{ "id": "plaquenil", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "PLAQUENIL", "generic": "羟氯喹硫酸盐", "aliases": [ "PLAQUENIL", "hydroxychloroquine sulfate", "hydroxychloroquine", "羟氯喹硫酸盐", "羟氯喹" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 PLAQUENIL 羟氯喹硫酸盐口服薄膜衣片公开标签（DailyMed SPL v15，2026-05-21 发布）", "dosageFormClass": "口服薄膜衣片：每片羟氯喹硫酸盐 200 mg（相当于羟氯喹 155 mg）；本档案精确展示 NDC 59212-562-10 的 100 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1955（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Advanz Pharma US Corp. / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-plaquenil-hydroxychloroquine-sulfate-200mg-100-tablet-bottle-ndc-59212-562-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15，2026-05-21 发布", "en": "DailyMed SPL v15, published 21 May 2026" }, "dosageForm": { "zh": "羟氯喹硫酸盐口服薄膜衣片", "en": "hydroxychloroquine sulfate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-562-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片羟氯喹硫酸盐 200 mg（相当于羟氯喹 155 mg）；100 片瓶装", "en": "Hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine); 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341&name=100-counts.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "羟氯喹硫酸盐", "en": "hydroxychloroquine sulfate" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或使用方案", "en": "labelled amount per tablet; not an individual's tablet count or use plan" } }, { "ingredient": { "zh": "羟氯喹", "en": "hydroxychloroquine" }, "value": 155, "unit": "mg", "basisCode": "equivalent_base_per_tablet", "basisLabel": { "zh": "标签所列每片相当于羟氯喹的量；不是换算或调整指令", "en": "labelled hydroxychloroquine-equivalent amount per tablet; not a conversion or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "薄膜衣片", "en": "film-coated tablet" }, "imprint": "PLAQUENIL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-plaquenil-hydroxychloroquine-sulfate-200mg-100-tablet-bottle-ndc-59212-562-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341&name=100-counts.jpg", "alt": "PLAQUENIL 羟氯喹硫酸盐在美国 DailyMed 当前公开标签中的 200 mg、NDC 59212-562-10、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v15（2026-05-21 发布）", "presentation": "PLAQUENIL 羟氯喹硫酸盐口服薄膜衣片：每片 200 mg（相当于羟氯喹 155 mg），NDC 59212-562-10、100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 PLAQUENIL 羟氯喹硫酸盐口服薄膜衣片、每片 200 mg（相当于羟氯喹 155 mg）、NDC 59212-562-10、100 片瓶装展示面。它不代表其他 NDC、其他包装、其他市场、实际可得性、原研身份或可替代性；标签注明该片不应压碎或掰开，本页不把此图或毫克数字转成个人片数、联用、换药、停药或其他治疗结论，也不用于鉴定真伪。", "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLAQUENIL 说明书放大阅读：先核对每片 200 mg、准确瓶装与完整药单", "en": "PLAQUENIL label reading: check 200 mg per tablet, the exact bottle and the complete medicine list first" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为入口，帮助核对 PLAQUENIL、羟氯喹硫酸盐、口服薄膜衣片、每片标签量、准确瓶装与目标市场。它不提供个人片数、疗程、漏用补救、联用、停药或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check PLAQUENIL, hydroxychloroquine sulfate, film-coated oral tablets, labelled amount per tablet, the exact bottle and target market. It provides no individual tablet count, course, missed-use remedy, combination, stopping or switching plan." }, "checks": [ { "zh": "“200 mg”是这一准确片剂每片的标签量，并不是任何人每天该吃几片的网页指令；同一名称、不同市场、不同包装或另一种剂型都不能只按一个数字自行换算。", "en": "“200 mg” is the labelled amount in each tablet of this exact product, not a webpage instruction for how many tablets any person should take per day. The same name, a different market, another pack or another dosage form cannot be self-converted from one number." }, { "zh": "当前标签写明本片不应压碎或掰开。