{ "id": "tricor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "TRICOR", "generic": "非诺贝特", "aliases": [ "Tricor", "fenofibrate", "fenofibrate tablets", "非诺贝特", "非诺贝特片", "NDA 021656", "0074-3173-90", "0074-3189-90", "TRICOR 48 mg", "TRICOR 145 mg", "DISCN" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：TRICOR 48 mg 与 145 mg 口服片的 2025-06 有日期品牌标签、两张官方包装面板及 FDA Orange Book 2026-08-26 数据。Orange Book 将 NDA 021656 两个规格均列为 RLD、DISCN；本页不把说明书仍可访问误写成当前有货。", "dosageFormClass": "非诺贝特口服片：48 mg 黄色 FI 无刻痕片、145 mg 白色 FO 无刻痕片；两款历史 90 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004-11-05（FDA NDA 021656 的 48 mg／145 mg 批准日期）", "archiveSponsorText": "AbbVie Inc.（2025 美国标签与 2026-08-26 FDA Orange Book 数据所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "TRICOR", "Tricor", "非诺贝特片" ], "excludedProductCues": [ "TRILIPIX", "fenofibric acid", "非诺贝酸", "LOFIBRA", "LIPOFEN", "gemfibrozil", "吉非贝齐" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tricor-fenofibrate-48mg-90-tablet-bottle-ndc-0074317390", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期品牌标签（2025-06 修订）；FDA Orange Book 当前列为 DISCN，不代表仍有供应", "en": "Dated U.S. DailyMed brand label (revised Jun 2025); FDA Orange Book currently lists DISCN, not evidence of supply" }, "dosageForm": { "zh": "TRICOR 非诺贝特口服片", "en": "TRICOR fenofibrate oral tablet" }, "route": { "zh": "口服；标签要求整片吞服", "en": "oral; label says swallow whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-3173-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非诺贝特 48 mg；90 片瓶装；美国品牌条目已停止销售", "en": "Fenofibrate 48 mg per tablet; 90-tablet bottle; U.S. brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tricor-145-spl-02.jpg&archiveid=895466", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非诺贝特", "en": "fenofibrate" }, "value": 48, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或他汀换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or statin conversion" } } ], "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": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2025-11-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、无刻痕片", "en": "oval, unscored tablet" }, "imprint": "FI", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tricor-fenofibrate-145mg-90-tablet-bottle-ndc-0074318990", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期品牌标签（2025-06 修订）；FDA Orange Book 当前列为 DISCN，不代表仍有供应", "en": "Dated U.S. DailyMed brand label (revised Jun 2025); FDA Orange Book currently lists DISCN, not evidence of supply" }, "dosageForm": { "zh": "TRICOR 非诺贝特口服片", "en": "TRICOR fenofibrate oral tablet" }, "route": { "zh": "口服；标签要求整片吞服", "en": "oral; label says swallow whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-3189-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非诺贝特 145 mg；90 片瓶装；美国品牌条目已停止销售", "en": "Fenofibrate 145 mg per tablet; 90-tablet bottle; U.S. brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tricor-145-spl-03.jpg&archiveid=895466", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非诺贝特", "en": "fenofibrate" }, "value": 145, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或他汀换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or statin conversion" } } ], "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": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2026-03-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、无刻痕片", "en": "oval, unscored tablet" }, "imprint": "FO", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tricor-fenofibrate-48mg-90-tablet-bottle-ndc-0074317390", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tricor-145-spl-02.jpg&archiveid=895466", "alt": "TRICOR 非诺贝特 48 mg、NDC 0074-3173-90、90 片瓶装的美国 DailyMed 历史标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 有日期品牌标签，2025-06 修订；FDA Orange Book 当前列为 DISCN", "presentation": "TRICOR 每片非诺贝特 48 mg，黄色 FI 无刻痕片，NDC 0074-3173-90，90 片瓶装历史标签展示面。", "notice": "此图只对应所引有日期美国标签中的 48 mg 历史瓶装。它不代表 145 mg、其他非诺贝特产品、其他市场包装、当前供应或可购买状态，不用于鉴定真伪，也不生成个人片数。", "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRICOR 说明书放大阅读：48 mg 与 145 mg 是每片强度，历史包装不等于当前供应", "en": "TRICOR label reading: 48 mg and 145 mg are per-tablet strengths, and historical packs are not current supply" }, "summary": { "zh": "先核对 TRICOR、非诺贝特、准确强度、FI／FO 刻字、NDC 与目标市场，再读整片吞服、肾功能和联合用药警示。