{ "id": "lovenox", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Lovenox", "generic": "依诺肝素钠", "aliases": [ "LOVENOX", "enoxaparin", "enoxaparin sodium", "依诺肝素", "依诺肝素钠" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国当前 LOVENOX 依诺肝素钠注射液公开标签（处方信息 2025-05 修订；DailyMed SPL v33 于 2026-05-29 发布）", "dosageFormClass": "依诺肝素钠注射液：预充式单剂量注射器及多剂量瓶（当前美国标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下 / 静脉注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "1993（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lovenox-40mg-0-4ml-ndc-0075-0620-40", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-05 修订；DailyMed SPL v33 于 2026-05-29 发布", "en": "Prescribing information revised May 2025; DailyMed SPL v33 published 29 May 2026" }, "dosageForm": { "zh": "依诺肝素钠注射液；单剂量预充式注射器", "en": "enoxaparin sodium injection; single-dose prefilled syringe" }, "route": { "zh": "皮下或静脉（标签范围；不由网页决定个人给药途径）", "en": "subcutaneous or intravenous (label scope; this page does not determine an individual's route)" }, "routeCodes": [ "subcutaneous", "intravenous" ], "productCode": "NDC 0075-0620-40", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "40 mg/0.4 mL；100 mg/mL；10 支单剂量预充式注射器", "en": "40 mg/0.4 mL; 100 mg/mL; 10 single-dose prefilled syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59&name=5017a927-2a24-4f27-89f9-27c805bf7d59-26.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依诺肝素钠", "en": "enoxaparin sodium" }, "value": 100, "unit": "mg/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射量", "en": "labelled concentration; not an individual injection amount" } }, { "ingredient": { "zh": "依诺肝素钠", "en": "enoxaparin sodium" }, "value": 40, "unit": "mg", "basisCode": "per_single_dose_syringe", "basisLabel": { "zh": "每支单剂量预充式注射器标示量；不是个人给药指令", "en": "labelled amount in each single-dose prefilled syringe; not an individual administration instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "100 mg/mL", "numerator": { "value": 100, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 mg/mL（标签浓度；不是个人注射量）", "en": "100 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充式注射器（带自动安全装置）", "en": "single-dose prefilled syringe with automatic safety device" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": 10, "countUnit": { "zh": "支单剂量预充式注射器/盒", "en": "single-dose prefilled syringes per carton" } }, "deliveryDevice": { "typeCode": "automatic_safety_device", "name": { "zh": "自动安全装置", "en": "automatic safety device" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "支单剂量预充式注射器/盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lovenox-40mg-0-4ml-ndc-0075-0620-40", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59&name=5017a927-2a24-4f27-89f9-27c805bf7d59-26.jpg", "alt": "LOVENOX 依诺肝素钠当前美国 DailyMed 标签中的 40 mg/0.4 mL、NDC 0075-0620-40、十支单剂量预充式注射器纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v33（处方信息 2025-05 修订；2026-05-29 发布）", "presentation": "LOVENOX 依诺肝素钠注射液；40 mg/0.4 mL；NDC 0075-0620-40；十支单剂量预充式注射器（带自动安全装置）", "notice": "此图只对应美国当前标签中的 40 mg/0.4 mL 单剂量预充式注射器十支装。它不代表 30、60、80、100、120、150 mg 预充式注射器、300 mg/3 mL 多剂量瓶、其他依诺肝素产品或其他市场；不用于鉴定真伪，也不用于推导个人注射量、频率、疗程、补用、停用或转换。", "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "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": "LOVENOX 说明书放大阅读：mg、mL、浓度与注射器/药瓶必须一起核对", "en": "LOVENOX label reading: mg, mL, concentration and syringe/vial must be checked together" }, "summary": { "zh": "本模块只帮助阅读当前美国标签中的品牌、通用名、容器、浓度、NDC 和严重风险警示；不生成个人注射量、频率、疗程、漏用补救、停用、转换或联合方案。", "en": "This module only helps read brand, generic name, container, concentration, NDC and serious-risk warnings in the current U.S. label; it does not generate an individual's injection amount, frequency, duration, missed-use action, stopping, switching or combination plan." }, "checks": [ { "zh": "先把 LOVENOX、依诺肝素钠、准确 mg/mL、mg/每支（或每瓶）、容器类型、NDC、目标市场和标签版本一起核对。