{ "id": "lescol-xl-fluvastatin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "LESCOL XL", "generic": "氟伐他汀钠", "aliases": [ "Lescol XL", "fluvastatin", "fluvastatin sodium", "氟伐他汀", "氟伐他汀钠", "益脂可" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前 LESCOL XL 氟伐他汀钠 80 mg 缓释片公开标签（2023-11 修订；NDA 021192）；30 片瓶装与已记录 2021-02-28 营销终止日期的 100 片瓶装须分开阅读", "dosageFormClass": "氟伐他汀钠 80 mg 口服缓释片：每片相当于氟伐他汀 80 mg；本档案不并入 LESCOL 20 mg／40 mg 普通胶囊", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1993（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation／Sandoz Inc.（当前美国公开标签所列标签与生产资料主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LESCOL XL", "LESCOL XL 80 mg", "LESCOL XL extended-release tablet" ], "excludedProductCues": [ "LESCOL capsule 20 mg", "LESCOL capsule 40 mg", "fluvastatin 20 mg capsule", "fluvastatin 40 mg capsule", "氟伐他汀 20 mg 胶囊", "氟伐他汀 40 mg 胶囊" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lescol-xl-fluvastatin-er-tablet-80mg-30-bottle-ndc-0078035415-current-label", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2023)" }, "dosageForm": { "zh": "LESCOL XL 氟伐他汀钠 80 mg 口服缓释片", "en": "LESCOL XL fluvastatin sodium 80 mg extended-release oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0354-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于氟伐他汀 80 mg；30 片瓶装", "en": "Equivalent to fluvastatin 80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lescol-01.jpg&archiveid=898359", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟伐他汀（由氟伐他汀钠提供）", "en": "fluvastatin (provided as fluvastatin sodium)" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或他汀换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or statin-conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、轻微双凸、斜边薄膜衣片", "en": "round, slightly biconvex, bevelled film-coated tablet" }, "imprint": "LESCOL XL / 80", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lescol-xl-fluvastatin-er-tablet-80mg-100-bottle-ndc-0078035405-marketing-ended-2021", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2023)" }, "dosageForm": { "zh": "LESCOL XL 氟伐他汀钠 80 mg 口服缓释片", "en": "LESCOL XL fluvastatin sodium 80 mg extended-release oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0354-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于氟伐他汀 80 mg；100 片瓶装", "en": "Equivalent to fluvastatin 80 mg per tablet; 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟伐他汀（由氟伐他汀钠提供）", "en": "fluvastatin (provided as fluvastatin sodium)" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或他汀换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or statin-conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_marketing_ended", "marketingStartDate": null, "marketingEndDate": "2021-02-28", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、轻微双凸、斜边薄膜衣片", "en": "round, slightly biconvex, bevelled film-coated tablet" }, "imprint": "LESCOL XL / 80", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lescol-xl-fluvastatin-er-tablet-80mg-30-bottle-ndc-0078035415-current-label", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lescol-01.jpg&archiveid=898359", "alt": "LESCOL XL 氟伐他汀钠 80 mg、NDC 0078-0354-15、30 片瓶装在美国 DailyMed 当前公开标签中的官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2023-11 修订）", "presentation": "LESCOL XL 氟伐他汀钠缓释片：每片相当于氟伐他汀 80 mg，NDC 0078-0354-15，30 片瓶装。", "notice": "此图只对应当前美国公开标签中的 LESCOL XL 80 mg、NDC 0078-0354-15 与 30 片瓶装。