{ "id": "monoket", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "MONOKET", "generic": "异山梨酯单硝酸酯", "aliases": [ "MONOKET", "monoket", "isosorbide mononitrate", "异山梨酯单硝酸酯" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：本页仅链接 FDA 的 MONOKET 异山梨酯单硝酸酯 10 mg、20 mg 口服片历史说明书及 2022 年补充批准函；不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售、持有人或原研/仿制结论。", "dosageFormClass": "MONOKET 异山梨酯单硝酸酯 10 mg／20 mg 口服片（美国历史标签）；不得与同成分缓释片、其他硝酸酯或相近名称产品混作同一产品", "dosageFormClassCode": "oral_modified_release", "route": "口服（历史标签产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "FDA 美国历史公开说明书（2014-10 修订）及补充批准函（2022-02-01）", "archiveSponsorText": "未依据历史文件建立当前持有人或供应结论" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "IMDUR", "isosorbide mononitrate extended-release", "异山梨酯单硝酸酯缓释片", "nitroglycerin", "硝酸甘油", "isosorbide dinitrate", "二硝酸异山梨酯" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-monoket-isosorbide-mononitrate-tablet-10mg-100bottle-ndc-62175-3610-1-historical", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史公开说明书（2014-10 修订）", "en": "FDA U.S. historical prescribing information (revised Oct 2014)" }, "dosageForm": { "zh": "MONOKET 异山梨酯单硝酸酯口服片", "en": "MONOKET isosorbide mononitrate oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62175-3610-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片异山梨酯单硝酸酯 10 mg；100 片瓶装（美国历史标签）", "en": "Isosorbide mononitrate 10 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "异山梨酯单硝酸酯", "en": "isosorbide mononitrate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率、换算或换药指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET 10 mg、NDC 62175-3610-1、100 片瓶装的美国历史标签身份字段（2014-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-monoket-isosorbide-mononitrate-tablet-20mg-100bottle-ndc-62175-3620-1-historical", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史公开说明书（2014-10 修订）", "en": "FDA U.S. historical prescribing information (revised Oct 2014)" }, "dosageForm": { "zh": "MONOKET 异山梨酯单硝酸酯口服片", "en": "MONOKET isosorbide mononitrate oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62175-3620-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片异山梨酯单硝酸酯 20 mg；100 片瓶装（美国历史标签）", "en": "Isosorbide mononitrate 20 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "异山梨酯单硝酸酯", "en": "isosorbide mononitrate" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率、换算或换药指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET 20 mg、NDC 62175-3620-1、100 片瓶装的美国历史标签身份字段（2014-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史说明书文字，但未保留与单一规格、单一包装一一对应的官方包装图，故不展示包装图片", "en": "Historical-label text was reviewed, but no official package image matching one exact strength and package was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 FDA 历史说明书中 MONOKET、异山梨酯单硝酸酯、10 mg／20 mg、两个 NDC 与各 100 片瓶装的文字身份字段。此次未保留能与单一强度、单一 NDC 和单一历史包装逐一对应、可安全公开展示的官方图片；为避免把零售图、版本不明图、同成分缓释片、其他硝酸酯或其他市场图片误作准确 MONOKET 包装，页面不展示包装图片，只保留可放大阅读的一手文件。", "en": "This dossier retains MONOKET, isosorbide mononitrate, 10 mg/20 mg, two NDCs and each 100-tablet bottle as text identity fields from the FDA historical prescribing information. No official image that can safely be matched one to one to one strength, one NDC and one historical package was retained; to avoid treating a retail image, version-uncertain image, same-ingredient extended-release tablet, other nitrate or another-market image as an exact MONOKET pack, the page withholds package imagery and retains the primary document for enlarged reading." }, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MONOKET 历史说明书放大阅读", "en": "MONOKET historical label reading in larger print" }, "summary": { "zh": "先按准确品牌、通用名、片剂形式、每片标示量与目标市场读这份 FDA 历史文件；它不替代今天的处方、现行标签或专业人员的个人判断。", "en": "Read this FDA historical document first by exact brand, generic name, tablet form, labelled amount per tablet and target market; it does not replace today's prescription, current label or a professional's individual assessment." }, "checks": [ { "zh": "10 mg 与 20 mg 是两种分别列出的历史片剂身份。