{ "id": "amaryl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Amaryl", "generic": "格列美脲", "aliases": [ "AMARYL", "glimepiride", "格列美脲" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：DailyMed 历史公开标签（2018-12 修订）。该标签记录三种瓶装的美国营销终止日期为 2023-08-31；本页因此仅作历史文件和药盒身份阅读，不将其表述为当前在售、供应或任何其他市场状态。", "dosageFormClass": "格列美脲口服片：1 mg、2 mg、4 mg（历史美国标签所列；各 100 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（历史美国标签所列初始批准年份）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC（历史美国标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "glimepiride generic tablet", "格列美脲仿制片", "glimepiride injection", "格列美脲注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-amaryl-glimepiride-tablet-1mg-100-bottle-ndc-0039022110-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史公开标签（Sanofi-Aventis；2018-12 修订；标签记录美国营销终止于 2023-08-31）", "en": "U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)" }, "dosageForm": { "zh": "AMARYL 格列美脲口服片（历史美国标签）", "en": "AMARYL glimepiride oral tablet (historical U.S. label)" }, "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 0039-0221-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列美脲 1 mg；100 片瓶装（美国历史标签）", "en": "Glimepiride 1 mg per tablet; 100-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列美脲", "en": "glimepiride" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "1 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "1 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "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": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "扁平椭圆片；两处刻痕（外观线索不是分片指令）", "en": "flat oval tablet with two score marks (an appearance clue, not a splitting instruction)" }, "imprint": "AMA RYL", "scoreStatus": "double-bisect", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amaryl-glimepiride-tablet-2mg-100-bottle-ndc-0039022210-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史公开标签（Sanofi-Aventis；2018-12 修订；标签记录美国营销终止于 2023-08-31）", "en": "U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)" }, "dosageForm": { "zh": "AMARYL 格列美脲口服片（历史美国标签）", "en": "AMARYL glimepiride oral tablet (historical U.S. label)" }, "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 0039-0222-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列美脲 2 mg；100 片瓶装（美国历史标签）", "en": "Glimepiride 2 mg per tablet; 100-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列美脲", "en": "glimepiride" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "2 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "2 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "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": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "扁平椭圆片；两处刻痕（外观线索不是分片指令）", "en": "flat oval tablet with two score marks (an appearance clue, not a splitting instruction)" }, "imprint": "AMA RYL", "scoreStatus": "double-bisect", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amaryl-glimepiride-tablet-4mg-100-bottle-ndc-0039022310-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史公开标签（Sanofi-Aventis；2018-12 修订；标签记录美国营销终止于 2023-08-31）", "en": "U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)" }, "dosageForm": { "zh": "AMARYL 格列美脲口服片（历史美国标签）", "en": "AMARYL glimepiride oral tablet (historical U.S. label)" }, "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 0039-0223-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列美脲 4 mg；100 片瓶装（美国历史标签）", "en": "Glimepiride 4 mg per tablet; 100-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列美脲", "en": "glimepiride" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "4 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "4 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "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": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "扁平椭圆片；两处刻痕（外观线索不是分片指令）", "en": "flat oval tablet with two score marks (an appearance clue, not a splitting instruction)" }, "imprint": "AMA RYL", "scoreStatus": "double-bisect", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史美国标签文字，但未保留可一一对应的官方包装图，故不展示包装图片", "en": "Historical U.S. label text was reviewed, but no one-to-one official package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 DailyMed 历史公开标签中 AMARYL、格列美脲、1 mg／2 mg／4 mg、三个 NDC、100 片瓶装、片剂颜色与刻痕文字，并明确该三种美国产品记录的营销终止日期为 2023-08-31。