{
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  "id" : "trastazumabjpi",
  "meta" : {
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  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"ja\" lang=\"ja\"><p><b>Generated Narrative: Composition</b><a name=\"trastazumabjpi\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Composition &quot;trastazumabjpi&quot;  (Language &quot;ja&quot;) </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: id:\u00a0fcats34placeholder</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000155538)</span></p><p><b>date</b>: 2002-08-01 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-orgchugai.html\">Organization/orgchugai</a> &quot;Chugai Pharmaceutical Co., Ltd.&quot;</p><p><b>title</b>: Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td>Official <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-composition-attestation-mode.html\">Composition Attestation Mode</a>#official)</span></td><td>2002-08-01 13:28:17+0000</td></tr></table></div>"
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    "coding" : [{
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    }],
    "text" : "Package Leaflet"
  },
  "subject" : [{
    "reference" : "MedicinalProductDefinition/medprodherceptin150"
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  "author" : [{
    "reference" : "Organization/orgchugai"
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  "title" : "Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use",
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      "coding" : [{
        "system" : "http://hl7.org/fhir/composition-attestation-mode",
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    "time" : "2002-08-01T13:28:17Z"
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  "section" : [{
    "title" : "アロマターゼ阻害剤/閉経後乳癌治療剤",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "0"
      }],
      "text" : "アロマターゼ阻害剤/閉経後乳癌治療剤"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
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        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
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  {
    "title" : "1. 警告",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "1"
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      "text" : "1. 警告"
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      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "2.1"
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        "text" : "1.1"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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    {
      "title" : "1.2",
      "code" : {
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          "system" : "https://pmda.jp/",
          "code" : "2.1"
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      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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      "title" : "1.3",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "2.1"
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      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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        "coding" : [{
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  {
    "title" : "2. 禁忌(次の患者には投与しないこと)",
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      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "2"
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      "text" : "禁忌(次の患者には投与しないこと)"
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    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
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    "section" : [{
      "title" : "2.1",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "2.1"
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        "text" : "2.1"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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        "coding" : [{
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    {
      "title" : "2.2",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "2.2"
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      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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      "title" : "2.3",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "2.3"
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      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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    "title" : "3. 組成・性状",
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      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "3"
      }],
      "text" : "3. 組成・性状"
    },
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      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
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      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "3.1"
        }],
        "text" : "3.1 組成"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
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    {
      "title" : "3.2 製剤の性状",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "3.2"
        }],
        "text" : "3.2 製剤の性状"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
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  {
    "title" : "4. 効能又は効果",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "4"
      }],
      "text" : "効能又は効果"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
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    "title" : "5. 効能又は効果に関連する注意",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "5"
      }],
      "text" : "効能又は効果に関連する注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
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    "title" : "6. 用法及び用量",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "6"
      }],
      "text" : "用法及び用量"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
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    "title" : "7. 用法及び用量に関連する注意",
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      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "7"
      }],
      "text" : "7. 用法及び用量に関連する注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
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    "title" : "8. 重要な基本的注意",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "8"
      }],
      "text" : "重要な基本的注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
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      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
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    },
    "section" : [{
      "title" : "8.1",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "8.1"
        }],
        "text" : "8.1"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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      "title" : "8.2",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "8.2"
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        "text" : "8.2"
      },
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        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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    {
      "title" : "8.3",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "8.3"
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        "text" : "8.3"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
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    },
    {
      "title" : "8.4",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "8.4"
        }],
        "text" : "8.4"
      },
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        "status" : "additional",
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      },
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    }]
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  {
    "title" : "9. 特定の背景を有する患者に関する注意",
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      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "9"
      }],
      "text" : "特定の背景を有する患者に関する注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
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    },
    "section" : [{
      "title" : "9.1",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "9.2"
        }],
        "text" : "9.1"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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      "title" : "9.2 腎機能障害患者",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "9.2"
        }],
        "text" : "9.2 腎機能障害患者"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
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      "section" : [{
        "title" : "9.2.1 重度の腎障害のある患者",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "9"
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          "text" : "9.2.1 重度の腎障害のある患者"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
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    {
      "title" : "9.3 肝機能障害患者",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "9.3"
        }],
        "text" : "9.3 肝機能障害患者"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
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      },
      "section" : [{
        "title" : "9.3.1 重度の肝障害のある患者",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "9.3.1"
          }],
          "text" : "9.3.1 重度の肝障害のある患者"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
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    {
      "title" : "9.4",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "9.4"
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        "text" : "9.4"
      },
      "text" : {
        "status" : "additional",
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      },
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        "coding" : [{
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    {
      "title" : "9.5 妊婦",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "9"
        }],
        "text" : "9.5 妊婦"
      },
      "text" : {
        "status" : "additional",
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      },
      "emptyReason" : {
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    },
    {
      "title" : "9.6 授乳婦",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "9.6"
        }],
