{ "id": "reglan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "REGLAN", "generic": "甲氧氯普胺", "aliases": [ "REGLAN", "metoclopramide", "metoclopramide hydrochloride", "甲氧氯普胺" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 DailyMed 当前 REGLAN（metoclopramide hydrochloride）口服片标签，2026-02-09 更新。本档案仅对应标签列出的美国处方片及两个 NDC；不推定中国大陆或其他市场的当前批准、持有人、供应、可得性或个人适用性。", "dosageFormClass": "口服片：5 mg、10 mg（DailyMed 当前美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1979（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "ANI Pharmaceuticals, Inc. / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "metoclopramide injection", "甲氧氯普胺注射液", "metoclopramide oral solution", "metoclopramide ODT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-reglan-metoclopramide-tablet-5mg-100bottle-ndc-62559-165-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2026-02-09 更新）", "en": "Current U.S. DailyMed public label (updated 9 Feb 2026)" }, "dosageForm": { "zh": "REGLAN 甲氧氯普胺口服片", "en": "REGLAN metoclopramide oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-165-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；100 片瓶装", "en": "5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de55c133-eb08-4a35-91a2-5dc093027397&name=Label-5mg.jpg&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氧氯普胺", "en": "metoclopramide" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色（标签描述）", "en": "green (label description)" }, "shape": { "zh": "椭圆形（标签描述）", "en": "elliptical (label description)" }, "imprint": "REGLAN / 5; ANI", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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-reglan-metoclopramide-tablet-10mg-100bottle-ndc-62559-166-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2026-02-09 更新）", "en": "Current U.S. DailyMed public label (updated 9 Feb 2026)" }, "dosageForm": { "zh": "REGLAN 甲氧氯普胺口服片", "en": "REGLAN metoclopramide oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-166-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；100 片瓶装", "en": "10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de55c133-eb08-4a35-91a2-5dc093027397&name=Label-10mg.jpg&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氧氯普胺", "en": "metoclopramide" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色（标签描述）", "en": "white (label description)" }, "shape": { "zh": "胶囊形、双边刻痕（标签描述）", "en": "capsule-shaped, double-edge scored (label description)" }, "imprint": "REGLAN; ANI 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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-reglan-metoclopramide-tablet-5mg-100bottle-ndc-62559-165-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de55c133-eb08-4a35-91a2-5dc093027397&name=Label-5mg.jpg&type=img", "alt": "REGLAN 甲氧氯普胺在美国 DailyMed 当前标签中的 5 mg、NDC 62559-165-01、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2026-02-09 更新）", "presentation": "REGLAN 甲氧氯普胺：每片 5 mg，NDC 62559-165-01，100 片瓶装。", "notice": "此图只对应美国 DailyMed 当前标签中的 REGLAN、甲氧氯普胺、每片 5 mg、NDC 62559-165-01 与 100 片瓶装。它只帮助核对品牌、通用名、每片标签量、包装数量和来源；不用于鉴定真伪，也不证明 10 mg 产品、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、时间、开始、停用、联用或换药方案。", "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "REGLAN 说明书放大阅读：5、10 mg 是片剂身份，不是“该吃几片”", "en": "REGLAN label reading: 5 and 10 mg identify tablets; they do not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 DailyMed 当前美国标签中的 REGLAN、甲氧氯普胺、口服片、每片标示量和黑框警告。它不提供个人片数、起止时间、联用、换药或购买方案。", "en": "This module reads only REGLAN, metoclopramide, oral tablets, labelled amount per tablet and the boxed warning in the current U.S. DailyMed label. It provides no individual tablet count, start/stop timing, co-use, switching or purchase plan." }, "checks": [ { "zh": "把 REGLAN、甲氧氯普胺、口服片、每片 5 或 10 mg、NDC、实际包装和目标市场一起核对。mg 是一片准确产品的标示量，不是网页可以换算成个人每天该用多少片的规则，也不能据此把注射剂、口服液、口崩片、另一市场产品或另一种药自行互换。", "en": "Check REGLAN, metoclopramide, oral-tablet form, the stated 5 or 10 mg per tablet, NDC, actual pack and target market together. Mg is the labelled amount in an exact tablet, not a web rule for how many tablets an individual should use, and it cannot self-convert an injection, oral solution, orally disintegrating tablet, another-market product or another medicine." }, { "zh": "该标签的黑框警告涉及迟发性运动障碍；标签写明风险与治疗持续时间及累计暴露有关。