{
  "id": "savaysa",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-28",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "SAVAYSA",
    "generic": "依度沙班（美国标签：依度沙班甲苯磺酸盐；日本：依度沙班甲苯磺酸盐水合物）",
    "aliases": [
      "Savaysa",
      "LIXIANA",
      "Lixiana",
      "リクシアナ",
      "edoxaban",
      "edoxaban tosylate",
      "edoxaban tosilate",
      "依度沙班",
      "依度沙班甲苯磺酸盐",
      "依度沙班甲苯磺酸盐水合物",
      "65597-201-30",
      "65597-202-30",
      "65597-202-05",
      "65597-203-05",
      "DSC L15",
      "DSC L30",
      "DSC L60"
    ],
    "marketBrandNames": [
      {
        "name": "LIXIANA",
        "market": {
          "zh": "欧盟",
          "en": "European Union"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "EMA 集中许可产品名；准确国家包装和供应须按当地现行资料核对。",
          "en": "EMA central-authorisation product name; exact national packs and supply require current local review."
        },
        "source": {
          "id": "src_7996b926bd9d287a",
          "label": "EMA：LIXIANA 欧盟集中许可产品页与产品资料入口",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      },
      {
        "name": "リクシアナ",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "PMDA 当前产品页所列日文商品名；不与美国 NDC 或欧盟包装合并。",
          "en": "Japanese trade name in the current PMDA product page; not merged with U.S. NDCs or EU packs."
        },
        "source": {
          "id": "src_a74821c7ca0cde93",
          "label": "PMDA：リクシアナ錠 15 mg／30 mg／60 mg 当前公众产品页",
          "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      }
    ],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "抗凝与血液",
    "sourceArchiveMarket": "美国：SAVAYSA 依度沙班薄膜衣口服片，NDA 206316，DailyMed 页面 2025-07-10 更新。欧盟：LIXIANA 集中上市许可自 2015-06-19 有效，EMA 产品资料入口提供欧盟官方语言版本。日本：PMDA 当前产品页列示リクシアナ錠 15/30/60 mg、现行说明书、患者用药指南与风险管理资料。本页分别保留三地监管身份，不据此推定中国大陆或其他市场的批准、商品名、包装、供应、可售资格或可替代性。",
    "dosageFormClass": "依度沙班薄膜衣口服片：美国 SAVAYSA 15 mg、30 mg、60 mg；本档案分别建立 15 mg/30 片瓶、30 mg/30 片瓶、30 mg/50 片医院用泡罩纸盒及 60 mg/50 片医院用泡罩纸盒身份。欧盟 LIXIANA 与日本リクシアナ的规格和包装须按各自文件另行核对，不与美国 NDC 合并。",
    "dosageFormClassCode": "oral_solid",
    "route": "口服（高风险跨市场抗凝准确产品身份字段）",
    "routeCode": "oral",
    "historicalApprovalEntry": "2015-01-08（FDA NDA 206316 批准）；2015-06-19（欧盟 LIXIANA 上市许可）",
    "archiveSponsorText": "Daiichi Sankyo Inc.（美国）；Daiichi Sankyo Europe GmbH（欧盟）；第一三共株式会社（日本）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "apixaban",
      "ELIQUIS",
      "阿哌沙班",
      "rivaroxaban",
      "XARELTO",
      "利伐沙班",
      "dabigatran",
      "PRADAXA",
      "达比加群酯",
      "warfarin",
      "COUMADIN",
      "华法林",
      "heparin",
      "肝素",
      "another-market edoxaban pack",
      "其他市场依度沙班包装"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-savaysa-edoxaban-15mg-30-bottle-ndc-65597-201-30",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 美国公开标签（页面 2025-07-10 更新；处方信息 2023-10 修订）",
        "en": "U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)"
      },
      "dosageForm": {
        "zh": "SAVAYSA 依度沙班薄膜衣口服片",
        "en": "SAVAYSA edoxaban film-coated oral tablet"
      },
      "route": {
        "zh": "口服（高风险抗凝准确产品身份字段）",
        "en": "oral (higher-risk anticoagulant exact-product identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 65597-201-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片依度沙班 15 mg；30 片瓶装",
        "en": "Edoxaban 15 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-07.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）",
            "en": "edoxaban (supplied as edoxaban tosylate)"
          },
          "value": 15,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "橙色",
          "en": "orange"
        },
        "shape": {
          "zh": "圆形、无刻痕薄膜衣片",
          "en": "round, unscored film-coated tablet"
        },
        "imprint": "DSC L15",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "id": "src_a4dc149f928ad43b",
        "label": "DailyMed（NLM）：SAVAYSA 依度沙班 15 mg，NDC 65597-201-30，30 片瓶装美国标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
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        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-savaysa-edoxaban-30mg-30-bottle-ndc-65597-202-30",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 美国公开标签（页面 2025-07-10 更新；处方信息 2023-10 修订）",
        "en": "U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)"
      },
      "dosageForm": {
        "zh": "SAVAYSA 依度沙班薄膜衣口服片",
        "en": "SAVAYSA edoxaban film-coated oral tablet"
      },
      "route": {
        "zh": "口服（高风险抗凝准确产品身份字段）",
        "en": "oral (higher-risk anticoagulant exact-product identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 65597-202-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片依度沙班 30 mg；30 片瓶装",
        "en": "Edoxaban 30 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-08.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
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          "ingredient": {
            "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）",
            "en": "edoxaban (supplied as edoxaban tosylate)"
          },
          "value": 30,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "粉红色",
          "en": "pink"
        },
        "shape": {
          "zh": "圆形、无刻痕薄膜衣片",
          "en": "round, unscored film-coated tablet"
        },
        "imprint": "DSC L30",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "audience": "public",
        "reviewStatus": "approved",
