{ "id": "fosamax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Fosamax", "generic": "阿仑膦酸钠", "aliases": [ "alendronate", "alendronate sodium" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "骨骼健康", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v10，2026-03-12 生效；不代表供应）", "dosageFormClass": "口服片剂及口服溶液（当前美国公开标签所列；本页精确包装卡仅为 70 mg、4 片单元用量泡罩包装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（DailyMed 当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Organon LLC / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-fosamax-alendronate-sodium-tablet-70mg-4-blister-ndc-78206-135-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v10（2026-03-12 生效）", "en": "DailyMed SPL v10 (effective 12 Mar 2026)" }, "dosageForm": { "zh": "FOSAMAX 阿仑膦酸钠口服片", "en": "FOSAMAX alendronate sodium oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-135-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿仑膦酸钠 70 mg；4 片单元用量泡罩包装", "en": "Alendronate sodium 70 mg per tablet; unit-of-use blister pack of 4" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56&type=img&name=fosamax-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿仑膦酸钠", "en": "alendronate sodium" }, "value": 70, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或漏用处理", "en": "labelled amount per tablet; not an individual's tablet count, frequency or missed-use action" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_blister_pack", "typeLabel": { "zh": "单元用量泡罩包装", "en": "unit-of-use blister package" }, "fill": null, "countPerPackage": 4, "countUnit": { "zh": "片/泡罩包装", "en": "tablets per blister package" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "片/单元用量泡罩包装", "en": "tablets per unit-of-use blister package" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形未包衣片", "en": "oval uncoated tablet" }, "imprint": "31 / bone outline", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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-fosamax-alendronate-sodium-tablet-70mg-4-blister-ndc-78206-135-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56&type=img&name=fosamax-08.jpg", "alt": "FOSAMAX 阿仑膦酸钠在美国 DailyMed 当前公开标签中的 70 mg、NDC 78206-135-01、4 片单元用量泡罩包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v10（2026-03-12 生效）", "presentation": "FOSAMAX 阿仑膦酸钠：每片 70 mg，NDC 78206-135-01，4 片单元用量泡罩包装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 FOSAMAX、阿仑膦酸钠 70 mg、NDC 78206-135-01 与 4 片单元用量泡罩包装。它只帮助核对品牌、通用名、每片标示量、剂型、包装数量、外观线索和来源；不用于鉴定真伪，也不证明其他强度、口服溶液、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、频率、漏用处理、开始、停用或换药方案。", "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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": "FOSAMAX 说明书放大阅读：70 mg、4 片包装先是这一个产品的身份", "en": "FOSAMAX label reading: 70 mg and four tablets first identify this one product presentation" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 FOSAMAX、阿仑膦酸钠、70 mg 口服片、NDC 78206-135-01、4 片单元用量泡罩包装与目标市场。它不把这些标签文字转换为个人治疗、片数、频率、漏用处理、分片或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check FOSAMAX, alendronate sodium, a 70 mg oral tablet, NDC 78206-135-01, the four-tablet unit-of-use blister pack and target market. It does not turn label wording into an individual's treatment, tablet-count, frequency, missed-use, splitting or switching plan." }, "checks": [ { "zh": "先把商品名 FOSAMAX、通用名阿仑膦酸钠、口服片、每片 70 mg、NDC 78206-135-01、4 片单元用量泡罩包装与目标市场一起核对。70 mg 与“4 片”是这一张官方标签卡的身份字段，不是网页给任何人计算片数、频率或疗程的答案。", "en": "Check FOSAMAX, alendronate sodium, oral-tablet form, 70 mg per tablet, NDC 78206-135-01, the four-tablet unit-of-use blister pack and target market together. 70 mg and “four tablets” are identity fields for this official label card, not a web answer to anyone's tablet count, frequency or course." }, { "zh": "当前标签还提及口服溶液，但本档案没有为它建立精确包装卡。共同品牌或通用名不使片剂、口服溶液、其他强度或另一市场的产品可按片数、毫升数或经验自行换算、替换或叠加。", "en": "The current label also mentions oral solution, but this dossier does not establish an exact package card for it. A shared brand or generic name does not make tablets, oral solution, other strengths or another-market products self-convertible, substitutable or combinable by tablet count, millilitres or experience." }, { "zh": "该美国标签对吞服、饮水、进食/其他药物间隔和保持直立有产品特定要求。若吞咽困难、无法按标签姿势操作，或正在同时使用多种药物，应先请药师或开方团队核对，不要从网页自行改用、掰开或改时间。", "en": "This U.S. label has product-specific instructions about swallowing, water, spacing from food/other medicines and remaining upright. With swallowing difficulty, inability to follow those positioning instructions, or multiple medicines, ask a pharmacist or prescriber before self-switching, splitting or changing timing from a webpage." }, { "zh": "出现吞咽或胸部不适、明显胃肠道症状、牙科/手术计划或其他新的健康问题时，带上实际包装和完整药单联系专业人员；本页不判断是否应继续、暂停或更换。", "en": "With swallowing or chest discomfort, significant gastrointestinal symptoms, a dental/procedure plan or another new health issue, bring the actual pack and complete medicine list to a professional; this page does not decide whether to continue, pause or change." } ], "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿仑膦酸钠怎样起作用：它在骨吸收部位影响破骨细胞活动", "en": "How alendronate works: it affects osteoclast activity at sites of bone resorption" }, "summary": { "zh": "DailyMed 当前公开标签说明阿仑膦酸钠会与骨的羟基磷灰石结合，并在骨吸收部位抑制破骨细胞活动和骨吸收。