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: bundle-epi-type3-example-morphine

Document Subject

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

Document Content

1. What Morphine Unimedic is and what it is used for

Morphine Unimedic contains the active substance morphine hydrochloride. It is an opioid analgesic used for severe pain.

2. What you need to know before you take Morphine Unimedic

Do not take if allergic to morphine.

3. How to take Morphine Unimedic

Use as directed by your doctor.

4. Possible side effects

May cause nausea, vomiting, or constipation.

5. How to store Morphine Unimedic

Keep out of reach of children.

6. Contents of the pack and other information

Content: Morphine hydrochloride 1 mg/ml.

Additional Resources Included in Document

Entry 2

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 3

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 4

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 5

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 6

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 7

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 8

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

Entry 9

Resource ClinicalUseDefinition:

Language: en

type: Indication

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

indication

DiseaseSymptomProcedures

-Concept
*Pain

Entry 10

Resource ClinicalUseDefinition:

Language: en

type: Contraindication

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

contraindication

DiseaseSymptomProcedures

-Concept
*Acute asthma

Entry 11

Resource ClinicalUseDefinition:

Language: en

type: Interaction

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

interaction

Interactants

-Item[x]
*Alcohol

Entry 12

Resource ClinicalUseDefinition:

Language: en

type: Warning

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

Warnings

-Description
*

Risk of opioid dependence.

Entry 13

Resource ClinicalUseDefinition:

Language: en

type: Undesirable Effect

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

undesirableEffect

SymptomConditionEffects

-Concept
*Nausea

Entry 14

Resource MedicationKnowledge:

Language: en

code: Morphine

status: Active

indicationGuideline

dosingGuideline

treatmentIntent: Analgesia

dosage

Dosages

-Text
*10 mg every 4 hours