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          "text" : "効能又は効果に関連する注意"
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          "status" : "additional",
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              "code" : "9.3"
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            "coding" : [{
              "system" : "https://pmda.jp/",
              "code" : "9"
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            "text" : "9.5 妊婦"
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              "system" : "https://pmda.jp/",
              "code" : "9.6"
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            "text" : "9.6 授乳婦"
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          "text" : "10. 相互作用"
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              "system" : "https://pmda.jp/",
              "code" : "9"
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            "text" : "10.1"
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            "coding" : [{
              "system" : "https://pmda.jp/",
              "code" : "10"
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            "text" : "10.2 併用注意(併用に注意すること)"
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          "coding" : [{
            "system" : "https://pmda.jp/",
            "code" : "11"
          }],
          "text" : "11. 副作用"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>"
        },
        "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>"
        }
      },
      {
        "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>"
        },
        "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>"
            }
          },
          {
            "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>"
            }
          }]
        },
        {
          "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>"
            }
          }]
        }]
      },
      {
        "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>"
            }
          },
          {
            "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>"
            }
          },
          {
            "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",
            "code" : "unavailable"
          }]
        }
      },
      {
        "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"
          }]
        }
      },
      {
        "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>"
        }
      },
      {
        "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"
          }]
        }
      }]
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Organization/orgohara",
    "resource" : {
      "resourceType" : "Organization",
      "id" : "orgohara",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_orgohara\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization orgohara</b></p><a name=\"orgohara\"> </a><a name=\"hcorgohara\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-org-id</code>/sim672212\u00a0(use:\u00a0official,\u00a0)</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{https://PMDA-org-type.jp/ tbd}\">Marketing authorisation holder</span></p><p><b>name</b>: Ohara Pharmaceutical Co., Ltd.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324(work)</td></tr></table></div>"
      },
      "identifier" : [{
        "use" : "official",
        "system" : "https://pmda-org-id",
        "value" : "sim672212"
      }],
      "active" : true,
      "type" : [{
        "coding" : [{
          "system" : "https://PMDA-org-type.jp/",
          "code" : "tbd",
          "display" : "Marketing authorisation holder"
        }],
        "text" : "Marketing authorisation holder"
      }],
      "name" : "Ohara Pharmaceutical Co., Ltd.",
      "contact" : [{
        "address" : {
          "use" : "work",
          "type" : "physical",
          "text" : "15 Nihonbashi Muromachi, Chuo-ku, Tokyo 8324",
          "line" : ["15 Nihonbashi Muromachi"],
          "city" : "Tokyo",
          "postalCode" : "8324",
          "country" : "Tokyo"
        }
      }]
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authsimvastatin20",
    "resource" : {
      "resourceType" : "RegulatedAuthorization",
      "id" : "authsimvastatin20",
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_authsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization authsimvastatin20</b></p><a name=\"authsimvastatin20\"> </a><a name=\"hcauthsimvastatin20\"> </a><p><b>identifier</b>: <code>https://pmda-approvalandlicenseno/</code>/22500AMX01227000\u00a0(use:\u00a0official,\u00a0)</p><p><b>subject</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#2189011F1262; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ /#100000072062}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>holder</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p></div>"
      },
      "identifier" : [{
        "use" : "official",
        "system" : "https://pmda-approvalandlicenseno/",
        "value" : "22500AMX01227000"
      }],
      "subject" : [{
        "reference" : "MedicinalProductDefinition/medprodsimvastatin20"
      }],
      "type" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi/",
          "code" : "/#100000072062"
        }],
        "text" : "Marketing Authorisation"
      },
      "region" : [{
        "coding" : [{
          "system" : "urn:iso:std:iso:3166",
          "code" : "JP"
        }],
        "text" : "Japan"
      }],
      "status" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/publication-status",
          "code" : "active"
        }],
        "text" : "Active"
      },
      "statusDate" : "2002-08-01T13:28:17Z",
      "holder" : {
        "reference" : "Organization/orgohara"
      }
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/medprodsimvastatin20",
    "resource" : {
      "resourceType" : "MedicinalProductDefinition",
      "id" : "medprodsimvastatin20",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_medprodsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition medprodsimvastatin20</b></p><a name=\"medprodsimvastatin20\"> </a><a name=\"hcmedprodsimvastatin20\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>http://iyaku.info/medicine</code>/2189011F1262</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Simvastatin 20 mg tablets</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Simvastatin</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 20 mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: tablet</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 JP}\">Japan</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 ja-JP}\">Japanese (Japan)</span></td></tr></table></blockquote></div>"
      },