骨吸收与骨形成相互关联；这段机制不能推断个人骨折风险、检查结果或继续、暂停与更换治疗的决定。", "en": "The current DailyMed public label explains that alendronate binds bone hydroxyapatite and inhibits osteoclast activity and bone resorption at resorption sites. Bone resorption and bone formation are linked; this mechanism cannot infer an individual's fracture risk, test result or a decision to continue, pause or change treatment." }, "checks": [ { "zh": "“影响破骨细胞”描述的是骨重塑中的一条路径，不是个人骨密度、骨折风险或治疗效果的网页结论。检查结果和治疗选择需要由专业人员结合完整情况解释。", "en": "“Affecting osteoclasts” describes one pathway in bone remodelling; it is not a webpage conclusion about an individual's bone density, fracture risk or treatment response. Test results and treatment choices need professional interpretation in full context." }, { "zh": "共同机制不使 70 mg 片、口服溶液、其他强度或另一市场产品可自行互换。强度、剂型、频率和现行处方必须作为完整产品信息分别核对。", "en": "A shared mechanism does not make the 70 mg tablet, oral solution, another strength or another-market product self-interchangeable. Strength, dosage form, frequency and the current prescription must be checked as complete product information." }, { "zh": "吞服姿势、饮水、空腹及与其他药物的间隔是标签和实际产品层面的要求，不能由机制反推。吞咽困难、无法按标签操作或需调整任何药物时，请先请药师或开方团队核对。", "en": "Swallowing position, water, fasting and spacing from other medicines are requirements of the label and actual product; they cannot be inferred from mechanism. With swallowing difficulty, inability to follow the label or a need to adjust any medicine, ask a pharmacist or prescriber first." } ], "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（临床药理；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Fosamax", "generic": "阿仑膦酸钠", "dosageFormClass": "口服片剂及口服溶液（当前美国公开标签所列；本页精确包装卡仅为 70 mg、4 片单元用量泡罩包装）" }, "labelSource": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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" }, "productRoutes": [ { "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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" }, "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 的当前 FOSAMAX（alendronate sodium）美国公开标签列示口服片剂与口服溶液，并标注美国初始批准年份为 1995。本页只展示已逐项核对的 70 mg、4 片单元用量泡罩包装身份；它不据此推定其他强度、口服溶液、其他市场的当前批准、包装、供应、原研关系或可售资格。", "history": "骨骼健康相关药品也必须将品牌、通用名、剂型、标示强度、目标市场和标签版本一起核对。即使同为 FOSAMAX 或阿仑膦酸钠，70 mg 泡罩包装的资料也不能代替其他强度、口服溶液或另一市场产品的现行标签。", "sourceDocuments": [ { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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" }, { "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 020560", "approvalTimeline": [ { "date": "1995", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "DailyMed 当前 FOSAMAX 公开标签列示 Initial U.S. Approval: 1995。该年份不代表当前包装、供应、持有人、其他市场状态或个人适用性。", "en": "The current DailyMed FOSAMAX public label lists Initial U.S. Approval: 1995. This year does not establish the current package, supply, holder, another-market status or individual suitability." }, "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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" } }, { "date": "2026-03-12", "title": { "zh": "当前美国公开标签生效", "en": "Current U.S. public label effective" }, "detail": { "zh": "DailyMed 产品页列示 FOSAMAX SPL v10 的生效日期为 2026-03-12。本页的精确包装图仅对应同一来源中 70 mg、NDC 78206-135-01 的 4 片单元用量泡罩包装。", "en": "The DailyMed product page lists an effective date of 12 Mar 2026 for FOSAMAX SPL v10. The exact package image on this page corresponds only to the same source's 70 mg, NDC 78206-135-01, four-tablet unit-of-use blister pack." }, "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个精确 70 mg、4 片泡罩包装面板", "en": "Current public label and one exact 70 mg four-tablet blister panel linked" }, "detail": { "zh": "该图只对应 NDC 78206-135-01；不建立其他强度、口服溶液、其他包装、实际供应或其他市场结论。", "en": "The image corresponds only to NDC 78206-135-01; it does not establish another strength, oral solution, another package, actual supply or another-market status." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国当前标签推定其他市场的商品名、批准、包装、供应、原研关系或可替代性。", "en": "No other-market trade name, approval, package, supply, originator relationship or interchangeability is inferred from the current U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "70 mg 与 4 片包装是什么意思？", "en": "What do 70 mg and a four-tablet pack mean?" }, "answer": { "zh": "它们是这张准确美国包装标签的身份信息：每片标示量与包装内片数。网页不会把它们转成任何人的服用频率、片数、漏用处理、分片或换药方案；请以实际包装、现行处方和药师/开方团队的复核为准。", "en": "They are identity information for this exact U.S. package label: the stated amount per tablet and tablet count in the pack. This site does not turn them into anyone's frequency, tablet count, missed-use action, splitting or switching plan; use the actual package, current prescription and pharmacist/prescriber review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/fosamax/", "en": "https://origindrug.com/en/drugs/fosamax/" }, "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." ] }