{ "id": "femara", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "FEMARA", "generic": "来曲唑", "aliases": [ "FEMARA", "letrozole", "来曲唑" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国：DailyMed 当前 FEMARA 公开标签（SPL v32，2026-06-11 更新）列示来曲唑 2.5 mg 口服薄膜衣片、NDC 0078-0249-15 与 30 片塑料瓶装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "来曲唑口服薄膜衣片：每片 2.5 mg（美国当前公开标签所列；30 片塑料瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "anastrozole", "阿那曲唑", "exemestane", "依西美坦", "tamoxifen", "他莫昔芬", "other letrozole package", "其他来曲唑包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-femara-letrozole-tablet-2-5mg-30-bottle-ndc-0078-0249-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v32；2026-06-11 更新）", "en": "Current U.S. DailyMed public label (SPL v32; updated 11 Jun 2026)" }, "dosageForm": { "zh": "FEMARA 来曲唑口服薄膜衣片", "en": "FEMARA letrozole film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0249-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片来曲唑 2.5 mg；30 片塑料瓶装", "en": "Letrozole 2.5 mg per tablet; 30-tablet plastic bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=femara-07.jpg&setid=82b77d74-085f-45ac-a7dd-1f5c038bf406", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "来曲唑", "en": "letrozole" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、联用、换药或调整规则", "en": "Labelled amount per tablet; not an individual's tablet count, treatment duration, co-use, switching or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "圆形、轻微双凸且带斜边薄膜衣片，约 7 mm", "en": "round, slightly biconvex, beveled film-coated tablet, about 7 mm" }, "imprint": "FV / CG", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis Pharmaceuticals；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-femara-letrozole-tablet-2-5mg-30-bottle-ndc-0078-0249-15", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=femara-07.jpg&setid=82b77d74-085f-45ac-a7dd-1f5c038bf406", "alt": "FEMARA 来曲唑 2.5 mg、NDC 0078-0249-15、30 片塑料瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v32（2026-06-11 更新）", "presentation": "FEMARA 来曲唑：每片 2.5 mg，NDC 0078-0249-15，30 片塑料瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 FEMARA、来曲唑 2.5 mg、NDC 0078-0249-15 与 30 片塑料瓶装。它只帮助核对品牌、通用名、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表其他来曲唑包装、阿那曲唑、依西美坦、他莫昔芬、其他内分泌治疗产品、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的片数、疗程、联用、换药或停药方案。", "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑 2.5 mg、30 片塑料瓶装当前美国公开标签面板（Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FEMARA／来曲唑说明书放大阅读：先认清 2.5 mg、NDC 与 30 片塑料瓶装", "en": "FEMARA label reading: identify 2.5 mg, NDC and the 30-tablet plastic bottle first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 FEMARA、来曲唑、每片 2.5 mg、准确 NDC、30 片塑料瓶装、外形与警示。它不提供个人片数、用药时间、疗程、同服、停用、换药、分片或购买方案。", "en": "This module reads only FEMARA, letrozole, 2.5 mg per tablet, the exact NDC, 30-tablet plastic bottle, appearance and warnings in the current U.S. DailyMed label. It provides no individual tablet count, timing, treatment duration, co-use, stopping, switching, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 FEMARA、来曲唑、2.5 mg、实际 NDC、30 片塑料瓶装、深黄色圆片、FV/CG 压印与目标市场。mg 是这个准确片剂每片的标示量，不是网页可计算的个人片数、疗程、与其他内分泌治疗产品换算或联用规则。", "en": "Check FEMARA, letrozole, 2.5 mg, the actual NDC, 30-tablet plastic bottle, dark-yellow round tablet, FV/CG imprint and target market together. mg is the labelled amount in that exact tablet, not a web calculation for tablet count, treatment duration, conversion to another endocrine therapy or co-use." }, { "zh": "当前标签所示片剂无刻痕；颜色、大小、圆形和压印只用于辅助核对，不能鉴定真伪，也不是自行掰开、减量或由一种包装替换另一种的指令。", "en": "The displayed current-label tablet is unscored. Colour, size, round shape and imprint are supporting checks only; they cannot authenticate a product and are not instructions to self-split, reduce use or replace one package with another." }, { "zh": "当前标签把骨密度、胆固醇、疲劳/头晕/嗜睡、肝功能和胚胎-胎儿毒性等列为需要阅读和专业核对的内容。