{
  "id": "farxiga",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-23",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Farxiga",
    "generic": "达格列净",
    "aliases": [
      "安达唐",
      "フォシーガ",
      "dapagliflozin"
    ],
    "marketBrandNames": [
      {
        "name": "フォシーガ",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "PMDA 当前产品页列フォシーガ片 5 mg／10 mg、达格列净成分及阿斯利康株式会社；仅作为日文名称、片剂与市场记录的核对入口，不确认其他包装、供应、可售资格或可自行换药。",
          "en": "The current PMDA product page lists FORXIGA (フォシーガ) 5 mg and 10 mg tablets, dapagliflozin and AstraZeneca K.K.; it is only a check point for the Japanese name, tablet form and market record, not another pack, supply, availability or self-directed switching."
        },
        "source": {
          "id": "src_57c86a992bcc667d",
          "label": "PMDA：フォシーガ錠 5 mg／10 mg 当前产品页",
          "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969019F1027_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": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "name": "安达唐",
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "evidenceStatus": "first_party_brand_history",
        "note": {
          "zh": "阿斯利康中国 2017 年新闻稿将安达唐®标为达格列净片；这是可追溯的历史品牌/通用名线索，不替代中国大陆当前批准、标签、供应或可售资格核验。",
          "en": "A 2017 AstraZeneca China release identifies 安达唐® as dapagliflozin tablets. This is a traceable historical brand/generic-name cue, not a current Mainland China approval, label, supply or availability finding."
        },
        "source": {
          "id": "src_1ef2111ce3b78170",
          "label": "阿斯利康中国：安达唐®／达格列净片历史上市新闻稿（2017）",
          "url": "https://www.astrazeneca.com.cn/zh/media/press-releases/2017/_sglt2_0.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "first_party_release",
          "market": "CN",
          "accessStatus": "public_access_with_site_controls",
          "accessMode": "javascript_or_cookie_controls",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      }
    ],
    "mainlandChinaTradeNameCue": {
      "value": "安达唐®",
      "status": "discovery_cue_requires_target_market_verification",
      "source": {
        "id": "src_120799f95f53075d",
        "label": "青岛市人民政府：2024 年医院药品记录中的安达唐／达格列净片 10 mg 记录",
        "url": "https://www.qingdao.gov.cn/ywdt/zwzl/ggqsydwgk/wsjk_208049/yy/qdsdbrmyy/zzbs/jg/202409/P020240913416639640028.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "government_medicine_listing",
        "market": "CN",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-12",
        "reviewedAt": "2026-09-12"
      }
    }
  },
  "identity": {
    "therapeuticArea": "代谢",
    "sourceArchiveMarket": "美国 FARXIGA 公开品牌标签（DailyMed 2026-06 更新）；日本 PMDA 当前フォシーガ片 5 mg／10 mg 产品记录；中国大陆安达唐®／达格列净片一手历史品牌资料（2017；不作为当前批准、供应或可售资格结论）",
    "dosageFormClass": "美国与日本公开来源均列达格列净口服片 5 mg、10 mg；本档案仅分别展示美国 30 片瓶装面板，其他市场包装须按当地文件核对",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "2014（FDA 标签所列美国初始批准）",
    "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed（NLM）公开标签；PMDA 日本产品记录；阿斯利康中国历史品牌资料"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "XIGDUO XR",
      "dapagliflozin metformin",
      "QTERN",
      "dapagliflozin saxagliptin",
      "QTERNMET XR",
      "dapagliflozin saxagliptin metformin"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-farxiga-dapagliflozin-tablet-5mg-0310620530",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前公开标签（2026-06 更新）",
        "en": "current DailyMed public label (updated Jun 2026)"
      },
      "dosageForm": {
        "zh": "达格列净口服薄膜衣片",
        "en": "dapagliflozin oral film-coated tablet"
      },
      "route": {
        "zh": "口服（仅作标签产品身份字段）",
        "en": "oral (label product-identity field only)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0310-6205-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片 5 mg；30 片瓶装",
        "en": "5 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69&name=farxiga_5mg_30ct.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "达格列净",
            "en": "dapagliflozin"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令",
            "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-21",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "圆形",
          "en": "round"
        },
        "imprint": "5 / 1427",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_5a208081956d67a5",
