/fhir/referenceNumber", "value" : "946126" }], "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" : "100000074063", "display" : "Suspension for injection in pre-filled syringe" }] }, "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" : "100000096601", "display" : "Diphtherie-Pertussis-Poliomyelitis-Tetanus" }, { "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/atcGroup", "valueString" : "???" }], "system" : "http://www.whocc.no/atc", "code" : "J07CA02", "display" : "Diphtherie-Pertussis-Poliomyelitis-Tetanus" }] }], "name" : [{ "productName" : "Repevax Injektionssuspension in einer Fertigspritze" }] } }, { "fullUrl" : "PackagedProductDefinition/6056875", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "6056875", "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition 6056875

identifier: http://ema.europa.eu/fhir/dataCarrierIdentifier/6056875

packageFor: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

containedItemQuantity: 10.0 Spritze (Details: unitsOfPresentation code200000002150 = '200000002150')

MarketingStatuses

-Status
*Keine Daten übermittelt

Packagings

-Type
*Fertigspritze
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/dataCarrierIdentifier", "value" : "6056875" }], "packageFor" : [{ "reference" : "MedicinalProductDefinition/946126" }], "containedItemQuantity" : [{ "value" : 10.0, "unit" : "Spritze", "system" : "https://ema.europa.eu/fhir/vs/unitsOfPresentation", "code" : "200000002150" }], "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/2-00284", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "2-00284", "text" : { "status" : "generated", "div" : "

Generated Narrative: RegulatedAuthorization 2-00284

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/2-00284

subject: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

status: Valid

holder: Sanofi Winthrop Industrie

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/marketingAuthorizationNumber", "value" : "2-00284" }], "subject" : [{ "reference" : "MedicinalProductDefinition/946126" }], "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-100021551", "display" : "Sanofi Winthrop Industrie" } } }, { "fullUrl" : "AdministrableProductDefinition/2035865", "resource" : { "resourceType" : "AdministrableProductDefinition", "id" : "2035865", "text" : { "status" : "generated", "div" : "

Generated Narrative: AdministrableProductDefinition 2035865

identifier: http://ema.europa.eu/fhir/???/2035865

formOf: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

RouteOfAdministrations

-Code
*intramuskuläre Anwendung
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/???", "value" : "2035865" }], "formOf" : [{ "reference" : "MedicinalProductDefinition/946126" }], "routeOfAdministration" : [{ "code" : { "coding" : [{ "code" : "100000073600", "display" : "intramuskuläre Anwendung" }] } }] } }, { "fullUrl" : "Ingredient/115684", "resource" : { "resourceType" : "Ingredient", "id" : "115684", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 115684

identifier: http://ema.europa.eu/fhir/???/115684

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*CORYNEBACTERIUM DIPHTHERIAE (AUSZUG, PRODUKTE)
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "115684" }, "for" : [{ "reference" : "AdministrableProductDefinition/2035865" }], "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" : "1708114", "display" : "CORYNEBACTERIUM DIPHTHERIAE (AUSZUG, PRODUKTE)" }] } } } } }, { "fullUrl" : "Ingredient/327186", "resource" : { "resourceType" : "Ingredient", "id" : "327186", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 327186

identifier: http://ema.europa.eu/fhir/???/327186

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*BORDETELLA PERTUSSIS
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "327186" }, "for" : [{ "reference" : "AdministrableProductDefinition/2035865" }], "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" : "1708214", "display" : "BORDETELLA PERTUSSIS" }] } } } } }, { "fullUrl" : "Ingredient/1606254", "resource" : { "resourceType" : "Ingredient", "id" : "1606254", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 1606254

identifier: http://ema.europa.eu/fhir/???/1606254

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*CLOSTRIDIUM TETANI (AUSZUG, PRODUKTE)
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "1606254" }, "for" : [{ "reference" : "AdministrableProductDefinition/2035865" }], "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" : "1708219", "display" : "CLOSTRIDIUM TETANI (AUSZUG, PRODUKTE)" }] } } } } }, { "fullUrl" : "Ingredient/875640", "resource" : { "resourceType" : "Ingredient", "id" : "875640", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 875640

identifier: http://ema.europa.eu/fhir/???/875640

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection

role: Wirkstoff

substance

Codes

-Concept
*POLIOMYELITISVIRUS
" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "875640" }, "for" : [{ "reference" : "AdministrableProductDefinition/2035865" }], "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" : "1709005", "display" : "POLIOMYELITISVIRUS" }] } } } } }] }