{
  "id": "eliquis",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-20",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Eliquis",
    "generic": "阿哌沙班",
    "aliases": [
      "エリキュース",
      "apixaban"
    ],
    "marketBrandNames": [
      {
        "name": "エリキュース",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "PMDA 当前产品页列示エリキュース錠 2.5 mg、5 mg及阿哌沙班成分；仅作为日文名称、片剂与市场记录的核对入口，不确认其他剂型、包装、供应、可售资格或可自行换药。",
          "en": "The current PMDA product page lists ELIQUIS (エリキュース) 2.5 mg and 5 mg tablets with apixaban; it is only a check point for the Japanese name, tablet form and market record, not another form, pack, supply, availability or self-directed switching."
        },
        "source": {
          "id": "src_9deb014111f17795",
          "label": "PMDA：エリキュース錠 2.5 mg／5 mg 当前产品页",
          "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339004F1029_1?user=1",
          "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": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      }
    ],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "心血管",
    "sourceArchiveMarket": "美国公开监管标签档案；日本 PMDA 当前产品记录（エリキュース錠 2.5 mg／5 mg）",
    "dosageFormClass": "口服片剂：2.5 mg、5 mg；FDA 2025 标签另列儿科口服混悬用途制剂，应与成人片剂分开核对",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "2012（FDA 2025 标签所列美国初始批准）",
    "archiveSponsorText": "Bristol Myers Squibb / Pfizer / FDA 与 DailyMed 公开标签档案"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "ELIQUIS SPRINKLE",
      "ELIQUIS 0.15 mg",
      "ELIQUIS 0.5 mg",
      "tablets for oral suspension"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-eliquis-tablet-2-5mg-ndc-0003-0893-21",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v30，2025-05-05 发布",
        "en": "DailyMed SPL v30, published 5 May 2025"
      },
      "dosageForm": {
        "zh": "ELIQUIS 阿哌沙班成人口服薄膜衣片",
        "en": "ELIQUIS apixaban adult film-coated oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0003-0893-21",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片 2.5 mg；60 片瓶装",
        "en": "2.5 mg per tablet; 60-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0&type=img&name=apixa-2.5mg-label.jpg.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "阿哌沙班",
            "en": "apixaban"
          },
          "value": 2.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标示量；不是个人片数、停药或换药规则",
            "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-20",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "圆形、双凸薄膜衣片",
          "en": "round biconvex film-coated tablet"
        },
        "imprint": "893 / 2½",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_f362259220a403fe",
        "label": "DailyMed（NLM）：ELIQUIS 阿哌沙班当前美国公开标签（Bristol Myers Squibb / Pfizer；SPL v30，2025-05-05 发布）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-eliquis-tablet-5mg-ndc-0003-0894-21",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v30，2025-05-05 发布",
        "en": "DailyMed SPL v30, published 5 May 2025"
      },
      "dosageForm": {
        "zh": "ELIQUIS 阿哌沙班成人口服薄膜衣片",
        "en": "ELIQUIS apixaban adult film-coated oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0003-0894-21",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片 5 mg；60 片瓶装",
        "en": "5 mg per tablet; 60-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0&type=img&name=apixa-5.0mg-label.jpg.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "阿哌沙班",
            "en": "apixaban"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标示量；不是个人片数、停药或换药规则",
            "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-20",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "粉红色",
          "en": "pink"
        },
        "shape": {
          "zh": "椭圆形、双凸薄膜衣片",
          "en": "oval biconvex film-coated tablet"
        },
        "imprint": "894 / 5",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_f362259220a403fe",
        "label": "DailyMed（NLM）：ELIQUIS 阿哌沙班当前美国公开标签（Bristol Myers Squibb / Pfizer；SPL v30，2025-05-05 发布）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-eliquis-tablet-5mg-ndc-0003-0894-21",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0&type=img&name=apixa-5.0mg-label.jpg.jpg",
    "alt": "ELIQUIS 阿哌沙班在美国 DailyMed 当前公开标签中的 5 mg、NDC 0003-0894-21、60 片瓶装展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed SPL v30（2025-05-05 发布）",
    "presentation": "ELIQUIS 阿哌沙班：每片 5 mg，NDC 0003-0894-21，60 片瓶装展示面。",
    "notice": "此图只对应美国 DailyMed 当前标签中的 ELIQUIS、阿哌沙班 5 mg、NDC 0003-0894-21 与 60 片瓶装。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 2.5 mg、儿童口服混悬用途制剂、启动包装、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、停药、漏用补救、联用或换药方案。",
    "source": {
      "id": "src_f362259220a403fe",
      "label": "DailyMed（NLM）：ELIQUIS 阿哌沙班当前美国公开标签（Bristol Myers Squibb / Pfizer；SPL v30，2025-05-05 发布）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "ELIQUIS 说明书放大阅读：片剂、不同 mg 与抗凝药不能自行停用",
      "en": "ELIQUIS label reading: tablets, different mg strengths and no self-stopping of an anticoagulant"
    },
    "summary": {
      "zh": "本模块以 FDA 与 DailyMed 的 2025 美国公开标签为阅读入口，帮助核对 ELIQUIS、阿哌沙班、成人口服片剂、2.5 mg/5 mg 包装文字，并把联用、出血和操作前后的问题带回专业核对；它不生成个体剂量、停药或转换方案。",
      "en": "This module uses 2025 U.S. FDA and DailyMed public labels as a reading entry point for ELIQUIS, apixaban, adult oral tablets and 2.5 mg/5 mg package wording, and brings combination, bleeding and procedure questions back to professional review; it does not create an individual dose, stop or switch plan."