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        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-savaysa-edoxaban-30mg-50-hospital-blister-carton-ndc-65597-202-05",
      "marketCode": "US",
      "labelVersion": {
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        "en": "U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)"
      },
      "dosageForm": {
        "zh": "SAVAYSA 依度沙班薄膜衣口服片",
        "en": "SAVAYSA edoxaban film-coated oral tablet"
      },
      "route": {
        "zh": "口服（高风险抗凝准确产品身份字段）",
        "en": "oral (higher-risk anticoagulant exact-product identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 65597-202-05",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片依度沙班 30 mg；5 板 × 10 片、共 50 片医院用泡罩板纸盒",
        "en": "Edoxaban 30 mg per tablet; five 10-tablet blister cards, 50 tablets total, hospital-use carton"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-09.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
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          "ingredient": {
            "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）",
            "en": "edoxaban (supplied as edoxaban tosylate)"
          },
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          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "医院用泡罩板纸盒",
          "en": "hospital-use blister-card carton"
        },
        "fill": null,
        "countPerPackage": 50,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 50,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "粉红色",
          "en": "pink"
        },
        "shape": {
          "zh": "圆形、无刻痕薄膜衣片",
          "en": "round, unscored film-coated tablet"
        },
        "imprint": "DSC L30",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
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        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-savaysa-edoxaban-60mg-50-hospital-blister-carton-ndc-65597-203-05",
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      "labelVersion": {
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      },
      "dosageForm": {
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        "en": "SAVAYSA edoxaban film-coated oral tablet"
      },
      "route": {
        "zh": "口服（高风险抗凝准确产品身份字段）",
        "en": "oral (higher-risk anticoagulant exact-product identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 65597-203-05",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片依度沙班 60 mg；5 板 × 10 片、共 50 片医院用泡罩板纸盒",
        "en": "Edoxaban 60 mg per tablet; five 10-tablet blister cards, 50 tablets total, hospital-use carton"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-10.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
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          "ingredient": {
            "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）",
            "en": "edoxaban (supplied as edoxaban tosylate)"
          },
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          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "医院用泡罩板纸盒",
          "en": "hospital-use blister-card carton"
        },
        "fill": null,
        "countPerPackage": 50,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
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      "listingStatus": {
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        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
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      },
      "package": {
        "count": 50,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "圆形、无刻痕薄膜衣片",
          "en": "round, unscored film-coated tablet"
        },
        "imprint": "DSC L60",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
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      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
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  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-savaysa-edoxaban-15mg-30-bottle-ndc-65597-201-30",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-07.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66",
    "alt": "SAVAYSA 依度沙班 15 mg、NDC 65597-201-30、30 片瓶装的美国 DailyMed 标签展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 页面 2025-07-10 更新；处方信息 2023-10 修订",
    "presentation": "SAVAYSA 依度沙班 15 mg、NDC 65597-201-30、30 片瓶装标签展示面。片剂为橙色圆形无刻痕薄膜衣片，刻印 DSC L15。",
    "notice": "此图只对应所引美国 DailyMed 标签中的 SAVAYSA 15 mg、NDC 65597-201-30、30 片瓶装。它不代表 30 mg、60 mg、LIXIANA／リクシアナ、其他依度沙班产品、其他市场包装或当前可得性；不用于鉴定真伪，也不生成个人片数、补服、停药、换药或手术前后方案。",
    "source": {
      "id": "src_a4dc149f928ad43b",
      "label": "DailyMed（NLM）：SAVAYSA 依度沙班 15 mg、NDC 65597-201-30、30 片瓶装美国标签面板",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "SAVAYSA／LIXIANA 说明书放大阅读：先认清抗凝药，再核对出血、停药与操作风险",
      "en": "SAVAYSA/LIXIANA label reading: identify the anticoagulant, then review bleeding, interruption and procedure risks"
    },
    "summary": {
      "zh": "依度沙班是高风险口服抗凝药。美国标签有黑框警告：部分非瓣膜性房颤患者的肾功能范围会影响药物是否适用；过早停用可能增加缺血事件；接受脊柱/硬膜外穿刺或麻醉时可能发生脊髓或硬膜外血肿。网页不计算肌酐清除率、不选择强度，也不安排停药、桥接、补服或转换。",
      "en": "Edoxaban is a higher-risk oral anticoagulant. The U.S. label carries boxed warnings about reduced efficacy in a renal-function subgroup with nonvalvular atrial fibrillation, ischaemic risk after premature discontinuation, and spinal or epidural haematoma around neuraxial procedures. The site does not calculate creatinine clearance, select a strength, or plan interruption, bridging, missed use or switching."
