{ "id": "xalatan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Xalatan", "generic": "拉坦前列素", "aliases": [ "latanoprost" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "眼科健康", "sourceArchiveMarket": "美国 XALATAN 公开标签（2023-05-15 生效；DailyMed SPL v2 于 2024-10-25 发布）", "dosageFormClass": "眼用滴眼液：0.005%（50 mcg/mL）；本档案精确展示 NDC 58151-419-35、125 mcg/2.5 mL、一支 2.5 mL 瓶装", "dosageFormClassCode": "other", "route": "眼用", "routeCode": "other", "historicalApprovalEntry": "1996（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Viatris Specialty LLC / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "XALATAN 5 mL", "XALATAN 0.005% 5 mL", "latanoprost 0.005% 5 mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xalatan-latanoprost-ophthalmic-solution-0-005pct-58151-419-35", "marketCode": "US", "labelVersion": { "zh": "2023-05-15 生效；DailyMed SPL v2 于 2024-10-25 发布", "en": "effective 15 May 2023; DailyMed SPL v2 published 25 Oct 2024" }, "dosageForm": { "zh": "拉坦前列素眼用滴眼液", "en": "latanoprost ophthalmic solution" }, "route": { "zh": "眼用（仅作标签产品身份字段）", "en": "ophthalmic use (label product-identity field only)" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 58151-419-35", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.005%（50 mcg/mL）；125 mcg/2.5 mL；1 支 2.5 mL 瓶装", "en": "0.005% (50 mcg/mL); 125 mcg/2.5 mL; one 2.5 mL bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&name=image-02.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉坦前列素", "en": "latanoprost" }, "value": 50, "unit": "mcg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人滴数、频次或换算指令", "en": "labelled concentration; not an individual drop count, frequency or conversion instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "50 mcg/mL (0.005%)", "numerator": { "value": 50, "unit": "mcg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "50 mcg/mL（0.005%；标签浓度）", "en": "50 mcg/mL (0.005%; labelled concentration)" } }, "container": { "typeCode": "dropper_bottle", "typeLabel": { "zh": "滴眼液瓶", "en": "ophthalmic dropper bottle" }, "fill": { "value": 2.5, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支 2.5 mL 瓶装/盒", "en": "2.5 mL bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8cc23d9dd2569529", "label": "DailyMed（NLM）：XALATAN 拉坦前列素当前美国公开标签与精确 2.5 mL 纸盒面板（Viatris Specialty LLC；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&version=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-xalatan-latanoprost-ophthalmic-solution-0-005pct-58151-419-35", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&name=image-02.jpg", "alt": "XALATAN 拉坦前列素 0.005%（50 mcg/mL）、NDC 58151-419-35、2.5 mL 瓶装的美国 DailyMed 公开标签纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v2（2024-10-25 发布）", "presentation": "XALATAN 眼用滴眼液：0.005%（50 mcg/mL）；NDC 58151-419-35；125 mcg/2.5 mL；一支 2.5 mL 瓶装纸盒面板。", "notice": "此图是 Viatris Specialty LLC 的美国 DailyMed SPL v2 公开纸盒面板，仅对应 0.005%（50 mcg/mL）、NDC 58151-419-35、125 mcg/2.5 mL 和一支 2.5 mL 瓶装；不用于鉴定真伪。它不代表 Pfizer 2022 标签档案、另一拉坦前列素包装、其他市场、其他浓度或任何个人滴数、储存、联用、漏用或转换方案。", "source": { "id": "src_8cc23d9dd2569529", "label": "DailyMed（NLM）：XALATAN 当前美国公开标签与精确 2.5 mL 纸盒面板（Viatris Specialty LLC；SPL v2，2024-10-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&version=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XALATAN 说明书放大阅读：0.005%、50 mcg/mL、2.5 mL 是不同身份字段", "en": "XALATAN label reading: 0.005%, 50 mcg/mL and 2.5 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 XALATAN、拉坦前列素、0.005%/50 mcg/mL、2.5 mL 瓶装和眼用剂型。它不提供任何人的滴数、用药时间、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 XALATAN, latanoprost, 0.005%/50 mcg/mL, a 2.5 mL bottle 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": "0.005% 与 50 mcg/mL 是同一滴眼液浓度的两种标签写法；2.5 mL 是该瓶的标示容量。它们用于确认准确产品，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": "0.005% and 50 mcg/mL are two label formats for the concentration of this eye-drop solution; 2.5 mL is the stated bottle volume. They help identify the exact 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“滴眼液”而自行混用、轮换或替代。该标签对与其他前列腺素类眼用产品、其他滴眼液和隐形眼镜有具体核对事项；应带实际药瓶和完整眼用/全身用药清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 eye drops. This label has 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": "滴眼液瓶、盖子、容量和标签图只帮助识别来源，不能验证真伪、确认是否为另一种拉坦前列素包装，或确认当前储存与使用要求。