    },
    "checks": [
      {
        "zh": "先同时核对 ELIQUIS、通用名阿哌沙班（apixaban）、成人口服片剂、每片标示强度和目标市场。2.5 mg、5 mg 是标签所列片剂强度线索；它们不是任何人应服用几片的答案，也不能把不同剂型按 mg 自行互换。",
        "en": "Check ELIQUIS, the generic name apixaban, adult oral tablet form, stated strength per tablet and target market together. 2.5 mg and 5 mg are labelled tablet-strength clues; they are not an answer to how many tablets anyone should take and do not make different dosage forms self-interchangeable by milligrams."
      },
      {
        "zh": "该标签提示过早停用会增加血栓事件风险。无论是担心出血、看到不同规格、药盒用完或考虑手术牙科操作，都不应据此自行停药、跳过、补服或改用另一种“抗凝/抗血栓”药。",
        "en": "The label warns that premature discontinuation increases thrombotic-event risk. Whether the concern is bleeding, a different strength, a finished pack, surgery or dental work, do not self-stop, skip, make up or substitute another “blood-thinning” medicine."
      },
      {
        "zh": "阿司匹林、止痛抗炎药、其他影响凝血的药物、部分抗抑郁药和草本/保健品都应完整告知开方团队和药师。网页不能把相互作用信息变成个人的“能用/不能用”清单。",
        "en": "Aspirin, anti-inflammatory pain medicines, other medicines affecting clotting, some antidepressants and herbs or supplements all belong in the complete list for the prescribing team and pharmacist. A webpage cannot turn interaction information into a personal “can/cannot use” list."
      },
      {
        "zh": "出现异常出血或计划侵入性操作时，应按当地医疗团队给出的具体指示处理；本页图片不能用于确认手中产品真伪或决定临时停药。",
        "en": "For unusual bleeding or a planned invasive procedure, follow the specific instructions of the local care team. This page's image cannot authenticate a product in hand or decide a temporary interruption."
      }
    ],
    "source": {
      "id": "src_f362259220a403fe",
      "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "阿哌沙班怎样起作用：它选择性抑制凝血因子 Xa",
      "en": "How apixaban works: it selectively inhibits coagulation factor Xa"
    },
    "summary": {
      "zh": "FDA 公开标签说明阿哌沙班选择性抑制游离和凝块结合的凝血因子 Xa 及凝血酶原酶活性，进而降低凝血酶生成和血栓形成。这说明的是凝血通路中的作用位置，不为任何人决定剂量、停药、转换或与其他抗凝/抗血小板药的组合。",
      "en": "The FDA public label explains that apixaban selectively inhibits free and clot-bound factor Xa and prothrombinase activity, reducing thrombin generation and thrombus development. This identifies a location in the coagulation pathway; it does not decide anyone's dose, interruption, conversion or combination with other anticoagulant or antiplatelet medicines."
    },
    "checks": [
      {
        "zh": "“同为因子 Xa 抑制剂”不是可互换或可叠加的理由。药物名称、强度、给药时间、适用情形、肾肝功能和完整药单都可能影响专业转换安排。",
        "en": "“Both are factor Xa inhibitors” is not a reason to interchange or combine them. Medicine name, strength, dosing time, use context, kidney and liver function, and the complete medicine list can all affect a professionally managed conversion."
      },
      {
        "zh": "机制也不能把“防血栓”和“出血风险”平衡成个人指令。异常出血、计划手术或牙科操作、漏服或拿到不同包装时，应按医疗团队的具体指示处理，不要依据网页自停、补服或加用另一种药。",
        "en": "Mechanism also cannot turn the balance between clot prevention and bleeding risk into personal instructions. With unusual bleeding, planned surgery or dental work, missed use or a different pack, follow the specific care-team instructions; do not self-stop, make up or add another medicine from a webpage."
