{ "id": "mestinon", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Mestinon", "generic": "溴吡斯的明", "aliases": [ "pyridostigmine", "pyridostigmine bromide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经肌肉", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v20，2023-02-02 发布）", "dosageFormClass": "口服溶液、即释片与缓释片：相同品牌与通用名不建立自行换算、替换或掰开关系（美国公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1955–1965（DailyMed 当前美国标签所列三种剂型的历史营销记录节点）", "archiveSponsorText": "Bausch Health US, LLC / 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-mestinon-immediate-tablet-60mg-ndc-0187-3010-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2023-02-02 发布）", "en": "DailyMed SPL v20 (published 2 February 2023)" }, "dosageForm": { "zh": "溴吡斯的明溴化物即释口服片", "en": "pyridostigmine bromide immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-3010-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 60 mg；100 片瓶装", "en": "60 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=60mg-label-01.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "溴吡斯的明溴化物", "en": "pyridostigmine bromide" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "MESTINON / V / 60", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 60 mg 即释片、100 片瓶装（NDC 0187-3010-30；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" }, { "id": "us-mestinon-timespan-er-tablet-180mg-ndc-0187-3013-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2023-02-02 发布）", "en": "DailyMed SPL v20 (published 2 February 2023)" }, "dosageForm": { "zh": "MESTINON TIMESPAN 缓释口服片", "en": "MESTINON TIMESPAN extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-3013-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 180 mg；30 片瓶装（TIMESPAN 缓释片）", "en": "180 mg per tablet; 30-tablet bottle (TIMESPAN extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "溴吡斯的明溴化物", "en": "pyridostigmine bromide" }, "value": 180, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light straw yellow" }, "shape": { "zh": "椭圆形胶囊状片", "en": "oval capsule-shaped tablet" }, "imprint": "MES / V / 180", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON TIMESPAN 180 mg 缓释片、30 片瓶装（NDC 0187-3013-30；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" }, { "id": "us-mestinon-oral-solution-60mg-per-5ml-ndc-0187-3012-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2023-02-02 发布）", "en": "DailyMed SPL v20 (published 2 February 2023)" }, "dosageForm": { "zh": "溴吡斯的明溴化物口服溶液", "en": "pyridostigmine bromide oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-3012-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含 60 mg；473 mL 瓶装", "en": "60 mg per 5 mL; 473 mL bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=70394173-d6cf-49f7-8379-75d00bcd48fb-00.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "溴吡斯的明溴化物", "en": "pyridostigmine bromide" }, "value": 60, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标示量", "en": "labelled amount per 5 mL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": { "value": 473, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶", "en": "bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "瓶/包装", "en": "bottle per package" } }, "physicalClues": { "color": { "zh": "液体制剂；请以准确标签和量取工具核对", "en": "liquid formulation; check the exact label and measuring device" }, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 口服溶液 60 mg/5 mL、473 mL 瓶装（NDC 0187-3012-20；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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": "us-mestinon-immediate-tablet-60mg-ndc-0187-3010-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=60mg-label-01.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "alt": "MESTINON 溴吡斯的明溴化物 60 mg 即释口服片、NDC 0187-3010-30、100 片瓶装的美国 DailyMed 公开标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v20（2023-02-02 发布）", "presentation": "MESTINON 溴吡斯的明溴化物 60 mg 即释口服片；NDC 0187-3010-30；100 片瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 MESTINON 60 mg 即释片、NDC 0187-3010-30、100 片瓶装。它不代表 180 mg TIMESPAN 缓释片、60 mg/5 mL 口服溶液、其他包装、其他市场或当前可得性；不用于鉴定真伪，也不提供个人片数、口服液毫升数、掰开、替换或调整建议。", "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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": "MESTINON 说明书放大阅读：60 mg 片、180 mg TIMESPAN 与 60 mg/5 mL 口服液须分别核对", "en": "MESTINON label reading: 60 mg tablets, 180 mg TIMESPAN and 60 mg/5 mL oral solution must be checked separately" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 MESTINON、溴吡斯的明溴化物、准确剂型、每单位标示量、NDC 和包装。