{ "id": "lumigan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Lumigan", "generic": "比马前列素", "aliases": [ "bimatoprost" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "卢美根®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_210742865baabc7a", "label": "国家人口健康科学数据中心药学数据中心：贝美前列素滴眼液／卢美根历史注册资料", "url": "https://pharm.ncmi.cn/zysjk/ypjkyp/202312/t20231205_398786.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "眼科健康", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（SPL v19，2026-07-28 发布；本档案精确展示 0.01% 纸盒面板）", "dosageFormClass": "眼用滴眼液：0.01%（0.1 mg/mL）；本档案精确展示 5 mL fill in 10 mL container（NDC 0023-3205-05）", "dosageFormClassCode": "other", "route": "眼用", "routeCode": "other", "historicalApprovalEntry": "2010-08-31（LUMIGAN 0.01% FDA NDA 022184 原始申请批准）", "archiveSponsorText": "Allergan / AbbVie；DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lumigan-bimatoprost-001pct-5ml-ndc-0023-3205-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19（2026-07-28 发布）", "en": "DailyMed SPL v19 (published 28 Jul 2026)" }, "dosageForm": { "zh": "LUMIGAN 比马前列素眼用滴眼液", "en": "LUMIGAN bimatoprost ophthalmic solution" }, "route": { "zh": "眼用", "en": "ophthalmic" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 0023-3205-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "0.01%（0.1 mg/mL）；10 mL 瓶内实装 5 mL", "en": "0.01% (0.1 mg/mL); 5 mL fill in a 10 mL container" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631&name=lumigan-01-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "比马前列素", "en": "bimatoprost" }, "value": 0.1, "unit": "mg/mL", "basisCode": "per_mL", "basisLabel": { "zh": "标签浓度；不是个人滴数", "en": "labelled concentration; not an individual drop count" } } ], "concentration": null, "container": { "typeCode": "dropper_bottle", "typeLabel": { "zh": "10 mL 滴眼瓶", "en": "10 mL dropper bottle" }, "fill": { "value": 5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 0.01%、5 mL、NDC 0023-3205-05 当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631&name=lumigan-01-03.jpg", "alt": "LUMIGAN 比马前列素 0.01%（0.1 mg/mL）、NDC 0023-3205-05、5 mL fill in 10 mL container 的美国 DailyMed 公开标签纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v19（2026-07-28 发布）", "presentation": "LUMIGAN 眼用滴眼液：0.01%（0.1 mg/mL）；NDC 0023-3205-05；5 mL fill in a 10 mL container；精确美国公开纸盒面板。", "notice": "此图是 Allergan / AbbVie 的美国 DailyMed SPL v19 公开纸盒面板，仅对应 LUMIGAN、比马前列素 0.01%（0.1 mg/mL）、NDC 0023-3205-05 与 5 mL fill in a 10 mL container；不用于鉴定真伪。它不代表其他 NDC、其他容量、其他市场、当前可得性、原研身份、可替代性或任何个人滴数、储存、联用、漏用或转换方案。", "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 当前美国公开标签与精确 5 mL 纸盒面板（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LUMIGAN 说明书放大阅读：0.01%、0.1 mg/mL 与 5 mL 是不同身份字段", "en": "LUMIGAN label reading: 0.01%, 0.1 mg/mL and 5 mL are different identity fields" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 LUMIGAN、比马前列素、0.01%/0.1 mg/mL、精确 5 mL 容器面板和眼用剂型。它不提供任何人的滴数、时间、漏用处理、联用、转换或眼压处理方案。", "en": "This module uses the U.S. DailyMed public label to check LUMIGAN, bimatoprost, 0.01%/0.1 mg/mL, the exact 5 mL container panel and ophthalmic use. It does not provide an individual's drop count, timing, missed-use handling, combination, switching or eye-pressure-management plan." }, "checks": [ { "zh": "0.01% 与 0.1 mg/mL 是同一滴眼液浓度的两种标签写法；5 mL 是该精确面板所示容器的填充量，10 mL 是容器标示容量。