{
  "id": "uroxatral-alfuzosin",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-02",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "UROXATRAL",
    "generic": "盐酸阿夫唑嗪缓释片",
    "aliases": [
      "Uroxatral",
      "alfuzosin",
      "alfuzosin hydrochloride",
      "阿夫唑嗪",
      "盐酸阿夫唑嗪",
      "盐酸阿夫唑嗪缓释片",
      "X10",
      "UROXATRAL",
      "alfuzosin hydrochloride extended-release tablets",
      "NDA 021287",
      "59212-200-30",
      "59212-200-10"
    ],
    "marketBrandNames": [
      {
        "name": "UROXATRAL",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "NDA 021287；当前品牌标签列 10 mg 缓释片的 30 片与 100 片瓶装。监管标签不等于实时供应。",
          "en": "NDA 021287; the current brand label lists 10 mg extended-release tablets in 30- and 100-tablet bottles. A regulatory label is not live supply."
        },
        "source": {
          "id": "src_1b716f891d349535",
          "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      }
    ],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "泌尿健康",
    "sourceArchiveMarket": "美国 DailyMed 当前品牌标签列 UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片的 30 片与 100 片防儿童开启瓶装，均归入 NDA 021287。网页核对的是当前标签与包装身份，不证明当地实时库存、购买资格、个人适用性或其他国家包装。",
    "dosageFormClass": "盐酸阿夫唑嗪 10 mg 口服缓释片：圆形三层片，一层白色夹在两层黄色之间，刻印 X10。当前标签明确整片吞服，不得压碎、掰开或咀嚼。",
    "dosageFormClassCode": "oral_modified_release",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "2003（美国初始批准年份）",
    "archiveSponsorText": "Advanz Pharma (US) Corp.（当前美国品牌标签包装方）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "UROXATRAL",
      "Uroxatral alfuzosin",
      "alfuzosin hydrochloride extended-release tablets",
      "盐酸阿夫唑嗪缓释片"
    ],
    "excludedProductCues": [
      "FLOMAX",
      "tamsulosin",
      "坦索罗辛",
      "CARDURA",
      "doxazosin",
      "多沙唑嗪",
      "CARDURA XL",
      "HYTRIN",
      "terazosin",
      "MINIPRESS",
      "prazosin"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-uroxatral-alfuzosin-10mg-30-tablet-bottle-ndc-5921220030",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国品牌标签（SPL v9；2024-12-05 生效）",
        "en": "Current U.S. DailyMed brand label (SPL v9; effective 5 Dec 2024)"
      },
      "dosageForm": {
        "zh": "UROXATRAL 盐酸阿夫唑嗪口服缓释片",
        "en": "UROXATRAL alfuzosin hydrochloride extended-release oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 59212-200-30",
      "pouchCode": null,
      "applicationNumber": "NDA 021287",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸阿夫唑嗪 10 mg；30 片防儿童开启瓶装",
        "en": "Alfuzosin hydrochloride 10 mg per tablet; 30-tablet child-resistant bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uroxatral---30-counts.jpg&setid=9fc7f119-f36b-44cf-945d-940160f3afe3&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸阿夫唑嗪",
            "en": "alfuzosin hydrochloride"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频率或与另一种 α 阻滞剂的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another alpha blocker"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "防儿童开启瓶装",
          "en": "child-resistant bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色/白色/黄色三层",
          "en": "yellow/white/yellow three-layer"
        },
        "shape": {
          "zh": "圆形三层缓释片；一层白色夹在两层黄色之间",
          "en": "round three-layer extended-release tablet; one white layer between two yellow layers"
        },
        "imprint": "X10",
        "scoreStatus": "unscored_do_not_split_crush_or_chew",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_1b716f891d349535",
        "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-uroxatral-alfuzosin-10mg-100-tablet-bottle-ndc-5921220010",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国品牌标签（SPL v9；2024-12-05 生效）",