    },
    "checks": [
      {
        "zh": "先同时核对商品名、依度沙班、目标市场、15/30/60 mg 每片强度、包装、NDC 或当地批准资料。相同成分名不表示美国 SAVAYSA、欧盟 LIXIANA、日本リクシアナ及其他市场包装可以互换。",
        "en": "Check the brand, edoxaban, target market, 15/30/60 mg strength per tablet, pack, NDC or local authorisation record together. A shared ingredient name does not make U.S. SAVAYSA, EU LIXIANA, Japanese リクシアナ or another market pack interchangeable."
      },
      {
        "zh": "把肾功能、体重、年龄、肝脏情况、近期手术/拔牙/腰穿计划、跌倒，以及包含全部处方药、非处方药和补充剂的完整药单一起交给开方团队或药师核对。其他抗凝药、抗血小板药、溶栓药、部分止痛药和部分抗抑郁药可能增加出血风险；不要自行同服、轮换或错开。",
        "en": "Have the prescriber or pharmacist review renal function, body weight, age, liver status, planned surgery/dental work/lumbar puncture, falls, and a complete medicine list containing every prescription, non-prescription product and supplement. Other anticoagulants, antiplatelets, thrombolytics, some pain medicines and some antidepressants may increase bleeding risk; do not self-combine, alternate or space them."
      },
      {
        "zh": "不要因一次漏服、出血担忧、准备检查或看见另一种抗凝药就自行停用、加倍、补服或换药。美国、欧盟和日本说明书的具体规则可能不同，必须回到本人处方、目标市场现行说明书和负责治疗团队。",
        "en": "Do not self-stop, double, make up or switch because of one missed use, bleeding concern, a planned test or another anticoagulant. Exact rules can differ across U.S., EU and Japanese labels; return to the individual's prescription, current target-market label and treating team."
      },
      {
        "zh": "持续或严重出血、黑便、呕血、咳血、血尿、突发剧烈头痛、一侧无力、言语含糊、明显头晕/昏厥、跌倒撞头或意识改变需要立即使用当地急救渠道，并带上全部药盒和用药清单；不要等待网页回复。",
        "en": "Persistent or severe bleeding, black stools, vomiting or coughing blood, blood in urine, sudden severe headache, one-sided weakness, slurred speech, marked dizziness/fainting, a fall with head impact or altered consciousness requires local emergency help immediately. Bring every medicine pack and the medicine list; do not wait for a web response."
      }
    ],
    "source": {
      "id": "src_a4dc149f928ad43b",
      "label": "DailyMed（NLM）：SAVAYSA 当前美国公开标签（黑框警告、出血、相互作用与患者指导）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "依度沙班怎样起作用：直接抑制凝血因子 Xa，减少凝血酶生成",
      "en": "How edoxaban works: direct factor Xa inhibition reduces thrombin generation"
    },
    "summary": {
      "zh": "美国标签说明，依度沙班是选择性凝血因子 Xa 抑制剂，不需要抗凝血酶 III 参与；抑制 Xa 会减少凝血酶生成和血栓形成。这个机制解释抗凝与出血为何要同时关注，但不能推导任何人的强度、频率、疗程、停用或换药。",
      "en": "The U.S. label describes edoxaban as a selective factor Xa inhibitor that does not require antithrombin III. Factor Xa inhibition reduces thrombin generation and thrombus formation. This explains why anticoagulation and bleeding must be considered together, but it cannot determine anyone's strength, frequency, duration, interruption or switch."