共同成分、相近 mg 数字或相似名称都不构成自行加减、掰片、补用、轮换、替换或把不同剂型换算的依据。", "en": "10 mg and 20 mg are two separately listed historical tablet identities. A shared ingredient, nearby mg number or similar name is not a basis for self-adjusting, splitting, making up, alternating, substituting or converting another dosage form." }, { "zh": "请把 MONOKET 与同成分缓释片、其他硝酸酯和名称相近产品分开核对。若实际药盒或完整药单中出现这些项目，先让药师或开方团队核对，而不是据页面自行叠加、错开、换用或停用。", "en": "Check MONOKET separately from same-ingredient extended-release tablets, other nitrates and similarly named products. If these appear on the actual pack or complete medicine list, ask a pharmacist or prescribing team to review them before any self-directed combining, spacing, switching or stopping." }, { "zh": "所引 2014 年文件记载了与若干勃起功能障碍用药和利奥西呱有关的禁忌警示。它是历史标签阅读线索，不是针对个人的停药、联用或紧急处理建议；任何实际同用问题需要尽快由了解完整药单的专业人员确认。", "en": "The cited 2014 document records contraindication warnings involving certain erectile-dysfunction medicines and riociguat. This is a historical-label reading cue, not personal advice to stop, combine or manage an urgent issue; any actual co-use question needs prompt confirmation by a professional who knows the complete medicine list." } ], "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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": "异山梨酯单硝酸酯怎样起作用：历史标签描述其使血管平滑肌松弛", "en": "How isosorbide mononitrate works: the historical label describes relaxation of vascular smooth muscle" }, "summary": { "zh": "FDA 的 MONOKET 历史说明书将异山梨酯单硝酸酯列为有机硝酸酯，并说明其主要药理作用是使血管平滑肌松弛，继而扩张外周动脉和静脉。这个机制概述只帮助理解为何血压、头晕、其他硝酸酯及完整药单需要一起核对；它不告诉任何人在胸痛时怎么做、吃几片、何时服、如何加减、联用、停用或换药。", "en": "The FDA historical MONOKET label identifies isosorbide mononitrate as an organic nitrate and describes its principal pharmacological action as relaxation of vascular smooth muscle, followed by dilation of peripheral arteries and veins. This mechanism overview only helps explain why blood pressure, dizziness, other nitrates and the complete medicine list need review together; it does not tell anyone what to do during chest pain, how many tablets to take, when to take them, or how to adjust, combine, stop or switch treatment." }, "checks": [ { "zh": "“血管平滑肌松弛”解释的是药理路径，不代表 MONOKET 10 mg／20 mg 片剂、同成分缓释片、二硝酸异山梨酯、硝酸甘油或其他心血管药可以自行按毫克数互换、叠加、错开或轮换。请把准确药盒和完整药单交由药师或开方团队逐项核对。", "en": "“Vascular smooth-muscle relaxation” explains a pharmacological pathway. It does not make MONOKET 10 mg/20 mg tablets, same-ingredient extended-release tablets, isosorbide dinitrate, nitroglycerin or another cardiovascular medicine self-convertible by milligrams, combinable, separable or alternatable. Have a pharmacist or prescribing team review the exact packs and complete medicine list item by item." }, { "zh": "这份历史标签也明确指出该口服产品起效不够快，不能用于终止一次急性心绞痛发作。机制页面和历史文件都不是急性胸痛自救指南；如有新的或加重的胸痛、晕厥、明显呼吸困难或其他紧急症状，应立即使用当地紧急医疗路径，而不是依据网页自行调整药物。", "en": "The historical label also explicitly states that this oral product does not act rapidly enough to abort an acute angina episode. Neither a mechanism page nor a historical document is an acute-chest-pain self-care guide; with new or worsening chest pain, fainting, marked breathing difficulty or another emergency symptom, use the local emergency pathway immediately rather than self-adjusting medicine from a webpage." }, { "zh": "历史标签中关于 PDE5 抑制剂、利奥西呱、酒精及其他血管扩张药的内容，是提示要完整核对相互作用的线索，不是网页给出的个人停药、联用、错开时间或紧急处理结论。任何实际同用或不适问题，应让了解完整药单的专业人员尽快判断。", "en": "The historical-label material on PDE5 inhibitors, riociguat, alcohol and other vasodilators is a cue for complete interaction review, not a webpage conclusion about an individual's stopping, co-use, spacing or urgent management. Any actual co-use or symptom concern needs prompt assessment by a professional who knows the complete medicine list." } ], "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）美国历史处方信息（2014-10 修订；临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MONOKET", "generic": "异山梨酯单硝酸酯", "dosageFormClass": "MONOKET 异山梨酯单硝酸酯 10 mg／20 mg 口服片（美国历史标签）；不得与同成分缓释片、其他硝酸酯或相近名称产品混作同一产品" }, "labelSource": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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 历史说明书列示 MONOKET 异山梨酯单硝酸酯 10 mg 和 20 mg 口服片。