        "label": "DailyMed（NLM）：FARXIGA 达格列净 5 mg、30 片瓶装美国公开标签面板（AstraZeneca，2026-06 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "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-farxiga-dapagliflozin-tablet-10mg-0310621030",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前公开标签（2026-06 更新）",
        "en": "current DailyMed public label (updated Jun 2026)"
      },
      "dosageForm": {
        "zh": "达格列净口服薄膜衣片",
        "en": "dapagliflozin oral film-coated tablet"
      },
      "route": {
        "zh": "口服（仅作标签产品身份字段）",
        "en": "oral (label product-identity field only)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0310-6210-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片 10 mg；30 片瓶装",
        "en": "10 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69&name=farxiga_10mg_30ct.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "达格列净",
            "en": "dapagliflozin"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令",
            "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-21",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色",
          "en": "yellow"
        },
        "shape": {
          "zh": "菱形",
          "en": "diamond-shaped"
        },
        "imprint": "10 / 1428",
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_5a208081956d67a5",
        "label": "DailyMed（NLM）：FARXIGA 达格列净 10 mg、30 片瓶装美国公开标签面板（AstraZeneca，2026-06 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "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-farxiga-dapagliflozin-tablet-5mg-0310620530",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=farxiga_5mg_30ct.jpg&setid=72ad22ae-efe6-4cd6-a302-98aaee423d69&type=img",
    "alt": "FARXIGA 5 mg 达格列净口服片剂在美国 DailyMed 公开标签中的瓶装主展示图",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前公开标签（2026-06 更新）",
    "presentation": "FARXIGA（达格列净）5 mg、30 片瓶装主展示面（NDC 0310-6205-30；DailyMed 2026-06 公开标签）。",
    "notice": "此图只对应美国 DailyMed 公开标签中的 FARXIGA、达格列净 5 mg、NDC 0310-6205-30、30 片瓶装；只帮助核对来源与产品身份，不用于鉴定真伪，也不证明 10 mg、其他 NDC、含达格列净的复方产品、其他市场标签、原研身份、当前可得性、目标市场批准或可替代性。",
    "source": {
      "id": "src_5a208081956d67a5",
      "label": "DailyMed（NLM）：FARXIGA 达格列净 5 mg、30 片瓶装美国公开标签面板（AstraZeneca，2026-06 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "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": "FARXIGA 说明书放大阅读：5 mg 与 10 mg 先是不同产品强度",
      "en": "FARXIGA label reading: 5 mg and 10 mg first identify different product strengths"
    },
    "summary": {
      "zh": "本模块以 DailyMed 公开标签为阅读入口，帮助将 FARXIGA、达格列净、口服片剂和每片强度分开核对；它不把包装数字转成个人每天该服几片的结论。",
      "en": "This module uses the public DailyMed label as a reading entry point. It helps distinguish FARXIGA, dapagliflozin, oral-tablet form and strength per tablet; it does not turn package numbers into a conclusion about how many tablets anyone should take each day."
    },
    "checks": [
      {
        "zh": "先同时核对商品名、通用名、口服片剂、每片强度和目标市场：美国标签使用 FARXIGA，日本 PMDA 使用フォシーガ，中国历史一手资料使用安达唐®。5 mg/10 mg 表示每片所标示的产品强度；不同名称、市场或同为达格列净，均不代表任何人可以自行加倍、减半、替代或换药。",
        "en": "Check the brand, generic name, oral-tablet form, strength per tablet and target market together: the U.S. label uses FARXIGA, PMDA uses フォシーガ in Japan, and historical AstraZeneca China material uses 安达唐®. 5 mg/10 mg identifies the stated strength per tablet; different names, markets or the same dapagliflozin ingredient do not permit independent doubling, halving, substitution or switching."
      },
      {
        "zh": "糖尿病、心力衰竭或慢性肾病等标签词不能从药盒反推出个人适用性。尤其在肾功能、进食饮水、急性疾病或围手术期变化时，应由具体处方和当地专业人员判断，而不是依据旧标签或网络摘要自行调整。",
        "en": "Label terms such as diabetes, heart failure or chronic kidney disease cannot be used to infer individual suitability from a package. Changes in kidney function, eating or drinking, acute illness or the perioperative period require the exact prescription and local professional assessment, not self-adjustment from an old label or web summary."
      },
      {
        "zh": "若同时使用利尿剂、胰岛素或其他降糖产品，任何新增、停用、补服或换用都应带完整药单向药师/开方团队核对。相互作用或低血糖提示不是个人的“能用/不能用”清单。",
        "en": "If diuretics, insulin or other glucose-lowering products are also used, bring the complete medicine list to a pharmacist or prescribing team before any addition, stop, make-up dose or switch. Interaction or hypoglycaemia wording is not a personal “can/cannot use” list."