不要把“分成两半”当作减半、补用、调整或与其他药互换的办法；如实际药盒、吞咽状况或处方与页面不同，请带着实物问药师或开方团队。", "en": "The current label states that these tablets should not be crushed or divided. Do not treat “half a tablet” as a way to halve, make up, adjust or interchange medicine; if the actual pack, swallowing situation or prescription differs from this page, take the pack to a pharmacist or prescribing team." }, { "zh": "当前标签提示视网膜毒性与累计用量和治疗时间有关，并列出基线及治疗期间眼科检查。网页不能据此判断个人眼部症状、是否需要检查或何时调整；出现视力变化或其他担忧时，应尽快联系当地医疗团队。", "en": "The current label notes that retinal toxicity is related to cumulative dosage and treatment duration and lists baseline and during-treatment eye examinations. A webpage cannot decide an individual's eye symptoms, need for testing or timing of adjustment; contact the local care team promptly for visual changes or another concern." }, { "zh": "标签还提示心肌病、心律失常及多种合并药物相关风险。不要凭网页把任何降糖药、抗癫痫药、免疫相关药、抗感染药、胃药、草本或补充剂自行加、停、换或错开；请带完整处方药、非处方药与补充剂清单逐项让医生或药师核对。", "en": "The label also notes cardiomyopathy, arrhythmias and risks involving multiple co-medications. Do not self-add, stop, switch or separate any glucose-lowering medicine, antiseizure medicine, immune-related medicine, anti-infective, stomach medicine, herb or supplement from a webpage; have a clinician or pharmacist review the complete prescription, OTC and supplement list item by item." } ], "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Warnings, Dosage and Administration, Patient Counseling；Advanz Pharma US Corp.；SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "PLAQUENIL 怎样起作用：标签所述抗炎/免疫调节路径仍有未完全明确之处", "en": "How PLAQUENIL works: the label describes anti-inflammatory and immunomodulatory pathways that remain incompletely understood" }, "summary": { "zh": "美国 PLAQUENIL 标签将羟氯喹描述为 4-氨基喹啉类抗疟药和抗风湿药，并说明其在类风湿关节炎、系统性红斑狼疮及皮肤型红斑狼疮中的抗炎/免疫调节作用机制尚未完全明确。机制阅读帮助理解标签边界，不判断任何人的诊断、疗效、片数或联用结果。", "en": "The U.S. PLAQUENIL label describes hydroxychloroquine as a 4-aminoquinoline antimalarial and antirheumatic drug, and states that its anti-inflammatory/immunomodulatory mechanism in rheumatoid arthritis, systemic lupus erythematosus and chronic discoid lupus erythematosus is not fully understood. Mechanism reading helps interpret label boundaries; it does not decide anyone's diagnosis, response, tablet count or co-use result." }, "checks": [ { "zh": "“机制尚未完全明确”不是资料缺失后的猜测空间，而是提醒不能从一个机制词推断某个人一定有效、一定无效，或自行改变治疗方案。", "en": "“Not fully understood” is not space for a guess after missing information; it is a reminder that one mechanism term cannot predict that an individual will respond, will not respond or should self-change a treatment plan." }, { "zh": "“抗炎”“免疫调节”或“抗疟”是标签中的类别/作用线索，不是把不同疾病、不同剂型、不同品牌或相同通用名产品自动视为可替代、可同用或可按相同片数使用的依据。", "en": "“Anti-inflammatory”, “immunomodulatory” or “antimalarial” are labelled class/action clues, not grounds to treat different diseases, dosage forms, brands or products sharing a generic name as automatically interchangeable, combinable or usable at the same tablet count." }, { "zh": "对合并多药的老人或家属，最有用的下一步不是尝试从机制推演相互作用，而是把每一盒药、每一种非处方药和补充剂列齐，让药师或医生依准确诊断、检查和现行标签进行复核。", "en": "For an older person or family member using multiple medicines, the useful next step is not to reason out interactions from a mechanism. List every pack, OTC product and supplement so a pharmacist or clinician can review them against the exact diagnosis, tests and current labels." } ], "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Clinical Pharmacology；Advanz Pharma US Corp.；SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PLAQUENIL", "generic": "羟氯喹硫酸盐", "dosageFormClass": "口服薄膜衣片：每片羟氯喹硫酸盐 200 mg（相当于羟氯喹 155 mg）；本档案精确展示 NDC 59212-562-10 的 100 片瓶装" }, "labelSource": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 PLAQUENIL 公开标签将其列为羟氯喹硫酸盐口服薄膜衣片。