    },
    "checks": [
      {
        "zh": "“抑制 Xa”不表示所有口服抗凝药都一样。依度沙班、阿哌沙班、利伐沙班、达比加群酯、华法林及注射抗凝药的成分、机制、监测、适用范围和转换规则不同。",
        "en": "“Factor Xa inhibition” does not make all oral anticoagulants the same. Edoxaban, apixaban, rivaroxaban, dabigatran, warfarin and injectable anticoagulants differ in ingredient, mechanism, monitoring, labelled uses and transition rules."
      },
      {
        "zh": "药效机制不能判断某个人的肾功能范围、体重或其他药物是否需要改变方案；这些事实必须由专业人员结合目标市场说明书和处方核对。网页不提供肌酐清除率计算器或剂量选择器。",
        "en": "A mechanism cannot decide whether an individual's renal-function range, body weight or other medicines require a change. A professional must review those facts against the target-market label and prescription. The site does not provide a creatinine-clearance calculator or dose selector."
      },
      {
        "zh": "抗凝药减少血栓风险也会带来出血风险。最有用的行动是随身保留准确药名和强度、主动告诉手术/牙科/急诊团队、记录异常出血，并在严重症状时立即求助。",
        "en": "Anticoagulation reduces clotting risk and also creates bleeding risk. Useful actions are to carry the exact drug name and strength, tell surgical, dental and emergency teams, record unusual bleeding, and seek immediate help for serious symptoms."
      }
    ],
    "source": {
      "id": "src_a4dc149f928ad43b",
      "label": "DailyMed（NLM）：SAVAYSA 当前美国公开标签（12.1 Mechanism of Action）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "SAVAYSA",
      "generic": "依度沙班（美国标签：依度沙班甲苯磺酸盐；日本：依度沙班甲苯磺酸盐水合物）",
      "dosageFormClass": "依度沙班薄膜衣口服片：美国 SAVAYSA 15 mg、30 mg、60 mg；本档案分别建立 15 mg/30 片瓶、30 mg/30 片瓶、30 mg/50 片医院用泡罩纸盒及 60 mg/50 片医院用泡罩纸盒身份。欧盟 LIXIANA 与日本リクシアナ的规格和包装须按各自文件另行核对，不与美国 NDC 合并。"
    },
    "labelSource": {
      "id": "src_a4dc149f928ad43b",
      "label": "DailyMed（NLM）：SAVAYSA 依度沙班当前美国公开标签（Daiichi Sankyo；页面 2025-07-10 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-28",
      "reviewedAt": "2026-08-28"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_a4dc149f928ad43b",
          "label": "DailyMed（NLM）：SAVAYSA 依度沙班当前美国公开标签（Daiichi Sankyo；页面 2025-07-10 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "美国国家医学图书馆 DailyMed",
          "en": "U.S. National Library of Medicine DailyMed"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "公开药品标签",
          "en": "Public medicine label"
        },
        "reviewedAt": "2026-08-28",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_091d0d5a399120ee",
          "label": "FDA：SAVAYSA NDA 206316 批准函（2015-01-08；15/30/60 mg）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-08-28",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_7996b926bd9d287a",
          "label": "EMA：LIXIANA 欧盟集中许可产品页（许可自 2015-06-19 有效）",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "EMA",
          "en": "EMA"
        },
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "recordType": {
          "zh": "监管产品记录或欧盟产品资料",
          "en": "Regulatory product record or EU product information"
        },
        "reviewedAt": "2026-08-28",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_7c0fe3f96c686f05",
          "label": "EMA：LIXIANA 欧盟产品资料（含专业资料、标签与患者说明书）",
          "url": "https://www.ema.europa.eu/en/documents/product-information/lixiana-epar-product-information_en.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "EMA",
          "en": "EMA"
        },
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "recordType": {
          "zh": "监管产品记录或欧盟产品资料",
          "en": "Regulatory product record or EU product information"
        },
        "reviewedAt": "2026-08-28",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_a74821c7ca0cde93",
          "label": "PMDA：リクシアナ錠 15/30/60 mg 当前产品页与患者资料入口",
          "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "PMDA",
          "en": "PMDA"
        },
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "recordType": {
          "zh": "监管产品记录",
          "en": "Regulatory product record"
        },
        "reviewedAt": "2026-08-28",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_9d995775b9ea1d49",
          "label": "PMDA：リクシアナ錠当前电子说明书入口",
          "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/14987081102751",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "PMDA",
          "en": "PMDA"
        },
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "recordType": {
          "zh": "监管产品记录",
          "en": "Regulatory product record"
        },
        "reviewedAt": "2026-08-28",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      }
    ],
    "recordRoute": {
      "status": "product_level_public_record_verified",
      "authority": {
        "zh": "美国国家医学图书馆 DailyMed",
        "en": "U.S. National Library of Medicine DailyMed"
      },
      "market": {
        "zh": "美国",
        "en": "United States"
      },
      "recordType": {
        "zh": "公开药品标签",
        "en": "Public medicine label"
      },
      "reviewedAt": "2026-08-28",
      "scope": {
        "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
        "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
      }
    },
    "channels": [
      {
        "id": "china-nmpa-drug-evaluation-centre",
        "authority": "NMPA 药品评价中心",
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "title": {
          "zh": "药物警戒快讯与安全警示",
          "en": "Drug-vigilance bulletins and safety notices"
        },
        "purpose": {
          "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。",
          "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item."