        "en": "Current U.S. DailyMed brand label (SPL v9; effective 5 Dec 2024)"
      },
      "dosageForm": {
        "zh": "UROXATRAL 盐酸阿夫唑嗪口服缓释片",
        "en": "UROXATRAL alfuzosin hydrochloride extended-release oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 59212-200-10",
      "pouchCode": null,
      "applicationNumber": "NDA 021287",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸阿夫唑嗪 10 mg；100 片防儿童开启瓶装",
        "en": "Alfuzosin hydrochloride 10 mg per tablet; 100-tablet child-resistant bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uroxatral---100-count-.jpg&setid=9fc7f119-f36b-44cf-945d-940160f3afe3&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸阿夫唑嗪",
            "en": "alfuzosin hydrochloride"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频率或与另一种 α 阻滞剂的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another alpha blocker"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "防儿童开启瓶装",
          "en": "child-resistant bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "黄色/白色/黄色三层",
          "en": "yellow/white/yellow three-layer"
        },
        "shape": {
          "zh": "圆形三层缓释片；一层白色夹在两层黄色之间",
          "en": "round three-layer extended-release tablet; one white layer between two yellow layers"
        },
        "imprint": "X10",
        "scoreStatus": "unscored_do_not_split_crush_or_chew",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_1b716f891d349535",
        "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-uroxatral-alfuzosin-10mg-30-tablet-bottle-ndc-5921220030",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uroxatral---30-counts.jpg&setid=9fc7f119-f36b-44cf-945d-940160f3afe3&type=img",
    "alt": "UROXATRAL 盐酸阿夫唑嗪 10 mg、NDC 59212-200-30、30 片瓶装的 DailyMed 官方标签面板",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前美国品牌标签（SPL v9；2024-12-05 生效）",
    "presentation": "10 mg：圆形黄色/白色/黄色三层缓释片，刻印 X10；NDC 59212-200-30，30 片防儿童开启瓶装。另有 NDC 59212-200-10 的 100 片准确包装。",
    "notice": "此图只对应美国 NDC 59212-200-30 的 10 mg、30 片瓶装，不代表 100 片包装、其他厂家、其他国家包装或实时库存，也不用于鉴定真伪。",
    "source": {
      "id": "src_1b716f891d349535",
      "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "UROXATRAL 说明书放大阅读：10 mg、缓释三层片与整瓶数量要分开看",
      "en": "UROXATRAL enlarged label: separate 10 mg per tablet, the three-layer extended-release form and bottle count"
    },
    "summary": {
      "zh": "10 mg 是每片盐酸阿夫唑嗪的标示量；30 或 100 Tablets 是整瓶数量。当前标签明确整片吞服，不得压碎、掰开或咀嚼；网页不根据毫克数计算个人片数。",
      "en": "10 mg is the labelled alfuzosin hydrochloride amount per tablet; 30 or 100 Tablets is the bottle count. The current label says to swallow the tablet whole and not crush, split or chew it; the site does not calculate an individual's tablet count from milligrams."
    },
    "checks": [
      {
        "zh": "这是一种缓释三层片。不要因吞咽困难、想减量或外观有分层就自行掰开、研碎或咀嚼；请让药师按实际药盒与现行标签核对可行处理或替代剂型。",
        "en": "This is a three-layer extended-release tablet. Do not split, crush or chew it because of swallowing difficulty, a desired reduction or its layered appearance; have a pharmacist review the actual pack and current label for handling or another suitable form."
      },
      {
        "zh": "标签提示站立性低血压、头晕与晕厥，并指出与降压药或硝酸酯同用时风险可能增加。老人、有跌倒史或使用多种心血管药者，应优先把完整药单、血压情况与实际包装交给医生或药师核对；不要自行错开或停掉一盒。",
        "en": "The label warns about postural hypotension, dizziness and syncope and notes potentially increased risk with antihypertensive medicines or nitrates. Older adults, people with falls or several cardiovascular medicines should prioritise full-list, blood-pressure and exact-pack review with a clinician or pharmacist; do not self-separate or stop a pack."
