{ "id": "precose", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Precose", "generic": "阿卡波糖", "aliases": [ "acarbose", "阿卡波糖", "拜唐苹", "Glucobay", "阿卡波糖片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "拜唐苹®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_281bcdb5add33c39", "label": "泾县人民政府：医保高值药品参考清单中的拜唐苹／阿卡波糖片记录", "url": "https://www.ahxx.gov.cn/group1/M00/47/45/Cpc8VmZo5wiAK4pvAAM6bEblTyM892.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 PRECOSE 拜耳历史公开标签（DailyMed，生效 2020-02-29；三个 NDC 的产品数据均列示该日营销结束）。本页只展示该历史文件中的三种准确 100 片瓶装；拜耳中国官网可确认“拜唐苹®”为其处方药组合中的名称，但不替代中国大陆现行标签或批准记录。", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（美国拜耳历史公开标签所列；每个包装分别核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（FDA NDA 020482 原始审批资料）", "archiveSponsorText": "Bayer / DailyMed 公开标签档案；拜耳中国历史公开产品组合线索" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NDC 43353-908", "43353-908", "Aphena Pharma Solutions", "Acarbose (Precose) 50 mg 9000 tablets" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-precose-acarbose-historical-tablet-25mg-ndc-50419-863-51", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国拜耳历史公开标签（生效 2020-02-29；产品记录列示该日营销结束）", "en": "DailyMed U.S. Bayer historical public label (effective 29 Feb 2020; product data list marketing end on that date)" }, "dosageForm": { "zh": "阿卡波糖口服片（历史标签）", "en": "acarbose oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-863-51", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿卡波糖 25 mg；100 片瓶装（拜耳历史标签展示面）", "en": "Acarbose 25 mg per tablet; 100-tablet bottle (Bayer historical-label panel)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&archiveid=673217", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿卡波糖", "en": "acarbose" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、调整或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, adjustment or conversion 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": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至淡黄色", "en": "white to pale yellow" }, "shape": { "zh": "圆形、无刻痕片", "en": "round, unscored tablet" }, "imprint": { "zh": "PRECOSE（单面）／25（另一面）", "en": "PRECOSE (one side) / 25 (other side)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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-precose-acarbose-historical-tablet-50mg-ndc-50419-861-51", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国拜耳历史公开标签（生效 2020-02-29；产品记录列示该日营销结束）", "en": "DailyMed U.S. Bayer historical public label (effective 29 Feb 2020; product data list marketing end on that date)" }, "dosageForm": { "zh": "阿卡波糖口服片（历史标签）", "en": "acarbose oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-861-51", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿卡波糖 50 mg；100 片瓶装（拜耳历史标签展示面）", "en": "Acarbose 50 mg per tablet; 100-tablet bottle (Bayer historical-label panel)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&archiveid=673217", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿卡波糖", "en": "acarbose" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、调整或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, adjustment or conversion 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": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至淡黄色", "en": "white to pale yellow" }, "shape": { "zh": "圆形、无刻痕片", "en": "round, unscored tablet" }, "imprint": { "zh": "PRECOSE / 50（同面）", "en": "PRECOSE / 50 (same side)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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-precose-acarbose-historical-tablet-100mg-ndc-50419-862-51", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国拜耳历史公开标签（生效 2020-02-29；产品记录列示该日营销结束）", "en": "DailyMed U.S. Bayer historical public label (effective 29 Feb 2020; product data list marketing end on that date)" }, "dosageForm": { "zh": "阿卡波糖口服片（历史标签）", "en": "acarbose oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-862-51", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿卡波糖 100 mg；100 片瓶装（拜耳历史标签展示面）", "en": "Acarbose 100 mg per tablet; 100-tablet bottle (Bayer historical-label panel)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&archiveid=673217", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿卡波糖", "en": "acarbose" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、调整或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, adjustment or conversion 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": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至淡黄色", "en": "white