{ "id": "malarone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-16", "status": "published_traceable_archive" }, "names": { "brand": "Malarone", "generic": "阿托伐醌/丙胍", "aliases": [ "MALARONE", "atovaquone", "proguanil hydrochloride", "阿托伐醌", "盐酸丙胍", "proguanil", "atovaquone and proguanil hydrochloride", "阿托伐醌/盐酸丙胍", "0173-0675-01", "GX CM3" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "成人片与儿童片（FDA 2013 标签档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000（FDA 2013 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MALARONE adult-strength tablets 250 mg/100 mg" ], "excludedProductCues": [ "MALARONE pediatric tablets", "MALARONE paediatric tablets", "62.5 mg atovaquone", "25 mg proguanil hydrochloride", "NDC 0173-0676-01" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-malarone-atovaquone-proguanil-film-coated-tablet-adult-250mg-100mg-100ct-ndc-0173-0675-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签，2026-06-10 更新", "en": "DailyMed public label, updated 10 Jun 2026" }, "dosageForm": { "zh": "MALARONE 阿托伐醌/盐酸丙胍薄膜衣口服片（成人片）", "en": "MALARONE atovaquone/proguanil hydrochloride film-coated oral tablet (adult tablet)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0675-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿托伐醌 250 mg／盐酸丙胍 100 mg；100 片儿童安全瓶装", "en": "Atovaquone 250 mg / proguanil hydrochloride 100 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=malarone-spl-graphic-03.jpg&setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐醌", "en": "atovaquone" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、预防或治疗方案", "en": "labelled amount per tablet; not an individual's tablet count, prevention or treatment plan" } }, { "ingredient": { "zh": "盐酸丙胍", "en": "proguanil hydrochloride" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、预防或治疗方案", "en": "labelled amount per tablet; not an individual's tablet count, prevention or treatment plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片儿童安全瓶装", "en": "100-tablet child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round, biconvex film-coated tablet" }, "imprint": "GX CM3", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_625c68d495bcd278", "label": "DailyMed（NLM）：MALARONE 阿托伐醌/盐酸丙胍当前美国公开标签（GSK；2026-06-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=malarone-spl-graphic-03.jpg&setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887&type=img", "alt": "MALARONE 阿托伐醌/丙胍在美国 DailyMed GSK 公开标签中的成人片 100 片装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（GSK，2026-06 修订；包装图稿 2024-01）", "presentation": "MALARONE 成人片：每片阿托伐醌 250 mg / 盐酸丙胍 100 mg、100 片装标签图（DailyMed GSK 公开标签所列）。", "notice": "此为美国 DailyMed GSK 公开标签中明确对应 MALARONE 成人片、每片阿托伐醌 250 mg / 盐酸丙胍 100 mg、100 片装的标签图，只帮助核对品牌、两个成分、成人片、标示强度、包装数量和来源；不用于鉴定真伪，也不证明儿童片、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_625c68d495bcd278", "label": "DailyMed（NLM）：MALARONE 公开标签（GSK，2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MALARONE 说明书放大阅读：成人片和儿童片的两种成分不能只看总片数", "en": "MALARONE label reading: adult and paediatric tablets contain two components and cannot be read from tablet count alone" }, "summary": { "zh": "以 FDA 2013 MALARONE 美国标签为阅读入口，核对阿托伐醌/盐酸丙胍、成人片或儿童片、两种成分、包装和目标市场；不提供旅行前后个人预防或治疗用量、补服、换药或组合方案。", "en": "Using the FDA's 2013 U.S. MALARONE label as an entry point, this checks atovaquone/proguanil hydrochloride, adult or paediatric tablets, two components, package and target market; it does not provide an individual's prevention or treatment amount, make-up use, switching or combination plan." }, "checks": [ { "zh": "成人片标签标示每片阿托伐醌 250 mg 与盐酸丙胍 100 mg；儿童片是另一种两成分产品。