      },
      {
        "zh": "标签将酮康唑、伊曲康唑、利托那韦等强 CYP3A4 抑制剂列为禁忌联用，并提示西地那非、他达拉非等 PDE5 抑制剂可增加症状性低血压风险。网页不提供自行错开时间、减半或临时停用方案。",
        "en": "The label contraindicates potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir and warns that PDE5 inhibitors such as sildenafil or tadalafil can increase symptomatic-hypotension risk. The site provides no self-directed spacing, halving or temporary-stop plan."
      },
      {
        "zh": "准备白内障手术或其他眼科操作时，应主动告诉眼科团队现在或过去使用过 UROXATRAL/其他 α 阻滞剂。标签并不支持患者为此自行停药。",
        "en": "Before cataract surgery or another eye procedure, tell the eye team about current or previous UROXATRAL/other alpha-blocker use. The label does not support self-stopping for this reason."
      },
      {
        "zh": "出现晕厥、跌倒受伤、持续疼痛勃起或其他急性严重不适时，应优先联系当地紧急医疗服务；不要等待网页判断或自行用另一种药抵消。",
        "en": "For fainting, a fall with injury, a persistent painful erection or another acute severe problem, prioritise local emergency medical services; do not wait for a webpage decision or self-counteract with another medicine."
      }
    ],
    "source": {
      "id": "src_1b716f891d349535",
      "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "阿夫唑嗪怎样起作用：阻断下尿路的突触后 α1 肾上腺素能受体",
      "en": "How alfuzosin works: blocking post-synaptic alpha-1 adrenoceptors in the lower urinary tract"
    },
    "summary": {
      "zh": "当前标签说明，阿夫唑嗪对前列腺、膀胱底/膀胱颈、前列腺包膜与前列腺尿道的突触后 α1 受体产生拮抗作用，可使膀胱颈和前列腺平滑肌松弛，从而改善尿流和相关症状。它不缩小前列腺，也不因为会影响血压就成为降压药；机制不能决定个人是否适用。",
      "en": "The current label explains that alfuzosin antagonises post-synaptic alpha-1 receptors in the prostate, bladder base/neck, prostatic capsule and prostatic urethra, allowing bladder-neck and prostate smooth muscle to relax and improving urine flow and related symptoms. It does not shrink the prostate, nor does blood-pressure effect make it an antihypertensive; mechanism cannot determine individual suitability."
    },
    "checks": [
      {
        "zh": "UROXATRAL、FLOMAX、CARDURA、CARDURA XL、HYTRIN 与 MINIPRESS 不是同一种药。共同的 α 阻滞相关机制不建立 mg 换算、交替或叠加规则；当前 UROXATRAL 标签明确不应与其他 α 肾上腺素能拮抗剂合用。",
        "en": "UROXATRAL, FLOMAX, CARDURA, CARDURA XL, HYTRIN and MINIPRESS are not one medicine. A related alpha-blocking mechanism does not create milligram conversion, alternation or combination rules; the current UROXATRAL label says it should not be used with another alpha-adrenergic antagonist."
      },
      {
        "zh": "“改善尿流”不是诊断前列腺良性增生或排除前列腺癌的依据。相似症状需要专业检查；不要只按症状、年龄或他人经验自行开始或替换。",
        "en": "“Improves urine flow” does not diagnose benign prostatic hyperplasia or rule out prostate cancer. Similar symptoms need professional evaluation; do not self-start or substitute from symptoms, age or someone else's experience."
      },
      {
        "zh": "作用机理不能替代完整药单与个体评估。老人出现站立不稳、晕厥或跌倒，或同用降压药、硝酸酯、PDE5 抑制剂、抗真菌药或抗病毒药时，应及时核对而不是自行停换。",
        "en": "Mechanism does not replace complete-list and individual review. Unsteadiness on standing, syncope or a fall in an older adult, or co-use with antihypertensives, nitrates, PDE5 inhibitors, antifungals or antivirals requires timely review rather than self-stopping or switching."
