{ "id": "avelox", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Avelox", "generic": "莫西沙星", "aliases": [ "moxifloxacin", "moxifloxacin hydrochloride" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 2020 历史公开标签档案：本页建立一张 400 mg、NDC 50419-530-01、30 片瓶装的文字身份卡；不代表当前包装、供应或其他市场状态", "dosageFormClass": "口服片剂：400 mg 莫西沙星（FDA 2020 标签所列；本页仅覆盖口服片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（FDA 2020 标签所列美国初始批准）", "archiveSponsorText": "Bayer / FDA 公开历史标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avelox-moxifloxacin-tablet-400mg-ndc-50419-530-01-30-bottle-historical-2020", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2020-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2020; not a current-package or availability finding)" }, "dosageForm": { "zh": "莫西沙星椭圆形暗红色薄膜衣口服片", "en": "moxifloxacin oblong dull-red film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-530-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg；30 片瓶装（美国历史标签）", "en": "400 mg per tablet; 30-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莫西沙星", "en": "moxifloxacin" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数或剂量", "en": "historical labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "暗红色", "en": "dull red" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oblong film-coated tablet" }, "imprint": "BAYER / M400", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 莫西沙星 400 mg 口服片、30 片瓶装（NDC 50419-530-01；2020 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验到再包装历史标签，故不展示为原品牌包装", "en": "A repackaged historical label was located, so it is not shown as an original-brand package" }, "summary": { "zh": "DailyMed 的 AVELOX ABC PACK 历史标签列示 RedPharm Drug Inc. 为包装方。即使标签中含有 AVELOX 与 Bayer 文字，也不能把该再包装历史标签当作本页原品牌包装图；因此本页不展示该图。", "en": "The DailyMed AVELOX ABC PACK historical label lists RedPharm Drug Inc. as the packager. Even where the label includes AVELOX and Bayer wording, that repackaged historical label cannot be presented as this record's original-brand package image; it is therefore not shown here." }, "source": { "id": "src_ef07988484e1ce20", "label": "DailyMed（NLM）：AVELOX ABC PACK 再包装历史标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe9226f8-64f4-4eff-8339-ed3fce0896f2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AVELOX 说明书放大阅读：400 mg 口服片与静脉制剂不能按同一数字互推", "en": "AVELOX label reading: a 400 mg oral tablet and an intravenous product cannot be inferred from the same number" }, "summary": { "zh": "本模块以 FDA 2020 美国 AVELOX 公开标签为阅读入口。该文件同时包含口服片与静脉制剂；本页仅帮助核对 400 mg 口服片的品牌、通用名、剂型、给药途径和警告位置，不判断个人是否需要抗菌药，也不生成片数、疗程、换药或联用方案。", "en": "This module uses the 2020 U.S. FDA AVELOX public label as a reading entry point. The file includes both oral tablets and intravenous products; this page only helps identify the 400 mg oral tablet’s brand, generic, dosage form, route and warning locations. It does not decide whether an individual needs an antibacterial medicine or create a tablet count, course, switching or combination plan." }, "checks": [ { "zh": "先同时核对 AVELOX、莫西沙星、400 mg、口服片和目标市场。400 mg 是该口服片的身份字段，不是任何人“今天该用几片、用多久”或能否把剩药继续使用的答案。", "en": "First check AVELOX, moxifloxacin, 400 mg, oral tablet and target market together. 400 mg is an identity field for that oral tablet, not an answer to how many tablets anyone should use today, for how long, or whether leftovers can be continued." }, { "zh": "同一 FDA 文件也列有静脉制剂；口服片与静脉输注产品的剂型、路径和管理要求不同，不能把静脉袋文字、口服片数字或另一种莫西沙星/氟喹诺酮产品互相换算。", "en": "The same FDA file also lists an intravenous product. Oral tablets and intravenous infusions differ in dosage form, route and handling requirements; intravenous-bag wording, oral-tablet numbers and another moxifloxacin or fluoroquinolone product must not be converted across one another." }, { "zh": "FDA 标签含氟喹诺酮类严重不良反应、心律风险和相互作用相关警告。若出现肌腱疼痛或肿胀、麻木刺痛、明显神经或精神状态改变、心悸或晕厥、呼吸困难、皮疹或面部/口腔肿胀等急性或严重不适，应及时使用当地医疗支持，而不是依据网页自行换另一种抗菌药或继续使用。", "en": "The FDA label includes warnings about serious fluoroquinolone reactions, heart-rhythm risk and interactions. With acute or serious symptoms such as tendon pain or swelling, numbness or tingling, marked neurologic or mental-status change, palpitations or fainting, breathing difficulty, rash, or swelling of the face or mouth, use timely local medical support rather than switching to another antibacterial medicine or continuing based on a webpage." }, { "zh": "抗菌药是否需要、选择哪一种、给药途径和疗程必须由具体感染、检查资料、个人状况、完整药单和目标市场现行标签共同决定。尤其同时使用影响心律、血糖、抗凝、含矿物质补充剂或多种处方/非处方产品时，应带实际药盒请医生或药师复核。", "en": "Whether an antibacterial medicine is needed, which one is selected, route and course must be determined from the specific infection, testing, individual circumstances, complete medicine list and current target-market label. Especially with products that affect heart rhythm, glucose or anticoagulation, mineral-containing supplements, or multiple prescription/OTC products, bring the actual pack to a clinician or pharmacist for review." } ], "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "莫西沙星怎样起作用：它干扰细菌 DNA 复制所需的两种酶", "en": "How moxifloxacin works: it interferes with two enzymes needed for bacterial DNA replication" }, "summary": { "zh": "FDA 2020 公开标签描述莫西沙星抑制细菌 DNA 旋转酶（拓扑异构酶 II）和拓扑异构酶 IV；这些酶与细菌 DNA 的复制、转录、修复和重组有关。