它帮助核对商品名、通用名、缓释剂型、每片标示量、NDC 和包装；不用于鉴定真伪，也不代表 100 片瓶装、普通 LESCOL 胶囊、其他氟伐他汀、其他他汀、其他市场、当前有货、原研身份、可替代性或任何人的片数和换药方案。", "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LESCOL XL 说明书放大阅读：80 mg 缓释片不是 20／40 mg 普通胶囊的网页换算项", "en": "LESCOL XL label reading: the 80 mg extended-release tablet is not a web conversion for 20/40 mg conventional capsules" }, "summary": { "zh": "当前美国标签只把 LESCOL XL 建立为每片相当于氟伐他汀 80 mg 的缓释片，并要求整片吞服，不得掰开、压碎或咀嚼。本页不把缓释片与 LESCOL 20 mg／40 mg 普通胶囊、其他规格或其他他汀按数字换算。", "en": "The current U.S. label establishes LESCOL XL as an extended-release tablet equivalent to fluvastatin 80 mg per tablet and says to swallow it whole without breaking, crushing or chewing. This page does not numerically convert it to LESCOL 20 mg/40 mg conventional capsules, another strength or another statin." }, "checks": [ { "zh": "先同时核对 LESCOL XL、氟伐他汀钠、缓释片、每片 80 mg、实际 NDC 和瓶装数量。mg 是准确缓释片每片的标示量，不是个人应吃几片，也不是把两粒 40 mg 普通胶囊自动当作一片 80 mg 缓释片的许可。", "en": "Check LESCOL XL, fluvastatin sodium, extended-release tablet, 80 mg per tablet, the actual NDC and bottle count together. The mg figure is the labelled amount in the exact extended-release tablet, not an individual's tablet count or permission to treat two 40 mg conventional capsules as one 80 mg extended-release tablet." }, { "zh": "LESCOL XL 缓释片须整片吞服，不得掰开、压碎或咀嚼。片剂无刻痕；外观和官方包装面板只用于辅助核对，不能证明真伪或允许自行改变缓释结构。", "en": "Swallow LESCOL XL extended-release tablets whole; do not break, crush or chew them. The tablet is unscored. Appearance and the official package panel support identity checking only and cannot authenticate a pack or permit self-alteration of the release design." }, { "zh": "LESCOL 普通胶囊 20 mg／40 mg 与 LESCOL XL 80 mg 缓释片不是只看总毫克数就相同的产品。剂型、释放结构、目标市场现行标签和处方必须一起核对，网页不安排互换、轮换或补服。", "en": "LESCOL conventional 20 mg/40 mg capsules and the LESCOL XL 80 mg extended-release tablet are not the same product merely because totals can be added. Form, release design, current target-market label and prescription must be reviewed together; the site does not arrange substitution, rotation or make-up use." }, { "zh": "无法解释的肌肉痛、压痛或无力，尤其伴不适、发热或深色尿，可能需要尽快医疗评估；当前标签列有肌病和横纹肌溶解警示。肝功能问题、甲状腺功能减退、肾功能问题及环孢素、吉非贝齐等完整药单也应交给药师或开方团队核对。", "en": "Unexplained muscle pain, tenderness or weakness, especially with malaise, fever or dark urine, may need prompt medical assessment; the current label includes myopathy and rhabdomyolysis warnings. Liver concerns, hypothyroidism, kidney concerns and a complete medicine list including ciclosporin or gemfibrozil also need pharmacist or prescriber review." }, { "zh": "怀孕、可能怀孕或哺乳时，不要凭网页自行继续、停用、隔天吃或换成另一种他汀；尽快联系开方团队或药师，按准确市场和现行说明书处理。", "en": "When pregnant, possibly pregnant or breastfeeding, do not use this page to self-continue, stop, alternate days or switch to another statin; contact the prescribing team or pharmacist promptly using the exact market and current label." } ], "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氟伐他汀怎样起作用：HMG-CoA 还原酶抑制机制不是他汀等量换算表", "en": "How fluvastatin works: HMG-CoA reductase inhibition is not a statin equivalence table" }, "summary": { "zh": "当前标签将氟伐他汀描述为 HMG-CoA 还原酶抑制剂，通过抑制胆固醇合成相关路径发挥作用。