      "identifier" : [{
        "system" : "http://iyaku.info/medicine",
        "value" : "2189011F1262"
      }],
      "type" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/medicinal-product-type",
          "code" : "MedicinalProduct",
          "display" : "Medicinal Product"
        }]
      },
      "domain" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/medicinal-product-domain",
          "code" : "Human",
          "display" : "Human use"
        }]
      },
      "status" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/publication-status",
          "code" : "active",
          "display" : "active"
        }]
      },
      "legalStatusOfSupply" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi",
          "code" : "100000072084",
          "display" : "Medicinal product subject to medical prescription"
        }]
      },
      "name" : [{
        "productName" : "Simvastatin 20 mg tablets",
        "type" : {
          "coding" : [{
            "system" : "https://spor.ema.europa.eu/lists/220000000000",
            "code" : "220000000001"
          }],
          "text" : "Full name"
        },
        "part" : [{
          "part" : "Simvastatin",
          "type" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/lists/220000000000",
              "code" : "220000000002"
            }],
            "text" : "Invented name part"
          }
        },
        {
          "part" : "Simvastatin",
          "type" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/lists/220000000000",
              "code" : "220000000003"
            }],
            "text" : "Scientific name part"
          }
        },
        {
          "part" : "20 mg",
          "type" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/lists/220000000000",
              "code" : "220000000004"
            }],
            "text" : "Strength part"
          }
        },
        {
          "part" : "tablet",
          "type" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/lists/220000000000",
              "code" : "220000000005"
            }],
            "text" : "Pharmaceutical dose form part"
          }
        }],
        "usage" : [{
          "country" : {
            "coding" : [{
              "system" : "urn:iso:std:iso:3166",
              "code" : "JP"
            }]
          },
          "jurisdiction" : {
            "coding" : [{
              "system" : "urn:iso:std:iso:3166",
              "code" : "JP"
            }]
          },
          "language" : {
            "coding" : [{
              "system" : "urn:ietf:bcp:47",
              "code" : "ja-JP"
            }]
          }
        }]
      }]
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packsimvastatin20",
    "resource" : {
      "resourceType" : "PackagedProductDefinition",
      "id" : "packsimvastatin20",
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_packsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition packsimvastatin20</b></p><a name=\"packsimvastatin20\"> </a><a name=\"hcpacksimvastatin20\"> </a><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/sim4291012F1022\u00a0(use:\u00a0official,\u00a0)</p><p><b>name</b>: Simvastatin 20 mg tablets blister</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000155527}\">Chemical Medininal Prodcut</span></p><p><b>packageFor</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#2189011F1262; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>containedItemQuantity</b>: 20 mg</p><p><b>manufacturer</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p><h3>Packagings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td style=\"display: none\">*</td><td><code>https://spor.ema.europa.eu/pmswi</code>/placeholder</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073496}\">Blister</span></td><td>30</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000003222}\">PolyVinyl Chloride</span></td></tr></table></div>"
      },
      "identifier" : [{
        "use" : "official",
        "system" : "https://pmda-packinsertno/",
        "value" : "sim4291012F1022"
      }],
      "name" : "Simvastatin 20 mg tablets blister",
      "type" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi",
          "code" : "100000155527",
          "display" : "Chemical Medininal Prodcut"
        }]
      },
      "packageFor" : [{
        "reference" : "MedicinalProductDefinition/medprodsimvastatin20"
      }],
      "status" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/publication-status",
          "code" : "active",
          "display" : "Active"
        }]
      },
      "statusDate" : "2002-08-01T13:28:17Z",
      "containedItemQuantity" : [{
        "value" : 20,
        "unit" : "mg"
      }],
      "manufacturer" : [{
        "reference" : "Organization/orgohara"
      }],
      "packaging" : {
        "identifier" : [{
          "system" : "https://spor.ema.europa.eu/pmswi",
          "value" : "placeholder"
        }],
        "type" : {
          "coding" : [{
            "system" : "https://spor.ema.europa.eu/rmswi",
            "code" : "100000073496",
            "display" : "Blister"
          }]
        },
        "quantity" : 30,
        "material" : [{
          "coding" : [{
            "system" : "https://spor.ema.europa.eu/rmswi",
            "code" : "200000003222",
            "display" : "PolyVinyl Chloride"
          }]
        }]
      }
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodsimvastatin20",
    "resource" : {
      "resourceType" : "AdministrableProductDefinition",
      "id" : "adminprodsimvastatin20",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_adminprodsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition adminprodsimvastatin20</b></p><a name=\"adminprodsimvastatin20\"> </a><a name=\"hcadminprodsimvastatin20\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-AdministrableProductDefinition-uv-epi.html\">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/9721571303255BF02181E8EC5AD60DF9</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#MedicinalProductDefinition_medprodsimvastatin20\">MedicinalProductDefinition: identifier = http://iyaku.info/medicine#2189011F1262; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 10219000}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 15054000}\">15054000</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundlejpisimvastatin20.html#ManufacturedItemDefinition_manitemsimvastatin20\">ManufacturedItemDefinition: identifier = https://pmda-sccj#sim874291\u00a0(use:\u00a0official,\u00a0); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><h3>RouteOfAdministrations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 20053000}\">20053000</span></td></tr></table></div>"
      },
      "identifier" : [{
