bundlejpicarbamazepine200
type: Bundle
node role: treeRoot
id:
  v: bundlejpicarbamazepine200
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi
    l: Bundle-uv-epi
language:
  v: ja
identifier:
  system:
    v: https://www.pmda.jp/
    l: www.pmda.jp
  value:
    v: jpiplaceholder
type:
  v: document
timestamp:
  v: 2002-08-01T13:28:17Z
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Composition/carbamazepine200jpi
    l: carbamazepine200jpi
  resource: carbamazepine200jpi
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Organization/orgfujinaga
    l: orgfujinaga
  resource: orgfujinaga
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Authorizations/authcarbamazepine200
    l: authcarbamazepine200
  resource: authcarbamazepine200
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodcarbamazepine200
    l: medprodcarbamazepine200
  resource: medprodcarbamazepine200
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packcarbamazepine200
    l: packcarbamazepine200
  resource: packcarbamazepine200
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodcarbamazepine200
    l: adminprodcarbamazepine200
  resource: adminprodcarbamazepine200
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemcarbamazepine200
    l: manitemcarbamazepine200
  resource: manitemcarbamazepine200
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/carbamazepine
    l: carbamazepine
  resource: carbamazepine
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subcarbamazepine200
    l: subcarbamazepine200
  resource: subcarbamazepine200

carbamazepine200jpi
type: Composition
id:
  v: carbamazepine200jpi
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi
    l: Composition-uv-epi
language:
  v: ja
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Composition carbamazepine200jpi Language: ja Profile: Composition (ePI) identifier: https://spor.ema.europa.eu/rmswi//fcats34placeholder status: Final type: Package Leaflet date: 2002-08-01 13:28:17+0000 author: Organization Fujinaga Pharmaceutical Co., Ltd. title: Tegretol (carbamazepine) 200 mg for tablet Attesters - Mode Time * Official 2002-08-01 13:28:17+0000
identifier:
  system:
    v: https://spor.ema.europa.eu/rmswi/
    l: rmswi
  value:
    v: fcats34placeholder
status:
  v: final
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/
      l: spor.ema.europa.eu
    code:
      v: 100000155538
  text:
    v: Package Leaflet
subject:
  l: medprodcarbamazepine200
  reference:
    v: MedicinalProductDefinition/medprodcarbamazepine200
date:
  v: 2002-08-01T13:28:17Z
author:
  l: orgfujinaga
  reference:
    v: Organization/orgfujinaga
title:
  v: Tegretol (carbamazepine) 200 mg for tablet
attester:
  mode:
    coding:
      system:
        v: http://hl7.org/fhir/composition-attestation-mode
        l: composition-attestation-mode
      code:
        v: official
  time:
    v: 2002-08-01T13:28:17Z
section:
  title:
    v: アロマターゼ阻害剤/閉経後乳癌治療剤
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 0
    text:
      v: アロマターゼ阻害剤/閉経後乳癌治療剤
  text:
    status:
      v: additional
    div:
      v: unavailable
section:
  title:
    v: 1. 警告
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 1
    text:
      v: 1. 警告
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 1.1
    code:
      text:
        v: 1.1
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 1.2
    code:
      text:
        v: 1.2
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 1.3
    code:
      text:
        v: 1.3
    text:
      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 2. 禁忌(次の患者には投与しないこと)
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 2
    text:
      v: 禁忌(次の患者には投与しないこと)
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 2.1
    code:
      text:
        v: 2.1
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 2.2
    code:
      text:
        v: 2.2
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 2.3
    code:
      text:
        v: 2.3
    text:
      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 3. 組成・性状
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 3
    text:
      v: 3. 組成・性状
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 3.1 組成
    code:
      text:
        v: 3.1 組成
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 3.2 製剤の性状
    code:
      text:
        v: 3.2 製剤の性状