        },
        "source": {
          "id": "src_05ff2860226564d4",
          "label": "国家药监局药品评价中心：药物警戒与安全警示入口",
          "url": "https://www.cdr-adr.org.cn/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-drug-safety-communications",
        "authority": "FDA",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "药物安全通讯",
          "en": "Drug Safety Communications"
        },
        "purpose": {
          "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。",
          "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications."
        },
        "source": {
          "id": "src_9177df9e1825aa72",
          "label": "FDA：Drug Safety Communications",
          "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-medwatch",
        "authority": "FDA MedWatch",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "安全信息与严重问题报告",
          "en": "Safety information and serious-problem reporting"
        },
        "purpose": {
          "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。",
          "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality."
        },
        "source": {
          "id": "src_e4739cd55d27ab51",
          "label": "FDA：MedWatch 药品安全信息与不良事件报告计划",
          "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "ema-pharmacovigilance",
        "authority": "EMA",
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "title": {
          "zh": "药物警戒概览与 EudraVigilance",
          "en": "Pharmacovigilance overview and EudraVigilance"
        },
        "purpose": {
          "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。",
          "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment."
        },
        "source": {
          "id": "src_2ad42a3deae747d1",
          "label": "EMA：Pharmacovigilance overview",
          "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "javascript_or_cookie_controls",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mhra-drug-safety-update",
        "authority": "MHRA",
        "market": {
          "zh": "英国",
          "en": "United Kingdom"
        },
        "title": {
          "zh": "Drug Safety Update",
          "en": "Drug Safety Update"
        },
        "purpose": {
          "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。",
          "en": "Primary UK MHRA medicine-safety updates for professionals and the public."
        },
        "source": {
          "id": "src_23fdbe67abeafc63",
          "label": "MHRA：Drug Safety Update",
          "url": "https://www.gov.uk/drug-safety-update",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "UK",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "pmda-drug-safety",
        "authority": "PMDA",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "title": {
          "zh": "药品安全信息",
          "en": "Medicine safety information"
        },
        "purpose": {
          "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。",
          "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents."
        },
        "source": {
          "id": "src_06d6be2880f12024",
          "label": "PMDA：Safety Information Regarding Drugs",
          "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mfds-drug-safety-letters",
        "authority": "MFDS",
        "market": {
          "zh": "韩国",
          "en": "Republic of Korea"
        },
        "title": {
          "zh": "药品安全性书信",
          "en": "Medicine safety letters"
        },
        "purpose": {
          "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。",
          "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case."
        },
        "source": {
          "id": "src_2d7f5018cd05eff4",
          "label": "MFDS：药品安全性书信（韩文原始资料）",
          "url": "https://www.mfds.go.kr/brd/m_545/list.do",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "KR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "hsa-adverse-events",
        "authority": "HSA",
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "title": {
          "zh": "不良反应报告与药物安全信息",
          "en": "Adverse-event reporting and medicine-safety information"
        },
        "purpose": {
          "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。",
          "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information."
        },
        "source": {
          "id": "src_9240397d5a8574c1",
          "label": "HSA：Report adverse events",
          "url": "https://www.hsa.gov.sg/adverse-events/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "SG",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "health-canada-medeffect-advisories",
        "authority": "Health Canada",
        "market": {
          "zh": "加拿大",
          "en": "Canada"
        },
        "title": {
          "zh": "MedEffect 加拿大：建议、警告与召回",
          "en": "MedEffect Canada: advisories, warnings and recalls"
        },
        "purpose": {
          "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。",
          "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item."
        },
        "source": {
          "id": "src_212ec921fa6634ad",
          "label": "Health Canada：MedEffect Canada 建议、警告与召回",
          "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "tga-safety-alerts",
        "authority": "TGA",
        "market": {
          "zh": "澳大利亚",
          "en": "Australia"
        },
        "title": {
          "zh": "药品安全警示",
          "en": "Medicine safety alerts"
        },
        "purpose": {
          "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。",
          "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products."