      }
    ],
    "source": {
      "id": "src_1b716f891d349535",
      "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "UROXATRAL",
      "generic": "盐酸阿夫唑嗪缓释片",
      "dosageFormClass": "盐酸阿夫唑嗪 10 mg 口服缓释片：圆形三层片，一层白色夹在两层黄色之间，刻印 X10。当前标签明确整片吞服，不得压碎、掰开或咀嚼。"
    },
    "labelSource": {
      "id": "src_1b716f891d349535",
      "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_1b716f891d349535",
          "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        },
        "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": "2026-09-02",
        "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_249177a776aa72bb",
          "label": "DailyMed（NLM）：UROXATRAL 当前美国电子说明书 PDF（可放大阅读）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=9fc7f119-f36b-44cf-945d-940160f3afe3",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        },
        "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": "2026-09-02",
        "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_e7f55520529db924",
          "label": "FDA：UROXATRAL NDA 021287 美国历史标签档案（2014；仅作批准史补充）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        },
        "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": "2026-09-02",
        "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": "2026-09-02",
      "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": "UROXATRAL 是盐酸阿夫唑嗪 10 mg 缓释片的美国品牌档案，用于帮助读者核对良性前列腺增生相关症状场景中的准确产品。10 mg 是每片含量，30/100 Tablets 是整瓶片数，不是个人每天片数。老人或同时使用多种药物者尤其要核对站立性低血压、晕厥和跌倒、降压药/硝酸酯、PDE5 抑制剂、强 CYP3A4 抑制剂及白内障手术信息；网页不替个人决定时间、片数、联用或换药。",
    "history": "当前 DailyMed 标签列美国初始批准年份为 2003，SPL v9 于 2024-12-05 生效，展示 Advanz Pharma (US) Corp. 的 30 片与 100 片包装。FDA 2014 标签仅作为历史批准档案补充；现行安全阅读以当前 DailyMed 标签为主。FLOMAX、CARDURA/CARDURA XL 等虽可能涉及相似症状或 α 受体，却是不同成分、剂型、NDA 与说明书，不能按 mg 自行换算、轮换或叠加。",
    "sourceDocuments": [
      {
        "id": "src_1b716f891d349535",
        "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      {
        "id": "src_249177a776aa72bb",
        "label": "DailyMed（NLM）：UROXATRAL 当前美国电子说明书 PDF（可放大阅读）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=9fc7f119-f36b-44cf-945d-940160f3afe3",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      {
        "id": "src_e7f55520529db924",
        "label": "FDA：UROXATRAL NDA 021287 美国历史标签档案（2014；仅作批准史补充）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      }
    ],
    "applicationNumber": "NDA 021287",
    "approvalTimeline": [
      {
        "date": "2003",
        "title": {
          "zh": "UROXATRAL 美国初始批准",
          "en": "Initial U.S. approval of UROXATRAL"
        },
        "detail": {
          "zh": "当前 DailyMed 标签列示的初始批准年份。",
          "en": "Initial approval year stated by the current DailyMed label."
        },
        "source": {
          "id": "src_1b716f891d349535",
          "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      },
      {
        "date": "2014",
        "title": {
          "zh": "FDA 历史标签档案",
          "en": "FDA historical label archive"
        },
        "detail": {
          "zh": "保留 NDA 021287 的历史标签供批准史追溯，不替代当前标签。",
          "en": "A historical NDA 021287 label is retained for approval-history traceability and does not replace the current label."
        },
        "source": {
          "id": "src_e7f55520529db924",
          "label": "FDA：UROXATRAL NDA 021287 美国历史标签档案（2014；仅作批准史补充）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      },
      {
        "date": "2024-12-05",
        "title": {
          "zh": "当前 DailyMed SPL 生效",
          "en": "Current DailyMed SPL effective"
        },
        "detail": {
          "zh": "当前两个 Advanz Pharma 品牌瓶装、患者信息、警示与相互作用可公开阅读。",
          "en": "The two current Advanz Pharma brand bottles, patient information, warnings and interactions are publicly readable."