这里将品牌、通用名、准确片剂强度、历史文件日期和官方原文入口分开呈现；10 mg 与 20 mg 是各自片剂的标签身份，不是个人片数、频率、补用、换药或与其他硝酸酯/同成分产品换算的指令。", "history": "FDA 于 2014-10 修订的历史说明书是本页的主要电子阅读文件。FDA 的 2022-02-01 补充批准函确认了针对 MONOKET 10 mg、20 mg 片剂的一个补充申请；函中所述为检验设施变更，不能据此推定当前标签、生产商、市场供应或个人用药。", "sourceDocuments": [ { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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_7df690dfa72d84ab", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg NDA 020215/S-027 补充批准函（2022-02-01，更正件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020215Orig1s027Correctedltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020215（FDA 历史标签与 2022 补充批准函）", "approvalTimeline": [ { "date": "2014-10", "title": { "zh": "FDA 历史说明书修订", "en": "FDA historical prescribing-information revision" }, "detail": { "zh": "本页链接的 MONOKET 异山梨酯单硝酸酯 10 mg／20 mg 口服片 FDA 说明书标示为 2014-10 修订。它是可复核的历史阅读入口，不代表当前标签、供应、持有人、其他市场状态或个人用药。", "en": "The linked FDA prescribing information for MONOKET isosorbide mononitrate 10 mg/20 mg oral tablets is marked revised October 2014. It is a traceable historical-reading entry point, not a conclusion about current labeling, supply, holder, another-market status or individual use." }, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.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": "2022-02-01", "title": { "zh": "NDA 020215/S-027 补充批准（更正件）", "en": "NDA 020215/S-027 supplemental approval (corrected letter)" }, "detail": { "zh": "FDA 的更正批准函记载 MONOKET 10 mg、20 mg 片剂的补充申请于 2022-02-01 获批，所述事项为增加备选辅料分析检测设施。该监管节点不建立当前标签、当前生产商、供应、个人用法或任何市场的可售资格。", "en": "The FDA corrected approval letter records approval on 1 Feb 2022 of a supplement for MONOKET 10 mg and 20 mg tablets, described as adding an alternate analytical testing facility for excipients. This regulatory node does not establish current labeling, current manufacturer, supply, individual use or sale eligibility in any market." }, "source": { "id": "src_7df690dfa72d84ab", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg NDA 020215/S-027 补充批准函（2022-02-01，更正件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020215Orig1s027Correctedltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_letter", "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": "已链接历史标签与补充批准函", "en": "Historical label and supplemental-approval letter linked" }, "detail": { "zh": "仅对应本页所列 FDA 历史文件，不能据此推定当前供应、现行标签、持有人或购买资格。", "en": "Only the FDA historical documents listed on this page are linked; current supply, labeling, holder and sale eligibility are not inferred." } }, { "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": "不从美国历史文件推定当地商品名、批准、规格、供应、原研关系或可替代性。", "en": "No local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. historical documents." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "这份 FDA 历史文件能代表我手上或本地药房的现行产品吗？", "en": "Does this FDA historical document represent the current product in my hand or local pharmacy?" }, "answer": { "zh": "不能自动代表。它的价值是提供准确品牌、通用名、历史片剂呈现和原始文件的阅读入口；当前产品问题必须回到实际药盒和目标市场的现行官方标签，并由专业人员核对。", "en": "Not automatically. Its value is an entry point to the exact brand, generic name, historical tablet presentations and original document; current-product questions must return to the actual pack and the target market's current official label with professional review." } } ], "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/monoket/", "en": "https://origindrug.com/en/drugs/monoket/" }, "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." ] }