        },
        "source": {
          "id": "src_ffe6142814f88fac",
          "label": "TGA：Safety alerts",
          "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "AU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "swissmedic-pharmacovigilance",
        "authority": "Swissmedic",
        "market": {
          "zh": "瑞士",
          "en": "Switzerland"
        },
        "title": {
          "zh": "药物警戒与不良反应报告",
          "en": "Pharmacovigilance and suspected adverse-reaction reporting"
        },
        "purpose": {
          "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。",
          "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality."
        },
        "source": {
          "id": "src_c854f813ce2671df",
          "label": "Swissmedic：Pharmacovigilance",
          "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "CH",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "medsafe-safety-communications",
        "authority": "Medsafe",
        "market": {
          "zh": "新西兰",
          "en": "New Zealand"
        },
        "title": {
          "zh": "药品安全通讯",
          "en": "Medicine safety communications"
        },
        "purpose": {
          "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。",
          "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information."
        },
        "source": {
          "id": "src_3510c1a523ec9769",
          "label": "Medsafe：Safety Communications",
          "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "NZ",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "sahpra-safety-information",
        "authority": "SAHPRA",
        "market": {
          "zh": "南非",
          "en": "South Africa"
        },
        "title": {
          "zh": "药物安全信息、警示与药物警戒",
          "en": "Medicine safety information, alerts and pharmacovigilance"
        },
        "purpose": {
          "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。",
          "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information."
        },
        "source": {
          "id": "src_25b0aaefee742163",
          "label": "SAHPRA：Safety Information Updates / Pharmacovigilance",
          "url": "https://www.sahpra.org.za/safety-information-and-updates/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "ZA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "who-medicine-safety-alerts",
        "authority": "WHO",
        "market": {
          "zh": "全球",
          "en": "Global"
        },
        "title": {
          "zh": "药品与疫苗安全警示档案",
          "en": "Medicine and vaccine safety-alert archive"
        },
        "purpose": {
          "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。",
          "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market."
        },
        "source": {
          "id": "src_9a7dc56ec34c7e1a",
          "label": "WHO：Safety alerts for medicines and vaccines",
          "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "GLOBAL",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "anvisa-pharmacovigilance",
        "authority": "Anvisa",
        "market": {
          "zh": "巴西",
          "en": "Brazil"
        },
        "title": {
          "zh": "药物警戒、警示与 VigiMed",
          "en": "Pharmacovigilance, alerts and VigiMed"
        },
        "purpose": {
          "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。",
          "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item."
        },
        "source": {
          "id": "src_5de362c12580111d",
          "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）",
          "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "BR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      }
    ],
    "notices": [],
    "boundary": {
      "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。",
      "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline."
    },
    "scope": "official_routes_only_no_live_alert_inference"
  },
  "archive": {
    "summary": "SAVAYSA／LIXIANA 是依度沙班口服抗凝药的不同市场商品名。它抑制凝血因子 Xa，适应症、限制和具体使用规则必须对应所在市场、疾病情境、肾功能、体重、完整药单与现行说明书。最重要的普通人提示不是自行计算片数，而是：不要凭网页停药、补服、换成另一种抗凝药，做手术、拔牙、腰穿或硬膜外操作前主动说明正在使用抗凝药；出现持续或严重出血、黑便、呕血、咳血、突发剧烈头痛、明显无力或意识改变时立即使用当地急救渠道。",
    "history": "FDA 于 2015-01-08 批准 SAVAYSA NDA 206316 的 15、30、60 mg 口服片；当前 DailyMed 页面显示 2025-07-10 更新，处方信息正文修订于 2023-10。EMA 记录 LIXIANA 欧盟许可自 2015-06-19 有效，产品资料在 2025-08-27 更新。日本 PMDA 当前公众页列示リクシアナ錠 15/30/60 mg，并提供患者用药指南和出血倾向等安全资料入口。",
    "sourceDocuments": [
      {
        "id": "src_a4dc149f928ad43b",