        "text" : "9.6 授乳婦"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
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  },
  {
    "title" : "10. 相互作用",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "10"
      }],
      "text" : "10. 相互作用"
    },
    "text" : {
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    },
    "emptyReason" : {
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    "section" : [{
      "title" : "10.1",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "9"
        }],
        "text" : "10.1"
      },
      "text" : {
        "status" : "additional",
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      },
      "emptyReason" : {
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    },
    {
      "title" : "10.2 併用注意(併用に注意すること)",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "10"
        }],
        "text" : "10.2 併用注意(併用に注意すること)"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
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  },
  {
    "title" : "11. 副作用",
    "code" : {
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        "system" : "https://pmda.jp/",
        "code" : "11"
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      "text" : "11. 副作用"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    },
    "section" : [{
      "title" : "11.1 重大な副作用",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "11.1"
        }],
        "text" : "11.1 重大な副作用"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "11.1.1",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "11.1.1"
          }],
          "text" : "11.1.1"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    },
    {
      "title" : "11.2 その他の副作用",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "11.2"
        }],
        "text" : "11.2 その他の副作用"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      }
    }]
  },
  {
    "title" : "12. 臨床検査結果に及ぼす影響",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "12"
      }],
      "text" : "12. 臨床検査結果に及ぼす影響"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "13. 過量投与",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "13"
      }],
      "text" : "13. 過量投与"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "14. 適用上の注意",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "14"
      }],
      "text" : "14. 適用上の注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    },
    "section" : [{
      "title" : "14.1 薬剤交付時の注意",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "14.1"
        }],
        "text" : "14.1 薬剤交付時の注意"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      }
    }]
  },
  {
    "title" : "15. その他の注意",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "13"
      }],
      "text" : "15. その他の注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    },
    "section" : [{
      "title" : "15.1",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "15.1"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      }
    },
    {
      "title" : "15.2 非臨床試験に基づく情報",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "15.2 非臨床試験に基づく情報"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      }
    }]
  },
  {
    "title" : "16. 薬物動態",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "13"
      }],
      "text" : "16. 薬物動態"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    },
    "section" : [{
      "title" : "16.1 血中濃度",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "16.1 血中濃度"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      }
    },
    {
      "title" : "16.2 吸収",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "16.2 吸収"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "16.2.1 食事の影響",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.2.1 食事の影響"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    },
    {
      "title" : "16.3 分布",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "16.3 分布"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "16.3.1 組織内濃度",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.3.1 組織内濃度"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "16.3.2 胎児・胎盤移行性",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.3.2 胎児・胎盤移行性"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "16.3.3 蛋白結合率",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.3.3 蛋白結合率"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    },
    {
      "title" : "16.5 排泄",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "16.5 排泄"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "16.5.1",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.5.1"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "16.5.2",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.5.2"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    },
    {
      "title" : "16.6 特定の背景を有する患者",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "16.6 特定の背景を有する患者"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "16.6.1 腎機能障害患者における体内動態",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.6.1 腎機能障害患者における体内動態"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "16.6.2 肝機能障害患者における体内動態",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "16.6.2 肝機能障害患者における体内動態"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    }]
  },
  {
    "title" : "17. 臨床成績",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "17"
      }],
      "text" : "17. 臨床成績"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    },
    "section" : [{
      "title" : "17.1 有効性及び安全性に関する試験",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "13"
        }],
        "text" : "17.1 有効性及び安全性に関する試験"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "17.1.1 国内臨床試験",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "17.1.1 国内臨床試験"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "17.1.2 ブリッジング試験",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "17.1.2 ブリッジング試験"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "17.1.3 海外臨床試験(第III相試験)",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "17.1.3 海外臨床試験(第III相試験)"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "17.1.4 海外大規模比較試験(第III相試験 術後補助療法)",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "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" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "17.1.5 海外比較試験(術後補助療法)",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "13"
          }],
          "text" : "17.1.5 海外比較試験(術後補助療法)"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "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" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "16"
          }],
          "text" : "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" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    }]
  },
  {
    "title" : "18. 薬効薬理",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "18"
      }],
      "text" : "18. 薬効薬理"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    },
    "section" : [{
      "title" : "18.1 作用機序",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "17"
        }],
        "text" : "18.1 作用機序"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "18.1.1 アロマターゼ阻害作用",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "17"
          }],
          "text" : "18.1.1 アロマターゼ阻害作用"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    },
    {
      "title" : "18.2 抗腫瘍効果",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "17"
        }],
        "text" : "18.2 抗腫瘍効果"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      }
    },
    {
      "title" : "18.3 エストロゲン抑制作用",
      "code" : {
        "coding" : [{
          "system" : "https://pmda.jp/",
          "code" : "17"
        }],
        "text" : "18.3 エストロゲン抑制作用"
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
      },
      "emptyReason" : {
        "coding" : [{
          "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
          "code" : "unavailable"
        }]
      },
      "section" : [{
        "title" : "18.3.1",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "17"
          }],
          "text" : "18.3.1"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      },
      {
        "title" : "18.3.2",
        "code" : {
          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "17"
          }],
          "text" : "18.3.2"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "emptyReason" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
            "code" : "unavailable"
          }]
        }
      }]
    }]
  },
  {
    "title" : "19. 有効成分に関する理化学的知見",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "19"
      }],
      "text" : "19. 有効成分に関する理化学的知見"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
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      }]
    }
  },
  {
    "title" : "20. 取扱い上の注意",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "9"
      }],
      "text" : "20. 取扱い上の注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
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  },
  {
    "title" : "21. 承認条件",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "9"
      }],
      "text" : "21. 承認条件"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "22. 包装",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "22"
      }],
      "text" : "22. 包装"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "23. 主要文献",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "23"
      }],
      "text" : "23. 主要文献"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "24. 文献請求先及び問い合わせ先",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "24"
      }],
      "text" : "24. 文献請求先及び問い合わせ先"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "25. 保険給付上の注意",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "9"
      }],
      "text" : "25. 保険給付上の注意"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "26. 製造販売業者等",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "26"
      }],
      "text" : "26. 製造販売業者等"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  },
  {
    "title" : "26.1 製造販売元",
    "code" : {
      "coding" : [{
        "system" : "https://pmda.jp/",
        "code" : "26"
      }],
      "text" : "26.1 製造販売元"
    },
    "text" : {
      "status" : "additional",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
    },
    "emptyReason" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/list-empty-reason",
        "code" : "unavailable"
      }]
    }
  }]
}