bundle-epi-type2-example-acetaminophen
type: Bundle
node role: treeRoot
id:
  v: bundle-epi-type2-example-acetaminophen
language:
  v: en
identifier:
  system:
    v: http://ema.europa.eu/identifier
    l: identifier
  value:
    v: WONDERDRUG-500MG-BUNDLE
type:
  v: document
timestamp:
  v: 2023-01-25T12:00:00Z
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-epi-type2-example-acetaminophen
    l: composition-epi-type2-example-acetaminophen
  resource: composition-epi-type2-example-acetaminophen
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type2-example-acme
    l: org-epi-type2-example-acme
  resource: org-epi-type2-example-acme
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
    l: mpd-epi-type2-example-acetaminophen
  resource: mpd-epi-type2-example-acetaminophen
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/RegulatedAuthorization/ra-epi-type2-example-acetaminophen
    l: ra-epi-type2-example-acetaminophen
  resource: ra-epi-type2-example-acetaminophen
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/PackagedProductDefinition/ppd-epi-type2-example-acetaminophen
    l: ppd-epi-type2-example-acetaminophen
  resource: ppd-epi-type2-example-acetaminophen
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen
    l: mid-epi-type2-example-acetaminophen
  resource: mid-epi-type2-example-acetaminophen
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/AdministrableProductDefinition/apd-epi-type2-example-acetaminophen
    l: apd-epi-type2-example-acetaminophen
  resource: apd-epi-type2-example-acetaminophen
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-active
    l: ingredient-epi-type2-example-acetaminophen-active
  resource: ingredient-epi-type2-example-acetaminophen-active
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-1
    l: ingredient-epi-type2-example-acetaminophen-excipient-1
  resource: ingredient-epi-type2-example-acetaminophen-excipient-1
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-2
    l: ingredient-epi-type2-example-acetaminophen-excipient-2
  resource: ingredient-epi-type2-example-acetaminophen-excipient-2
entry:
  full url:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-acetaminophen-excipient-3
    l: ingredient-epi-type2-example-acetaminophen-excipient-3
  resource: ingredient-epi-type2-example-acetaminophen-excipient-3
entry:
  resource: MedicinalProductDefinition
    id:
      v: mpd-epi-type2-example-acetaminophen-100mg
    language:
      v: en
    text:
      status:
        v: generated
      div:
        v: Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-acetaminophen-100mg identifier: http://ema.europa.eu/identifier/WONDERDRUG-100MG name productName: WonderDrug 100 mg tablets part part: WonderDrug type: Invented Name Part part part: 100 mg type: Strength part part part: tablets type: Form part
    identifier:
      system:
        v: http://ema.europa.eu/identifier
        l: identifier
      value:
        v: WONDERDRUG-100MG
    name:
      product name:
        v: WonderDrug 100 mg tablets
entry:
  resource: PackagedProductDefinition
    id:
      v: ppd-epi-type2-example-acetaminophen-100mg-1
    language:
      v: en
    text:
      status:
        v: generated
      div:
        v: Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-100mg-1 packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-100MG packaging type: Box quantity: 1 packaging type: Blister quantity: 2 containedItem Items - Reference * ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg amount: 60 Tablet
    package for:
      l: mpd-epi-type2-example-acetaminophen-100mg
      reference:
        v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-100mg
    packaging:
      quantity:
        v: 1
entry:
  resource: PackagedProductDefinition
    id:
      v: ppd-epi-type2-example-acetaminophen-100mg-2
    language:
      v: en
    text:
      status:
        v: generated
      div:
        v: Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-100mg-2 packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-100MG packaging type: Box quantity: 1 packaging type: Bottle containedItem Items - Reference * ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-100mg amount: 30 Tablet
    package for:
      l: mpd-epi-type2-example-acetaminophen-100mg
      reference:
        v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-100mg
    packaging:
      quantity:
        v: 1
entry:
  resource: MedicinalProductDefinition
    id:
      v: mpd-epi-type2-example-acetaminophen-200mg
    language:
      v: en
    text:
      status:
        v: generated
      div:
        v: Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-acetaminophen-200mg identifier: http://ema.europa.eu/identifier/WONDERDRUG-200MG name productName: WonderDrug 200 mg tablets part part: WonderDrug type: Invented Name Part part part: 200 mg type: Strength part part part: tablets type: Form part
    identifier:
      system:
        v: http://ema.europa.eu/identifier
        l: identifier
      value:
        v: WONDERDRUG-200MG
    name:
      product name:
        v: WonderDrug 200 mg tablets
entry:
  resource: PackagedProductDefinition
    id:
      v: ppd-epi-type2-example-acetaminophen-200mg-1
    language:
      v: en
    text:
      status:
        v: generated
      div:
        v: Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-200mg-1 packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-200MG packaging type: Box quantity: 1 packaging type: Blister quantity: 2 containedItem Items - Reference * ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg amount: 20 Tablet
    package for:
      l: mpd-epi-type2-example-acetaminophen-200mg
      reference:
        v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-200mg
    packaging:
      quantity:
        v: 1
entry:
  resource: PackagedProductDefinition
    id:
      v: ppd-epi-type2-example-acetaminophen-200mg-2
    language:
      v: en
    text:
      status:
        v: generated
      div:
        v: Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen-200mg-2 packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-200MG packaging type: Box quantity: 1 packaging type: Bottle containedItem Items - Reference * ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen-200mg amount: 40 Tablet
    package for:
      l: mpd-epi-type2-example-acetaminophen-200mg
      reference:
        v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-200mg
    packaging:
      quantity:
        v: 1

