bundlejpiherceptin150
type: Bundle
node role: treeRoot
id:
  v: bundlejpiherceptin150
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/trastazumabjpi
    l: trastazumabjpi
  resource: trastazumabjpi
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Organization/orgchugai
    l: orgchugai
  resource: orgchugai
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Authorizations/authherceptin150
    l: authherceptin150
  resource: authherceptin150
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodherceptin150
    l: medprodherceptin150
  resource: medprodherceptin150
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packherceptinvial
    l: packherceptinvial
  resource: packherceptinvial
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodherceptin150
    l: adminprodherceptin150
  resource: adminprodherceptin150
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemherceptin150
    l: manitemherceptin150
  resource: manitemherceptin150
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/trastazumab
    l: trastazumab
  resource: trastazumab
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/carnubawax
    l: carnubawax
  resource: carnubawax
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/crystallinecellulose
    l: crystallinecellulose
  resource: crystallinecellulose
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/mannitol
    l: mannitol
  resource: mannitol
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/hypromelose
    l: hypromelose
  resource: hypromelose
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/lightanhydroussilicicacid
    l: lightanhydroussilicicacid
  resource: lightanhydroussilicicacid
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/magnesiumcarbonate
    l: magnesiumcarbonate
  resource: magnesiumcarbonate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/magnesiumstearate
    l: magnesiumstearate
  resource: magnesiumstearate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/methylparaben
    l: methylparaben
  resource: methylparaben
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/polyethyleneglycol
    l: polyethyleneglycol
  resource: polyethyleneglycol
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/polysorbate
    l: polysorbate
  resource: polysorbate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/polyvinylalcohol
    l: polyvinylalcohol
  resource: polyvinylalcohol
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/sucrose
    l: sucrose
  resource: sucrose
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/silicondioxide
    l: silicondioxide
  resource: silicondioxide
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/sodiumstarch
    l: sodiumstarch
  resource: sodiumstarch
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/syntehticwax
    l: syntehticwax
  resource: syntehticwax
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/talc
    l: talc
  resource: talc
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/titaniumdioxide2
    l: titaniumdioxide2
  resource: titaniumdioxide2
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subherceptin150
    l: subherceptin150
  resource: subherceptin150

trastazumabjpi
type: Composition
id:
  v: trastazumabjpi
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 trastazumabjpi 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 Chugai Pharmaceutical Co., Ltd. title: Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use 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: medprodherceptin150
  reference:
    v: MedicinalProductDefinition/medprodherceptin150
date:
  v: 2002-08-01T13:28:17Z
author:
  l: orgchugai
  reference:
    v: Organization/orgchugai
title:
  v: Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use
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
  empty reason:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/list-empty-reason
        l: list-empty-reason
      code:
        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
  empty reason:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/list-empty-reason
        l: list-empty-reason
      code:
        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
  empty reason:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/list-empty-reason
        l: list-empty-reason
      code:
        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

orgchugai
type: Organization
id:
  v: orgchugai
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 orgchugai Profile: Organization (ePI) identifier: https://pmda-org-id/672212 (use: official, ) active: true type: Marketing authorisation holder name: Chugai Pharmaceutical Co., Ltd. Contacts - Address * Medical Information Department 2-1-1 Nihonbashi Muromachi, Chuo-ku, Tokyo 103-8324(work)
identifier:
  use:
    v: official
  system:
    v: https://pmda-org-id
    l: pmda-org-id
  value:
    v: 672212
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: Chugai Pharmaceutical Co., Ltd.
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: Medical Information Department 2-1-1 Nihonbashi Muromachi, Chuo-ku, Tokyo 103-8324
    line:
      v: 2-1-1 Nihonbashi Muromachi
    city:
      v: Tokyo
    postal code:
      v: 103-8324
    country:
      v: Tokyo

authherceptin150
type: RegulatedAuthorization
id:
  v: authherceptin150
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 authherceptin150 Profile: RegulatedAuthorization (ePI) identifier: https://pmda-approvalandlicenseno//21300AMY00128 (use: official, ) subject: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; 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 Chugai Pharmaceutical Co., Ltd.
identifier:
  use:
    v: official
  system:
    v: https://pmda-approvalandlicenseno/
    l: pmda-approvalandlicenseno
  value:
    v: 21300AMY00128
subject:
  l: medprodherceptin150
  reference:
    v: MedicinalProductDefinition/medprodherceptin150
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: orgchugai
  reference:
    v: Organization/orgchugai