orgfujinaga
type: Organization
id:
  v: orgfujinaga
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization orgfujinaga Profile: Organization (ePI) identifier: https://pmda-org-id/fujinaga (use: official, ) active: true type: Marketing authorisation holder name: Fujinaga Pharmaceutical Co., Ltd. Contacts - Address * Medicine Consultation Office Front Place Nihonbashi 2-14-1 Nihonbashi, Chuo-ku,(work)
identifier:
  use:
    v: official
  system:
    v: https://pmda-org-id
    l: pmda-org-id
  value:
    v: fujinaga
active:
  v: true
type:
  coding:
    system:
      v: https://PMDA-org-type.jp/
      l: PMDA-org-type.jp
    code:
      v: tbd
    display:
      v: Marketing authorisation holder
  text:
    v: Marketing authorisation holder
name:
  v: Fujinaga Pharmaceutical Co., Ltd.
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: Medicine Consultation Office Front Place Nihonbashi 2-14-1 Nihonbashi, Chuo-ku,
    line:
      v: 2-14-1 Nihonbashi
    city:
      v: Chuo-ku
    postal code:
      v: 103-8324
    country:
      v: Tokyo

authcarbamazepine200
type: RegulatedAuthorization
id:
  v: authcarbamazepine200
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi
    l: RegulatedAuthorization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization authcarbamazepine200 Profile: RegulatedAuthorization (ePI) identifier: https://pmda-approvalandlicenseno//22700AMX00173 (use: official, ) subject: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#1139002F1070; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation region: Japan status: Active statusDate: 2002-08-01 13:28:17+0000 holder: Organization Fujinaga Pharmaceutical Co., Ltd.
identifier:
  use:
    v: official
  system:
    v: https://pmda-approvalandlicenseno/
    l: pmda-approvalandlicenseno
  value:
    v: 22700AMX00173
subject:
  l: medprodcarbamazepine200
  reference:
    v: MedicinalProductDefinition/medprodcarbamazepine200
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: /#100000072062
  text:
    v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: JP
  text:
    v: Japan
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
  text:
    v: Active
status date:
  v: 2002-08-01T13:28:17Z
holder:
  l: orgfujinaga
  reference:
    v: Organization/orgfujinaga

medprodcarbamazepine200
type: MedicinalProductDefinition
id:
  v: medprodcarbamazepine200
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi
    l: MedicinalProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: MedicinalProductDefinition medprodcarbamazepine200 Profile: MedicinalProductDefinition (ePI) identifier: http://iyaku.info/medicine/1139002F1070 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Tegretol (carbamazepine) 200 mg for tablet type: Full name part part: Tegretol type: Invented name part part part: carbamazepine type: Scientific name part part part: 200 mg type: Strength part part part: tablet type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Japan Japan Japanese (Region=Japan)
identifier:
  system:
    v: http://iyaku.info/medicine
    l: medicine
  value:
    v: 1139002F1070
type:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-type
      l: medicinal-product-type
    code:
      v: MedicinalProduct
    display:
      v: Medicinal Product
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
name:
  product name:
    v: Tegretol (carbamazepine) 200 mg for tablet
  type:
    coding:
      system:
        v: https://spor.ema.europa.eu/lists/220000000000
        l: https://spor.ema.europa.eu/lists/220000000000
      code:
        v: 220000000001
    text:
      v: Full name
  part:
    part:
      v: Tegretol
    type:
      text:
        v: Invented name part
  part:
    part:
      v: carbamazepine
    type:
      text:
        v: Scientific name part
  part:
    part:
      v: 200 mg
    type:
      text:
        v: Strength part
  part:
    part:
      v: tablet
    type:
      text:
        v: Pharmaceutical dose form part