        "system" : "https://www.who-umc.org/phpid",
        "value" : "9721571303255BF02181E8EC5AD60DF9"
      }],
      "status" : "active",
      "formOf" : [{
        "reference" : "MedicinalProductDefinition/medprodsimvastatin20"
      }],
      "administrableDoseForm" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi",
          "code" : "10219000"
        }],
        "text" : "Tablet"
      },
      "unitOfPresentation" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi",
          "code" : "15054000"
        }]
      },
      "producedFrom" : [{
        "reference" : "ManufacturedItemDefinition/manitemsimvastatin20"
      }],
      "routeOfAdministration" : [{
        "code" : {
          "coding" : [{
            "system" : "https://spor.ema.europa.eu/rmswi",
            "code" : "20053000"
          }]
        }
      }]
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemsimvastatin20",
    "resource" : {
      "resourceType" : "ManufacturedItemDefinition",
      "id" : "manitemsimvastatin20",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_manitemsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition manitemsimvastatin20</b></p><a name=\"manitemsimvastatin20\"> </a><a name=\"hcmanitemsimvastatin20\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-ManufacturedItemDefinition-uv-epi.html\">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://pmda-sccj</code>/sim874291\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/ 10219000}\">Tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://standardterms.edqm.eu/browse/get_concepts/UOP/ 15054000}\">15054000</span></p><p><b>manufacturer</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p></div>"
      },
      "identifier" : [{
        "use" : "official",
        "system" : "https://pmda-sccj",
        "value" : "sim874291"
      }],
      "status" : "active",
      "manufacturedDoseForm" : {
        "coding" : [{
          "system" : "https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/",
          "code" : "10219000"
        }],
        "text" : "Tablet"
      },
      "unitOfPresentation" : {
        "coding" : [{
          "system" : "https://standardterms.edqm.eu/browse/get_concepts/UOP/",
          "code" : "15054000"
        }]
      },
      "manufacturer" : [{
        "reference" : "Organization/orgohara"
      }]
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredientsimvastatin20",
    "resource" : {
      "resourceType" : "Ingredient",
      "id" : "ingredientsimvastatin20",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredientsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredientsimvastatin20</b></p><a name=\"ingredientsimvastatin20\"> </a><a name=\"hcingredientsimvastatin20\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-Ingredient-uv-epi.html\">Ingredient (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>for</b>: <a href=\"ManufacturedItemDefinition-manitemherceptin150.html\">ManufacturedItemDefinition: identifier = https://pmda-sccj#874291\u00a0(use:\u00a0official,\u00a0); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000</a></p><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072072}\">Active</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Manufacturer</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta AGG2FN16EV}\">trastazumab</span></td></tr></table><h3>Strengths</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style=\"display: none\">*</td><td>20 mg</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}\">active ingredient - basis of strength</span></td></tr></table></blockquote></div>"
      },
      "identifier" : {
        "use" : "official",
        "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
        "value" : "AGG2FN16EV"
      },
      "status" : "active",
      "for" : [{
        "reference" : "ManufacturedItemDefinition/manitemherceptin150"
      }],
      "role" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi",
          "code" : "100000072072",
          "display" : "Active"
        }]
      },
      "manufacturer" : [{
        "manufacturer" : {
          "reference" : "Organization/orgohara"
        }
      }],
      "substance" : {
        "code" : {
          "concept" : {
            "coding" : [{
              "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
              "code" : "AGG2FN16EV",
              "display" : "trastazumab"
            }]
          }
        },
        "strength" : [{
          "presentationQuantity" : {
            "value" : 20,
            "unit" : "mg"
          },
          "basis" : {
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
              "code" : "ACTIB"
            }],
            "text" : "active ingredient - basis of strength"
          }
        }]
      }
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subsimvastatin20",
    "resource" : {
      "resourceType" : "SubstanceDefinition",
      "id" : "subsimvastatin20",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_subsimvastatin20\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition subsimvastatin20</b></p><a name=\"subsimvastatin20\"> </a><a name=\"hcsubsimvastatin20\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-SubstanceDefinition-uv-epi.html\">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/AGG2FN16EV\u00a0(use:\u00a0official,\u00a0)</p><p><b>version</b>: 39</p><p><b>status</b>: <span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}\">Validated (UNII)</span></p><p><b>description</b>: </p><div><p>White to pale yellow</p>\n</div><p><b>manufacturer</b>: <a href=\"Organization-orgohara.html\">Organization Ohara Pharmaceutical Co., Ltd.</a></p><h3>Structures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>MolecularFormula</b></td></tr><tr><td style=\"display: none\">*</td><td>C25H38O5</td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>simvastatin</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}\">Chemical Name</span></td></tr></table></div>"
      },
      "identifier" : [{
        "use" : "official",
        "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
        "value" : "AGG2FN16EV"
      }],
      "version" : "39",
      "status" : {
        "coding" : [{
          "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
          "code" : "1"
        }],
        "text" : "Validated (UNII)"
      },
      "description" : "White to pale yellow",
      "manufacturer" : [{
        "reference" : "Organization/orgohara"
      }],
      "structure" : {
        "molecularFormula" : "C25H38O5"
      },
      "name" : [{
        "name" : "simvastatin",
        "type" : {
          "coding" : [{
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "code" : "1"
          }],
          "text" : "Chemical Name"
        }
      }]
    }
  }]
}