本页帮助核对商品名、通用名、每片标签量、准确瓶装面板、目标市场和标签版本；它不把 200 mg 变成任何人的片数、疗程、联用、换药、停药或购买建议。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1955。该年份只定位这一美国公开标签档案；相近名称、相同通用名、不同包装或其他市场版本，都需要按准确产品和当地现行资料重新核对。", "sourceDocuments": [ { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 009768", "approvalTimeline": [ { "date": "1955", "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 PLAQUENIL 标签列示 Initial U.S. Approval: 1955。该年份只定位这一美国档案，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 PLAQUENIL label lists Initial U.S. Approval: 1955. This year locates this U.S. archive only; 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_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05-21", "title": { "zh": "DailyMed 当前公开 SPL v15", "en": "Current public SPL v15 published on DailyMed" }, "detail": { "zh": "DailyMed 将该 PLAQUENIL 口服薄膜衣片 SPL v15 的发布日期列为 2026-05-21。本页只选取一个准确 200 mg、NDC 59212-562-10、100 片瓶装面板，不据此推定其他 NDC、包装、市场、库存、疗程、个人片数、联用或替代关系。", "en": "DailyMed lists 21 May 2026 as the publication date for PLAQUENIL film-coated oral-tablet SPL v15. This page selects only one exact 200 mg, NDC 59212-562-10, 100-tablet bottle panel and does not establish another NDC, pack, market, stock, course, individual tablet count, co-use or substitution relationship." }, "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前口服薄膜衣片标签与一个准确瓶装面板", "en": "Current film-coated-tablet label and one exact bottle panel linked" }, "detail": { "zh": "本页展示的面板只对应羟氯喹硫酸盐每片 200 mg（相当于羟氯喹 155 mg）、NDC 59212-562-10、100 片瓶装。它不建立实际在售、库存、个人片数、治疗时长、检查安排、联用、停药、换药或其他包装状态。", "en": "The displayed panel only corresponds to hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine), NDC 59212-562-10, 100-tablet bottle. It does not establish actual availability, stock, individual tablet count, treatment duration, testing schedule, co-use, stopping, switching or another-pack status." } }, { "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": "不从美国标签或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需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 or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "PLAQUENIL 200 mg 是否表示一天吃一片，或可以掰半片减量？", "en": "Does PLAQUENIL 200 mg mean one tablet a day, or that half a tablet can be used to reduce a dose?" }, "answer": { "zh": "不是。200 mg 是这一准确片剂每片的标签量；当前标签写明不应压碎或掰开。网页不把标签量变成个人片数、减量、补用、疗程、换药或其他调整规则。请带实际药瓶、处方和完整药单向药师或开方团队核对。", "en": "No. 200 mg is the labelled amount in each tablet of this exact product; the current label states that it should not be crushed or divided. This page does not turn a labelled amount into an individual tablet count, reduction, make-up use, course, switch or adjustment rule. Take the actual bottle, prescription and complete medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "为什么页面提示眼睛、心脏和所有合并药都要一起核对？", "en": "Why does the page say that eyes, the heart and all co-medications need joint review?" }, "answer": { "zh": "这是当前标签中视网膜毒性、心肌病/心律失常及相互作用警示的阅读入口，并不替代个人风险判断。视力变化、心悸、晕厥或其他急性严重不适应及时联系当地医疗团队；所有药物、非处方药和补充剂应由熟悉准确处方的人逐项复核。", "en": "It is a reading entry point for the current label's retinal-toxicity, cardiomyopathy/arrhythmia and interaction warnings, not a substitute for an individual risk assessment. Contact local medical care promptly for visual changes, palpitations, fainting or another acute serious concern; every medicine, OTC product and supplement should be reviewed item by item by someone who knows the exact prescription." } } ], "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/plaquenil/", "en": "https://origindrug.com/en/drugs/plaquenil/" }, "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." ] }