{
  "id": "elavil-amitriptyline",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-13",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "ELAVIL",
    "generic": "阿米替林盐酸盐普通口服片",
    "aliases": [
      "Elavil",
      "amitriptyline",
      "amitriptyline hydrochloride",
      "amitriptyline hydrochloride tablets",
      "阿米替林",
      "盐酸阿米替林",
      "盐酸阿米替林片",
      "ELAVIL",
      "NDA 012703",
      "ELAVIL 10 mg",
      "ELAVIL 25 mg",
      "ELAVIL 50 mg",
      "ELAVIL 75 mg",
      "ELAVIL 100 mg",
      "ELAVIL 150 mg"
    ],
    "marketBrandNames": [
      {
        "name": "ELAVIL",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "historical_regulatory_record",
        "note": {
          "zh": "NDA 012703：10/25/50/75/100/150 mg 历史单方口服片均为 RLD，当前均为 DISCN；监管历史不等于实时供应。",
          "en": "NDA 012703: historical 10/25/50/75/100/150 mg single-ingredient oral tablets are RLD entries and currently DISCN; regulatory history is not live-supply evidence."
        },
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "name": "AMITRIPTYLINE HYDROCHLORIDE",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "dated_regulatory_record",
        "note": {
          "zh": "当前可公开阅读的是 Zydus 仿制药标签；不把它改写成 ELAVIL 原品牌包装。",
          "en": "The current publicly readable source is a Zydus generic label; it is not rewritten as an original ELAVIL pack."
        },
        "source": {
          "id": "src_1738f8543d1db3f0",
          "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-13",
          "reviewedAt": "2026-09-13"
        }
      }
    ],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "精神健康",
    "sourceArchiveMarket": "FDA Orange Book 的 ELAVIL NDA 012703 记录对应 10、25、50、75、100、150 mg 历史口服片 RLD 条目，均为 DISCN，且数据记录为非因安全性或有效性撤市。当前公开阅读来源是 Zydus 的仿制药阿米替林盐酸盐薄膜衣片标签；它不是历史 ELAVIL 品牌包装、实时库存或其他市场状态。ELAVIL 的注射剂（NDA 012704）与本页口服片分开，不可混作同一产品。",
    "dosageFormClass": "阿米替林盐酸盐普通口服片。历史 ELAVIL 口服片、阿米替林注射剂、含氯氮卓的复方及其他三环类抗抑郁药在成分、剂型、规格与风险边界上均不是同一产品，不能只按名称、用途或 mg 自行换算、拼接、叠加或替换。",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "美国历史口服片批准早于 1982 年（FDA Orange Book 记录）",
    "archiveSponsorText": "AstraZeneca Pharmaceuticals LP（FDA 历史 NDA/RLD 条目申请主体）；Zydus Lifesciences Limited（当前公开仿制药标签主体）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "ELAVIL",
      "Elavil",
      "amitriptyline hydrochloride tablets",
      "盐酸阿米替林片"
    ],
    "excludedProductCues": [
      "ELAVIL injection",
      "amitriptyline injection",
      "chlordiazepoxide and amitriptyline",
      "氯氮平",
      "氯氮平与阿米替林复方",
      "other tricyclic antidepressants"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "status": "withheld_repackaged_or_non_exact_visual",
    "title": {
      "zh": "未展示 ELAVIL 外观图：历史原研与当前仿制药标签不能混作同一包装",
      "en": "ELAVIL image withheld: a historical originator and a current generic label are not one package"
    },
    "summary": {
      "zh": "本次核验保留了历史 ELAVIL 口服片的 FDA 产品身份及当前阿米替林盐酸盐仿制药公开说明书，但未保留能与历史 ELAVIL、特定规格、特定包装和公开一手来源逐一对应的准确外观图。为避免把仿制药、注射剂、其他市场、历史版本或来源不明图片误作原品牌外观，本页不展示包装图。",
      "en": "This review retains the historical FDA identity for ELAVIL oral tablets and a current public generic amitriptyline label, but no exact public image was retained that matches historical ELAVIL, one strength, one pack and a primary source one-to-one. To avoid presenting generic, injectable, other-market, historical-version or source-uncertain imagery as the originator appearance, this page shows no package image."