to pale yellow" }, "shape": { "zh": "圆形、无刻痕片", "en": "round, unscored tablet" }, "imprint": { "zh": "PRECOSE / 100（同面）", "en": "PRECOSE / 100 (same side)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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": { "presentationId": "us-precose-acarbose-historical-tablet-25mg-ndc-50419-863-51", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&archiveid=673217", "alt": "PRECOSE 阿卡波糖美国拜耳历史公开标签中的 25 mg、NDC 50419-863-51、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 拜耳历史公开标签，生效 2020-02-29；产品数据列示同日营销结束", "presentation": "PRECOSE：每片阿卡波糖 25 mg，NDC 50419-863-51，100 片瓶装历史展示面。", "notice": "此图只对应美国 DailyMed 拜耳历史公开标签中的 PRECOSE、阿卡波糖 25 mg、NDC 50419-863-51 与 100 片瓶装。它只帮助核对商品名、通用名、每片标签量、包装、外形线索和来源；不用于鉴定真伪，也不证明 50 mg／100 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人使用方案。", "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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": "PRECOSE / 拜唐苹说明书放大阅读：25 mg、50 mg、100 mg 首先用于确认准确片剂", "en": "PRECOSE / Glucobay label reading: 25 mg, 50 mg and 100 mg first identify the exact tablet" }, "summary": { "zh": "本模块以 FDA/DailyMed 的 PRECOSE 历史公开标签为阅读入口，并保留拜耳中国的中文名称线索。它帮助核对 PRECOSE、阿卡波糖、拜唐苹/Glucobay、口服片、每片标示量和目标市场；不提供任何人的片数、服药时点、联合方案、转换或停药方案。", "en": "This module uses the FDA/DailyMed historical PRECOSE public label and preserves Bayer China's Chinese trade-name clue. It helps check PRECOSE, acarbose, 拜唐苹/Glucobay, oral tablet, labelled amount per tablet and target market; it does not provide anyone's tablet count, timing, combination, switching or stopping plan." }, "checks": [ { "zh": "25 mg、50 mg、100 mg 是历史美国标签所列每片标示量，不是“今天应吃几片”的答案。应同时核对商品名、通用名、准确片剂、每片标示量、实际包装、标签版本和目标市场；任何一项不同都不能自行按 mg 换算、拼量或替换。", "en": "25 mg, 50 mg and 100 mg are labelled amounts per tablet in the historical U.S. label, not an answer to ‘how many tablets today.’ Check trade name, generic name, exact tablet, amount per tablet, actual pack, label version and target market together; a difference in any one does not permit self-conversion, combining strengths or substitution." }, { "zh": "“拜唐苹®”是拜耳中国官网可追溯的中文产品名称线索；它不能单独证明手上药盒的批准文号、生产者、规格、包装外观或当前状态。对照时应把药盒全部文字、通用名和官方现行记录一起交给药师或医生核对。", "en": "‘拜唐苹®’ is a traceable Chinese product-name clue on Bayer China's website; it alone cannot establish the approval number, manufacturer, strength, package appearance or current status of a pack in hand. For comparison, have a pharmacist or clinician review all pack text, the generic name and the current official record together." }, { "zh": "该标签列有消化道反应、肝功能、血糖变化和与其他降糖治疗共同使用时的核对事项。正在使用其他降糖药、胰岛素、保健品或多种处方/非处方药时，应携带完整药单和实际包装让专业人员核对；网页不能判断个人是否应联用、调整或换药。", "en": "The label contains checks involving gastrointestinal effects, liver function, glucose changes and co-use with other glucose-lowering treatment. With other glucose medicines, insulin, supplements or multiple prescription/OTC products, take the complete medicine list and actual packs for professional review; a webpage cannot decide whether an individual should combine, adjust or switch." }, { "zh": "持续或严重腹痛、呕吐、脱水、意识改变、疑似低血糖不适、严重过敏表现或其他急性问题，不能按网页或包装数字自行处理。应及时使用当地医疗支持，而不是自行加量、补用、停用或改用另一种降糖产品。", "en": "Persistent or severe abdominal pain, vomiting, dehydration, altered awareness, suspected low-glucose symptoms, severe allergic features or another acute problem cannot be managed from a webpage or package numbers. Use timely local medical support rather than self-increasing, catch-up use, stopping or changing to another glucose-lowering product." } ], "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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": "阿卡波糖怎样起作用：标签描述其延缓膳食碳水化合物的消化", "en": "How acarbose works: the label describes delayed digestion of dietary carbohydrate" }, "summary": { "zh": "DailyMed 历史公开标签将 PRECOSE 描述为 α-葡萄糖苷酶抑制剂，并说明阿卡波糖可延缓摄入碳水化合物的消化。这解释的是标签中的药理路径，不能判断个人血糖问题、饮食选择、片数、用药时点、联用或调整方案。", "en": "The DailyMed historical public label describes PRECOSE as an alpha-glucosidase inhibitor and explains that acarbose delays digestion of ingested carbohydrate. This describes a labelled pharmacologic pathway; it cannot determine an individual's glucose issue, dietary choices, tablet count, timing, combination or adjustment plan." }, "checks": [ { "zh": "“延缓碳水化合物消化”不是对任何人血糖结果、饮食或治疗需要的判断。