包装上的 mg、mL 或 mg/mL 是产品身份字段，不是网页可以换算成个人应注射多少的答案。", "en": "Check LOVENOX, enoxaparin sodium, the exact mg/mL, mg per syringe (or vial), container type, NDC, target market and label version together. Milligrams, millilitres and mg/mL on a package identify the product; they are not a web answer for an individual's injection amount." }, { "zh": "单剂量预充式注射器与多剂量瓶是不同容器。即使通用名相同、数字相近或都写“依诺肝素”，也不能自行抽取、转移、分装、补用、共享、按刻度调整或把一种容器换成另一种。", "en": "Single-dose prefilled syringes and a multiple-dose vial are different containers. Even with the same generic name, similar numbers or the same ‘enoxaparin’ wording, do not self-withdraw, transfer, divide, make up, share, adjust by markings or replace one container with another." }, { "zh": "依诺肝素与普通肝素、华法林、阿哌沙班、利伐沙班、阿司匹林、氯吡格雷、布洛芬/萘普生及某些补充剂都可能使完整药单的核对很重要。不要因都写“抗凝”“防血栓”或“止痛”就自行叠加、轮换、暂停或替换。", "en": "Enoxaparin, unfractionated heparin, warfarin, apixaban, rivaroxaban, aspirin, clopidogrel, ibuprofen/naproxen and some supplements can make a complete medicine-list review important. Do not self-combine, alternate, pause or substitute merely because labels mention anticoagulation, clot prevention or pain relief." }, { "zh": "计划做脊柱/硬膜外麻醉、腰穿、手术或牙科操作，或发生跌倒、头部受伤、异常或大量出血、黑便、呕血、明显头晕/晕厥等情况时，应及时联系开方团队或当地紧急医疗支持；网页不决定是否自行停用或何时恢复。", "en": "For planned spinal/epidural anaesthesia, lumbar puncture, surgery or dental procedures, or a fall, head injury, unusual or heavy bleeding, black stools, vomiting blood, marked dizziness/fainting or another acute concern, promptly contact the prescribing team or local urgent-care support; this page does not decide self-stopping or restarting." }, { "zh": "标签中的抗凝机制和包装强度都不能回答某人为什么需要抗凝、何时注射、注射多少、是否能用另一种抗凝药替换，或漏用后如何处理。需要这些答案时，请携带实际包装与完整药单咨询药师或医生。", "en": "Neither the label's anticoagulant mechanism nor package strength can answer why a person needs anticoagulation, when or how much to inject, whether another anticoagulant can replace it, or what to do after a missed use. For those answers, take the actual package and complete medicine list to a pharmacist or clinician." } ], "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依诺肝素怎样起作用：标签描述其主要抗 Xa 与抗 IIa 活性", "en": "How enoxaparin works: the label describes predominant anti-factor Xa and anti-factor IIa activity" }, "summary": { "zh": "当前标签将依诺肝素描述为低分子量肝素，其抗凝活性与对抗凝血酶 III 的结合有关，并主要表现为抗 Xa 与抗 IIa 活性。该段只解释标签中的药理路径，不判断任何人是否需要抗凝、个人风险、注射量、时间表、监测、联用或转换。", "en": "The current label describes enoxaparin as a low-molecular-weight heparin whose anticoagulant activity is linked to binding antithrombin III, with predominant anti-factor Xa and anti-factor IIa activity. This explains a label-described pathway, not whether anyone needs anticoagulation, their individual risk, injection amount, schedule, monitoring, co-use or switching." }, "checks": [ { "zh": "“影响凝血因子”不等于网页可以判断胸痛、腿肿、呼吸困难、瘀青、出血或化验结果的原因，也不能替代对血栓、出血、肾功能、体重、年龄、妊娠、手术计划和完整药单的专业评估。", "en": "‘Affects clotting factors’ does not let a webpage determine the cause of chest pain, leg swelling, breathing trouble, bruising, bleeding or a laboratory result, nor replace professional assessment of clotting, bleeding, kidney function, weight, age, pregnancy, procedure plans and the full medicine list." }, { "zh": "同为抗凝药、都作用于凝血路径，或包装上都出现单位/浓度文字，不表示依诺肝素与普通肝素、华法林、直接口服抗凝药、抗血小板药或另一种依诺肝素包装可自行等量替换、叠加、轮换或转换。", "en": "A shared anticoagulant class, clotting-pathway effect or unit/concentration wording on a package does not make enoxaparin self-equivalent, combinable, alternatable or convertible with unfractionated heparin, warfarin, direct oral anticoagulants, antiplatelet medicines or another enoxaparin package." }, { "zh": "机制页面不能处理异常出血、过敏、神经系统症状、疑似误用、手术/硬膜外相关问题或任何急性严重不适。