打开、储存、与其他滴眼液间隔、隐形眼镜及任何漏用问题，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": "A dropper bottle, cap, volume and label image only help identify a source. They cannot authenticate a product, show that it is another latanoprost presentation or confirm current storage and handling requirements. Opening, storage, spacing from another eye drop, contact lenses and missed-use questions must follow the current label and professional instructions for the exact product in hand." }, { "zh": "标签列有虹膜、眼周组织/睫毛变化、眼内炎症、黄斑水肿及感染等警示。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, periocular tissue/eyelash changes, intraocular inflammation, macular oedema and infection. 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_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "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": "拉坦前列素怎样起作用：标签将其归为前列腺素 F2α 类似物", "en": "How latanoprost works: the label classifies it as a prostaglandin F2α analogue" }, "summary": { "zh": "DailyMed 标签将 XALATAN 描述为前列腺素 F2α 类似物，用于降低开角型青光眼或高眼压患者升高的眼内压。这解释标签中的药理类别与用途边界，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 XALATAN as a prostaglandin F2α analogue for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. This explains a class and labelled-use boundary; it does not determine anyone's cause of eye pressure, suitability, drop count, combination or switching plan." }, "checks": [ { "zh": "“前列腺素 F2α 类似物”是药理类别，不是凭症状、一次眼压值或眼药水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": "“Prostaglandin F2α analogue” is a pharmacologic class, not a basis for deciding a need for treatment from symptoms, one pressure reading or eye-drop appearance. Glaucoma and ocular-hypertension assessment still requires an eye examination, the current label and professional judgement." }, { "zh": "共同属于前列腺素相关眼用产品，不使 XALATAN 与另一种同类滴眼液可自行叠加、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 class does not make XALATAN self-combinable, alternatable, substitutable or concentration-convertible with another related 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_d6d95eb61be4fd6a", "label": "FDA：XALATAN 2022 美国处方信息（NDA 020597）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Xalatan", "generic": "拉坦前列素", "dosageFormClass": "眼用滴眼液：0.005%（50 mcg/mL）；本档案精确展示 NDC 58151-419-35、125 mcg/2.5 mL、一支 2.5 mL 瓶装" }, "labelSource": { "id": "src_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "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_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d6d95eb61be4fd6a", "label": "FDA：XALATAN 2022 美国处方信息（NDA 020597）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "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": "本页精确建立美国 XALATAN（latanoprost）0.005%（50 mcg/mL）、NDC 58151-419-35、125 mcg/2.5 mL、一支 2.5 mL 瓶装的标签阅读身份。浓度、瓶内标示总量和容器容量是不同字段；不得据此自行计算滴数、使用频次、储存、联用、转换或眼压处理方案。", "history": "本档案链接的 DailyMed 页面是美国公开标签阅读入口，页面所列包装商为 Viatris Specialty LLC。标签版本、包装、冷藏/储存文字和眼用操作要求都只对应所引产品；不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_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "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_d6d95eb61be4fd6a", "label": "FDA：XALATAN 2022 美国处方信息（NDA 020597）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_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 020597", "approvalTimeline": [ { "date": "1996", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1996。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1996. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5cc92379c2974805", "label": "DailyMed: XALATAN public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "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" } }, { "date": "2022-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2022-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5cc92379c2974805", "label": "DailyMed: XALATAN public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "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/xalatan/", "en": "https://origindrug.com/en/drugs/xalatan/" }, "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." ] }