共同机制只能帮助理解药物类别，不能决定个人适合哪一种他汀、能否隔天轮换、是否同服、需要多少强度或是否需要全基因筛查。", "en": "The current label describes fluvastatin as an HMG-CoA reductase inhibitor acting on a cholesterol-synthesis pathway. A shared mechanism helps explain the drug class but cannot decide which statin fits an individual, whether alternate-day rotation or co-use is suitable, what intensity is needed or whether whole-genome screening is required." }, "checks": [ { "zh": "LESCOL XL、MEVALOTIN、LIPITOR、CRESTOR、ZOCOR 和 LIVALO 都不能只凭他汀类别或毫克数自行等量换算、隔天轮换或叠加。", "en": "LESCOL XL, MEVALOTIN, LIPITOR, CRESTOR, ZOCOR and LIVALO cannot be self-converted, alternated by day or combined from statin class or milligram numbers alone." }, { "zh": "年龄、肌肉症状、肝肾功能、甲状腺状况、相互作用、适应症和治疗目标都会影响专业判断。网页不会从单次化验、症状或药名替个人挑选他汀。", "en": "Age, muscle symptoms, liver/kidney function, thyroid status, interactions, indication and treatment goals may affect professional judgement. The site does not select a statin for an individual from one laboratory result, symptom or medicine name." }, { "zh": "基因检测可能在特定问题中参与解释，但‘他汀’或某个副作用不等于人人需要全基因组筛查；是否检测及怎样解释须由合格专业人员结合实际产品和临床背景决定。", "en": "Genetic testing can inform selected questions, but a statin or one adverse effect does not mean everyone needs whole-genome screening. A qualified professional must decide whether to test and how to interpret results using the actual product and clinical context." } ], "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LESCOL XL", "generic": "氟伐他汀钠", "dosageFormClass": "氟伐他汀钠 80 mg 口服缓释片：每片相当于氟伐他汀 80 mg；本档案不并入 LESCOL 20 mg／40 mg 普通胶囊" }, "labelSource": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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": "2026-08-30", "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": "LESCOL XL 是氟伐他汀钠 80 mg 口服缓释片的美国品牌档案。当前 DailyMed 标签展示 30 片瓶装的准确 NDC 和官方包装面板，并保留 100 片瓶装的历史营销终止日期。本页帮助普通读者分清每片 80 mg、缓释结构、准确包装和普通 LESCOL 胶囊的产品边界；不按毫克数计算个人片数，也不把氟伐他汀与普伐他汀、阿托伐他汀、瑞舒伐他汀等自行换算、隔天轮换或叠加。", "history": "当前标签列示氟伐他汀 Initial U.S. Approval 为 1993；FDA 2020 年 NDA 021192／S-031 补充批准函记录了 LESCOL XL 标签更新。DailyMed 当前页面列出 80 mg 缓释片的 30 片瓶装和 100 片瓶装，其中 100 片 NDC 的营销终止日期为 2021-02-28。文件日期和状态用于产品身份核对，不代表实时库存。", "sourceDocuments": [ { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_fcba6e98b5ba90b4", "label": "FDA：LESCOL XL NDA 021192／S-031 标签补充批准函（2020）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021192Orig1s031ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_document", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_c6710913079ea037", "label": "Novartis：LESCOL／氟伐他汀钠公开产品资料页", "url": "https://www.novartis.com/node/35261", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "NDA 021192", "approvalTimeline": [ { "date": "1993", "title": { "zh": "氟伐他汀美国初始批准年份", "en": "Initial U.S. approval year for fluvastatin" }, "detail": { "zh": "当前 LESCOL XL 美国公开标签列示 Initial U.S. Approval: 1993。该年份定位美国品牌历史，不建立其他市场状态。", "en": "The current U.S. LESCOL XL label states Initial U.S. Approval: 1993. This date locates U.S. brand history and does not establish another market's status." }, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2020", "title": { "zh": "NDA 021192／S-031 标签补充批准", "en": "NDA 021192/S-031 supplemental labelling approval" }, "detail": { "zh": "FDA 补充批准函记录 LESCOL XL 标签更新，包含他汀类新的免疫介导坏死性肌病安全信息。", "en": "The FDA supplemental approval letter records a LESCOL XL label update including new statin-class safety information on immune-mediated necrotising