它们用于确认产品，不是网页给任何人计算应滴几滴、能用多久或能否补用的答案。", "en": "0.01% and 0.1 mg/mL are two label formats for the concentration of this eye-drop solution; 5 mL is the fill volume of this exact panel and 10 mL is the stated container size. They help identify the product, not calculate how many drops anyone should use, how long it lasts or whether to make up use." }, { "zh": "眼用滴眼液不能仅因都写有“青光眼”“眼压”或“前列腺素”而自行混用、轮换或替代。标签对其他前列腺素类眼用产品、其他滴眼液和隐形眼镜有特定核对事项；应带实际药瓶和完整眼用/全身药单请眼科医生或药师核对。", "en": "Eye drops cannot be self-combined, alternated or substituted merely because they mention glaucoma, eye pressure or prostaglandins. The label has product-specific checks involving other prostaglandin eye products, other drops and contact lenses; have an ophthalmologist or pharmacist review the actual bottles and complete eye/systemic medicine list." }, { "zh": "包装图、NDC、填充量和容器容量只帮助比对来源，不能验证真伪、确认另一种比马前列素包装，或确认当前储存与使用要求。任何开封、储存、与其他滴眼液间隔、隐形眼镜或漏用问题，都必须按手上准确产品的现行标签和专业人员说明处理。", "en": "The package image, NDC, fill volume and container size only help compare a source. They cannot authenticate a product, identify another bimatoprost package or confirm current storage and handling requirements. Any opening, storage, spacing from another eye drop, contact-lens or missed-use question must follow the current label and professional instructions for the exact product in hand." }, { "zh": "标签列有虹膜、眼睑/睫毛变化、眼内炎症、黄斑水肿与细菌性角膜炎等警示。出现视力变化、明显眼痛、红肿、外伤或任何急性眼部问题时，应及时使用当地眼科或紧急医疗渠道；网页不判断是否自行继续、暂停或换药。", "en": "The label includes warnings about iris, eyelid/eyelash changes, intraocular inflammation, macular oedema and bacterial keratitis. With vision change, marked eye pain, redness/swelling, injury or another acute eye concern, use local ophthalmic or urgent-care pathways promptly; this page does not decide self-continuation, pause or switching." } ], "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "比马前列素怎样起作用：标签描述其与房水外流路径有关", "en": "How bimatoprost works: the label describes an association with aqueous-humour outflow pathways" }, "summary": { "zh": "DailyMed 标签将比马前列素描述为具有降低眼内压活性的前列酰胺结构类似物，并说明其被认为与经小梁网和葡萄膜巩膜路径增加房水外流有关。该机制帮助理解药理路径，不判断任何人的眼压原因、是否适用、滴数、联用或转换方案。", "en": "The DailyMed label describes bimatoprost as a structural prostamide analogue with ocular-hypotensive activity and states that it is believed to increase aqueous-humour outflow through trabecular-meshwork and uveoscleral pathways. This explains a pharmacologic pathway; it does not determine anyone's cause of eye pressure, suitability, drop count, combination or switching plan." }, "checks": [ { "zh": "“与房水外流有关”解释的是药理路径，不是凭症状、一次眼压数值或药瓶外观判断是否需要用药的依据。青光眼和高眼压相关评估仍需要眼科检查、现行标签和专业人员判断。", "en": "“Associated with aqueous-humour outflow” explains a pharmacologic pathway, not a basis for deciding a need for treatment from symptoms, one pressure value or bottle appearance. Glaucoma and ocular-hypertension assessment still requires an eye examination, the current label and professional judgement." }, { "zh": "共同属于前列腺素或相关眼用产品，不使 LUMIGAN 与另一种滴眼液可自行叠加、轮换、替换或按浓度换算。完整眼用和全身药单、实际产品、既往眼部反应与检查计划都应一起交由专业人员核对。", "en": "A shared prostaglandin-related eye-product description does not make LUMIGAN self-combinable, alternatable, substitutable or concentration-convertible with another drop. The complete eye/systemic medicine list, actual products, prior eye reactions and examination plan need professional review together." }, { "zh": "机制页面不能把“降低眼压”转换成对视物模糊、疼痛、发红、手术前后或突然视力变化的个人处理方案。