该 PDF 包含瓶身展示文字，但本轮未保留一个经逐一核对、可安全作为准确历史包装图公开展示的独立图像资源；为避免把历史图误读为当前在售、其他市场或可用于真伪判断的药盒，本页不展示包装图片，只保留可放大阅读的一手标签。", "en": "This dossier retains AMARYL, glimepiride, 1 mg/2 mg/4 mg, three NDCs, 100-tablet bottles, color and score-mark wording from a DailyMed historical public label, which records U.S. marketing end for all three products on 31 Aug 2023. The PDF includes bottle display text, but this review did not retain a separately verified image safe to present as an exact historical pack; to avoid reading a historical image as current marketing, another-market packaging or a means of authentication, the page shows no package image and retains the primary label for enlarged reading." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMARYL 历史说明书放大阅读：先认清 1／2／4 mg 与历史市场状态", "en": "AMARYL historical-label reading: identify 1/2/4 mg and the historical market record first" }, "summary": { "zh": "本模块只阅读 Sanofi-Aventis 的美国历史标签：AMARYL、格列美脲、1/2/4 mg 每片、三个 NDC、100 片瓶装与 2023-08-31 的美国营销终止记录。它不提供个人血糖处理、片数、漏用、分片、进餐、加药、停药、与其他降糖药联用或换药方案。", "en": "This module reads only Sanofi-Aventis' U.S. historical label: AMARYL, glimepiride, 1/2/4 mg per tablet, three NDCs, 100-tablet bottles and the U.S. marketing-end record of 31 Aug 2023. It does not provide individual glucose management, tablet count, missed-use, splitting, meals, add-on therapy, stopping, co-use with another glucose-lowering medicine or switching plans." }, "checks": [ { "zh": "先同时核对 AMARYL、格列美脲、1/2/4 mg、NDC、100 片瓶装和市场。mg 是这一历史标签中每片的标示量；不是网页可换算成每天几片、把两种强度相加或在其他降糖药之间替代的规则。", "en": "Check AMARYL, glimepiride, 1/2/4 mg, NDC, the 100-tablet bottle and market together. mg is a labelled amount per tablet in this historical label, not a web rule for tablets per day, adding strengths or replacing another glucose-lowering medicine." }, { "zh": "该历史标签描述三种片剂都有两处刻痕。刻痕和颜色是药盒/药片核对线索，不是自行掰开、调量、混用或以另一强度替代的指令；历史标签也不能外推到仿制片、其他市场或当前产品。", "en": "This historical label describes two score marks on all three tablets. Score marks and color are pack/tablet checking clues, not instructions to self-split, change use, combine products or substitute another strength; the historical label also cannot be extended to a generic tablet, another market or a current product." }, { "zh": "标签对低血糖、严重过敏反应、G6PD 缺乏相关溶血性贫血及多种相互作用给出警示；老年人、肾功能受损或合并其他降糖药的人尤其需要让了解完整病史和药单的专业团队核对。页面不据此决定任何人继续、暂停、补用或改变治疗。", "en": "The label warns about hypoglycemia, serious hypersensitivity, hemolytic anemia related to G6PD deficiency and multiple interactions; older people, people with renal impairment or people using another glucose-lowering medicine especially need review by a professional who knows the complete history and medicine list. This page does not decide continuation, pausing, make-up use or a treatment change for anyone." }, { "zh": "疑似低血糖、意识改变、抽搐、严重过敏表现或其他急性严重不适，应使用当地紧急与医疗渠道；不要依照本页自行补糖、补药、停药或调整。", "en": "For suspected hypoglycemia, altered consciousness, seizure, serious allergic features or another acute serious concern, use local urgent and medical pathways; do not self-treat with sugar, make up medicine, stop or adjust based on this page." } ], "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Warnings, interactions and product identity）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "格列美脲怎样起作用：促进胰岛 β 细胞释放胰岛素", "en": "How glimepiride works: it stimulates insulin release from pancreatic beta cells" }, "summary": { "zh": "该历史标签将格列美脲描述为主要通过刺激胰岛 β 细胞释放胰岛素来降低血糖；磺脲类与 β 细胞膜上的磺脲受体结合，继而影响 ATP 敏感性钾通道。这是作用路径的说明，不是任何个人血糖目标、片数、适用性、联用或换药方案。", "en": "This historical label describes glimepiride as primarily lowering blood glucose by stimulating insulin release from pancreatic beta cells; sulfonylureas bind the beta-cell sulfonylurea receptor and then affect the ATP-sensitive potassium channel. This explains a pathway, not an individual's glucose target, tablet count, suitability, co-use or switching plan." }, "checks": [ { "zh": "“促进胰岛素释放”解释了为何需要严肃对待低血糖风险，但不表示网页可判断任何人该吃多少、该与胰岛素/二甲双胍/其他降糖药如何合用或何时停用。", "en": "‘Stimulating insulin release’ explains why hypoglycemia risk needs serious attention, but does not let a webpage decide how much anyone should use, how to combine it with insulin/metformin/another glucose-lowering medicine or when to stop." }, { "zh": "同为降糖药、名称相近、血糖读数变化或包装上都有 mg，均不能证明产品可以自行叠加、轮换、补用或替换。