请把实际药盒、全部处方药、非处方药、补充剂与相关检查资料交给开方团队或药师逐项核对；网页不能把这些条目变成个人的“能否继续、联用或更换”结论。", "en": "The current label identifies bone mineral density, cholesterol, fatigue/dizziness/somnolence, liver function and embryo-fetal toxicity as items for reading and professional review. Give the actual pack, all prescription medicines, OTC products, supplements and relevant test information to the prescribing team or pharmacist for item-by-item review; this page cannot turn them into an individual continue, co-use or switching decision." }, { "zh": "出现呼吸困难、面部或喉部肿胀、明显过敏样反应、胸痛、严重或令人担心的不适时，应优先使用当地医疗支持；不要通过同时停换多种药来试探原因。", "en": "With breathing difficulty, swelling of the face or throat, a marked allergy-like reaction, chest pain, or a severe or worrying symptom, prioritise local medical support; do not test the cause by stopping or changing several medicines at once." } ], "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Warnings, Precautions and Patient Counseling；Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "机制阅读：标签所述芳香化酶抑制路径，不是自行选择、替代或联用规则", "en": "Mechanism reading: the label's aromatase-inhibition pathway is not a self-selection, substitution or co-use rule" }, "summary": { "zh": "当前美国标签将来曲唑描述为芳香化酶抑制剂，并说明其降低雌激素合成。这帮助读者理解标签术语；它不能判断某人应否使用、与阿那曲唑、依西美坦或他莫昔芬如何衔接、能否同服、持续多久或是否适合。", "en": "The current U.S. label describes letrozole as an aromatase inhibitor and explains reduced estrogen synthesis. This helps readers understand label language; it cannot decide whether someone should use it, how it relates to anastrozole, exemestane or tamoxifen, whether products can be used together, duration or suitability." }, "checks": [ { "zh": "“芳香化酶抑制剂”“激素受体”或任何一个机制词，不能证明不同产品相等、可替代或可自行叠加；每个实际产品、目标市场标签和完整药单都需要单独核对。", "en": "“Aromatase inhibitor”, “hormone receptor”, or any one mechanism term does not prove that products are equal, interchangeable or suitable for self-directed combining; each actual product, target-market label and complete medicine list needs separate review." }, { "zh": "机制页不把个人诊断、病理结果、年龄、骨密度、心血管病史、肝功能、其他疾病或完整药单简化为“该不该吃、吃多久或换哪一种”的答案；已有检查或基因报告也须由专业人员结合这些资料解释。", "en": "A mechanism page does not reduce an individual's diagnosis, pathology, age, bone density, cardiovascular history, liver function, other conditions or complete medicine list to an answer about whether to use it, duration or what to change to; existing tests or genetic reports also need professional interpretation with those materials." }, { "zh": "不要把机制、包装图或 2.5 mg 数字用于处理急性症状、补用、停用、换药或联用。现实问题必须回到准确产品的现行目标市场标签和开方团队或药师。", "en": "Do not use mechanism, a package image or the 2.5 mg number to handle an acute symptom, make-up use, stopping, switching or co-use. Real questions must return to the current target-market label for the exact product and the prescribing team or pharmacist." } ], "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Clinical Pharmacology；Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "FEMARA", "generic": "来曲唑", "dosageFormClass": "来曲唑口服薄膜衣片：每片 2.5 mg（美国当前公开标签所列；30 片塑料瓶装）" }, "labelSource": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "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": "2026-08-25", "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": "2026-08-25", "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 的当前 FEMARA（letrozole）美国公开标签列示 2.5 mg 口服薄膜衣片、NDC、30 片塑料瓶装、深黄色圆片外观与 FV/CG 压印。