遇到急性或严重眼部问题，应优先联系当地眼科与紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page cannot turn “lowers eye pressure” into personal management for blurred vision, pain, redness, before/after procedures or sudden vision change. With an acute or serious eye concern, prioritise local ophthalmic and urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Clinical Pharmacology；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lumigan", "generic": "比马前列素", "dosageFormClass": "眼用滴眼液：0.01%（0.1 mg/mL）；本档案精确展示 5 mL fill in 10 mL container（NDC 0023-3205-05）" }, "labelSource": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LUMIGAN（bimatoprost）美国公开标签将其列为 0.01%（0.1 mg/mL）眼用滴眼液。此页帮助把品牌、通用名、浓度、精确容器面板、眼用剂型和目标市场一起核对；不据此生成个人滴数、时间、漏用处理、联用、转换或眼压处理方案。", "history": "本页的精确 0.01% 面板对应 FDA NDA 022184（原始申请于 2010-08-31 获批）。FDA 的 NDA 021275 则对应 0.03% 的 2001 历史记录，不能以品牌或通用名把两种浓度、批准记录或包装自动合并。此处建立的是美国公开标签阅读入口，不能据此推定中国大陆或其他市场的当前批准、持有人、可获得性、价格、原研/仿制关系或可售资格。", "sourceDocuments": [ { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d40822b50afd9241", "label": "FDA：LUMIGAN 0.01% NDA 022184 原始申请批准函（2010-08-31）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_3545e9938960e517", "label": "FDA：LUMIGAN 0.03% NDA 021275 历史审批行政资料（2001；不代表本页 0.01% 面板）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan%200.03%20percent%20Opthalmis%20Solution_admindocs.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022184 (0.01% current label panel)", "approvalTimeline": [ { "date": "2001-03-16", "title": { "zh": "LUMIGAN 0.03% 的历史原始批准", "en": "Historical original approval for LUMIGAN 0.03%" }, "detail": { "zh": "FDA Drugs@FDA 记录 NDA 021275 的 0.03% 原始申请于 2001-03-16 获批。该节点仅用于说明它与本页 0.01% 面板不同，不能把两种浓度或包装自动合并。", "en": "FDA Drugs@FDA records approval of the original 0.03% application, NDA 021275, on 16 Mar 2001. This node only distinguishes it from the 0.01% panel on this page; it does not merge the concentrations or packages." }, "source": { "id": "src_3545e9938960e517", "label": "FDA: LUMIGAN 0.03% NDA 021275 historical approval materials (2001)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan%200.03%20percent%20Opthalmis%20Solution_admindocs.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2010-08-31", "title": { "zh": "LUMIGAN 0.01% NDA 022184 原始申请批准", "en": "LUMIGAN 0.01% NDA 022184 original application approval" }, "detail": { "zh": "FDA Drugs@FDA 公开记录将 0.01% 的原始申请（ORIG 1）标为 2010-08-31 获批；这是本页精确 0.01% 面板对应的监管节点。", "en": "The FDA Drugs@FDA public record lists original application ORIG 1 for 0.01% as approved on 31 Aug 2010; this is the regulatory node for the exact 0.01% panel on this page." }, "source": { "id": "src_d40822b50afd9241", "label": "FDA: LUMIGAN 0.01% NDA 022184 original approval letter (2010-08-31)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-07-28", "title": { "zh": "DailyMed 当前 SPL v19 公开", "en": "Current SPL v19 published on DailyMed" }, "detail": { "zh": "DailyMed 将当前 LUMIGAN SPL v19 的 Published Date 列为 2026-07-28；该公开日期不代表实际在售、库存或其他市场状态。", "en": "DailyMed lists 28 Jul 2026 as the Published Date for current LUMIGAN SPL v19; it does not establish actual marketing, stock or another-market status." }, "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed: current LUMIGAN 0.01% public label, SPL v19", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lumigan/", "en": "https://origindrug.com/en/drugs/lumigan/" }, "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." ] }