应带上全部处方药、非处方药、补充剂和实际产品让药师或开方团队逐项核对。", "en": "Being glucose-lowering medicines, having similar names, a changing glucose reading or mg on both packages does not establish that products can be self-combined, alternated, made up or replaced. Bring all prescription medicines, OTC products, supplements and actual packs for item-by-item pharmacist or prescriber review." }, { "zh": "本历史美国标签的机制资料不能建立其他市场的产品状态，也不能替代当前标签、血糖监测计划、饮食/活动建议或个体化治疗。", "en": "This historical U.S. label's mechanism material does not establish product status in another market and cannot replace a current label, glucose-monitoring plan, diet/activity advice or individualised care." } ], "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Amaryl", "generic": "格列美脲", "dosageFormClass": "格列美脲口服片：1 mg、2 mg、4 mg（历史美国标签所列；各 100 片瓶装）" }, "labelSource": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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": "2026-08-23", "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 AMARYL（glimepiride）历史美国标签列出 1 mg、2 mg、4 mg 口服片及各自 100 片瓶装、NDC 与外观线索；该同一标签记录三种产品在美国的营销终止日期为 2023-08-31。本页帮助读者辨认历史药盒与阅读一手资料，不把 mg、包装数字、刻痕或“降糖药”类别转换为个人片数、加减、联用、替换、停用或购买结论。", "history": "该档案以 DailyMed 的 2018-12 修订历史标签为唯一产品身份锚点。标签列示 Initial U.S. Approval: 1995、NDA 020496，并分别记录 NDC 0039-0221-10、0039-0222-10、0039-0223-10 的美国营销终止日期为 2023-08-31。它不能说明今天任何地点的库存、批准、可售、医保、是否为原研或能否与其他格列美脲/其他降糖产品互换。", "sourceDocuments": [ { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（NDA 020496）", "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 020496（历史美国标签产品记录）", "approvalTimeline": [ { "date": "1995", "title": { "zh": "历史标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the historical label" }, "detail": { "zh": "DailyMed 的 AMARYL 历史美国标签列示 Initial U.S. Approval: 1995。这只定位所引美国历史档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The AMARYL U.S. historical DailyMed label lists Initial U.S. Approval: 1995. This locates only the cited U.S. historical archive and does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2018-12", "title": { "zh": "历史公开标签修订", "en": "Historical public-label revision" }, "detail": { "zh": "所引 AMARYL 标签标示为 2018-12 修订。该日期只标识文件版本，不能代表当前标签、当前安全结论、库存、购买资格或其他市场状态。", "en": "The cited AMARYL label is marked revised Dec 2018. The date identifies only the document version and does not represent current labelling, current safety conclusions, stock, purchase eligibility or another-market status." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2023-08-31", "title": { "zh": "历史产品记录列示美国营销终止日期", "en": "U.S. marketing-end date listed in historical product data" }, "detail": { "zh": "同一历史公开标签的三个 NDC 产品记录均列示 2023-08-31 为美国营销终止日期。因此本页不将 AMARYL 表述为当前在售、可购、可替代或仍在美国供应；现行产品问题须回到目标市场的现行官方资料与专业人员。", "en": "All three NDC product records in the same historical public label list 31 Aug 2023 as a U.S. marketing-end date. This page therefore does not describe AMARYL as currently marketed, purchasable, interchangeable or still supplied in the United States; current-product questions require current target-market official material and a professional." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（NDC 0039-0221/0222/0223；营销终止记录）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史产品记录列示三个 NDC 于 2023-08-31 营销终止", "en": "Historical product records list marketing ended for three NDCs on 31 Aug 2023" }, "detail": { "zh": "本页只保留 AMARYL 格列美脲 1 mg、2 mg、4 mg、三个 NDC 与 100 片瓶装的历史标签身份和原始文件入口；不建立当前在售、库存、购买、换用或供应结论。", "en": "This page retains only the historical-label identity and primary-document entry point for AMARYL glimepiride 1 mg, 2 mg and 4 mg, the three NDCs and 100-tablet bottles; it does not establish current marketing, stock, purchase, switching or supply." } }, { "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": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从这份美国历史标签推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this U.S. historical label; each market needs separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "AMARYL 的 1、2、4 mg、100 片瓶装和历史刻痕能否用来决定今天怎样服、怎么掰或换另一种降糖药？", "en": "Can AMARYL's historical 1, 2 and 4 mg strengths, 100-tablet bottles and score marks decide how to use it today, split it or change to another glucose-lowering medicine?" }, "answer": { "zh": "不能。这些资料只识别所引美国历史标签中的准确片剂与瓶装，且三个 NDC 已被该标签记录为美国营销终止。共同通用名、相近 mg、颜色、刻痕或包装文字均不建立自行开始、增加、重复、掰开、停用、联用、轮换或替换关系；请将现行药盒、处方和完整药单交由药师或开方团队复核。", "en": "No. These details identify only the exact tablets and bottles in the cited U.S. historical label, whose three NDCs are recorded as marketing-ended in the United States. A shared generic name, similar mg number, color, score marks or package wording does not establish self-initiation, increase, repetition, splitting, stopping, co-use, alternation or substitution; have a pharmacist or prescribing team review the current pack, prescription and complete medicine list." } } ], "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/amaryl/", "en": "https://origindrug.com/en/drugs/amaryl/" }, "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." ] }