packcarbamazepine200
type: PackagedProductDefinition
id:
  v: packcarbamazepine200
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi
    l: PackagedProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition packcarbamazepine200 Profile: PackagedProductDefinition (ePI) identifier: https://pmda-packinsertno//placeholder2 (use: official, ) name: Tegretol (carbamazepine) 200 mg for tablet in bottles type: Chemical Medininal Prodcut packageFor: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#1139002F1070; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2002-08-01 13:28:17+0000 containedItemQuantity: 200 mg manufacturer: Organization Fujinaga Pharmaceutical Co., Ltd. Packagings - Identifier Type Quantity Material * https://spor.ema.europa.eu/pmswi/123456 Bottle 28 PolyVinyl Chloride
identifier:
  use:
    v: official
  system:
    v: https://pmda-packinsertno/
    l: pmda-packinsertno
  value:
    v: placeholder2
name:
  v: Tegretol (carbamazepine) 200 mg for tablet in bottles
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000155527
    display:
      v: Chemical Medininal Prodcut
package for:
  l: medprodcarbamazepine200
  reference:
    v: MedicinalProductDefinition/medprodcarbamazepine200
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2002-08-01T13:28:17Z
contained item quantity:
  value:
    v: 200
  unit:
    v: mg
manufacturer:
  l: orgfujinaga
  reference:
    v: Organization/orgfujinaga
packaging:
  identifier:
    system:
      v: https://spor.ema.europa.eu/pmswi
      l: pmswi
    value:
      v: 123456
  type:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073497
      display:
        v: Bottle
  quantity:
    v: 28
  material:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 200000003222
      display:
        v: PolyVinyl Chloride

adminprodcarbamazepine200
type: AdministrableProductDefinition
id:
  v: adminprodcarbamazepine200
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi
    l: AdministrableProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition adminprodcarbamazepine200 Profile: AdministrableProductDefinition (ePI) identifier: https://www.who-umc.org/phpid/FB9808F4FED210183F412F9998622287 status: Active formOf: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#1139002F1070; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Tablet unitOfPresentation: 15054000 producedFrom: ManufacturedItemDefinition: identifier = https://pmda-sccj#placeholder (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 RouteOfAdministrations - Code * 20053000
identifier:
  system:
    v: https://www.who-umc.org/phpid
    l: phpid
status:
  v: active
form of:
  l: medprodcarbamazepine200
  reference:
    v: MedicinalProductDefinition/medprodcarbamazepine200
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 10219000
  text:
    v: Tablet
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 15054000
produced from:
  l: manitemcarbamazepine200
  reference:
    v: ManufacturedItemDefinition/manitemcarbamazepine200
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 20053000

manitemcarbamazepine200
type: ManufacturedItemDefinition
id:
  v: manitemcarbamazepine200
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi
    l: ManufacturedItemDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition manitemcarbamazepine200 Profile: ManufacturedItemDefinition (ePI) identifier: https://pmda-sccj/placeholder (use: official, ) status: Active manufacturedDoseForm: Tablet unitOfPresentation: 15054000 manufacturer: Organization Fujinaga Pharmaceutical Co., Ltd.
identifier:
  use:
    v: official
  system:
    v: https://pmda-sccj
    l: pmda-sccj
  value:
    v: placeholder
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/
      l: SOM
    code:
      v: 10219000
  text:
    v: Tablet
unit of presentation:
  coding:
    system:
      v: https://standardterms.edqm.eu/browse/get_concepts/UOP/
      l: UOP
    code:
      v: 15054000
manufacturer:
  l: orgfujinaga
  reference:
    v: Organization/orgfujinaga

carbamazepine
type: Ingredient
id:
  v: carbamazepine
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient carbamazepine Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//33CM23913M (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#placeholder (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Active Manufacturers - Manufacturer * Organization Fujinaga Pharmaceutical Co., Ltd. substance Codes - Concept * carbamazepine Strengths - Presentation[x] Basis * 200 mg active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 33CM23913M
status:
  v: active
for:
  l: manitemcarbamazepine200
  reference:
    v: ManufacturedItemDefinition/manitemcarbamazepine200
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072072
    display:
      v: Active
manufacturer:
  manufacturer:
    l: orgfujinaga
    reference:
      v: Organization/orgfujinaga
substance:
  strength:
    presentation: Quantity
      value:
        v: 200
      unit:
        v: mg
    basis:
      text:
        v: active ingredient - basis of strength