它不提供任何人的片数、口服液毫升数、间隔、漏用处理、联用、转换或停药方案。", "en": "This module uses the U.S. DailyMed public label to check MESTINON, pyridostigmine bromide, the exact form, labelled amount per unit, NDC and pack. It does not provide anyone's tablet count, oral-solution millilitres, interval, missed-use action, combination, switching or stopping plan." }, "checks": [ { "zh": "60 mg 即释片、180 mg TIMESPAN 缓释片和每 5 mL 含 60 mg 的口服液，是标签分别列出的产品身份。相同品牌或通用名不能使它们自行按 mg、片数或 mL 换算、补用、叠加或替代。", "en": "The 60 mg immediate-release tablet, 180 mg TIMESPAN extended-release tablet and oral solution containing 60 mg per 5 mL are separately listed product identities. A shared brand or generic name does not make them self-convertible, make-up interchangeable, combinable or substitutable by milligrams, tablets or millilitres." }, { "zh": "60 mg 即释片标签描述有四等分刻痕，180 mg TIMESPAN 标签描述无刻痕；这些是外观核对字段，不是网页批准任何人掰开、压碎、分装或按比例减量的指令。涉及准确片剂的处理须以现行标签、处方和药师/开方团队为准。", "en": "The 60 mg immediate-release tablet is described as quadrisect scored and the 180 mg TIMESPAN tablet as unscored. These are appearance-check fields, not permission from this webpage for anyone to split, crush, repackage or proportionally reduce a tablet. Handling the exact tablet must follow the current label, prescription and pharmacist/prescribing-team advice." }, { "zh": "口服液“60 mg/5 mL”是该液体的浓度身份信息，不是把片剂换算成家庭量匙或个人 mL 数的公式。应同时核对准确产品、标签、随附量取工具和开方信息；网页不生成换算或量取建议。", "en": "Oral-solution wording of “60 mg/5 mL” is a concentration identity field, not a formula for changing tablets into household-spoon or personal millilitre amounts. Check the exact product, label, supplied measuring device and prescribing information together; this page does not generate a conversion or measuring instruction." }, { "zh": "标签提示过量或不足的表现可能难以区分，并涉及严重无力、呼吸/吞咽困难、明显分泌物或严重胃肠道症状等紧急风险。出现急性、严重或进行性不适时，应优先使用当地紧急医疗支持；不要依据网页自行加量、补用、暂停或换成另一种产品。", "en": "The label notes that signs of too much or too little may be difficult to distinguish and addresses urgent risks including severe weakness, breathing/swallowing difficulty, marked secretions or serious gastrointestinal symptoms. With an acute, serious or progressive concern, prioritise local urgent medical support; do not self-increase, make up, pause or change product from this page." } ], "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "溴吡斯的明怎样起作用：标签描述其抑制胆碱酯酶，但机制不是个人调整依据", "en": "How pyridostigmine works: the label describes cholinesterase inhibition, not a basis for personal adjustment" }, "summary": { "zh": "DailyMed 标签将溴吡斯的明描述为口服活性胆碱酯酶抑制剂，可抑制乙酰胆碱的分解并帮助神经冲动传递。它解释的是标签中的药理路径，不判断任何人的症状原因、产品选择、片数、口服液毫升数、联用或调整方案。", "en": "The DailyMed label describes pyridostigmine as an orally active cholinesterase inhibitor that inhibits acetylcholine breakdown and helps nerve-impulse transmission. This explains a labelled pharmacologic pathway; it does not determine anyone's symptom cause, product choice, tablet count, oral-solution millilitres, combination or adjustment plan." }, "checks": [ { "zh": "“抑制胆碱酯酶”不是对任何无力、疲劳、眼睑、吞咽、呼吸或胃肠道症状的自我诊断，也不能替代由专业人员结合准确产品、病情和检查资料作出的判断。", "en": "“Cholinesterase inhibition” is not a self-diagnosis for weakness, fatigue, eyelid, swallowing, breathing or gastrointestinal symptoms, and cannot replace professional judgement based on the exact product, condition and clinical information." }, { "zh": "共享这一机制、相近通用名或同为口服产品，不使 MESTINON 的液体、即释片、缓释片或另一种神经肌肉相关药物可以自行叠加、轮换、按 mg 换算或替代。完整药单和现行标签必须一起复核。", "en": "A shared mechanism, similar generic name or oral route does not make MESTINON liquid, immediate-release tablets, extended-release tablets or another neuromuscular medicine self-combinable, alternatable, milligram-convertible or substitutable. The complete medicine list and current labels require joint review." }, { "zh": "机制页面不能处理突然或加重的无力、呼吸/吞咽困难、晕厥、严重分泌物或其他急性不适。