Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

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

Example Bundle: da8e3290-e187-4ee7-860f-1397221a20ea

Last updated: 2025-12-11 02:08:31+0000; Language: en

Bundle da8e3290-e187-4ee7-860f-1397221a20ea of type searchset

Entry 1 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD

Search:Mode = match

Resource MedicinalProductDefinition:

version: 1; Last updated: 2025-11-26 09:21:19+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition

identifier: http://ema.europa.eu/fhir/mpId/SE-100001732-00056117, http://ema.europa.eu/fhir/eurdId/10549

domain: Human use

status: Current

combinedPharmaceuticalDoseForm: Solution for injection

indication:

Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.

legalStatusOfSupply: Medicinal product subject to special medical prescription

classification: morphine

name

productName: Morphine Unimedic 1 mg/ml injektionsvätska, lösning

part

part: Morphine Unimedic

type: Scientific name part

part

part: 1 mg/ml

type: Strength part

part

part: Injektionsvätska, lösning

type: Pharmaceutical dose form part

Usages

-CountryLanguage
*Kingdom of SwedenSwedish

Entry 2 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/RegulatedAuthorization/MorphineUni-1mgml-Solution-SE-BS-RA

Search:Mode = include

Resource RegulatedAuthorization:

version: 1; Last updated: 2025-11-26 09:23:15+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/56117

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine

type: Marketing Authorisation

region: Kingdom of Sweden

status: Valid

statusDate: 2018-04-06

holder: Organization Unimedic Pharma AB

Cases

-TypeDate[x]
*First Authorisation2018-04-06

Entry 3 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/AdministrableProductDefinition/MorphineUni-1mgml-Solution-SE-BS-APD

Search:Mode = include

Resource AdministrableProductDefinition:

version: 1; Last updated: 2025-11-26 09:23:58+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition

status: Active

formOf: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine

administrableDoseForm: Solution for injection

producedFrom: ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule

RouteOfAdministrations

-Code
*Subcutaneous use

Entry 4 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/MorphineUni-1mgml-Solution-SE-BS-PPD

Search:Mode = include

Resource PackagedProductDefinition:

version: 1; Last updated: 2025-11-26 09:26:35+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition

identifier: http://ema.europa.eu/example/pcid/?ngen-9?

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine

containedItemQuantity: 10 Ampoule (Details: 200000000014 code200000002164 = '200000002164')

description:

Ampull, 10 x 10 ml

MarketingStatuses

-CountryStatus
*Kingdom of SwedenMarketed

packaging

type: Box

quantity: 1

material: Cardboard

packaging

type: Ampoule

quantity: 10

material: Glass

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule

amount: 10 millilitre(s) (Details: 100000110633~200000000014 code100000110662 = '100000110662')

Entry 5 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/Ingredient/MorphineUni-1mgml-Solution-SE-BS-ING

Search:Mode = include

Resource Ingredient:

version: 1; Last updated: 2025-11-26 09:26:27+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient

status: Active

for:

role: Active

substance

Codes

-Concept
*Morphine hydrochloride

strength

concentration: 1 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 millilitre(s) (Details: 100000110633 code100000110662 = '100000110662')

referenceStrength

Substances

-Concept
*Morphine

strength: 0.76 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 millilitre(s) (Details: 100000110633 code100000110662 = '100000110662')

Entry 6 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/Organization/LOC-100001090

Search:Mode = include

Resource Organization:

version: 1; Last updated: 2025-11-26 09:20:05+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization

identifier: https://spor.ema.europa.eu/v1/locations/LOC-100001090

name: Unimedic Pharma AB

Entry 7 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/ManufacturedItemDefinition/MorphineUni-1mgml-Solution-SE-BS-MID

Search:Mode = include

Resource ManufacturedItemDefinition:

version: 1; Last updated: 2025-11-26 09:22:32+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition

status: Active

manufacturedDoseForm: Solution for injection

unitOfPresentation: Ampoule