本页帮助读者把商品名、通用名、每片标示量、准确包装、公开电子说明书和药物警戒阅读路径放在一起；不把 mg、包装数量、肿瘤诊断或“同属内分泌治疗”转换为个人片数、疗程、同服、停用、换药、替代或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 1997，更新日期为 2026-06-11。2.5 mg、NDC 0078-0249-15 与 30 片塑料瓶装共同识别所展示的准确美国产品；相近药名、同为芳香化酶抑制剂、相似黄色圆片或其他市场产品，均不能建立与阿那曲唑、依西美坦、他莫昔芬、其他来曲唑包装或其他市场产品的自行互换、合用或换算关系。", "sourceDocuments": [ { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（FEMARA；NDA 020726）", "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 020726", "approvalTimeline": [ { "date": "1997", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 FEMARA 美国公开标签列示 Initial U.S. Approval: 1997。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current U.S. FEMARA public label lists Initial U.S. Approval: 1997. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-06-11", "title": { "zh": "DailyMed 当前 SPL v32 更新日期", "en": "Current DailyMed SPL v32 updated" }, "detail": { "zh": "DailyMed 将当前 FEMARA 公开标签的 Updated 日期列为 2026-06-11，版本为 SPL v32。本页只展示 2.5 mg、NDC 0078-0249-15 与 30 片塑料瓶装面板；不建立实际在售、库存、购买、个人片数、疗程、联用、停用、换药或其他市场状态。", "en": "DailyMed lists 11 Jun 2026 as Updated for the current FEMARA public label, version SPL v32. This page only displays the 2.5 mg/NDC 0078-0249-15/30-tablet plastic-bottle panel; it does not establish actual availability, stock, purchase, individual tablet count, treatment duration, co-use, stopping, switching or another-market status." }, "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与准确 30 片塑料瓶装面板", "en": "Current public label and exact 30-tablet plastic-bottle panel linked" }, "detail": { "zh": "本页展示 FEMARA 来曲唑 2.5 mg、NDC 0078-0249-15、30 片塑料瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、疗程、开始、停用、联用、换药或可替代性。", "en": "This page displays FEMARA letrozole 2.5 mg/NDC 0078-0249-15/30-tablet plastic bottle. It does not authenticate a product or establish actual availability, stock, purchase, individual tablet count, treatment duration, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "2.5 mg 与 30 片瓶装能不能用来自己决定片数、疗程，或换到另一种内分泌治疗产品？", "en": "Can 2.5 mg and a 30-tablet bottle be used to decide my own tablet count, treatment duration or switch to another endocrine therapy product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 FEMARA 片剂和包装。相近毫克数、包装照片、共同诊断或同属内分泌治疗范围，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请开方团队或药师复核。", "en": "No. These fields only identify the exact FEMARA tablets and package in the cited U.S. label. A nearby milligram number, package photo, shared diagnosis or endocrine-therapy context does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to the prescribing team or pharmacist for review." } }, { "question": { "zh": "为什么页面提到骨密度、胆固醇、肝功能和联用药，却不告诉我是否该改药？", "en": "Why does the page mention bone density, cholesterol, liver function and co-medications without telling me whether to change medicine?" }, "answer": { "zh": "这些是当前美国标签中警示、注意事项和患者咨询段落的阅读入口，不是个体化风险判断或治疗决策。出现急性严重不适或对现行处方有担忧时，请使用当地医疗支持；开方团队或药师需要结合准确产品、病史、检查和完整药单逐项复核。", "en": "These are reading entry points for the current U.S. label's warnings, precautions and patient-counselling sections, not an individual risk assessment or treatment decision. For an acute serious concern or worry about the current prescription, use local medical support; the prescribing team or pharmacist needs the exact product, history, tests and complete medicine list for item-by-item review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/femara/", "en": "https://origindrug.com/en/drugs/femara/" }, "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." ] }