空腹或餐后数字、症状、既往处方和其他药物都需要由当地医疗团队结合准确产品与检查资料解读。", "en": "‘Delays carbohydrate digestion’ is not a judgement about anyone's glucose result, diet or treatment need. Fasting or post-meal values, symptoms, prior prescriptions and other medicines require interpretation by a local care team together with the exact product and test information." }, { "zh": "相同的降糖类别描述或相近的包装数字，不使阿卡波糖与另一种降糖药、胰岛素、保健品或不同强度片剂可以自行叠加、轮换、按 mg 换算或替换。完整药单和现行标签应由专业人员一起核对。", "en": "A shared glucose-lowering class description or similar package number does not make acarbose self-combinable, alternatable, milligram-convertible or substitutable with another glucose medicine, insulin, supplement or different-strength tablet. The complete medicine list and current label need professional review together." }, { "zh": "机制说明不取代对急性不适、反复低血糖样症状、胃肠道问题、肝脏问题或任何新症状的处理。出现急性或严重问题时，应优先使用当地紧急医疗支持。", "en": "A mechanism explanation does not replace care for acute concerns, repeated low-glucose-like symptoms, gastrointestinal issues, liver concerns or any new symptom. With an acute or serious problem, prioritise local urgent medical support." } ], "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（Clinical Pharmacology；生效 2020-02-29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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": "Precose", "generic": "阿卡波糖", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（美国拜耳历史公开标签所列；每个包装分别核对）" }, "labelSource": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；三个准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；三个准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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 PRECOSE（acarbose）拜耳历史公开标签列示 25 mg、50 mg、100 mg 口服片，并为三个准确 NDC 保留各自的 100 片瓶装展示面。该来源产品数据列示 2020-02-29 为美国营销结束日期，因此页面不把图片或标签表述为当前在售、可购或现行外观。拜耳中国官网将“拜唐苹®”列入其处方药组合，可作为中文商品名的来源线索。页面帮助读者把品牌、通用名、每片标示量、剂型、目标市场和实际包装一起核对；不据此生成个人片数、用药时间、联用、转换或停药方案。", "history": "FDA 的 NDA 020482 原始审批资料记录 PRECOSE 的 1995 年审批文件；DailyMed 的拜耳历史公开标签则可追溯 25 mg（NDC 50419-863-51）、50 mg（NDC 50419-861-51）和 100 mg（NDC 50419-862-51）三个 100 片瓶装的准确展示面。三个产品数据均列示 2020-02-29 为美国营销结束日期，因此不证明现行供应、现行外观或任何市场的当前状态。两类文件的用途不同：前者用于历史审批定位，后者用于历史包装与标签阅读；均不等于中国大陆现行说明书、当前批准、医保、供应或个体化治疗结论。", "sourceDocuments": [ { "id": "src_43390a0ac784bf5e", "label": "FDA：PRECOSE（acarbose）NDA 020482 原始审批资料（1995）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020482Orig1s000rev.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；三个准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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_ef8b678b4ed549bf", "label": "拜耳中国：处方药产品组合中的拜唐苹®名称线索（历史公开页）", "url": "https://www.bayer.com.cn/zh-hans/divisions", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020482", "approvalTimeline": [ { "date": "1995-09-06", "title": { "zh": "FDA NDA 020482 原始审批", "en": "FDA NDA 020482 original approval" }, "detail": { "zh": "FDA Drugs@FDA 记录显示 PRECOSE（acarbose）NDA 020482 的原始申请于 1995-09-06 获批。所链接的历史审评文件在 2019 年公开；该文件日期不等同于原始审批日期。该历史节点不代表当前标签、规格、持有人、供应或其他市场状态。", "en": "FDA Drugs@FDA records the original PRECOSE (acarbose) application, NDA 020482, as approved on 1995-09-06. The linked historical review document was made public in 2019; its document date is not the original approval date. This historical point does not establish current labelling, strength, holder, supply or another-market status." }, "source": { "id": "src_43390a0ac784bf5e", "label": "FDA: PRECOSE (acarbose) NDA 020482 original approval record (1995)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020482Orig1s000rev.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020-02-29", "title": { "zh": "拜耳历史标签生效及产品数据列示营销结束", "en": "Historical Bayer label effective date and marketing-end date listed in product data" }, "detail": { "zh": "所引 DailyMed 拜耳历史公开标签标示生效日期为 2020-02-29，三个产品数据均列示该日为营销结束日期。该节点使本页图片限定为历史包装核对，不建立当前在售、库存、可购、可替代或其他市场状态。", "en": "The cited DailyMed Bayer historical public label is effective 29 Feb 2020, and each of the three product data entries lists that date as marketing end. This confines the page images to historical package checking and does not establish current marketing, stock, purchase, interchangeability or another-market status." }, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed: PRECOSE historical Bayer public label (effective 29 Feb 2020; marketing end listed in product data)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "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": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/precose/", "en": "https://origindrug.com/en/drugs/precose/" }, "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." ] }