{ "resourceType" : "Bundle", "id" : "asp-liste-9", "identifier" : { "value" : "1.2.40.0.34.4.16" }, "type" : "collection", "timestamp" : "2025-06-25T17:08:49.470+02:00", "entry" : [{ "fullUrl" : "https://www.ages.at/MedicinalProductDefinition/101273992", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "101273992", "text" : { "status" : "generated", "div" : "

Generated Narrative: MedicinalProductDefinition 101273992

identifier: https://www.ages.at/fhir/referenceNumber/101273992

domain: Human use

combinedPharmaceuticalDoseForm: Pulver zur Herstellung einer Injektions-/Infusionslösung

legalStatusOfSupply: Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung

classification: Benzylpenicillin

Names

-ProductName
*Penicillin G Kabi 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung
" }, "identifier" : [{ "system" : "https://www.ages.at/fhir/referenceNumber", "value" : "101273992" }], "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 use" }] }, "combinedPharmaceuticalDoseForm" : { "coding" : [{ "extension" : [{ "url" : "http://ema.europa.eu/fhir/extension/codeSystemName", "valueString" : "Combined Pharmaceutical Dose Form" }], "system" : "https://spor.ema.europa.eu/v1/lists/200000000004", "code" : "100000116186", "display" : "Pulver zur Herstellung einer Injektions-/Infusionslösung" }] }, "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" : "100000096140", "display" : "Benzylpenicillin" }, { "system" : "http://www.whocc.no/atc", "code" : "J01CE01", "display" : "Benzylpenicillin" }] }], "name" : [{ "productName" : "Penicillin G Kabi 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung" }] } }, { "fullUrl" : "https://www.ages.at/PackagedProductDefinition/6058839", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "6058839", "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition 6058839

identifier: http://ema.europa.eu/fhir/dataCarrierIdentifier/6058839

packageFor: Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200

containedItemQuantity: 10.0 Durchstechflasche (Details: Units Of Presentation code200000002158 = 'Durchstechflasche')

MarketingStatuses

-Status
*Keine Daten übermittelt

Packagings

-Type
*Durchstechflasche
" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/dataCarrierIdentifier", "value" : "6058839" }], "packageFor" : [{ "reference" : "MedicinalProductDefinition/101273992" }], "containedItemQuantity" : [{ "value" : 10.0, "unit" : "Durchstechflasche", "system" : "https://spor.ema.europa.eu/v1/lists/200000000014", "code" : "200000002158" }], "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" : "100000073563", "display" : "Durchstechflasche" }] } } } }, { "fullUrl" : "https://www.ages.at/RegulatedAuthorization/142464", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "142464", "text" : { "status" : "generated", "div" : "

Generated Narrative: RegulatedAuthorization 142464

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/142464

subject: Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200

status: Valid

holder: Fresenius Kabi Austria GmbH (Identifier: https://spor.ema.europa.eu/omswi/LOC-100001746)

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/marketingAuthorizationNumber", "value" : "142464" }], "subject" : [{ "reference" : "MedicinalProductDefinition/101273992" }], "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" : { "identifier" : { "system" : "https://spor.ema.europa.eu/omswi", "value" : "LOC-100001746" }, "display" : "Fresenius Kabi Austria GmbH" } } }, { "fullUrl" : "https://www.ages.at/AdministrableProductDefinition/2038377", "resource" : { "resourceType" : "AdministrableProductDefinition", "id" : "2038377", "text" : { "status" : "generated", "div" : "

Generated Narrative: AdministrableProductDefinition 2038377

identifier: http://ema.europa.eu/fhir/???/2038377

status: Active

formOf: Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200

routeOfAdministration

code: intramuskuläre Anwendung

routeOfAdministration

code: intravenöse Anwendung

" }, "identifier" : [{ "system" : "http://ema.europa.eu/fhir/???", "value" : "2038377" }], "status" : "active", "formOf" : [{ "reference" : "MedicinalProductDefinition/101273992" }], "routeOfAdministration" : [{ "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/v1/lists/100000073345", "code" : "100000073600", "display" : "intramuskuläre Anwendung" }] } }, { "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/v1/lists/100000073345", "code" : "100000073611", "display" : "intravenöse Anwendung" }] } }] } }, { "fullUrl" : "https://www.ages.at/Ingredient/1597141", "resource" : { "resourceType" : "Ingredient", "id" : "1597141", "text" : { "status" : "generated", "div" : "

Generated Narrative: Ingredient 1597141

identifier: http://ema.europa.eu/fhir/???/1597141

status: Active

for: Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200

role: Wirkstoff

substance

Codes

-Concept
*BENZYLPENICILLIN NATRIUM

strength

presentation: 1000000.0 IE (Details: Units Of Measurement code100000110671 = 'international unit(s)')/1.0 Durchstechflasche (Details: Units Of Presentation code200000002158 = 'Durchstechflasche')

referenceStrength

Substances

-Reference
*Bundle: identifier = 1.2.40.0.34.4.16; type = collection; timestamp = 2025-06-25 17:08:49+0200

strength: 938323.0 IE (Details: Units Of Measurement code100000110671 = 'international unit(s)')/1.0 Durchstechflasche (Details: Units Of Presentation code200000002158 = 'Durchstechflasche')

" }, "identifier" : { "system" : "http://ema.europa.eu/fhir/???", "value" : "1597141" }, "status" : "active", "for" : [{ "reference" : "AdministrableProductDefinition/2038377" }], "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" : "1708931", "display" : "BENZYLPENICILLIN NATRIUM" }] } }, "strength" : [{ "presentationRatio" : { "numerator" : { "value" : 1000000.0, "unit" : "IE", "system" : "https://spor.ema.europa.eu/v1/lists/100000110633", "code" : "100000110671" }, "denominator" : { "value" : 1.0, "unit" : "Durchstechflasche", "system" : "https://spor.ema.europa.eu/v1/lists/200000000014", "code" : "200000002158" } }, "referenceStrength" : [{ "substance" : { "reference" : { "reference" : "SubstanceDefinition/7421791" } }, "strengthRatio" : { "numerator" : { "value" : 938323.0, "unit" : "IE", "system" : "https://spor.ema.europa.eu/v1/lists/100000110633", "code" : "100000110671" }, "denominator" : { "value" : 1.0, "unit" : "Durchstechflasche", "system" : "https://spor.ema.europa.eu/v1/lists/200000000014", "code" : "200000002158" } } }] }] } } }, { "fullUrl" : "https://www.ages.at/SubstanceDefinition/7421791", "resource" : { "resourceType" : "SubstanceDefinition", "id" : "7421791", "text" : { "status" : "generated", "div" : "

Generated Narrative: SubstanceDefinition 7421791

Codes

-Code
*BENZYLPENICILLIN
" }, "code" : [{ "code" : { "coding" : [{ "system" : "https://spor.ema.europa.eu/v1/lists/substanceDefinition", "code" : "100000091070", "display" : "BENZYLPENICILLIN" }] } }] } }] }