网页不会用 48 与 145 的算术关系替任何人换药或计算片数。", "en": "Check TRICOR, fenofibrate, exact strength, FI/FO imprint, NDC and market before reading whole-tablet, kidney-function and co-medication warnings. The site never uses arithmetic between 48 and 145 to switch a medicine or calculate tablets." }, "checks": [ { "zh": "48 mg 和 145 mg 分别是每片非诺贝特标示量。包装上的 90 Tablets 是瓶内数量，不是每次吃 90 片；145 也不是把 48 mg 片自行凑成三片的许可。", "en": "48 mg and 145 mg are labelled fenofibrate amounts per tablet. '90 Tablets' is the bottle count, not 90 tablets per dose, and 145 does not permit self-assembling three 48 mg tablets." }, { "zh": "2025 标签要求整片吞服，并明确不得压碎、掰开、溶解或咀嚼。两种片均无刻痕；吞咽困难或需改变规格时，应让药师或开方团队核对其他可行产品。", "en": "The 2025 label says swallow whole and not to crush, break, dissolve or chew. Both tablets are unscored. If swallowing is difficult or a strength change is considered, ask the pharmacist or prescriber to review another appropriate product." }, { "zh": "标签要求老年人的剂量选择依据肾功能；65 岁及以上、肾功能受损、甲状腺功能未控制，或与他汀、秋水仙碱同用时，肌病和横纹肌溶解风险需要优先核对。不要据网页自行停用或叠加。", "en": "The label bases geriatric dosage selection on kidney function. Age 65 or older, renal impairment, uncontrolled hypothyroidism, and use with a statin or colchicine require priority review of myopathy and rhabdomyolysis risk. Do not self-stop or self-add from the page." }, { "zh": "华法林等香豆素抗凝药、免疫抑制剂、可能伤肾的药和胆汁酸结合树脂都属于需核对的药单项目。异常肌痛/无力伴发热或不适、深色尿、黄疸、面唇舌喉肿胀或呼吸困难，应及时联系医疗人员；严重急性表现使用当地急救。", "en": "Coumarin anticoagulants such as warfarin, immunosuppressants, potentially nephrotoxic medicines and bile-acid resins belong on the review list. Unexplained muscle pain/weakness with fever or malaise, dark urine, jaundice, swelling of the face/lips/tongue/throat or breathing trouble requires prompt medical contact; severe acute features require local emergency care." } ], "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "TRICOR 怎样起作用：非诺贝特转化为非诺贝酸并激活 PPARα 相关通路", "en": "How TRICOR works: fenofibrate becomes fenofibric acid and activates PPAR-alpha-related pathways" }, "summary": { "zh": "标签将 TRICOR 描述为 PPARα 激动剂。非诺贝特经酯酶水解为活性代谢物非诺贝酸，影响脂蛋白脂肪酶及富含甘油三酯颗粒的代谢。机制帮助理解它与他汀不是同一种药，但不能决定个人是否需要、选择 48 或 145 mg、是否联合或能否替换。", "en": "The label describes TRICOR as a PPAR-alpha agonist. Fenofibrate is hydrolysed by esterases to active fenofibric acid and affects lipoprotein lipase and triglyceride-rich particle metabolism. This helps explain why it is not a statin, but cannot decide individual need, 48 versus 145 mg, combination or substitution." }, "checks": [ { "zh": "“降脂药”是宽泛类别。TRICOR 与 LIPITOR、CRESTOR、ZOCOR、VYTORIN、VASCEPA 的成分和机制不同，不能按毫克数自行换算、隔天轮换或叠加。", "en": "'Lipid-lowering medicine' is a broad category. TRICOR differs in ingredient and mechanism from LIPITOR, CRESTOR, ZOCOR, VYTORIN and VASCEPA and cannot be self-converted by milligrams, alternated by day or combined." }, { "zh": "标签中的 PPARα 机制不能替代血脂、肾肝功能、甲状腺状态、完整药单和既往反应的评估，也不能证明非诺贝特在所有人群中降低心血管事件。", "en": "The label's PPAR-alpha mechanism cannot replace assessment of lipids, kidney/liver function, thyroid status, the complete medicine list and prior response, and does not prove cardiovascular-event reduction in every population." }, { "zh": "全基因筛查不是网页替个人选择非诺贝特或他汀的默认答案。具体决定应围绕准确产品、临床问题、化验和完整药单由负责团队判断。", "en": "Whole-genome screening is not the site's default answer for choosing fenofibrate or a statin. A decision should be made by the responsible team around the exact product, clinical question, laboratory data and complete medicine list." } ], "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "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": "TRICOR", "generic": "非诺贝特", "dosageFormClass": "非诺贝特口服片：48 mg 黄色 FI 无刻痕片、145 mg 白色 FO 无刻痕片；两款历史 90 片瓶装" }, "labelSource": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "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." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "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." } }, { "source": { "id": "src_213ba84e19ef7b7a", "label": "FDA Drugs@FDA：TRICOR NDA 021656 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021656", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "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": "TRICOR 是非诺贝特品牌片的美国历史档案。48 mg 与 145 mg 是两种不同的每片标示量，不是可以自己按三倍关系换算的片数。2025 标签要求整片吞服，不得压碎、掰开、溶解或咀嚼；老年人的剂量选择与肾功能有关，与他汀或秋水仙碱同处药单时还需优先核对肌病风险。FDA 当前数据已把两个品牌规格列为 DISCN，因此本页展示的是可追溯说明书和历史包装，不是当前库存或购买入口。", "history": "FDA 于 2004-11-05 批准 NDA 021656 的 TRICOR 48 mg 与 145 mg。