Bundle - ePI Type 3 WonderDrug Example - Global Core Electronic Medicinal Product Information (ePI) v1.1.0

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. 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 Type 3 WonderDrug Example

Document Details

version: 1.0; Last updated: 2023-10-27 10:00:00+0000; Language: en

Profile: Bundle - ePI Type 3

Final Document at 2023-10-27 by Organization WonderPharma Inc. for MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active

Document Subject

Language: en

Profile: MedicinalProductDefinition (ePI)

identifier: http://ema.europa.eu/identifier/WONDERDRUG-500MG

domain: Human use

status: Active

Contacts

Contact

Organization WonderPharma Inc.

name
productName: WonderDrug 500 mg tablets
part
part: WonderDrug
type: Invented name part
part
part: 500 mg
type: Strength part
part
part: tablets
type: Pharmaceutical dose form part
Usages
- Country Language
* Estonia Estonian

Document Content

WonderDrug Summary of Product Characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

Summary of Product Characteristics for WonderDrug

1. NAME OF THE MEDICINAL PRODUCT

WonderDrug 500 mg tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 500 mg of paracetamol.

2.1 General description
White, round, biconvex tablets.

2.2 Qualitative and quantitative composition
Each tablet contains 500 mg paracetamol.

Excipient(s) with known effect
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet. White, round, biconvex tablets.

4. CLINICAL PARTICULARS

Clinical information about WonderDrug.

4.1 Therapeutic indications
Symptomatic treatment of mild to moderate pain and/or fever.

4.2 Posology and method of administration
Adults: 1-2 tablets every 4-6 hours. Maximum 8 tablets in 24 hours.

4.3 Contraindications
Hypersensitivity to paracetamol or any of the excipients.

4.4 Special warnings and precautions for use
Caution in patients with hepatic or renal impairment.

4.5 Interaction with other medicinal products and other forms of interaction
Anticoagulants: Enhanced effect of warfarin with prolonged use.

4.6 Fertility, pregnancy and lactation
Can be used during pregnancy and lactation at recommended doses.

4.7 Effects on ability to drive and use machines
No known effect.

4.8 Undesirable effects
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris.
Summary of adverse reactions:
Very common (≥1/10): Nausea, headache
Common (≥1/100 to <1/10): Dizziness, fatigue
Uncommon (≥1/1,000 to <1/100): Allergic reactions, skin rash
Rare (≥1/10,000 to <1/1,000): Hepatotoxicity
System Organ Class Frequency Adverse Reaction
Gastrointestinal Very common Nausea
Nervous system Very common Headache
Skin Uncommon Rash, pruritus
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System Organ Class	Frequency	Adverse Reaction
Gastrointestinal	Very common	Nausea
Nervous system	Very common	Headache
Skin	Uncommon	Rash, pruritus

4.9 Overdose
Symptoms: Hepatic damage. Treatment: N-acetylcysteine.

5. PHARMACOLOGICAL PROPERTIES

Pharmacological properties of WonderDrug.

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, ATC code: N02BE01.

5.2 Pharmacokinetic properties
Rapidly absorbed from the GI tract. Peak plasma concentration in 30-60 minutes.

5.3 Preclinical safety data
No additional data of relevance.

6. PHARMACEUTICAL PARTICULARS

Pharmaceutical particulars for WonderDrug.

6.1 List of excipients
Pregelatinised starch, maize starch, magnesium stearate.

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
3 years.

6.4 Special precautions for storage
Store below 25°C.

6.5 Nature and contents of container
PVC/Aluminium blisters. Pack sizes: 10, 20, 30 tablets.

6.6 Special precautions for disposal
No special requirements.

7. MARKETING AUTHORISATION HOLDER

WonderPharma Inc., 123 Pharma Way, Prague, Czech Republic

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/23/1234/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15 January 2020

10. DATE OF REVISION OF THE TEXT

October 2023

Additional Resources Included in Document

Entry 2 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type3-example-pharma

Resource Organization:

Language: en
Profile: Organization (ePI)
identifier: https://spor.ema.europa.eu/omswi/LOC-100000000
active: true
type: Marketing authorisation holder
name: WonderPharma Inc.
Contacts
- Telecom Address
* +420 123 456 789, info@wonderpharma.example.com, https://www.wonderpharma.example.com WonderPharma Inc., 123 Pharma Way, Prague 10, 102 37, Czech Republic

Entry 3 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type3-example-wonderdrug

Resource MedicinalProductDefinition:

Language: en
Profile: MedicinalProductDefinition (ePI)
identifier: http://ema.europa.eu/identifier/WONDERDRUG-500MG
domain: Human use
status: Active
Contacts
- Contact
* Organization WonderPharma Inc.
name
productName: WonderDrug 500 mg tablets
part
part: WonderDrug
type: Invented name part
part
part: 500 mg
type: Strength part
part
part: tablets
type: Pharmaceutical dose form part
Usages
- Country Language
* Estonia Estonian