myopathy." }, "source": { "id": "src_fcba6e98b5ba90b4", "label": "FDA：LESCOL XL NDA 021192／S-031 标签补充批准函（2020）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021192Orig1s031ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_document", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-11", "title": { "zh": "当前公开标签修订", "en": "Current public-label revision" }, "detail": { "zh": "DailyMed 当前页面列示 2023-11 修订标签及 30 片瓶装官方面板；100 片瓶装另有 2021-02-28 营销终止日期。", "en": "The current DailyMed page lists the label revised Nov 2023 and an official 30-tablet bottle panel; the 100-tablet bottle separately carries a 28 Feb 2021 marketing-end date." }, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "公开来源访问复核", "en": "Public-source access review" }, "detail": { "zh": "本轮确认 DailyMed、FDA 与 Novartis 资料入口可访问。入口存在不等于实时供应或个人适用。", "en": "This review confirmed access to the DailyMed, FDA and Novartis source entries. Source availability does not establish real-time supply or individual suitability." }, "source": { "id": "src_c6710913079ea037", "label": "Novartis：LESCOL／氟伐他汀钠公开产品资料页", "url": "https://www.novartis.com/node/35261", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签已链接；实时供应未建立", "en": "Current public label linked; real-time supply not established" }, "detail": { "zh": "30 片瓶装有当前标签面板；100 片瓶装保留有日期营销终止记录。两者不能合并成实时库存结论。", "en": "The 30-tablet bottle has a current-label panel, while the 100-tablet bottle retains a dated marketing-end record. They cannot be merged into a real-time inventory conclusion." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行产品记录待逐市场建立", "en": "Current product records require market-by-market review" }, "detail": { "zh": "不从美国 LESCOL XL 标签外推其他市场的商品名、批准、规格、包装、持有人、供应或可替代性。", "en": "The U.S. LESCOL XL label is not extrapolated to another market's brand, approval, strength, package, holder, supply or interchangeability." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "两粒 40 mg 氟伐他汀胶囊是否等于一片 LESCOL XL 80 mg？", "en": "Do two 40 mg fluvastatin capsules equal one LESCOL XL 80 mg tablet?" }, "answer": { "zh": "不能由网页只按总毫克数判定。普通胶囊与缓释片的剂型和释放结构不同，准确产品、标签、处方和目标市场必须一起核对；不要自行拼接或替换。", "en": "A webpage cannot decide this from the total milligrams alone. Conventional capsules and extended-release tablets have different forms and release designs. Check the exact product, label, prescription and target market together; do not self-assemble or substitute." } }, { "question": { "zh": "可以一天吃 LESCOL XL、一天吃另一种他汀吗？", "en": "Can LESCOL XL be taken one day and another statin the next?" }, "answer": { "zh": "网页不能为个人确认这种轮换。不同他汀不是按毫克数直接等量，强度、相互作用、肝肾功能和处方目标可能不同。不要自行轮换、叠加或停用，应把实际药盒、处方、化验和完整药单交给开方团队或药师核对。", "en": "A webpage cannot confirm such rotation for an individual. Statins are not directly milligram-equivalent, and intensity, interactions, liver/kidney function and prescribing goals may differ. Do not self-rotate, combine or stop them; take the actual packs, prescription, laboratory data and complete medicine list to the prescribing team or pharmacist." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "statin-gene-testing-what-labels-can-and-cannot-say" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lescol-xl-fluvastatin/", "en": "https://origindrug.com/en/drugs/lescol-xl-fluvastatin/" }, "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." ] }