品牌相同、片数相同或只看一个通用名，都不能证明可自行换算或互换。", "en": "The adult-tablet label states atovaquone 250 mg plus proguanil hydrochloride 100 mg per tablet; paediatric tablets are a different two-component product. A shared brand, tablet count or one generic name does not establish self-conversion or interchangeability." }, { "zh": "旅行目的地、暴露风险、疾病诊断、肝肾状况、妊娠可能性、呕吐腹泻和完整药单都会改变专业判断；不要凭旅行日期或网页自行开始、补服、延长、停止或与其他抗感染药叠加。", "en": "Destination, exposure risk, diagnosis, liver/kidney status, possible pregnancy, vomiting/diarrhoea and the complete medicine list affect professional judgement; do not self-start, make up, extend, stop or combine with another anti-infective from travel dates or a webpage." }, { "zh": "旅行中或返程后发热、寒战、意识变化、持续呕吐/腹泻、黄疸、呼吸困难或其他急性问题，应及时使用当地医疗支持，并说明旅行地点、日期及实际药盒。", "en": "With fever, chills, mental-status change, persistent vomiting/diarrhoea, jaundice, breathing difficulty or another acute issue during or after travel, use timely local medical support and report destinations, dates and the actual package." } ], "source": { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿托伐醌/丙胍怎样起作用：两个成分作用于寄生虫核酸复制所需的不同路径", "en": "How atovaquone/proguanil works: its two ingredients act on different pathways needed for parasite nucleic-acid replication" }, "summary": { "zh": "DailyMed 的 MALARONE 标签将其描述为阿托伐醌与盐酸丙胍的固定剂量复方抗疟药：阿托伐醌选择性抑制寄生虫线粒体电子传递；丙胍主要经代谢物环胍通过二氢叶酸还原酶发挥作用。这解释药理路径，不判断旅行地点是否有疟疾风险、是否需要预防或治疗、该选何种产品、个人剂量或疗程。", "en": "The DailyMed MALARONE label describes a fixed-dose antimalarial combination of atovaquone and proguanil hydrochloride: atovaquone selectively inhibits parasite mitochondrial electron transport, while proguanil acts mainly through cycloguanil, a dihydrofolate-reductase inhibitor. This explains a pharmacologic pathway; it does not determine travel risk, whether prevention or treatment is needed, product selection, an individual dose or course." }, "checks": [ { "zh": "“两个成分、两条路径”不表示可以自行用阿托伐醌、丙胍、其他抗疟药或余药拼配、加量、轮换或替代。旅行目的地、暴露时间、准确产品、体重相关信息、既往病史、完整药单和目标市场现行建议都需要专业人员一并确认。", "en": "“Two ingredients, two pathways” does not permit self-combining, increasing, alternating or substituting atovaquone, proguanil, another antimalarial or leftovers. Destination, exposure timing, exact product, weight-related information, history, complete medicine list and current target-market guidance all need professional confirmation together." }, { "zh": "机制不能让成人片与儿童片互相按片数或单个数字换算。固定剂量复方中每个成分、每片规格、适用人群与实际包装都是产品身份的一部分；不要从网页推导个人服用方案。", "en": "Mechanism cannot make adult and paediatric tablets interchangeable by tablet count or one number. In a fixed-dose combination, each ingredient, each tablet strength, the intended population and actual pack are all part of product identity; do not derive an individual regimen from a webpage." }, { "zh": "该标签列有与其他药物及严重不适相关的警示。正在使用抗凝药、抗感染药或多种药物，或出现持续呕吐、严重腹泻、皮疹、呼吸不适或其他急性问题时，应及时联系当地医疗支持；不要仅凭机制页面自行开始、补服、停用或换药。", "en": "The label includes warnings related to other medicines and serious symptoms. With anticoagulants, anti-infectives or multiple medicines, or persistent vomiting, severe diarrhoea, rash, breathing trouble or another acute concern, contact local medical support promptly; do not self-start, redose, stop or switch based only on a mechanism page." } ], "source": { "id": "src_625c68d495bcd278", "label": "DailyMed（NLM）：MALARONE 公开标签（GSK，2026-06 修订；临床药理/微生物学）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Malarone", "generic": "阿托伐醌/丙胍", "dosageFormClass": "成人片与儿童片（FDA 2013 标签档案所列）" }, "labelSource": { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "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": "2026-08-20", "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": "FDA 的 MALARONE（atovaquone and proguanil hydrochloride）2013 美国标签档案列示成人片与儿童片，并列出美国初始批准年份为 2000。此处仅提供可复核的美国历史监管文件入口，不推定其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "成人与儿童片为不同强度呈现，必须以实际包装、规格、市场和现行标签逐项核验。历史标签不是个体预防、治疗、处方或购买的依据。", "sourceDocuments": [ { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "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 021078", "approvalTimeline": [ { "date": "2000", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2000。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_ccdd1206c299d442", "label": "FDA: MALARONE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2013-02", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2013-02 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2013-02 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_ccdd1206c299d442", "label": "FDA: MALARONE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/malarone/", "en": "https://origindrug.com/en/drugs/malarone/" }, "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." ] }