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: 8ca935a2-79e9-445b-a38c-f5ce4253f3f5

Last updated: 2025-12-11 02:21:13+0000; Language: en

Bundle 8ca935a2-79e9-445b-a38c-f5ce4253f3f5 of type searchset

Entry 1 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/MedicinalProductDefinition/Betaklav-500mg-125mg-EE-MPD

Search:Mode = match

Resource MedicinalProductDefinition:

version: 1; Last updated: 2025-11-26 10:51:48+0000; Language: en

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

identifier: http://ema.europa.eu/fhir/mpId/EE-100009540-30722, http://ema.europa.eu/fhir/pmsId/0000000000006

domain: Human use

status: Current

combinedPharmaceuticalDoseForm: Film-coated tablet

legalStatusOfSupply: Medicinal Product subject to medical prescription

classification: amoxicillin and beta-lactamase inhibitor, amoxicillin and beta-lactamase inhibitor

name

productName: Betaklav 500 mg/125 mg õhukese polümeerikattega tabletid

part

part: Betaklav

type: Invented name part

part

part: 500mg/125mg

type: Strength part

part

part: õhukese polümeerikattega tabletid

type: Pharmaceutical dose form part

Usages

-CountryLanguage
*Republic of EstoniaEstonian

Entry 2 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/RegulatedAuthorization/Betaklav-500mg-125mg-EE-RA

Search:Mode = include

Resource RegulatedAuthorization:

version: 1; Last updated: 2025-11-26 10:51:49+0000; Language: en

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

identifier: 879415

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor

type: Marketing Authorisation

region: Republic of Estonia

status: Valid - Renewed/Varied

statusDate: 2021-02-03

holder: Organization KRKA, d.d., Novo mesto

Entry 3 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/Betaklav-500mg-125mg-EE-PPD-1635117

Search:Mode = include

Resource PackagedProductDefinition:

version: 1; Last updated: 2025-11-26 10:51:50+0000; Language: en

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

identifier: http://ema.europa.eu/example/pcid/EE-100009540-30722-1635117

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor

containedItemQuantity: 10 tablet (Details: 200000000014 code200000002152 = '200000002152')

description:

Ribapakend (Al/Al) 10 õhukese polümeerikattega tabletti karbis

MarketingStatuses

-CountryStatus
*Republic of EstoniaMarketed

packaging

type: Box

quantity: 1

material: Cardboard

packaging

type: Strip

quantity: 1

material: Aluminium

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet

amount: 10

Entry 4 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/Betaklav-500mg-125mg-EE-PPD-1635207

Search:Mode = include

Resource PackagedProductDefinition:

version: 1; Last updated: 2025-11-26 10:51:50+0000; Language: en

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

identifier: http://ema.europa.eu/example/pcid/EE-100009540-30722-1635207

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor

containedItemQuantity: 500 tablet (Details: 200000000014 code200000002152 = '200000002152')

description:

Ribapakend (Al/Al) 500 õhukese polümeerikattega tabletti karbis

MarketingStatuses

-CountryStatus
*Republic of EstoniaMarketed

packaging

type: Box

quantity: 1

material: Cardboard

packaging

type: Strip

quantity: 1

material: Aluminium

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet

amount: 500

Entry 5 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/PackagedProductDefinition/Betaklav-500mg-125mg-EE-PPD-1635139

Search:Mode = include

Resource PackagedProductDefinition:

version: 1; Last updated: 2025-11-26 10:51:51+0000; Language: en

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

identifier: http://ema.europa.eu/example/pcid/EE-100009540-30722-1635139

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor

containedItemQuantity: 14 tablet (Details: 200000000014 code200000002152 = '200000002152')

description:

Blisterpakend (OPA/Al/PVC foil/Al foil) 14 õhukese polümeerikattega tabletti karbis

MarketingStatuses

-CountryStatus
*Republic of EstoniaMarketed

packaging

type: Box

quantity: 1

material: Cardboard

packaging

type: Blister

quantity: 1

material: Orientated PolyAmide, Aluminium, PolyVinyl Chloride

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet

amount: 14

Entry 6 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/AdministrableProductDefinition/Betaklav-500mg-125mg-EE-APD

Search:Mode = include

Resource AdministrableProductDefinition:

version: 1; Last updated: 2025-11-26 10:53:25+0000; Language: en

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

status: Active

formOf: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor

administrableDoseForm: Film-coated tablet

unitOfPresentation: Tablet

producedFrom: ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet

RouteOfAdministrations

-Code
*Oral use

Entry 7 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/Ingredient/Betaklav-500mg-125mg-EE-I-100000092629

Search:Mode = include

Resource Ingredient:

version: 1; Last updated: 2025-11-26 10:53:25+0000; Language: en

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

status: Active

for:

role: Active

substance

Codes

-Concept
*AMOXICILLIN TRIHYDRATE

strength

presentation: 573.892 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')

referenceStrength

Substances

-Concept
*Amoxicillin

strength: 500 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')

Entry 8 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/Ingredient/Betaklav-500mg-125mg-EE-I-100000093061

Search:Mode = include

Resource Ingredient:

version: 1; Last updated: 2025-11-26 10:53:26+0000; Language: en

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

status: Active

for:

role: Active

substance

Codes

-Concept
*POTASSIUM CLAVULANATE

strength

presentation: 151.915 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')

referenceStrength

Substances

-Concept
*CLAVULANIC ACID

strength: 125 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')

Entry 9 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/ManufacturedItemDefinition/Betaklav-500mg-125mg-EE-MID

Search:Mode = include

Resource ManufacturedItemDefinition:

version: 1; Last updated: 2025-11-26 10:51:49+0000; Language: en

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

status: Active

manufacturedDoseForm: Film-coated tablet

unitOfPresentation: Tablet

Entry 10 - fullUrl = http://sandbox.hl7europe.eu/unicom/fhir/Organization/LOC-100009540-KrkaNovoMesto

Search:Mode = include

Resource Organization:

version: 1; Last updated: 2025-11-26 10:50:40+0000; Language: en

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

identifier: https://spor.ema.europa.eu/v1/locations/LOC-100009540, https://spor.ema.europa.eu/v1/organisations/ORG-100000627

name: KRKA, d.d., Novo mesto