2019 年 FDA 又批准相关安全标签补充。AbbVie 2025-06 标签保留了两个规格、整片吞服、老年与肾功能、他汀/秋水仙碱、抗凝药等阅读边界；其包装条目分别记录 2025-11-30 与 2026-03-30 的营销结束日期。FDA Orange Book 2026-08-26 数据把两个规格均列为 DISCN。", "sourceDocuments": [ { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_213ba84e19ef7b7a", "label": "FDA Drugs@FDA：TRICOR NDA 021656 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021656", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_41c94f3376b38ce7", "label": "FDA：TRICOR／TRILIPIX 2019 补充批准信（NDA 021656/S-029）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009,%20021656Orig1s029,%20022224Orig1s015ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 021656（TRICOR 非诺贝特片 48 mg／145 mg；RLD；当前 DISCN）", "approvalTimeline": [ { "date": "2004-11-05", "title": { "zh": "FDA 批准 NDA 021656 的 48 mg／145 mg", "en": "FDA approved 48 mg and 145 mg under NDA 021656" }, "detail": { "zh": "Orange Book 当前数据保留两款产品的批准日期、RLD 与 DISCN 状态。该节点用于追溯产品史，不表示当前供应。", "en": "Current Orange Book data retain approval dates, RLD and DISCN status for both products. This traces product history and does not establish current supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2019-05-08", "title": { "zh": "FDA 批准补充安全标签", "en": "FDA approved a supplemental safety-label change" }, "detail": { "zh": "补充批准信把 TRICOR 48 mg／145 mg、NDA 021656 与上市后安全标签更新相连。", "en": "The supplement letter links TRICOR 48 mg/145 mg and NDA 021656 to a postmarketing safety-label update." }, "source": { "id": "src_41c94f3376b38ce7", "label": "FDA：TRICOR／TRILIPIX 2019 补充批准信（NDA 021656/S-029）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009,%20021656Orig1s029,%20022224Orig1s015ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "复核当前 FDA 产品状态", "en": "Current FDA product status reviewed" }, "detail": { "zh": "FDA Orange Book 数据将 48 mg 与 145 mg 两个 RLD 条目均列为 DISCN。该日期是本站复核日。", "en": "FDA Orange Book data list both 48 mg and 145 mg RLD rows as DISCN. This is the site's review date." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两种 RLD 品牌规格当前均列为 DISCN", "en": "Both RLD brand strengths currently listed as DISCN" }, "detail": { "zh": "保留 2025 有日期标签、两张官方历史包装面板和当前监管状态；不提供库存或购买路径。", "en": "Retains the dated 2025 label, two official historical package panels and current regulatory status; provides no stock or purchasing route." } }, { "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": "待逐项建立准确市场产品记录", "en": "Exact market-product records not established" }, "detail": { "zh": "不从美国品牌、通用名、mg 数字、颜色或 NDA 推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, generic name, milligram figures, colours or NDA." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "TRICOR 48 mg 可以一次吃三片当 145 mg 吗？", "en": "Can three TRICOR 48 mg tablets be used as 145 mg?" }, "answer": { "zh": "不能据网页这样做。三片 48 mg 的算术合计是 144 mg，但产品强度、处方和肾功能相关选择不能由 1 mg 差值或算术替代决定；请让药师或开方团队核对准确处方。", "en": "A webpage cannot authorise that. Three 48 mg tablets arithmetically total 144 mg, but product strength, prescription and kidney-related selection cannot be decided by arithmetic or a 1 mg difference. Ask the pharmacist or prescriber to check the exact prescription." } }, { "question": { "zh": "TRICOR 和阿托伐他汀、瑞舒伐他汀是同一种降脂药吗？", "en": "Is TRICOR the same lipid medicine as atorvastatin or rosuvastatin?" }, "answer": { "zh": "不是。TRICOR 是非诺贝特，标签将其描述为 PPARα 激动剂；阿托伐他汀和瑞舒伐他汀属于他汀类。不同机制不建立自行联用、换算或轮换关系，且标签提示与他汀同用时肌病风险增加。", "en": "No. TRICOR is fenofibrate, described by the label as a PPAR-alpha agonist, while atorvastatin and rosuvastatin are statins. Different mechanisms do not establish self-combination, conversion or alternation, and the label warns of increased myopathy risk with a statin." } }, { "question": { "zh": "为什么 FDA 还能看到说明书，但档案写已停止销售？", "en": "Why is an FDA label visible if the record says discontinued?" }, "answer": { "zh": "监管档案会长期保留历史标签和批准记录。FDA Orange Book 当前数据将两个规格列为 DISCN，所以可访问说明书不能证明当前有货、可购买或重新上市。", "en": "Regulatory archives retain historical labels and approvals. Current FDA Orange Book data list both strengths as DISCN, so an accessible label does not prove stock, purchasing availability or relaunch." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tricor/", "en": "https://origindrug.com/en/drugs/tricor/" }, "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." ] }