bundle-epi-type2-example-wondermox - Global Core Electronic Medicinal Product Information (ePI) v1.1.0

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-type2-example-wondermox

Document Details

Language: en

Final Document at 2025-12-10 by Organization KRKA, d.d., Novo mesto for 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

Document Subject

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: WonderMox 500 mg/125 mg õhukese polümeerikattega tabletid
part
part: WonderMox
type: Invented name part
part
part: 500mg/125mg
type: Strength part
part
part: õhukese polümeerikattega tabletid
type: Pharmaceutical dose form part
Usages
- Country Language
* Republic of Estonia Estonian

Document Content

1. What WonderMox is and what it is used for

WonderMox is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid.

2. What you need to know before you take WonderMox

Do not take WonderMox if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine.

3. How to take WonderMox

Always take this medicine exactly as your doctor or pharmacist has told you.

4. Possible side effects

Common side effects may include diarrhea, thrush (candida), feeling sick (nausea) or being sick (vomiting).

5. How to store WonderMox

Keep this medicine out of the sight and reach of children. Store in the original package in order to protect from moisture.

6. Contents of the pack and other information

The active substances are amoxicillin and clavulanic acid.

Additional Resources Included in Document

Entry 2

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: WonderMox 500 mg/125 mg õhukese polümeerikattega tabletid
part
part: WonderMox
type: Invented name part
part
part: 500mg/125mg
type: Strength part
part
part: õhukese polümeerikattega tabletid
type: Pharmaceutical dose form part
Usages
- Country Language
* Republic of Estonia Estonian

Entry 3

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 4

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
- Country Status
* Republic of Estonia Marketed
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 5

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
- Country Status
* Republic of Estonia Marketed
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 6

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
- Country Status
* Republic of Estonia Marketed
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 7

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 8

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:
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
ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
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 9

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:
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
ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet
AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet
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 10

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 11

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