subcarbamazepine200
type: SubstanceDefinition
id:
  v: subcarbamazepine200
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi
    l: SubstanceDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: SubstanceDefinition subcarbamazepine200 Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//33CM23913M (use: official, ) version: 39 status: Validated (UNII) description: White to pale yellow manufacturer: Organization Fujinaga Pharmaceutical Co., Ltd. Structures - MolecularFormula * C15H12N2O Names - Name Type * carbamazepine Chemical Name
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 33CM23913M
version:
  v: 39
status:
  coding:
    system:
      v: https://gsrs.ncats.nih.gov/ginas/app/beta/
      l: beta
    code:
      v: 1
  text:
    v: Validated (UNII)
description:
  v: White to pale yellow
manufacturer:
  l: orgfujinaga
  reference:
    v: Organization/orgfujinaga
structure:
  molecular formula:
    v: C15H12N2O
name:
  name:
    v: carbamazepine
  type:
    coding:
      system:
        v: https://gsrs.ncats.nih.gov/ginas/app/beta/
        l: beta
      code:
        v: 1
    text:
      v: Chemical Name

v: 2.1

v: 2.1

v: 2.1

v: 2.1

v: 2.2

v: 2.3

v: 3.1

v: 3.2

status:
  v: additional
div:
  v: unavailable

title:
  v: 4. 効能又は効果
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 4
  text:
    v: 効能又は効果
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 5. 効能又は効果に関連する注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 5
  text:
    v: 効能又は効果に関連する注意
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 6. 用法及び用量
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 6
  text:
    v: 用法及び用量
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 7. 用法及び用量に関連する注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 7
  text:
    v: 7. 用法及び用量に関連する注意
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 8. 重要な基本的注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 8
  text:
    v: 重要な基本的注意
text:
  status:
    v: additional
  div:
    v: unavailable
section:
  title:
    v: 8.1
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 8.1
    text:
      v: 8.1
  text:
    status:
      v: additional
    div:
      v: unavailable
section:
  title:
    v: 8.2
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 8.2
    text:
      v: 8.2
  text:
    status:
      v: additional
    div:
      v: unavailable
section:
  title:
    v: 8.3
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 8.3
    text:
      v: 8.3
  text:
    status:
      v: additional
    div:
      v: unavailable
section:
  title:
    v: 8.4
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 8.4
    text:
      v: 8.4
  text:
    status:
      v: additional
    div:
      v: unavailable

title:
  v: 9. 特定の背景を有する患者に関する注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 9
  text:
    v: 特定の背景を有する患者に関する注意
text:
  status:
    v: additional
  div:
    v: unavailable
section:
  title:
    v: 9.1
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 9.2
    text:
      v: 9.1
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      v: additional
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      v: unavailable
section:
  title:
    v: 9.2 腎機能障害患者
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 9.2
    text:
      v: 9.2 腎機能障害患者
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    status:
      v: additional
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      v: unavailable
  section:
    title:
      v: 9.2.1 重度の腎障害のある患者
    code:
      text:
        v: 9.2.1 重度の腎障害のある患者
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      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 9.3 肝機能障害患者
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 9.3
    text:
      v: 9.3 肝機能障害患者
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  section:
    title:
      v: 9.3.1 重度の肝障害のある患者
    code:
      text:
        v: 9.3.1 重度の肝障害のある患者
    text:
      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 9.4
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 9.4
    text:
      v: 9.4
  text:
    status:
      v: additional
    div:
      v: unavailable
section:
  title:
    v: 9.5 妊婦
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 9
    text:
      v: 9.5 妊婦
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    status:
      v: additional
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      v: unavailable
section:
  title:
    v: 9.6 授乳婦
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 9.6
    text:
      v: 9.6 授乳婦
  text:
    status:
      v: additional
    div:
      v: unavailable