出现此类担忧时，应优先使用当地医生、药师、急诊或紧急支持，而不是依据机制文字自行调整。", "en": "A mechanism page cannot manage unusual bleeding, allergy, neurologic symptoms, suspected misuse, procedure/epidural concerns or another acute severe problem. With these concerns, prioritise local clinicians, pharmacists or urgent support rather than self-adjusting from mechanism text." } ], "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Clinical Pharmacology；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lovenox", "generic": "依诺肝素钠", "dosageFormClass": "依诺肝素钠注射液：预充式单剂量注射器及多剂量瓶（当前美国标签所列）" }, "labelSource": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LOVENOX（enoxaparin sodium）当前美国公开标签列出预充式单剂量注射器和 300 mg/3 mL 多剂量瓶，且不同包装可出现 100 mg/mL 或 150 mg/mL 等浓度文字。本页只帮助核对品牌、通用名、准确 mg/mL、容器、NDC、目标市场和标签版本；不把强度或容量变成个人注射量、时间表、漏用补救、停药、转换或与其他抗凝药合用的方案。", "history": "当前美国标签列示 Initial U.S. Approval: 1993。该档案只保留 DailyMed SPL v33（处方信息 2025-05 修订，2026-05-29 发布）的公开阅读入口；不从该文件推定其他市场、其他依诺肝素包装、普通肝素、华法林、口服抗凝药或抗血小板药的当前状态或可替代性。", "sourceDocuments": [ { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "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" } ], "applicationNumber": "美国标签所列 Initial U.S. Approval: 1993", "approvalTimeline": [ { "date": "1993", "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 LOVENOX 美国标签列示 Initial U.S. Approval: 1993；该年份不自动说明其他市场的批准或产品状态。", "en": "The current U.S. LOVENOX label lists Initial U.S. Approval: 1993; that year does not establish approval or product status in another market." }, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed: current LOVENOX public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "当前处方信息修订月份", "en": "Current prescribing-information revision month" }, "detail": { "zh": "当前标签正文列示 Revised: 5/2025；该日期与 DailyMed 的公开日期分开记录。", "en": "The current label text lists Revised: 5/2025; this remains separate from the DailyMed publication date." }, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed: current LOVENOX public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05-29", "title": { "zh": "DailyMed SPL v33 公开", "en": "DailyMed SPL v33 published" }, "detail": { "zh": "DailyMed 将当前 SPL v33 的 Published Date 列为 2026-05-29；不把该日期解释为新的个人治疗建议。", "en": "DailyMed lists 29 May 2026 as the current SPL v33 Published Date; this date is not interpreted as a new individual-treatment recommendation." }, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed: current LOVENOX public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个精确包装展示", "en": "Current public label and one exact package panel linked" }, "detail": { "zh": "本档案图只对应 NDC 0075-0620-40 的 40 mg/0.4 mL 十支单剂量预充式注射器；不据此声称实际在售、库存、可获得性或其他包装状态。", "en": "The dossier image corresponds only to the 40 mg/0.4 mL, ten single-dose-syringe panel, NDC 0075-0620-40; it does not establish actual marketing, stock, availability or the status of another package." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、规格、包装、供应、可替代性或用药安排。", "en": "No local trade name, approval, strength, package, supply, interchangeability or use plan is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "40 mg/0.4 mL 是否等于任何人都该注射这一整支？", "en": "Does 40 mg/0.4 mL mean everyone should inject that whole syringe?" }, "answer": { "zh": "不是。这是一个美国标签包装的身份字段。页面不提供个人注射量、频率、疗程或漏用处理；请依据准确处方、手上包装和药师/医生的核对。", "en": "No. It identifies one U.S.-labelled package. This page provides no personal injection amount, frequency, duration or missed-use action; use the exact prescription, package in hand and pharmacist/clinician review." } }, { "question": { "zh": "能否自行用 LOVENOX 替换另一种抗凝或抗血小板药？", "en": "Can LOVENOX self-replace another anticoagulant or antiplatelet medicine?" }, "answer": { "zh": "不能。相同的‘抗凝/防血栓’用途文字并不建立可替代关系。必须由掌握具体原因、手术计划、肾功能、出血风险和完整药单的专业人员逐项核对。", "en": "No. A shared ‘anticoagulation/clot prevention’ description does not establish interchangeability. A professional who knows the specific reason, procedure plan, kidney function, bleeding risk and complete medicine list must review it item by item." } } ], "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/lovenox/", "en": "https://origindrug.com/en/drugs/lovenox/" }, "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." ] }