    },
    "source": {
      "id": "src_10e511bf83430e3b",
      "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市",
      "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_dataset",
      "documentKind": "regulatory_product_record",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-29",
      "reviewedAt": "2026-08-29"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "阿米替林说明书放大阅读：先分清历史品牌、每片 mg、嗜睡跌倒与同类药",
      "en": "Amitriptyline enlarged-label reading: first separate historical brand, mg per tablet, sedation/falls and related medicines"
    },
    "summary": {
      "zh": "ELAVIL 历史 10/25/50/75/100/150 mg 是每片阿米替林盐酸盐规格，不是个人片数，也不能与注射剂、复方、其他三环类抗抑郁药、SSRI/SNRI、镇静药或酒精按数字自行互换。当前公开说明书属于仿制药，须与手中药盒的成分、剂型、规格、市场和文件版本逐项核对。",
      "en": "Historical ELAVIL 10/25/50/75/100/150 mg figures are amitriptyline hydrochloride strengths per tablet. They are not an individual's tablet count and cannot be self-interchanged by numbers with injection, combinations, another tricyclic antidepressant, an SSRI/SNRI, sedatives or alcohol. The current public leaflet is generic and must be checked item by item against the pack in hand for ingredient, form, strength, market and document version."
    },
    "checks": [
      {
        "zh": "当前标签带有关于儿童、青少年和年轻成人自杀想法与行为风险的黑框警示。出现自伤/自杀想法、明显行为变化或紧急安全担忧时，应立即使用当地急救或危机支持；不要等待网页判断，也不要以此自行骤停、加量或换药。",
        "en": "The current label carries a boxed warning about suicidal thoughts and behaviours in children, adolescents and young adults. With self-harm/suicide thoughts, marked behaviour change or an urgent safety concern, use local emergency or crisis support immediately; do not wait for a website assessment or self-stop, increase or switch."
      },
      {
        "zh": "嗜睡、头晕、站起时不稳、视物模糊、口干、便秘或排尿困难都应按准确药盒和完整药单核对。老人、痴呆风险者、跌倒史、青光眼或排尿问题者，以及合用酒精、阿片类、苯二氮卓类、抗组胺药或其他镇静药者尤其需要专业复核。",
        "en": "Drowsiness, dizziness, unsteadiness on standing, blurred vision, dry mouth, constipation or urinary difficulty should be reviewed against the exact pack and complete medicine list. Older adults, people at dementia or fall risk, those with glaucoma or urinary problems, and people using alcohol, opioids, benzodiazepines, antihistamines or another sedative especially need professional review."
      },
      {
        "zh": "MAOI、其他影响血清素的药、曲马多、利奈唑胺、静脉亚甲蓝、某些心律药，以及影响中枢神经系统或心率节律的产品同处药单时，需要专业人员核对相互作用与心律风险。不要自行叠加、错开、轮换或用剩药替代。",
        "en": "An MAOI, another serotonergic medicine, tramadol, linezolid, intravenous methylene blue, some rhythm medicines, or a product affecting the central nervous system or cardiac rhythm on the same list requires professional interaction and rhythm-risk review. Do not self-combine, separate, alternate or substitute leftovers."
      },
      {
        "zh": "昏厥、明显心悸、抽搐、严重意识变化、呼吸困难、面唇舌喉肿胀或无法保持安全时，应立即使用当地急救服务并携带全部药盒；网页不据此决定是否停药、补服或加量。",
        "en": "Fainting, marked palpitations, seizure, severe altered awareness, breathing difficulty, face/lip/tongue/throat swelling or inability to remain safe requires local emergency services immediately with every medicine pack; the site does not decide interruption, make-up use or an increase."
      }
    ],
    "source": {
      "id": "src_1738f8543d1db3f0",
      "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-13",
      "reviewedAt": "2026-09-13"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "阿米替林怎样起作用：三环类药物的单胺再摄取与抗胆碱能影响，不等于可自行换药",
      "en": "How amitriptyline works: tricyclic monoamine-reuptake and anticholinergic effects do not make medicines self-interchangeable"
    },
    "summary": {
      "zh": "阿米替林属于三环类抗抑郁药；当前标签的药理资料可帮助理解其对单胺再摄取及其他受体作用为何会伴随嗜睡、抗胆碱能和心血管相关线索。机制只能解释药理关系，不能决定任何人适不适合、吃几片、何时使用、能否与另一种精神科或镇痛药同服。",
      "en": "Amitriptyline is a tricyclic antidepressant. Current-label pharmacology can help explain why its monoamine-reuptake and other receptor effects come with sedation, anticholinergic and cardiovascular cues. Mechanism explains a pharmacologic relationship only; it cannot decide individual suitability, tablet count, timing or co-use with another psychiatric or pain medicine."