      },
      {
        "zh": "不同市场、标签更新和再包装都会改变包装外观或文字；页面上的名称与强度只能帮助定位来源，不能验证手中产品真伪或当前获批状态。",
        "en": "Different markets, label updates and repackaging can change package appearance or wording. The name and strength on this page only help locate a source; they cannot authenticate a product in hand or establish current approval status."
      }
    ],
    "source": {
      "id": "src_81a270a4d25cd890",
      "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "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": "达格列净怎样起作用：它在肾脏近端小管降低葡萄糖重吸收",
      "en": "How dapagliflozin works: it reduces glucose reabsorption in the kidney's proximal tubule"
    },
    "summary": {
      "zh": "FDA 的 FARXIGA 公开标签将达格列净描述为 SGLT2 抑制剂：它降低肾脏近端小管对过滤后葡萄糖的重吸收，从而促进葡萄糖经尿液排出。它说明的是作用路径；并不能据此判断某个人该用哪种降糖药、是否适合联用、该喝多少水或该怎样调整用药。",
      "en": "The FDA public FARXIGA label describes dapagliflozin as an SGLT2 inhibitor: it lowers reabsorption of filtered glucose in the kidney's proximal tubule, promoting urinary glucose excretion. This describes an action pathway; it cannot determine which glucose-lowering medicine a person should use, whether products can be combined, how much fluid to drink or how use should be adjusted."
    },
    "checks": [
      {
        "zh": "可把“重吸收”理解为肾脏把过滤后的某些物质收回体内的一道步骤。这里的机制有助于理解为什么标签会提到尿糖和体液相关问题，但不能用尿量、一次血糖值、口渴或脚肿来推导自行加量、减量、补服或停药。",
        "en": "“Reabsorption” can be read as a kidney step that takes some filtered substances back into the body. This mechanism helps explain why the label discusses urinary glucose and fluid-related issues, but urine output, one glucose result, thirst or ankle swelling cannot be used to self-direct an increase, decrease, make-up dose or stop."
      },
      {
        "zh": "同一 FDA 标签也描述了钠重吸收和远端小管钠递送的变化。它提示把利尿剂、降压药、其他降糖药和全部实际包装带去一起核对的重要性；不能由此得出某两种药可自行叠加、轮换或互相替代。",
        "en": "The same FDA label also describes changes involving sodium reabsorption and distal-tubule sodium delivery. That highlights why diuretics, blood-pressure medicines, other glucose-lowering medicines and all actual packages should be reviewed together; it does not establish that any two products can be self-combined, alternated or substituted."
      },
      {
        "zh": "5 mg、10 mg、片剂外观和商品名属于产品身份信息，与“药物怎样起作用”是不同层面。即使通用名相同或机制相近，也必须由目标市场现行标签和专业人员核对具体剂型、规格、肾功能、急性疾病情况及完整用药清单。",
        "en": "5 mg, 10 mg, tablet appearance and brand name are product-identity information, a different layer from how a medicine works. Even with the same generic name or a related mechanism, the current target-market label and a professional must review the exact form, strength, kidney function, acute-illness context and complete medicine list."