出现这类问题时，应优先使用当地紧急医疗支持，而不是继续试验不同剂型或根据包装数字自行调整。", "en": "A mechanism page cannot manage sudden or worsening weakness, breathing/swallowing difficulty, fainting, severe secretions or another acute concern. With these problems, prioritise local urgent medical support rather than experimenting with forms or adjusting from package numbers." } ], "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Clinical Pharmacology；Bausch Health）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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": "Mestinon", "generic": "溴吡斯的明", "dosageFormClass": "口服溶液、即释片与缓释片：相同品牌与通用名不建立自行换算、替换或掰开关系（美国公开标签所列）" }, "labelSource": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" }, "productRoutes": [ { "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" }, "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": "DailyMed 的 MESTINON（pyridostigmine bromide）美国公开标签同时列出 60 mg/5 mL 口服溶液、60 mg 即释片和 180 mg TIMESPAN 缓释片。页面帮助把商品名、通用名、准确剂型、标示量、NDC、包装与目标市场一起核对；不把包装数字变成个人毫升数、片数、时间表、联用、转换或停药方案。", "history": "当前公开标签将三种口服产品并列，而它们具有不同 NDC、每单位标示量和缓释属性。共享品牌或通用名不能证明口服液、即释片与缓释片可以自行互换、按 mg 换算、掰开或以一种形式补另一种。此页仅提供美国公开标签的阅读入口，不作其他市场或实际可得性结论。", "sourceDocuments": [ { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" }, { "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 009829（60 mg 片）/ NDA 011665（180 mg TIMESPAN）/ NDA 015193（口服溶液；均为当前 DailyMed 标签列示的产品记录）", "approvalTimeline": [ { "date": "1955", "title": { "zh": "60 mg 片的历史营销记录节点", "en": "Historical marketing-record node for the 60 mg tablet" }, "detail": { "zh": "当前 DailyMed 标签在 60 mg 片的 NDC 表中列示 NDA 009829 与 1955 年营销起始节点。本页把它作为该美国公开标签的历史产品记录，不据此推定其他市场状态。", "en": "The current DailyMed label lists NDA 009829 and a 1955 marketing-start node for the 60 mg tablet. This page treats it as a historical product-record entry in the U.S. public label, not as evidence for another market." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" } }, { "date": "1959", "title": { "zh": "180 mg TIMESPAN 的历史营销记录节点", "en": "Historical marketing-record node for 180 mg TIMESPAN" }, "detail": { "zh": "当前 DailyMed 标签在 180 mg TIMESPAN 的 NDC 表中列示 NDA 011665 与 1959 年营销起始节点。其缓释属性与 60 mg 即释片和口服液须分别核对。", "en": "The current DailyMed label lists NDA 011665 and a 1959 marketing-start node for 180 mg TIMESPAN. Its extended-release property must be checked separately from the 60 mg immediate-release tablet and oral solution." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" } }, { "date": "1965", "title": { "zh": "口服溶液的历史营销记录节点", "en": "Historical marketing-record node for the oral solution" }, "detail": { "zh": "当前 DailyMed 标签在口服溶液的 NDC 表中列示 NDA 015193 与 1965 年营销起始节点。60 mg/5 mL 是液体产品身份字段，不是换算指令。", "en": "The current DailyMed label lists NDA 015193 and a 1965 marketing-start node for the oral solution. 60 mg/5 mL is a liquid-product identity field, not a conversion instruction." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" } }, { "date": "2023-02-02", "title": { "zh": "DailyMed 当前 SPL v20 公开", "en": "Current SPL v20 published on DailyMed" }, "detail": { "zh": "DailyMed 的当前 MESTINON SPL v20 公开日期为 2023-02-02。本页将其作为来源版本信息，不据此说明实际可得性或个人用药结论。", "en": "DailyMed lists 2 February 2023 as the publication date for the current MESTINON SPL v20. This page uses it as source-version information, not as evidence of availability or an individual-use conclusion." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签与三个精确包装身份", "en": "Current label and three exact package identities linked" }, "detail": { "zh": "本页分别列示 60 mg 即释片、180 mg TIMESPAN 缓释片与 60 mg/5 mL 口服溶液；不由此建立实际在售、库存、个人用量或可自行替换结论。", "en": "This page separately lists the 60 mg immediate-release tablet, 180 mg TIMESPAN extended-release tablet and 60 mg/5 mL oral solution; it does not establish actual availability, stock, individual use or self-directed interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地商品名、批准、规格、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, strength, pack, supply, originator relationship or interchangeability is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "60 mg、180 mg TIMESPAN 和 60 mg/5 mL 能否只按毫克数互换？", "en": "Can 60 mg, 180 mg TIMESPAN and 60 mg/5 mL be exchanged from milligrams alone?" }, "answer": { "zh": "不能。它们分别对应即释片、缓释片和口服液的不同产品身份。完整品牌、剂型、标示量、NDC、标签版本和处方都需要一起由药师或开方团队核对。", "en": "No. They identify different product forms: an immediate-release tablet, extended-release tablet and oral solution. The complete brand, form, labelled amount, NDC, label version and prescription need joint review by a pharmacist or prescribing team." } } ], "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/mestinon/", "en": "https://origindrug.com/en/drugs/mestinon/" }, "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." ] }