该机制只帮助理解药物类别，不能判断某种症状是否为细菌感染，也不能选择抗菌药、途径或疗程。", "en": "The 2020 FDA public label describes moxifloxacin as inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes involved in bacterial DNA replication, transcription, repair and recombination. This mechanism only helps explain a drug class; it cannot determine whether symptoms are bacterial or select an antibacterial medicine, route or course." }, "checks": [ { "zh": "“干扰细菌 DNA”不是感染诊断、培养结果或选药结论。是否需要抗菌药，仍须由具体感染、检查资料、个人状况和目标市场现行标签共同判断。", "en": "“Interferes with bacterial DNA” is not an infection diagnosis, culture result or medicine-selection conclusion. Whether an antibacterial medicine is needed still depends on the specific infection, testing, individual circumstances and current target-market label." }, { "zh": "同属氟喹诺酮类或共享作用路径，不使 AVELOX 与左氧氟沙星、环丙沙星或其他抗菌药可自行叠加、轮换、替换或按 mg 换算。产品身份、给药途径、强度、相互作用和现行处方必须分别核对。", "en": "Being in the fluoroquinolone class or sharing a pathway does not make AVELOX self-combinable, switchable, substitutable or milligram-convertible with levofloxacin, ciprofloxacin or another antibacterial medicine. Product identity, route, strength, interactions and current prescription must each be checked separately." }, { "zh": "机制页面也不能决定联用、换药、停用或疗程长短。正在使用多种药物、出现不适或考虑改变方案时，应带上实际包装和完整药单请医生或药师复核。", "en": "A mechanism page also cannot decide combination, switching, stopping or course length. With multiple medicines, symptoms or a contemplated change, take the actual pack and complete medicine list to a clinician or pharmacist for review." } ], "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（临床药理与微生物学）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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": "Avelox", "generic": "莫西沙星", "dosageFormClass": "口服片剂：400 mg 莫西沙星（FDA 2020 标签所列；本页仅覆盖口服片）" }, "labelSource": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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" }, "productRoutes": [ { "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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": "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." } }, "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": [ { "id": "fda-2013-systemic-fluoroquinolone-peripheral-neuropathy-label-change", "issuedAt": "2013-08-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：全身用氟喹诺酮类的周围神经病变标签更新", "en": "FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones" }, "summary": { "zh": "FDA 于 2013-08-15 发布药物安全通讯，要求全身用（口服或注射）氟喹诺酮类的说明书和患者用药指南更清楚说明周围神经病变风险；公告明确列出 Levaquin、Cipro 和 Avelox，并说明该风险可在开始用药后不久出现且可能持续。本记录是特定日期的美国类别监管通讯，不把同类关系变成任何个人的停药、改药、剂型转换或症状归因结论；出现疼痛、灼热、麻刺、麻木、无力或感觉异常等急性或令人担忧的不适，应使用当地医疗支持并由专业人员核对实际产品与完整药单。", "en": "On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list." }, "source": { "id": "src_15292a025a5f8cfe", "label": "FDA：2013-08-15 全身用氟喹诺酮类周围神经病变标签更新药物安全通讯", "url": "https://www.fda.gov/media/86575/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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": "FDA 的 AVELOX（moxifloxacin）2020 美国公开标签同时列有口服片和静脉制剂，并列示美国初始批准年份为 1999。本页建立一张 400 mg、NDC 50419-530-01、30 片瓶装的历史文字身份卡，用于核对品牌、通用名、口服剂型和历史市场文件；不把同一文件中的静脉制剂文字推成个人用法、片数、疗程、换药或购买结论。", "history": "“400 mg”、NDC 50419-530-01 与 30 片瓶装共同帮助确认该 FDA 历史文件所列的一款口服片身份，并不回答个人每天应使用多少、使用多久或能否继续使用。口服片、静脉制剂、其他氟喹诺酮类、其他市场标签和剩余抗菌药都不能仅凭名称或数字自行互换、拼量、轮换或继续使用。FDA 页面也说明该历史标签未必是最新获批标签，目标市场的现行官方文件须单独核对。", "sourceDocuments": [ { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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 021085 / 021277", "approvalTimeline": [ { "date": "1999", "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: 1999。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: 1999. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_487d9f44373cfb28", "label": "FDA: AVELOX tablet and injection label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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" } }, { "date": "2020-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2020-05 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 2020-05 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_487d9f44373cfb28", "label": "FDA: AVELOX tablet and injection label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.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" } } ], "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/avelox/", "en": "https://origindrug.com/en/drugs/avelox/" }, "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." ] }