      },
      {
        "zh": "本页机制不能取代相互作用核对。新开的处方药、非处方止痛药、抗血小板药、草本和保健品都应连同完整药单由医生或药师复核。",
        "en": "This page's mechanism cannot replace an interaction review. New prescriptions, OTC pain medicines, antiplatelet medicines, herbs and supplements all need review with the complete medicine list by a clinician or pharmacist."
      }
    ],
    "source": {
      "id": "src_db4dca754540adc9",
      "label": "FDA：ELIQUIS 2025-04 美国处方信息（临床药理）",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "Eliquis",
      "generic": "阿哌沙班",
      "dosageFormClass": "口服片剂：2.5 mg、5 mg；FDA 2025 标签另列儿科口服混悬用途制剂，应与成人片剂分开核对"
    },
    "labelSource": {
      "id": "src_f362259220a403fe",
      "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_f362259220a403fe",
          "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        },
        "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": "2026-08-20",
        "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_db4dca754540adc9",
          "label": "FDA：ELIQUIS 2025-04 美国处方信息（NDA 202155 / 220073）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        },
        "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": "2026-08-20",
        "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_9deb014111f17795",
          "label": "PMDA：エリキュース錠 2.5 mg／5 mg 当前产品页",
          "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339004F1029_1?user=1",
          "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": "2026-08-20",
          "reviewedAt": "2026-08-20"
        },
        "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": "2026-08-20",
        "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": "2026-08-20",
      "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": "FDA 与 DailyMed 的 ELIQUIS（apixaban）2025 美国公开标签将成人口服片剂列为 2.5 mg、5 mg，并列出美国初始批准年份为 2012；同份 FDA 标签还列有用于口服混悬液的不同儿科剂型。本页以成人片剂与公开标签为阅读入口，不把不同剂型、不同人群或其他市场产品自动混为可互换产品，也不推定各市场当前批准、供应或可售资格。",
    "history": "“ELIQUIS”“阿哌沙班”“2.5 mg/5 mg”“片剂”与口服混悬用途制剂是不同层次的身份信息，必须连同目标市场、完整药单和现行文件一起核对。抗凝药的漏服、出血、手术/牙科操作、换药或与其他抗凝/抗血小板药联用均不能从网页自行决定。",
    "sourceDocuments": [
      {
        "id": "src_db4dca754540adc9",
        "label": "FDA：ELIQUIS 2025-04 美国处方信息（NDA 202155 / 220073）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_f362259220a403fe",
        "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_5ed30b676fbb9773",
        "label": "FDA Drugs@FDA 官方检索入口",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "official_lookup_entry",
        "documentKind": "regulatory_lookup",
        "market": "US",
        "accessStatus": "public_access_requires_interaction",
        "accessMode": "interactive_lookup",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_9deb014111f17795",
        "label": "PMDA：エリキュース錠 2.5 mg／5 mg 当前产品页",
        "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339004F1029_1?user=1",
        "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": "2026-08-20",
        "reviewedAt": "2026-08-20"
      }
    ],
    "applicationNumber": "NDA 202155 / 220073",
    "approvalTimeline": [
      {
        "date": "2012",
        "title": {
          "zh": "FDA 标签所列美国初始批准年份",
          "en": "Initial U.S. approval year listed in the FDA label"
        },
        "detail": {
          "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2012。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。",
          "en": "The FDA label archive linked here lists Initial U.S. Approval: 2012. This historical locator is not a conclusion about current approval, availability, holder or another market."
        },
        "source": {
          "id": "src_db4dca754540adc9",
          "label": "FDA: ELIQUIS prescribing information",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "2025-04",
        "title": {
          "zh": "FDA 标签档案版本",
          "en": "FDA label archive version"
        },
        "detail": {
          "zh": "本页链接 2025-04 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。",
          "en": "This page links the 2025-04 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document."
        },
        "source": {
          "id": "src_db4dca754540adc9",
          "label": "FDA: ELIQUIS prescribing information",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "已链接公开标签档案",
          "en": "Public label archive linked"
        },
        "detail": {
          "zh": "仅对应本页所列 FDA 文件。",
          "en": "Only the FDA document listed on this page is linked."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本",
          "en": "Mainland China, EU, Japan"
        },
        "status": {
          "zh": "待逐项建立市场记录",
          "en": "Market record not established"
        },
        "detail": {
          "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。",
          "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "标签档案能代表现在的产品信息吗？",
          "en": "Does a label archive represent current product information?"
        },
        "answer": {
          "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。",
          "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label."
        }
      },
      {
        "question": {
          "zh": "为什么这里不展示价格或原研/仿制结论？",
          "en": "Why are price and originator/generic conclusions not shown?"
        },
        "answer": {
          "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。",
          "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "how-to-read-a-drug-label",
      "regulatory-sources-first"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/eliquis/",
    "en": "https://origindrug.com/en/drugs/eliquis/"
  },
  "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."
  ]
}