v: 9

v: 9.3.1

title:
  v: 10. 相互作用
code:
  coding:
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      l: pmda.jp
    code:
      v: 10
  text:
    v: 10. 相互作用
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    v: unavailable
section:
  title:
    v: 10.1
  code:
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        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 9
    text:
      v: 10.1
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      v: unavailable
section:
  title:
    v: 10.2 併用注意(併用に注意すること)
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        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 10
    text:
      v: 10.2 併用注意(併用に注意すること)
  text:
    status:
      v: additional
    div:
      v: unavailable

title:
  v: 11. 副作用
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  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 11
  text:
    v: 11. 副作用
text:
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    v: additional
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    v: unavailable
section:
  title:
    v: 11.1 重大な副作用
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 11.1
    text:
      v: 11.1 重大な副作用
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    status:
      v: additional
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  section:
    title:
      v: 11.1.1
    code:
      text:
        v: 11.1.1
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        v: additional
      div:
        v: unavailable
section:
  title:
    v: 11.2 その他の副作用
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 11.2
    text:
      v: 11.2 その他の副作用
  text:
    status:
      v: additional
    div:
      v: unavailable

v: 11.1.1

title:
  v: 12. 臨床検査結果に及ぼす影響
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  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 12
  text:
    v: 12. 臨床検査結果に及ぼす影響
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 13. 過量投与
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 13
  text:
    v: 13. 過量投与
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 14. 適用上の注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 14
  text:
    v: 14. 適用上の注意
text:
  status:
    v: additional
  div:
    v: unavailable
section:
  title:
    v: 14.1 薬剤交付時の注意
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 14.1
    text:
      v: 14.1 薬剤交付時の注意
  text:
    status:
      v: additional
    div:
      v: unavailable

title:
  v: 15. その他の注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 13
  text:
    v: 15. その他の注意
text:
  status:
    v: additional
  div:
    v: unavailable
section:
  title:
    v: 15.1
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 15.1
  text:
    status:
      v: additional
    div:
      v: unavailable
section:
  title:
    v: 15.2 非臨床試験に基づく情報
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 15.2 非臨床試験に基づく情報
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    status:
      v: additional
    div:
      v: unavailable

title:
  v: 16. 薬物動態
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  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 13
  text:
    v: 16. 薬物動態
text:
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    v: additional
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    v: unavailable
section:
  title:
    v: 16.1 血中濃度
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 16.1 血中濃度
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      v: additional
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      v: unavailable
section:
  title:
    v: 16.2 吸収
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 16.2 吸収
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    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 16.2.1 食事の影響
    code:
      text:
        v: 16.2.1 食事の影響
    text:
      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 16.3 分布
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 16.3 分布
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 16.3.1 組織内濃度
    code:
      text:
        v: 16.3.1 組織内濃度
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 16.3.2 胎児・胎盤移行性
    code:
      text:
        v: 16.3.2 胎児・胎盤移行性
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 16.3.3 蛋白結合率
    code:
      text:
        v: 16.3.3 蛋白結合率
    text:
      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 16.5 排泄
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 16.5 排泄
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 16.5.1
    code:
      text:
        v: 16.5.1
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 16.5.2
    code:
      text:
        v: 16.5.2
    text:
      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 16.6 特定の背景を有する患者
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 16.6 特定の背景を有する患者
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 16.6.1 腎機能障害患者における体内動態
    code:
      text:
        v: 16.6.1 腎機能障害患者における体内動態
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 16.6.2 肝機能障害患者における体内動態
    code:
      text:
        v: 16.6.2 肝機能障害患者における体内動態
    text:
      status:
        v: additional
      div:
        v: unavailable