medprodherceptin150
type: MedicinalProductDefinition
id:
  v: medprodherceptin150
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 medprodherceptin150 Profile: MedicinalProductDefinition (ePI) identifier: http://iyaku.info/medicine/4291447D2024 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Herceptin (trastazumab) 150 mg type: Full name part part: Herceptin type: Invented name part part part: trastazumab type: Scientific name part part part: 150 mg type: Strength part part part: Intravenous infusion 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: 4291447D2024
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: Herceptin (trastazumab) 150 mg
  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: Herceptin
    type:
      text:
        v: Invented name part
  part:
    part:
      v: trastazumab
    type:
      text:
        v: Scientific name part
  part:
    part:
      v: 150 mg
    type:
      text:
        v: Strength part
  part:
    part:
      v: Intravenous infusion
    type:
      text:
        v: Pharmaceutical dose form part

packherceptinvial
type: PackagedProductDefinition
id:
  v: packherceptinvial
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 packherceptinvial Profile: PackagedProductDefinition (ePI) identifier: https://pmda-packinsertno//4291012F1022 (use: official, ) name: Herceptin (trastazumab) 150 mg for Intravenous Use type: Chemical Medininal Prodcut packageFor: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; 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: 150 mg manufacturer: Organization Chugai Pharmaceutical Co., Ltd. Packagings - Identifier Type Quantity Material * https://spor.ema.europa.eu/pmswi/123456 Vial 28 Glass type I
identifier:
  use:
    v: official
  system:
    v: https://pmda-packinsertno/
    l: pmda-packinsertno
  value:
    v: 4291012F1022
name:
  v: Herceptin (trastazumab) 150 mg for Intravenous Use
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000155527
    display:
      v: Chemical Medininal Prodcut
package for:
  l: medprodherceptin150
  reference:
    v: MedicinalProductDefinition/medprodherceptin150
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: 150
  unit:
    v: mg
manufacturer:
  l: orgchugai
  reference:
    v: Organization/orgchugai
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: 100000073563
      display:
        v: Vial
  quantity:
    v: 28
  material:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 200000003204
      display:
        v: Glass type I

adminprodherceptin150
type: AdministrableProductDefinition
id:
  v: adminprodherceptin150
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 adminprodherceptin150 Profile: AdministrableProductDefinition (ePI) identifier: https://www.who-umc.org/phpid/7532F47F36A3585D1F348BBDDA057862 status: Active formOf: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; 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#874291 (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: medprodherceptin150
  reference:
    v: MedicinalProductDefinition/medprodherceptin150
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: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 20053000

manitemherceptin150
type: ManufacturedItemDefinition
id:
  v: manitemherceptin150
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 manitemherceptin150 Profile: ManufacturedItemDefinition (ePI) identifier: https://pmda-sccj/874291 (use: official, ) status: Active manufacturedDoseForm: Tablet unitOfPresentation: 15054000 manufacturer: Organization Chugai Pharmaceutical Co., Ltd.
identifier:
  use:
    v: official
  system:
    v: https://pmda-sccj
    l: pmda-sccj
  value:
    v: 874291
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: orgchugai
  reference:
    v: Organization/orgchugai

trastazumab
type: Ingredient
id:
  v: trastazumab
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 trastazumab Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//P188ANX8CK (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Active Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * trastazumab Strengths - Presentation[x] Basis * 150 mg active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: P188ANX8CK
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072072
    display:
      v: Active
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai
substance:
  strength:
    presentation: Quantity
      value:
        v: 150
      unit:
        v: mg
    basis:
      text:
        v: active ingredient - basis of strength

carnubawax
type: Ingredient
id:
  v: carnubawax
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 carnubawax Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//R12CBM0EIZ (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * Carnauba wax
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: R12CBM0EIZ
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

crystallinecellulose
type: Ingredient
id:
  v: crystallinecellulose
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 crystallinecellulose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//OP1R32D61U (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * crystalline cellulose
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: OP1R32D61U
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

mannitol
type: Ingredient
id:
  v: mannitol
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 mannitol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//3OWL53L36A (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * MANNITOL
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 3OWL53L36A
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

