{ "id": "livalo", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "LIVALO", "generic": "匹伐他汀", "aliases": [ "LIVALO", "pitavastatin", "pitavastatin calcium", "匹伐他汀" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 LIVALO 公开标签（SPL v12，2026-03-31 生效；处方信息 2026-03 修订）列示匹伐他汀 1 mg、2 mg、4 mg 口服薄膜衣片及各自 90 片瓶装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "匹伐他汀口服薄膜衣片：1 mg、2 mg、4 mg（美国当前公开标签所列；各 90 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Kowa Pharmaceuticals America, Inc.（所引美国公开标签所列经销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZYPITAMAG", "pitavastatin magnesium", "pitavastatin oral solution", "匹伐他汀口服溶液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-livalo-pitavastatin-tablet-1mg-90-bottle-ndc-6686910490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v12；2026-03-31 生效；处方信息 2026-03 修订）", "en": "Current U.S. DailyMed public label (SPL v12; effective 31 Mar 2026; prescribing information revised Mar 2026)" }, "dosageForm": { "zh": "LIVALO 匹伐他汀口服薄膜衣片", "en": "LIVALO pitavastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66869-104-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片匹伐他汀 1 mg；90 片瓶装", "en": "Pitavastatin 1 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-03.jpg&id=956917", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "匹伐他汀", "en": "pitavastatin" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用、换药或调整规则", "en": "labelled amount per tablet; not an individual's tablet count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片，约 6 mm；无刻痕，不是自行掰开指示", "en": "round film-coated tablet, about 6 mm; unscored, not a self-splitting instruction" }, "imprint": "KC / 1", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-livalo-pitavastatin-tablet-2mg-90-bottle-ndc-6686920490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v12；2026-03-31 生效；处方信息 2026-03 修订）", "en": "Current U.S. DailyMed public label (SPL v12; effective 31 Mar 2026; prescribing information revised Mar 2026)" }, "dosageForm": { "zh": "LIVALO 匹伐他汀口服薄膜衣片", "en": "LIVALO pitavastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66869-204-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片匹伐他汀 2 mg；90 片瓶装", "en": "Pitavastatin 2 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-04.jpg&id=956917", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "匹伐他汀", "en": "pitavastatin" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用、换药或调整规则", "en": "labelled amount per tablet; not an individual's tablet count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片，约 8 mm；无刻痕，不是自行掰开指示", "en": "round film-coated tablet, about 8 mm; unscored, not a self-splitting instruction" }, "imprint": "KC / 2", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-livalo-pitavastatin-tablet-4mg-90-bottle-ndc-6686940490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v12；2026-03-31 生效；处方信息 2026-03 修订）", "en": "Current U.S. DailyMed public label (SPL v12; effective 31 Mar 2026; prescribing information revised Mar 2026)" }, "dosageForm": { "zh": "LIVALO 匹伐他汀口服薄膜衣片", "en": "LIVALO pitavastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66869-404-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片匹伐他汀 4 mg；90 片瓶装", "en": "Pitavastatin 4 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-05.jpg&id=956917", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "匹伐他汀", "en": "pitavastatin" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用、换药或调整规则", "en": "labelled amount per tablet; not an individual's tablet count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片，约 10 mm；无刻痕，不是自行掰开指示", "en": "round film-coated tablet, about 10 mm; unscored, not a self-splitting instruction" }, "imprint": "KC / 4", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-livalo-pitavastatin-tablet-1mg-90-bottle-ndc-6686910490", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-03.jpg&id=956917", "alt": "LIVALO 匹伐他汀 1 mg、NDC 66869-104-90、90 片瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v12（2026-03-31 生效；处方信息 2026-03 修订）", "presentation": "LIVALO 匹伐他汀：每片 1 mg，NDC 66869-104-90，90 片瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 LIVALO、匹伐他汀 1 mg、NDC 66869-104-90 与 90 片瓶装。