      }
    ],
    "source": {
      "id": "src_33753de2058f22ce",
      "label": "FDA：FARXIGA 2024-06 处方信息（临床药理）",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_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": "Farxiga",
      "generic": "达格列净",
      "dosageFormClass": "美国与日本公开来源均列达格列净口服片 5 mg、10 mg；本档案仅分别展示美国 30 片瓶装面板，其他市场包装须按当地文件核对"
    },
    "labelSource": {
      "id": "src_81a270a4d25cd890",
      "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "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_81a270a4d25cd890",
          "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "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_770aed6324375a3f",
          "label": "FDA：FARXIGA 2023-05 美国标签档案（NDA 202293）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_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_33753de2058f22ce",
          "label": "FDA：FARXIGA 2024-06 处方信息（临床药理）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_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_5a208081956d67a5",
          "label": "DailyMed（NLM）：FARXIGA 达格列净美国公开品牌标签及 5 mg/10 mg 包装面板（AstraZeneca，2026-06 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "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_57c86a992bcc667d",
          "label": "PMDA：フォシーガ錠 5 mg／10 mg 当前产品页",
          "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969019F1027_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": "2026-08-20",
          "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": [
      {
        "id": "fda-faers-sglt2-2023-dka-label-update-listing",
        "issuedAt": "2023-09-30",
        "status": "fda_potential_signal_label_update_listing",
        "title": {
          "zh": "FDA FAERS 记录：SGLT2 抑制剂相关标签更新线索",
          "en": "FDA FAERS record: SGLT2-inhibitor labelling-update information"
        },
        "summary": {
          "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面标示数据截至 2026-03-13）列出 Jardiance（恩格列净）和 Farxiga（达格列净）等 SGLT2 抑制剂，并说明该类产品的“警告和注意事项”已于 2023 年 9 月更新，纳入持续时间延长的糖尿病酮症酸中毒与尿糖信息。该表是监管安全信号与标签更新记录，不可用于判断个人是否发生相关问题；个人情况仍需结合实际产品、症状、检验和专业评估处理。",
          "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, displayed as current through 2026-03-13, lists Jardiance (empagliflozin) and Farxiga (dapagliflozin) among SGLT2 inhibitors and says their Warnings and Precautions labelling was updated in September 2023 to include prolonged diabetic ketoacidosis and glucosuria information. This is a regulatory safety-signal and labelling-update record; it cannot determine an individual event or support self-stopping, switching or changing treatment."
        },
        "source": {
          "id": "src_8c74002392ff8c7f",
          "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（SGLT2 抑制剂标签更新）",
          "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      }
    ],
    "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": "FARXIGA、フォシーガ和安达唐®是达格列净在不同市场出现的名称线索。美国 DailyMed 标签展示 FARXIGA 5 mg 与 10 mg 口服薄膜衣片及各自 30 片瓶装 NDC；日本 PMDA 当前产品页列フォシーガ片 5 mg／10 mg；阿斯利康中国 2017 年资料将安达唐®对应达格列净片。页面把品牌、通用名、每片标示强度、市场、实际包装和来源分开核对；不将名称关系或包装数字变成个人片数、加减、补服、停用、替代或联用方案。",
    "history": "FDA 历史资料记录 FARXIGA 的美国初始批准年份为 2014；本页的两张包装面板只对应 DailyMed 2026-06 公开标签中所列的 5 mg/10 mg、30 片瓶装。PMDA 当前产品页把日本フォシーガ片 5 mg／10 mg与达格列净成分相连；阿斯利康中国 2017 年公开资料将安达唐®列为达格列净片名称。它们是跨市场检索线索，不表示不同市场的标签、包装、适应症、供应或产品可自行互换。XIGDUO XR、QTERN 与 QTERNMET XR 含有达格列净但属于不同复方产品，不能按名称或成分重叠并入本单方片剂档案。",
    "sourceDocuments": [
      {
        "id": "src_770aed6324375a3f",
        "label": "FDA：FARXIGA 2023-05 美国标签档案（NDA 202293）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_33753de2058f22ce",
        "label": "FDA：FARXIGA 2024-06 处方信息（临床药理）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_5a208081956d67a5",
        "label": "DailyMed（NLM）：FARXIGA 达格列净美国公开品牌标签及 5 mg/10 mg 包装面板（AstraZeneca，2026-06 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_81a270a4d25cd890",
        "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_57c86a992bcc667d",
        "label": "PMDA：フォシーガ錠 5 mg／10 mg 当前产品页",
        "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969019F1027_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": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_1ef2111ce3b78170",
        "label": "阿斯利康中国：安达唐®／达格列净片历史上市新闻稿（2017）",
        "url": "https://www.astrazeneca.com.cn/zh/media/press-releases/2017/_sglt2_0.html",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "first_party_release",
        "market": "CN",
        "accessStatus": "public_access_with_site_controls",
        "accessMode": "javascript_or_cookie_controls",
        "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"
      }
    ],
    "applicationNumber": "NDA 202293",
    "approvalTimeline": [
      {
        "date": "2014",
        "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: 2014。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: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market."
        },
        "source": {
          "id": "src_770aed6324375a3f",
          "label": "FDA: FARXIGA label archive",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "2023-05",
        "title": {
          "zh": "FDA 标签档案版本",
          "en": "FDA label archive version"
        },
        "detail": {
          "zh": "本页链接 2023-05 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 2023-05 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_770aed6324375a3f",
          "label": "FDA: FARXIGA label archive",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_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/farxiga/",
    "en": "https://origindrug.com/en/drugs/farxiga/"
  },
  "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."
  ]
}