hypromelose
type: Ingredient
id:
  v: hypromelose
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 hypromelose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//3NXW29V3WO (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * HYPROMELLOSE, UNSPECIFIED
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 3NXW29V3WO
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

lightanhydroussilicicacid
type: Ingredient
id:
  v: lightanhydroussilicicacid
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 lightanhydroussilicicacid Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//ETJ7Z6XBU4 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * light anhydrous silicic acid
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: ETJ7Z6XBU4
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

magnesiumcarbonate
type: Ingredient
id:
  v: magnesiumcarbonate
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 magnesiumcarbonate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//0E53J927NA (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * MAGNESIUM CARBONATE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 0E53J927NA
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

magnesiumstearate
type: Ingredient
id:
  v: magnesiumstearate
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 magnesiumstearate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//70097M6I30 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * MAGNESIUM STEARATE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 70097M6I30
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

methylparaben
type: Ingredient
id:
  v: methylparaben
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 methylparaben Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//A2I8C7HI9T (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * METHYLPARABEN
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: A2I8C7HI9T
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

polyethyleneglycol
type: Ingredient
id:
  v: polyethyleneglycol
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 polyethyleneglycol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//30IQX730WE (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * POLYETHYLENE GLYCOL 6000
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 30IQX730WE
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

polysorbate
type: Ingredient
id:
  v: polysorbate
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 polysorbate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//6OZP39ZG8H (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * POLYSORBATE 80
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 6OZP39ZG8H
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

polyvinylalcohol
type: Ingredient
id:
  v: polyvinylalcohol
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 polyvinylalcohol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//532B59J990 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * POLYVINYL ALCOHOL, UNSPECIFIED
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 532B59J990
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

sucrose
type: Ingredient
id:
  v: sucrose
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 sucrose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//C151H8M554 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * SUCROSE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: C151H8M554
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

silicondioxide
type: Ingredient
id:
  v: silicondioxide
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 silicondioxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//ETJ7Z6XBU4 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * SILICON DIOXIDE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: ETJ7Z6XBU4
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

sodiumstarch
type: Ingredient
id:
  v: sodiumstarch
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 sodiumstarch Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//5856J3G2A2 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * SODIUM STARCH GLYCOLATE TYPE A POTATO
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 5856J3G2A2
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

syntehticwax
type: Ingredient
id:
  v: syntehticwax
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 syntehticwax Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//5M631N9V0S (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * synthetic wax
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 5M631N9V0S
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

talc
type: Ingredient
id:
  v: talc
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 talc Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//7SEV7J4R1U (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * talc
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 7SEV7J4R1U
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

titaniumdioxide2
type: Ingredient
id:
  v: titaniumdioxide2
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 titaniumdioxide2 Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//15FIX9V2JP (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * TITANIUM DIOXIDE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 15FIX9V2JP
status:
  v: active
for:
  l: manitemherceptin150
  reference:
    v: ManufacturedItemDefinition/manitemherceptin150
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
manufacturer:
  manufacturer:
    l: orgchugai
    reference:
      v: Organization/orgchugai

subherceptin150
type: SubstanceDefinition
id:
  v: subherceptin150
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 subherceptin150 Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//P188ANX8CK (use: official, ) version: 39 status: Validated (UNII) description: White to pale yellow manufacturer: Organization Chugai Pharmaceutical Co., Ltd. Structures - MolecularFormula * C20H24O2 Names - Name Type * trastazumab Chemical Name
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: P188ANX8CK
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: orgchugai
  reference:
    v: Organization/orgchugai
structure:
  molecular formula:
    v: C20H24O2
name:
  name:
    v: trastazumab
  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: unavailable

v: 2.1

v: unavailable

v: 2.1

v: unavailable

v: 2.1

v: unavailable

v: 2.2

v: unavailable

v: 2.3

v: unavailable

status:
  v: additional
div:
  v: unavailable

coding:
  system:
    v: http://terminology.hl7.org/CodeSystem/list-empty-reason
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v: 9

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v: 11.1.1

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v: 13

v: unavailable

v: 13

v: unavailable

v: 13

v: unavailable

v: 13

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v: 13

v: unavailable

v: 16

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v: 17

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v: 17

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title:
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