v: 13

v: 13

v: 13

v: 13

v: 13

v: 13

v: 13

v: 13

title:
  v: 17. 臨床成績
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 17
  text:
    v: 17. 臨床成績
text:
  status:
    v: additional
  div:
    v: unavailable
section:
  title:
    v: 17.1 有効性及び安全性に関する試験
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 13
    text:
      v: 17.1 有効性及び安全性に関する試験
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 17.1.1 国内臨床試験
    code:
      text:
        v: 17.1.1 国内臨床試験
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 17.1.2 ブリッジング試験
    code:
      text:
        v: 17.1.2 ブリッジング試験
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 17.1.3 海外臨床試験(第III相試験)
    code:
      text:
        v: 17.1.3 海外臨床試験(第III相試験)
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 17.1.4 海外大規模比較試験(第III相試験 術後補助療法)
    code:
      text:
        v: 17.1.4 海外大規模比較試験(第III相試験 術後補助療法)
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 17.1.5 海外比較試験(術後補助療法)
    code:
      text:
        v: 17.1.5 海外比較試験(術後補助療法)
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 17.1.6 非盲検無作為化比較試験(第II/III相試験 転移性乳癌に対する第一次 ホルモン療法)
    code:
      text:
        v: 17.1.6 非盲検無作為化比較試験(第II/III相試験 転移性乳癌に対する第一次 ホルモン療法)
    text:
      status:
        v: additional
      div:
        v: unavailable

v: 13

v: 13

v: 13

v: 13

v: 13

v: 16

title:
  v: 18. 薬効薬理
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 18
  text:
    v: 18. 薬効薬理
text:
  status:
    v: additional
  div:
    v: unavailable
section:
  title:
    v: 18.1 作用機序
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 17
    text:
      v: 18.1 作用機序
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 18.1.1 アロマターゼ阻害作用
    code:
      text:
        v: 18.1.1 アロマターゼ阻害作用
    text:
      status:
        v: additional
      div:
        v: unavailable
section:
  title:
    v: 18.2 抗腫瘍効果
  code:
    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 17
    text:
      v: 18.2 抗腫瘍効果
  text:
    status:
      v: additional
    div:
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section:
  title:
    v: 18.3 エストロゲン抑制作用
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    coding:
      system:
        v: https://pmda.jp/
        l: pmda.jp
      code:
        v: 17
    text:
      v: 18.3 エストロゲン抑制作用
  text:
    status:
      v: additional
    div:
      v: unavailable
  section:
    title:
      v: 18.3.1
    code:
      text:
        v: 18.3.1
    text:
      status:
        v: additional
      div:
        v: unavailable
  section:
    title:
      v: 18.3.2
    code:
      text:
        v: 18.3.2
    text:
      status:
        v: additional
      div:
        v: unavailable

v: 17

v: 17

v: 17

title:
  v: 19. 有効成分に関する理化学的知見
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 19
  text:
    v: 19. 有効成分に関する理化学的知見
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 20. 取扱い上の注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 9
  text:
    v: 20. 取扱い上の注意
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 21. 承認条件
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 9
  text:
    v: 21. 承認条件
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 22. 包装
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 22
  text:
    v: 22. 包装
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 23. 主要文献
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 23
  text:
    v: 23. 主要文献
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 24. 文献請求先及び問い合わせ先
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 24
  text:
    v: 24. 文献請求先及び問い合わせ先
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 25. 保険給付上の注意
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 9
  text:
    v: 25. 保険給付上の注意
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 26. 製造販売業者等
code:
  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 26
  text:
    v: 26. 製造販売業者等
text:
  status:
    v: additional
  div:
    v: unavailable

title:
  v: 26.1 製造販売元
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  coding:
    system:
      v: https://pmda.jp/
      l: pmda.jp
    code:
      v: 26
  text:
    v: 26.1 製造販売元
text:
  status:
    v: additional
  div:
    v: unavailable

v: 220000000002

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l: 3166

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v: ja-JP

v: 33CM23913M

v: carbamazepine

v: ACTIB