Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
Last updated: 2025-12-11 13:01:46+0000; Language: en
Bundle d8afb81e-4e53-4c39-abea-562bfd84aeb4 of type searchset
Entry 1 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/MedicinalProductDefinition/Aprokam-50mg-Powder-SE-IS-MPD
Search:Mode = match
Resource MedicinalProductDefinition:
version: 1; Last updated: 2025-11-26 09:20:54+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinitionidentifier:
http://ema.europa.eu/fhir/mpId/SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId/615domain: Human use
status: Current
combinedPharmaceuticalDoseForm: Powder for solution for injection
indication:
Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.
legalStatusOfSupply: Medicinal product subject to medical prescription
classification: S01AA27
name
productName: Aprokam 50 mg Pulver till injektionsvÀtska, lösning
part
part: Aprokam
type: Invented name part
part
part: 50 mg
type: Strength part
part
part: pulver till injektionsvÀtska, lösning
type: Pharmaceutical dose form part
Usages
Country Language Kingdom of Sweden Swedish
Entry 2 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/RegulatedAuthorization/Aprokam-50mg-Powder-SE-IS-RA
Search:Mode = include
Resource RegulatedAuthorization:
version: 1; Last updated: 2025-11-26 09:23:04+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorizationidentifier:
http://ema.europa.eu/fhir/marketingAuthorizationNumber/46149type: Marketing Authorisation
region: Kingdom of Sweden
status: Valid
statusDate: 2012-07-12
holder: Organization Laboratoires THEA
Cases
Type Date[x] First Authorisation 2012-07-12
Entry 3 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/AdministrableProductDefinition/Aprokam-50mg-Powder-SE-IS-APD
Search:Mode = include
Resource AdministrableProductDefinition:
version: 1; Last updated: 2025-11-26 09:24:30+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinitionstatus: Active
administrableDoseForm: Solution for injection
RouteOfAdministrations
Code Intracameral use
Entry 4 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/Aprokam-50mg-Powder-SE-IS-PPD02
Search:Mode = include
Resource PackagedProductDefinition:
version: 1; Last updated: 2025-11-26 09:27:10+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinitionidentifier:
http://ema.europa.eu/example/pcid/?ngen-9?containedItemQuantity: 10 Vial (Details: 200000000014 code200000002158 = '200000002158')
description:
Injektionsflaska, 10 x 50 mg (inkl 10 sterila kanyler)
MarketingStatuses
Country Status Kingdom of Sweden Marketed packaging
type: Box
quantity: 1
material: Cardboard
packaging
type: Vial
quantity: 10
material: Glass
containedItem
Items
Reference ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial amount: 10 vial (Details: 200000000014 code200000002158 = '200000002158')
Entry 5 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/Aprokam-50mg-Powder-SE-IS-PPD01
Search:Mode = include
Resource PackagedProductDefinition:
version: 1; Last updated: 2025-11-26 09:27:47+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinitionidentifier:
http://ema.europa.eu/example/pcid/?ngen-9?containedItemQuantity: 10 Vial (Details: 200000000014 code200000002158 = '200000002158')
description:
Injektionsflaska, 10 x 50 mg
MarketingStatuses
Country Status Kingdom of Sweden Marketed packaging
type: Box
quantity: 1
material: Cardboard
packaging
type: Vial
quantity: 10
material: Cardboard
packaging
type: Vial
quantity: 1
material: Glass
containedItem
Items
Reference ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial amount: 1 Vial (Details: 200000000014 code200000002158 = '200000002158')
Entry 6 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/Ingredient/Aprokam-50mg-Powder-SE-IS-ING
Search:Mode = include
Resource Ingredient:
version: 1; Last updated: 2025-11-26 09:26:31+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLIngredientstatus: Active
for:
- MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27
- ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial
- AdministrableProductDefinition: status = active; administrableDoseForm = Solution for injection
role: Active
substance
Codes
Concept cefuroxime sodium strength
concentration: 52.6 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 unit(s) (Details: 100000110633 code100000110756 = '100000110756')
referenceStrength
Substances
Concept cefuroxime strength: 50 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 unit(s) (Details: 100000110633 code100000110756 = '100000110756')
Entry 7 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/ManufacturedItemDefinition/Aprokam-50mg-Powder-SE-IS-MID
Search:Mode = include
Resource ManufacturedItemDefinition:
version: 1; Last updated: 2025-11-26 09:22:19+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinitionstatus: Active
manufacturedDoseForm: Powder for solution for injection
unitOfPresentation: Vial
Entry 8 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/Organization/LOC-100005605
Search:Mode = include
Resource Organization:
version: 1; Last updated: 2025-11-26 09:20:15+0000; Language: en
Profile:
http://unicom-project.eu/fhir/StructureDefinition/PPLOrganizationidentifier:
https://spor.ema.europa.eu/v1/locations/LOC-100005605name: Laboratoires THEA
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-01-02
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