composition-epi-type2-example-acetaminophen
type: Composition
id:
  v: composition-epi-type2-example-acetaminophen
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Composition composition-epi-type2-example-acetaminophen status: Final type: Package Leaflet date: 2023-01-25 author: Organization Acme Pharma Inc. title: Package Leaflet: Information for the user - WonderDrug 500 mg tablets
status:
  v: final
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: Package Leaflet
subject:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
subject:
  l: mpd-epi-type2-example-acetaminophen-100mg
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-100mg
subject:
  l: mpd-epi-type2-example-acetaminophen-200mg
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen-200mg
date:
  v: 2023-01-25
author:
  l: org-epi-type2-example-acme
  reference:
    v: Organization/org-epi-type2-example-acme
title:
  v: Package Leaflet: Information for the user - WonderDrug 500 mg tablets
section:
  title:
    v: 1. What is in this leaflet
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi/
        l: rmswi
      code:
        v: 100000155538
    text:
      v: 1. What is in this leaflet
  text:
    status:
      v: generated
    div:
      v: 1. What is in this leaflet Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

mpd-epi-type2-example-acetaminophen
type: Uv
type: MedicinalProductDefinition
id:
  v: mpd-epi-type2-example-acetaminophen
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: MedicinalProductDefinition mpd-epi-type2-example-acetaminophen 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: Form part Usages - Country Language * Estonia Estonian
identifier:
  system:
    v: http://ema.europa.eu/identifier
    l: identifier
  value:
    v: WONDERDRUG-500MG
domain:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-domain
      l: medicinal-product-domain
    code:
      v: Human
    display:
      v: Human use
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
legal status of supply:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072084
    display:
      v: Medicinal product subject to medical prescription
contact:
  contact:
    l: org-epi-type2-example-acme
    reference:
      v: Organization/org-epi-type2-example-acme
name:
  product name:
    v: WonderDrug 500 mg tablets
  part:
    part:
      v: WonderDrug
  part:
    part:
      v: 500 mg
  part:
    part:
      v: tablets

org-epi-type2-example-acme
type: Uv
type: Organization
id:
  v: org-epi-type2-example-acme
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization org-epi-type2-example-acme 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
identifier:
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: LOC-100000000
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034
    display:
      v: Marketing authorisation holder
name:
  v: Acme Pharma Inc.
contact:
  address:
    text:
      v: 123 Pharma Way, 102 37 Prague 10, Czech Republic
    line:
      v: 123 Pharma Way
    city:
      v: Prague
    postal code:
      v: 102 37
    country:
      v: Czech Republic

ra-epi-type2-example-acetaminophen
type: RegulatedAuthorization
id:
  v: ra-epi-type2-example-acetaminophen
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization ra-epi-type2-example-acetaminophen 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 holder: Organization Acme Pharma Inc.
identifier:
  system:
    v: http://ema.europa.eu/identifier
    l: identifier
  value:
    v: MA-123456789
subject:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000061
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: http://hl7.org/fhir/country
      l: country
    code:
      v: EE
    display:
      v: Estonia
holder:
  l: org-epi-type2-example-acme
  reference:
    v: Organization/org-epi-type2-example-acme

ppd-epi-type2-example-acetaminophen
type: PackagedProductDefinition
id:
  v: ppd-epi-type2-example-acetaminophen
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition ppd-epi-type2-example-acetaminophen packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription packaging type: Box quantity: 1 packaging type: Blister containedItem Items - Reference * ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet amount: 30 Tablet
package for:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
packaging:
  type:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073498
      display:
        v: Box
  quantity:
    v: 1