        },
        "source": {
          "id": "src_1b716f891d349535",
          "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "当前公开品牌标签",
          "en": "Current public brand label"
        },
        "detail": {
          "zh": "NDA 021287；10 mg 缓释片，30 片与 100 片瓶装。",
          "en": "NDA 021287; 10 mg extended-release tablets in 30- and 100-tablet bottles."
        }
      },
      {
        "market": {
          "zh": "美国以外市场",
          "en": "Markets outside the United States"
        },
        "status": {
          "zh": "本档案未确认当地商品名、包装或供应",
          "en": "Local brand, pack and supply are not established by this dossier"
        },
        "detail": {
          "zh": "当地阿夫唑嗪产品须与本地药监记录、现行说明书和手中药盒逐项核对。",
          "en": "Local alfuzosin products require item-by-item checking against the local regulator, current leaflet and pack in hand."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "10 mg 是一天吃几片吗？",
          "en": "Does 10 mg tell me how many tablets to take in a day?"
        },
        "answer": {
          "zh": "不是。10 mg 是当前准确缓释片中每片的标示量，30/100 是整瓶数量。个人片数、时间与适用性必须以实际处方、当前标签和负责团队为准，网页不会按毫克数代算。",
          "en": "No. 10 mg is the labelled amount in each exact extended-release tablet, while 30/100 is the bottle count. Individual tablet count, timing and suitability require the actual prescription, current label and responsible team; the site does not calculate them from milligrams."
        }
      },
      {
        "question": {
          "zh": "吞咽困难，可以掰半或研碎吗？",
          "en": "Can it be halved or crushed if swallowing is difficult?"
        },
        "answer": {
          "zh": "当前 UROXATRAL 标签明确整片吞服，不得压碎、掰开或咀嚼。请让药师按手中准确产品核对处理选择，不要自行破坏缓释结构。",
          "en": "The current UROXATRAL label explicitly says to swallow the tablet whole and not crush, split or chew it. Ask a pharmacist to review options for the exact product in hand; do not disrupt the extended-release structure yourself."
        }
      },
      {
        "question": {
          "zh": "与西地那非/他达拉非或降压药一起出现怎么办？",
          "en": "What if sildenafil/tadalafil or a blood-pressure medicine is on the same list?"
        },
        "answer": {
          "zh": "不要自行错开、减半或停掉任何一盒。标签提示可能叠加降低血压并引起症状性低血压；请让药师或医生用准确药名、规格、用途、血压和完整药单逐项判断。",
          "en": "Do not self-separate, halve or stop any pack. The label warns of additive blood-pressure lowering and possible symptomatic hypotension; have a pharmacist or clinician review exact names, strengths, purposes, blood pressure and the full medicine list."
        }
      },
      {
        "question": {
          "zh": "能换成 FLOMAX 或 CARDURA 吗？",
          "en": "Can it be switched to FLOMAX or CARDURA?"
        },
        "answer": {
          "zh": "不能从相似用途或共同的 α 阻滞机制作这种结论。它们的成分、剂型、强度、NDA 与说明书不同，不能按 mg 自行一比一转换、叠加或轮换。",
          "en": "That conclusion cannot be made from a similar use or related alpha-blocking mechanism. Their ingredients, dosage forms, strengths, NDAs and labels differ; do not self-convert, combine or alternate them milligram for milligram."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dose-unit-literacy",
      "same-class-is-not-same-medicine",
      "dosage-forms-are-part-of-medicine-identity"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/uroxatral-alfuzosin/",
    "en": "https://origindrug.com/en/drugs/uroxatral-alfuzosin/"
  },
  "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."
  ]
}