    },
    "checks": [
      {
        "zh": "ELAVIL、NORPRAMIN、SINEQUAN、PAMELOR、TRAZODONE、CELEXA、LEXAPRO、ZOLOFT 等不是同一种药；共同涉及情绪、睡眠或疼痛问题不建立 mg 换算、轮换或叠加规则。",
        "en": "ELAVIL, NORPRAMIN, SINEQUAN, PAMELOR, TRAZODONE, CELEXA, LEXAPRO and ZOLOFT are not the same medicine. A shared relationship to mood, sleep or pain concerns does not establish milligram conversion, alternation or combination."
      },
      {
        "zh": "“有助睡眠”或“止痛”之类的日常说法不能把产品变成可随意加用的助眠药或止痛药。实际适应症、禁忌、年龄、心脏状况、其他中枢神经系统用药和当地标签必须逐项核对。",
        "en": "Everyday descriptions such as “helps sleep” or “helps pain” do not turn a product into a freely addable sleep or pain medicine. Actual indication, contraindications, age, cardiac status, other central-nervous-system medicines and the local label must be checked item by item."
      },
      {
        "zh": "基因筛查不是网页替个人选择阿米替林的默认答案。若负责团队认为药物基因、心电图、电解质、肝肾功能或其他检测会改变个人决策，应由其结合准确药品与完整临床资料解释。",
        "en": "Genetic screening is not the site's default answer for choosing amitriptyline. If the responsible team believes pharmacogenetics, ECG, electrolytes, kidney/liver function or another test may change an individual decision, that team should explain it using the exact medicine and complete clinical information."
      }
    ],
    "source": {
      "id": "src_1738f8543d1db3f0",
      "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-13",
      "reviewedAt": "2026-09-13"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "ELAVIL",
      "generic": "阿米替林盐酸盐普通口服片",
      "dosageFormClass": "阿米替林盐酸盐普通口服片。历史 ELAVIL 口服片、阿米替林注射剂、含氯氮卓的复方及其他三环类抗抑郁药在成分、剂型、规格与风险边界上均不是同一产品，不能只按名称、用途或 mg 自行换算、拼接、叠加或替换。"
    },
    "labelSource": {
      "id": "src_1738f8543d1db3f0",
      "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-13",
      "reviewedAt": "2026-09-13"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_1738f8543d1db3f0",
          "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-13",
          "reviewedAt": "2026-09-13"
        },
        "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": "2026-09-13",
        "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_10e511bf83430e3b",
          "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        },
        "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": "2026-08-29",
        "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": "2026-09-13",
      "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": "ELAVIL 是阿米替林盐酸盐普通口服片的历史美国原研档案。10、25、50、75、100、150 mg 是历史每片标签规格，不是个人片数、减量表或与其他精神科、镇痛或助眠药的换算比例。阿米替林可出现嗜睡、体位性低血压、抗胆碱能反应和心律相关风险线索；老人、跌倒风险者及多药使用者应优先让药师或开方团队核对完整药单、实际药盒、心脏病史、青光眼/排尿问题、便秘、酒精及其他中枢神经系统作用药。网页不决定个人剂量、频次、停药或换药。",
    "history": "FDA Orange Book 记录 ELAVIL NDA 012703 的六个单方口服片 RLD 条目均在 1982 年前获批，当前均为 DISCN，并注明未因安全性或有效性撤市。当前公开说明书为仿制药阿米替林盐酸盐片，帮助阅读当前类别与安全边界；本站不把它当作历史 ELAVIL 品牌外观、包装或供应证明。",
    "sourceDocuments": [
      {
        "id": "src_10e511bf83430e3b",
        "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市",
        "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_dataset",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      {
        "id": "src_1738f8543d1db3f0",
        "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-13",
        "reviewedAt": "2026-09-13"
      }
    ],
    "applicationNumber": "NDA 012703（ELAVIL 历史美国单方口服片）；当前公开仿制药标签：DailyMed SETID 4159b10e-f589-486c-969d-9b4544b098b5",
    "approvalTimeline": [
      {
        "date": "1981-12-31",
        "title": {
          "zh": "历史口服片批准时间仅记录为“1982 年前”",
          "en": "Historical oral-tablet approval is recorded only as “prior to 1982”"
        },
        "detail": {
          "zh": "FDA Orange Book 的 NDA 012703 口服片条目使用“Approved Prior to Jan 1, 1982”字段。本站不从该字段虚构具体批准日。",
          "en": "FDA Orange Book oral-tablet entries under NDA 012703 use the field “Approved Prior to Jan 1, 1982.” The site does not invent a specific approval date from that field."