它只帮助核对品牌、通用名、每片标示量、包装与来源；不用于鉴定真伪，也不代表 2/4 mg、其他包装、ZYPITAMAG、其他匹伐他汀、其他他汀、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、换药或停药方案。", "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀 1 mg、90 片瓶装当前美国公开标签面板（Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LIVALO／匹伐他汀说明书放大阅读：先认清 1／2／4 mg、NDC 与 90 片瓶装", "en": "LIVALO label reading: identify 1/2/4 mg, NDC and the 90-tablet bottle first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 LIVALO、匹伐他汀、每片 1/2/4 mg、准确 NDC、90 片瓶装、外形与警示。它不提供个人片数、用药时间、同服、停用、换药、分片或购买方案。", "en": "This module reads only LIVALO, pitavastatin, 1/2/4 mg per tablet, exact NDCs, 90-tablet bottles, appearance and warnings in the current U.S. DailyMed label. It provides no individual tablet count, timing, co-use, stopping, switching, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 LIVALO、匹伐他汀、1/2/4 mg、实际 NDC、90 片瓶装、白色圆形片、KC 压印与目标市场。mg 是这个准确片剂每片的标示量，不是网页可计算的个人片数、其他他汀换算或同类药叠加规则。", "en": "Check LIVALO, pitavastatin, 1/2/4 mg, the actual NDC, 90-tablet bottle, white round tablet, KC imprint and target market together. mg is the labelled amount in that exact tablet, not a web calculation for tablet count, conversion to another statin or combining same-class medicines." }, { "zh": "当前标签将三种片剂描述为无刻痕；颜色、大小、圆形和压印只用于辅助核对，不能鉴定真伪，也不是自行掰开、减量或由一种强度替换另一种的指令。", "en": "The current label describes all three tablets as unscored. Colour, size, round shape and imprint are supporting checks only; they cannot authenticate a product and are not instructions to self-split, reduce use or replace one strength with another." }, { "zh": "标签将年龄较大、肾功能问题、未控制甲状腺功能减退、某些联用药和其他降脂治疗列为需要专业核对的情形，并列有肌肉相关风险与环孢素禁忌。请把全部处方药、非处方药、补充剂与实际药盒交给药师或开方团队逐项核对；网页不能把这些条目变成个人的“能否同服”结论。", "en": "The label identifies older age, kidney concerns, uncontrolled hypothyroidism, certain co-medications and other lipid-lowering therapy as matters for professional review, and includes muscle-related risk and a cyclosporine contraindication. Give every prescription medicine, OTC product, supplement and actual pack to a pharmacist or prescriber for item-by-item review; this page cannot turn these items into an individual co-use decision." }, { "zh": "新发或明显的肌肉疼痛、压痛、无力，尤其伴随不适或发热，或出现黄疸样变化、深色尿、严重过敏样反应、呼吸困难或其他急性严重不适时，应优先使用当地医疗支持；不要通过同时停换多种药来试探原因。", "en": "With new or marked muscle pain, tenderness or weakness, especially with malaise or fever, or jaundice-like changes, dark urine, a serious allergy-like reaction, breathing difficulty or another acute serious concern, prioritise local medical support; do not test the cause by stopping and changing several medicines at once." } ], "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Warnings, Contraindications and Patient Counseling；Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "匹伐他汀怎样在标签中被描述：HMG-CoA 还原酶抑制路径，不是自行选药规则", "en": "How pitavastatin is described in the label: an HMG-CoA-reductase inhibition pathway, not a self-selection rule" }, "summary": { "zh": "当前美国标签将匹伐他汀描述为 HMG-CoA 还原酶抑制剂。该机制帮助理解“他汀”这一药物类别；它不能判断个人为何适合或不适合某一他汀、是否需要基因检测、能否同服、如何换药或应服几片。", "en": "The current U.S. label describes pitavastatin as an HMG-CoA reductase inhibitor. This helps explain the statin drug class; it cannot decide why an individual does or does not fit a statin, whether genetic testing is needed, whether medicines can be combined, how to switch or how many tablets to use." }, "checks": [ { "zh": "LIVALO、立普妥、可定、舒降之等产品即使都可被归入他汀相关范围，也不因此建立个人可自行交替、叠加、等量换算或依药名选药的关系。", "en": "Even where LIVALO, Lipitor, Crestor and Zocor can all be described in a statin-related context, that does not establish self-directed alternation, combining, equal conversion or name-based selection for an individual." }, { "zh": "机制页面不把任何人的肌肉症状、化验结果、肾肝功能、年龄、合并疾病或完整药单简化为“该选哪一种他汀”的答案；已有药物基因检测报告也须由专业人员结合这些资料解释。", "en": "A mechanism page does not reduce an individual's muscle symptoms, test results, kidney/liver function, age, coexisting conditions or complete medicine list to an answer about which statin to choose; an existing pharmacogenomic report also needs professional interpretation with those materials." }, { "zh": "不要把机制、包装图或一个 mg 数字用于处理急性症状、补用、停用、换药或联用。