Entry 4 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol-100mg

Resource MedicinalProductDefinition:

Language: en
Profile: MedicinalProductDefinition (ePI)
identifier: http://ema.europa.eu/identifier/WONDERDRUG-100MG
status: Active
Names
- ProductName
* WonderDrug 100 mg tablets

Entry 5 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol-200mg

Resource MedicinalProductDefinition:

Language: en
Profile: MedicinalProductDefinition (ePI)
identifier: http://ema.europa.eu/identifier/WONDERDRUG-200MG
status: Active
Names
- ProductName
* WonderDrug 200 mg tablets

Entry 6 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol

Resource MedicinalProductDefinition:

Language: en
Profile: MedicinalProductDefinition (ePI)
identifier: http://ema.europa.eu/identifier/WONDERDRUG-500MG
domain: Human use
status: Active
legalStatusOfSupply: Medicinal product subject to medical prescription
Contacts
- Contact
* Organization Acme Pharma Inc.
name
productName: WonderDrug 500 mg tablets
part
part: WonderDrug
type: Invented name part
part
part: 500 mg
type: Strength part
part
part: tablets
type: Pharmaceutical dose form part
Usages
- Country Language
* Estonia Estonian

Entry 7 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type2-example-acme

Resource Organization:

Language: en
Profile: Organization (ePI)
identifier: https://spor.ema.europa.eu/omswi/LOC-100000000
active: true
type: Marketing authorisation holder
name: Acme Pharma Inc.
Contacts
- Address
* 123 Pharma Way, 102 37 Prague 10, Czech Republic

Entry 8 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/RegulatedAuthorization/ra-epi-type2-example-paracetamol

Resource RegulatedAuthorization:

Language: en
Profile: RegulatedAuthorization (ePI)
identifier: http://ema.europa.eu/identifier/MA-123456789
subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription
type: Marketing Authorisation
region: Estonia
status: Active
holder: Organization Acme Pharma Inc.

Entry 9 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/PackagedProductDefinition/ppd-epi-type2-example-paracetamol

Resource PackagedProductDefinition:

Language: en
Profile: PackagedProductDefinition (ePI)
identifier: http://example.org/identifier/ppd-epi-type2-example-paracetamol
packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription
status: Active
packaging
type: Box
quantity: 1
packaging
type: Blister
containedItem
Items
- Reference
* ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet
amount: 30 Tablet

Entry 10 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/ManufacturedItemDefinition/mid-epi-type2-example-paracetamol

Resource ManufacturedItemDefinition:

Language: en
Profile: ManufacturedItemDefinition (ePI)
identifier: http://example.org/identifier/mid-epi-type2-example-paracetamol
status: Active
manufacturedDoseForm: Tablet
unitOfPresentation: Tablet
property
type: Shape
value: Round
property
type: Color
value: White
property
type: Size
value: 10 mm
property
type: Score
value: Scored
property
type: Imprint
value:
WD500

Entry 11 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/AdministrableProductDefinition/apd-epi-type2-example-paracetamol

Resource AdministrableProductDefinition:

Language: en
Profile: AdministrableProductDefinition (ePI)
identifier: http://example.org/identifier/apd-epi-type2-example-paracetamol
status: Active
formOf: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription
administrableDoseForm: Tablet
unitOfPresentation: Tablet
producedFrom: ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet
property
type: Shape
value: Round
property
type: Color
value: White
property
type: Flavor
value: None
property
type: Image
value: Tablet Image
RouteOfAdministrations
- Code
* Oral use

Entry 12 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-active

Resource Ingredient:

Language: en
Profile: Ingredient (ePI)
identifier: http://example.org/identifier/ingredient-epi-type2-example-paracetamol-active
status: Active
for: ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet
role: Active
function: API
group: Chemical
substance
Codes
- Concept
* Paracetamol
Strengths
- Presentation[x]
* 500 mg (Details: UCUM codemg = 'mg')/1 tablet (Details: EDQM Standard Terms code10219000 = 'Tablet')

Entry 13 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicationKnowledge/medication-knowledge-epi-type3-example

Resource MedicationKnowledge:

Language: en
status: Active
indicationGuideline
Indications
- Concept
* Fever
* Pain
dosingGuideline
treatmentIntent: Pain relief
dosage
type: Initial Treatment (Week 1)
dosage
sequence: 1
text: Take 1 tablet twice daily for the first week
timing: 2 per 1 day
DoseAndRates
- Type Dose[x]
* Ordered 1 tablet (Details: EDQM Standard Terms code10219000 = 'Tablet')
dosage
type: Maintenance Treatment (Weeks 2-4)
dosage
sequence: 2
text: Take 1 tablet once daily for three more weeks
timing: Once per 1 day
DoseAndRates
- Type Dose[x]
* Ordered 1 tablet (Details: EDQM Standard Terms code10219000 = 'Tablet')

Entry 14 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/ClinicalUseDefinition/cud-indication-1