mid-epi-type2-example-acetaminophen
type: Uv
type: ManufacturedItemDefinition
id:
  v: mid-epi-type2-example-acetaminophen
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition mid-epi-type2-example-acetaminophen status: Active manufacturedDoseForm: Tablet unitOfPresentation: Tablet Properties - Type Value[x] * colour White
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000073664
    display:
      v: Tablet
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002152
    display:
      v: Tablet
property:
  type:
    coding:
      code:
        v: colour
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/colour
        l: colour
      code:
        v: white
      display:
        v: White

apd-epi-type2-example-acetaminophen
type: AdministrableProductDefinition
id:
  v: apd-epi-type2-example-acetaminophen
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition apd-epi-type2-example-acetaminophen 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: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet RouteOfAdministrations - Code * Oral use
status:
  v: active
form of:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000073664
    display:
      v: Tablet
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002152
    display:
      v: Tablet
produced from:
  l: mid-epi-type2-example-acetaminophen
  reference:
    v: ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073619
      display:
        v: Oral use

ingredient-epi-type2-example-acetaminophen-active
type: Ingredient
id:
  v: ingredient-epi-type2-example-acetaminophen-active
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-active status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * Paracetamol Strengths - Presentation[x] * 500 mg (Details: UCUM codemg = 'mg')/1 tablet (Details: unit-of-presentation codetablet = 'tablet')
status:
  v: active
for:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
for:
  l: mid-epi-type2-example-acetaminophen
  reference:
    v: ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen
for:
  l: apd-epi-type2-example-acetaminophen
  reference:
    v: AdministrableProductDefinition/apd-epi-type2-example-acetaminophen
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072072
    display:
      v: Active
substance:
  strength:
    presentation: Ratio

ingredient-epi-type2-example-acetaminophen-excipient-1
type: Ingredient
id:
  v: ingredient-epi-type2-example-acetaminophen-excipient-1
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-excipient-1 status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Pregelatinised starch
status:
  v: active
for:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
for:
  l: mid-epi-type2-example-acetaminophen
  reference:
    v: ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen
for:
  l: apd-epi-type2-example-acetaminophen
  reference:
    v: AdministrableProductDefinition/apd-epi-type2-example-acetaminophen
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-epi-type2-example-acetaminophen-excipient-2
type: Ingredient
id:
  v: ingredient-epi-type2-example-acetaminophen-excipient-2
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-excipient-2 status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Maize starch
status:
  v: active
for:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
for:
  l: mid-epi-type2-example-acetaminophen
  reference:
    v: ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen
for:
  l: apd-epi-type2-example-acetaminophen
  reference:
    v: AdministrableProductDefinition/apd-epi-type2-example-acetaminophen
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-epi-type2-example-acetaminophen-excipient-3
type: Ingredient
id:
  v: ingredient-epi-type2-example-acetaminophen-excipient-3
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-epi-type2-example-acetaminophen-excipient-3 status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription ManufacturedItemDefinition: status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Magnesium stearate
status:
  v: active
for:
  l: mpd-epi-type2-example-acetaminophen
  reference:
    v: MedicinalProductDefinition/mpd-epi-type2-example-acetaminophen
for:
  l: mid-epi-type2-example-acetaminophen
  reference:
    v: ManufacturedItemDefinition/mid-epi-type2-example-acetaminophen
for:
  l: apd-epi-type2-example-acetaminophen
  reference:
    v: AdministrableProductDefinition/apd-epi-type2-example-acetaminophen
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

v: WonderDrug

coding:
  system:
    v: http://hl7.org/fhir/medicinal-product-name-part-type
    l: medicinal-product-name-part-type
  code:
    v: INV
  display:
    v: Invented Name Part

v: 100 mg

coding:
  system:
    v: http://hl7.org/fhir/medicinal-product-name-part-type
    l: medicinal-product-name-part-type
  code:
    v: STR
  display:
    v: Strength part

v: tablets

coding:
  system:
    v: http://hl7.org/fhir/medicinal-product-name-part-type
    l: medicinal-product-name-part-type
  code:
    v: FRM
  display:
    v: Form part

system:
  v: https://spor.ema.europa.eu/rmswi
  l: rmswi
code:
  v: 100000073498
display:
  v: Box

coding:
  system:
    v: https://spor.ema.europa.eu/rmswi
    l: rmswi
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