现实问题必须回到准确产品的现行目标市场标签和药师或医生。", "en": "Do not use mechanism, a package image or one mg number to handle an acute symptom, make-up use, stopping, switching or co-use. Real questions must return to the current target-market label for the exact product and a pharmacist or clinician." } ], "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Clinical Pharmacology；Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LIVALO", "generic": "匹伐他汀", "dosageFormClass": "匹伐他汀口服薄膜衣片：1 mg、2 mg、4 mg（美国当前公开标签所列；各 90 片瓶装）" }, "labelSource": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 LIVALO（pitavastatin）美国公开标签列示 1 mg、2 mg、4 mg 口服薄膜衣片、各自 90 片瓶装、NDC、白色圆形外观和 KC 压印。本页帮助读者把商品名、通用名、每片标示量、准确包装、公开电子说明书与药物警戒阅读路径放在一起；不把 mg、包装数量或“同属他汀”转换为个人片数、同服、轮换、停用、换药或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 2009，SPL v12 的生效日期为 2026-03-31。1/2/4 mg、各自 NDC 与 90 片瓶装是不同的产品身份字段；同为他汀、相近毫克数或相同白色圆片外观，均不能建立与阿托伐他汀、瑞舒伐他汀、辛伐他汀或其他匹伐他汀产品的自行互换、合用或换算关系。", "sourceDocuments": [ { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（LIVALO；NDA 022363）", "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 022363", "approvalTimeline": [ { "date": "2009", "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 LIVALO 美国公开标签列示 Initial U.S. Approval: 2009。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current U.S. LIVALO public label lists Initial U.S. Approval: 2009. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-03-31", "title": { "zh": "当前 SPL v12 生效日期", "en": "Current SPL v12 effective date" }, "detail": { "zh": "DailyMed 当前 LIVALO 公开标签的 Effective Time 为 2026-03-31，处方信息修订为 2026-03。本页只分别展示 1 mg、2 mg、4 mg 的 90 片瓶装面板；不建立实际在售、库存、购买、个人片数、联用、停用、换药或其他市场状态。", "en": "The current DailyMed LIVALO public label has an effective time of 31 Mar 2026 and prescribing information revised in Mar 2026. This page separately displays the 1 mg, 2 mg and 4 mg 90-tablet bottle panels; it does not establish actual availability, stock, purchase, individual tablet count, co-use, stopping, switching or another-market status." }, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与三组准确 90 片瓶装面板", "en": "Current public label and three exact 90-tablet bottle panels linked" }, "detail": { "zh": "本页分别展示 LIVALO 匹伐他汀 1 mg、NDC 66869-104-90；2 mg、NDC 66869-204-90；4 mg、NDC 66869-404-90 的 90 片瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、开始、停用、联用、换药或可替代性。", "en": "This page separately displays LIVALO pitavastatin 1 mg/NDC 66869-104-90, 2 mg/NDC 66869-204-90 and 4 mg/NDC 66869-404-90 90-tablet bottles. It does not authenticate a product or establish actual availability, stock, purchase, individual tablet count, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1、2、4 mg 与 90 片瓶装能不能用来自己决定片数、换到另一种他汀或与另一种他汀同服？", "en": "Can 1, 2, 4 mg and a 90-tablet bottle be used to decide my own tablet count, change to another statin or use it with another statin?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 LIVALO 片剂和包装。共同药物类别、相近毫克数、包装照片或同为降脂相关产品，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify the exact LIVALO tablets and packages in the cited U.S. label. A shared drug class, a nearby milligram number, a package photo or a related lipid-lowering context does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么页面提到年龄、肾脏、甲状腺和联用药，却不告诉我自己应选哪一种他汀？", "en": "Why does the page mention age, kidney issues, thyroid status and co-medications without telling me which statin to choose?" }, "answer": { "zh": "这些是当前标签中需要专业核对的风险与相互作用阅读线索，不是个体化选药或治疗决策。药师或医生需要把准确产品、病史、检查结果、既往反应与完整药单一起审查；出现急性严重不适时，应使用当地医疗支持。", "en": "These are label-based risk and interaction reading cues requiring professional review, not personalised drug selection or treatment decisions. A pharmacist or clinician needs the exact product, history, test results, prior reactions and complete medicine list together; for an acute serious concern, use local medical support." } } ], "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/livalo/", "en": "https://origindrug.com/en/drugs/livalo/" }, "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." ] }