        "label": "DailyMed（NLM）：SAVAYSA 依度沙班当前美国公开标签（Daiichi Sankyo；页面 2025-07-10 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      {
        "id": "src_091d0d5a399120ee",
        "label": "FDA：SAVAYSA NDA 206316 批准函（2015-01-08；15/30/60 mg）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      {
        "id": "src_7996b926bd9d287a",
        "label": "EMA：LIXIANA 欧盟集中许可产品页（许可自 2015-06-19 有效）",
        "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      {
        "id": "src_7c0fe3f96c686f05",
        "label": "EMA：LIXIANA 欧盟产品资料（含专业资料、标签与患者说明书）",
        "url": "https://www.ema.europa.eu/en/documents/product-information/lixiana-epar-product-information_en.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "EU",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      {
        "id": "src_a74821c7ca0cde93",
        "label": "PMDA：リクシアナ錠 15/30/60 mg 当前产品页与患者资料入口",
        "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "JP",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      },
      {
        "id": "src_9d995775b9ea1d49",
        "label": "PMDA：リクシアナ錠当前电子说明书入口",
        "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/14987081102751",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "JP",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-28",
        "reviewedAt": "2026-08-28"
      }
    ],
    "applicationNumber": "FDA NDA 206316（美国 SAVAYSA）；EMA EU/1/15/993（欧盟 LIXIANA）；日本产品身份见 PMDA 当前リクシアナ页面",
    "approvalTimeline": [
      {
        "date": "2015-01-08",
        "title": {
          "zh": "FDA 批准 SAVAYSA NDA 206316",
          "en": "FDA approved SAVAYSA NDA 206316"
        },
        "detail": {
          "zh": "FDA 批准函与 Drug Trials Snapshot 将 SAVAYSA、依度沙班、15/30/60 mg 口服片、NDA 206316 和 2015-01-08 批准日期相连。该节点只建立美国产品史，不自动建立欧盟、日本、中国大陆或其他市场的包装、供应或互换关系。",
          "en": "The FDA approval letter and Drug Trials Snapshot link SAVAYSA, edoxaban, 15/30/60 mg oral tablets, NDA 206316 and the approval date 8 Jan 2015. This establishes U.S. product history only; it does not automatically establish packaging, supply or interchangeability in the EU, Japan, Mainland China or another market."
        },
        "source": {
          "id": "src_091d0d5a399120ee",
          "label": "FDA：SAVAYSA NDA 206316 批准函（2015-01-08；15/30/60 mg）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      },
      {
        "date": "2015-06-19",
        "title": {
          "zh": "LIXIANA 获欧盟集中上市许可",
          "en": "LIXIANA received central EU marketing authorisation"
        },
        "detail": {
          "zh": "EMA 产品页将 LIXIANA 的欧盟集中上市许可日期列为 2015-06-19，并提供欧盟官方语言的产品资料、标签与患者说明书入口。该节点不把欧盟包装与美国 NDC 或日本产品合并。",
          "en": "EMA lists 19 Jun 2015 as the date of LIXIANA's central EU marketing authorisation and provides product information, labelling and patient leaflets in official EU languages. This node does not merge EU packs with U.S. NDCs or Japanese products."
        },
        "source": {
          "id": "src_7996b926bd9d287a",
          "label": "EMA：LIXIANA 欧盟集中许可产品页（许可自 2015-06-19 有效）",
          "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      },
      {
        "date": "2026-08-28",
        "title": {
          "zh": "美国、欧盟与日本现行公开入口联合复核",
          "en": "Current U.S., EU and Japanese public routes reviewed together"
        },
        "detail": {
          "zh": "本轮分别复核 DailyMed 当前美国标签、EMA LIXIANA 产品页/产品资料，以及 PMDA リクシアナ公众页/电子说明书入口。页面保留各市场边界，不把一次复核日期写成库存、购买或个人用药结论。",
          "en": "This review separately checked the current U.S. DailyMed label, EMA LIXIANA page/product information, and PMDA LIXIANA public page/electronic-label route. Market boundaries remain explicit; the review date is not a stock, purchase or individual-use conclusion."
        },
        "source": {
          "id": "src_a74821c7ca0cde93",
          "label": "PMDA：リクシアナ錠 15/30/60 mg 当前产品页与患者资料入口",
          "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-28",
          "reviewedAt": "2026-08-28"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "已链接当前标签、NDA 历史与四个准确包装身份",
          "en": "Current label, NDA history and four exact pack identities linked"
        },
        "detail": {
          "zh": "分别记录 SAVAYSA 15 mg/30 片瓶、30 mg/30 片瓶、30 mg/50 片医院泡罩纸盒及 60 mg/50 片医院泡罩纸盒的 NDC、颜色、刻印和来源；不建立库存、购买、真伪、个人片数、漏服、停用、转换或操作前后方案。",
          "en": "Separately records NDC, colour, imprint and source for SAVAYSA 15 mg/30-tablet bottle, 30 mg/30-tablet bottle, 30 mg/50-tablet hospital blister carton and 60 mg/50-tablet hospital blister carton. It does not establish stock, purchase, authenticity, individual tablet count, missed-use, interruption, transition or peri-procedure plans."