        },
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "date": "2025-10-04",
        "title": {
          "zh": "当前公开仿制药说明书更新",
          "en": "Current public generic label updated"
        },
        "detail": {
          "zh": "Zydus 阿米替林盐酸盐薄膜衣片说明书用于阅读当前类别与安全边界，不替代历史 ELAVIL 包装资料。",
          "en": "The Zydus amitriptyline hydrochloride film-coated-tablet label supports reading current class and safety boundaries; it does not replace historical ELAVIL pack evidence."
        },
        "source": {
          "id": "src_1738f8543d1db3f0",
          "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-13",
          "reviewedAt": "2026-09-13"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "历史 RLD；当前 DISCN",
          "en": "Historical RLD; currently DISCN"
        },
        "detail": {
          "zh": "ELAVIL 10/25/50/75/100/150 mg 口服片的 FDA 历史 RLD 条目均列为 DISCN，且记录为非因安全性或有效性撤市；不代表实时供应。",
          "en": "FDA historical RLD entries for ELAVIL 10/25/50/75/100/150 mg oral tablets are all DISCN and not withdrawn for safety or effectiveness; this is not live-supply evidence."
        }
      },
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "当前公开仿制药标签",
          "en": "Current public generic label"
        },
        "detail": {
          "zh": "公开说明书为 Zydus 阿米替林盐酸盐薄膜衣片；必须按实际包装、NDC 与标签版本确认。",
          "en": "The public leaflet is for Zydus amitriptyline hydrochloride film-coated tablets and must be checked against the actual pack, NDC and label version."
        }
      },
      {
        "market": {
          "zh": "美国以外市场",
          "en": "Markets outside the United States"
        },
        "status": {
          "zh": "当地商品名、批准、包装和供应未由本档案确认",
          "en": "Local brand, approval, pack and supply are not established by this dossier"
        },
        "detail": {
          "zh": "不从美国历史 RLD 或仿制药标签外推其他市场状态。",
          "en": "No other-market status is inferred from the U.S. historical RLD or generic label."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "ELAVIL 的 10/25/50/75/100/150 mg 是否等于我该吃几片？",
          "en": "Do historical ELAVIL 10/25/50/75/100/150 mg strengths tell me how many tablets to take?"
        },
        "answer": {
          "zh": "不等于。它们只是历史产品的每片规格。个人片数、频次、年龄、心脏风险、合并用药和任何调整必须由开方团队依据实际药盒、处方、检查结果与完整药单决定。",
          "en": "No. They are only per-tablet strengths for historical products. Individual tablet counts, frequency, age, cardiac risk, co-medications and any adjustment must be decided by the prescribing team using the actual pack, prescription, test results and complete medicine list."
        }
      },
      {
        "question": {
          "zh": "ELAVIL 与阿米替林注射剂或含氯氮卓的复方是一回事吗？",
          "en": "Are ELAVIL, amitriptyline injection and a chlordiazepoxide combination the same product?"
        },
        "answer": {
          "zh": "不是。历史 ELAVIL 本页只限单方口服片；注射剂的给药途径不同，复方另含其他活性成分。共同药名不能作为自行替换、叠加或换算依据。",
          "en": "No. This historical ELAVIL page is limited to single-ingredient oral tablets; injection has a different route and a combination contains another active ingredient. A shared medicine name is not a basis for self-substitution, combination or conversion."
        }
      },
      {
        "question": {
          "zh": "老人服用后出现困倦、混乱、站不稳或跌倒怎么办？",
          "en": "What if an older adult develops drowsiness, confusion, unsteadiness or a fall?"
        },
        "answer": {
          "zh": "及时联系当地医疗服务，并带上全部药盒和完整药单。网页不能判断具体原因，也不要自行骤停或补服；若有昏厥、抽搐、严重意识变化、呼吸困难或无法保持安全，应立即使用当地急救服务。",
          "en": "Contact local medical services promptly and take every medicine pack and the complete list. The site cannot determine the cause, and the medicine should not be abruptly self-stopped or made up. Fainting, seizure, severe altered awareness, breathing difficulty or inability to remain safe requires local emergency services immediately."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "same-class-is-not-same-medicine",
      "interactions-are-not-a-home-scheduling-problem",
      "dosage-forms-are-part-of-medicine-identity"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/elavil-amitriptyline/",
    "en": "https://origindrug.com/en/drugs/elavil-amitriptyline/"
  },
  "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."
  ]
}