        }
      },
      {
        "market": {
          "zh": "欧盟",
          "en": "European Union"
        },
        "status": {
          "zh": "已链接 EMA LIXIANA 集中许可与多语言产品资料",
          "en": "EMA LIXIANA central authorisation and multilingual product information linked"
        },
        "detail": {
          "zh": "EMA 提供产品专业资料、标签与患者说明书，并说明资料可在欧盟官方语言中获取；准确国家包装和供应仍须按当地资料核对，不与美国 SAVAYSA NDC 合并。",
          "en": "EMA provides professional information, labelling and the patient leaflet in official EU languages. Exact national packs and supply still require local review and are not merged with U.S. SAVAYSA NDCs."
        }
      },
      {
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "status": {
          "zh": "已链接 PMDA リクシアナ 15/30/60 mg 产品、安全与患者资料入口",
          "en": "PMDA LIXIANA 15/30/60 mg product, safety and patient-information routes linked"
        },
        "detail": {
          "zh": "PMDA 当前公众页列示リクシアナ錠 15/30/60 mg、依度沙班甲苯磺酸盐水合物，并提供患者指南与出血倾向等安全资料入口；本页不把日本产品号、包装或使用规则与美国/欧盟合并。",
          "en": "The current PMDA public page lists LIXIANA 15/30/60 mg tablets and edoxaban tosilate hydrate and provides patient-guide and bleeding-risk information routes. Japanese product numbers, packs and use rules are not merged with U.S./EU records."
        }
      },
      {
        "market": {
          "zh": "中国大陆及其他市场",
          "en": "Mainland China and other markets"
        },
        "status": {
          "zh": "待逐项建立现行监管产品记录",
          "en": "Current regulatory product record not established"
        },
        "detail": {
          "zh": "不从 SAVAYSA、LIXIANA、リクシアナ、共同成分或三个市场资料推定当地批准、商品名、包装、供应、原研/参比关系或互换；须按当地现行监管资料逐产品核对。",
          "en": "No local approval, trade name, packaging, supply, originator/reference relationship or interchangeability is inferred from SAVAYSA, LIXIANA, リクシアナ, a shared ingredient or the three reviewed market records; each product requires current local regulatory review."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "SAVAYSA、LIXIANA 和リクシアナ是同一种药吗，能直接替换吗？",
          "en": "Are SAVAYSA, LIXIANA and リクシアナ the same medicine and directly interchangeable?"
        },
        "answer": {
          "zh": "它们都可指向依度沙班产品，但属于不同监管市场。共同成分不能证明强度、辅料、包装、批准用途、限制、供应或处方规则完全相同，更不能建立自行替换。请用实际药盒、目标市场说明书和处方由药师或开方团队核对。",
          "en": "They can all identify edoxaban products, but they belong to different regulatory markets. A shared ingredient does not prove identical strength, excipients, packaging, authorised uses, restrictions, supply or prescription rules and cannot establish self-substitution. Have a pharmacist or prescriber review the actual pack, target-market label and prescription."
        }
      },
      {
        "question": {
          "zh": "15、30、60 mg 能否自己换算片数，或漏服后补两片？",
          "en": "Can 15, 30 and 60 mg be converted into a tablet count, or can two tablets be taken after a missed use?"
        },
        "answer": {
          "zh": "不能。mg 是准确片剂的每片标示量，个人强度和规则还取决于适应症、肾功能、体重、合并用药及目标市场说明书。网页不提供片数换算、漏服补量、停用或转换指令；请按本人处方联系开方团队或药师。",
          "en": "No. mg is the labelled amount per exact tablet; individual strength and rules also depend on the indication, renal function, body weight, co-medications and target-market label. The site provides no tablet-count conversion, missed-use make-up, interruption or transition instruction; follow the individual's prescription and contact the prescriber or pharmacist."
        }
      },
      {
        "question": {
          "zh": "做手术、拔牙或腰穿前能否自己停药？",
          "en": "Can it be self-stopped before surgery, dental work or lumbar puncture?"
        },
        "answer": {
          "zh": "不能由网页决定。抗凝中断与操作时间会同时涉及出血和血栓风险。尽早把准确药名、强度、最近使用时间、肾功能与完整药单告知负责操作和开方的团队，由他们按现行说明书和临床情况安排；不要自行停用或用另一种抗凝药替代。",
          "en": "A webpage cannot decide this. Anticoagulant interruption and procedure timing involve both bleeding and clotting risks. Tell the procedural and prescribing teams the exact drug, strength, last use, renal function and complete medicine list early, so they can plan from the current label and clinical context; do not self-stop or substitute another anticoagulant."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dosage-forms-are-part-of-medicine-identity",
      "how-to-read-a-drug-label"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/savaysa/",
    "en": "https://origindrug.com/en/drugs/savaysa/"
  },
  "limitations": [
    "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.",
    "Target-market current labels and official records must be checked separately."
  ]
}