这个警示用于提醒核对准确说明书和完整药单，不应被网页转写为任何个人开始、减少、停用、续用或换药指令。出现新的不自主动作、意识或呼吸方面的急性严重不适时，应优先使用当地紧急医疗渠道。", "en": "The label's boxed warning concerns tardive dyskinesia and states that risk relates to treatment duration and total cumulative exposure. This warning is a cue to check the exact leaflet and complete medicine list; a webpage must not turn it into an individual start, reduction, stopping, continuation or switching instruction. New involuntary movements or an acute serious concern involving consciousness or breathing require local urgent-care channels first." }, { "zh": "标签列出抗精神病药、中枢神经系统抑制剂、强 CYP2D6 抑制剂、MAO 抑制剂等相互作用线索，也特别提示帕金森病、癫痫、既往运动障碍、肝肾功能、年龄与多药并用需要专业复核。请把所有处方药、非处方药、草本和补充剂连同实际药盒交给药师或开方团队逐项核对；不要仅因名称相似或都是“胃肠道用药”就自行叠加或替代。", "en": "The label identifies interaction cues involving antipsychotics, central-nervous-system depressants, strong CYP2D6 inhibitors and MAO inhibitors, and flags Parkinson's disease, epilepsy, prior movement disorders, liver/kidney context, age and multiple medicines for professional review. Have a pharmacist or prescribing team check every prescription, OTC product, herb and supplement together with the actual packs; do not self-combine or substitute simply because names look similar or both are described as gastrointestinal medicines." }, { "zh": "本页对应的是 2026 年美国处方片标签，不能替代手中药盒随附的现行说明书。漏用、吞咽困难、包装不一致、准备掰开/研碎，或希望改变任何治疗时，应先请了解实际产品和目标市场标签的药师或医疗团队审阅。", "en": "This page corresponds to a 2026 U.S. prescription-tablet label and cannot replace the current leaflet supplied with the product in hand. For a missed use, swallowing difficulty, pack mismatch, contemplated splitting/crushing or any treatment change, first have a pharmacist or care team familiar with the actual product and target-market label review it." } ], "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新；黑框警告、片剂身份与相互作用）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "甲氧氯普胺怎样起作用：标签描述的多巴胺受体拮抗与胃肠动力路径", "en": "How metoclopramide works: the label's dopamine-receptor antagonism and gastrointestinal-motility pathway" }, "summary": { "zh": "DailyMed 当前标签描述，甲氧氯普胺在中枢具有多巴胺 D2 受体拮抗作用，并增强上消化道动力。机制解释用于理解一条药理路径；它不判断个人症状原因、是否适合、每次片数、联用、停用或替代。", "en": "The current DailyMed label describes central dopamine D2 receptor antagonism and enhanced upper-gastrointestinal motility with metoclopramide. This explains one pharmacologic pathway; it does not determine an individual's symptom cause, suitability, tablet count, co-use, stopping or replacement." }, "checks": [ { "zh": "“多巴胺 D2 受体拮抗”“增强胃肠动力”是药理路径用语，不表示所有止吐、促动力、抗精神病或相近用途产品可以自行叠加、轮换或按 mg 对等换算。", "en": "“Dopamine D2 receptor antagonism” and “enhanced gastrointestinal motility” are pharmacologic-pathway terms; they do not establish that antiemetic, pro-motility, antipsychotic or similarly used products can be self-combined, alternated or milligram-converted." }, { "zh": "同样出现“反胃”“胃食管反流”“胃轻瘫”或“多巴胺”文字，也不能证明两盒药适用于同一疾病、同一人或同一市场。应先核对准确商品名、通用名、片剂强度、目标市场标签和完整药单。", "en": "Shared words such as “nausea,” “gastroesophageal reflux,” “gastroparesis” or “dopamine” do not establish that two packs apply to the same condition, person or market. First check the exact brand, generic name, tablet strength, target-market label and complete medicine list." }, { "zh": "机制解释不能替代黑框警告、相互作用或药物警戒核对。涉及新增抗精神病药、镇静药、抗抑郁药、其他处方或非处方产品，或出现新的不自主动作、严重不适时，应让药师或医疗团队审阅完整药单；急性严重情况优先使用当地紧急医疗渠道。", "en": "A mechanism explanation does not replace boxed-warning, interaction or pharmacovigilance review. When an antipsychotic, sedating medicine, antidepressant, another prescription or OTC product is added, or a new involuntary movement or serious concern occurs, have a pharmacist or care team review the full medicine list; use local urgent-care channels first for an acute serious concern." } ], "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "REGLAN", "generic": "甲氧氯普胺", "dosageFormClass": "口服片：5 mg、10 mg（DailyMed 当前美国公开标签所列）" }, "labelSource": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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 当前美国公开标签将 REGLAN 列为甲氧氯普胺口服片，并列出 5 mg、10 mg 两种每片标示量。本页把商品名、通用名、片剂、每片标示量、准确 NDC、包装展示面和原始说明书入口并列；“mg”只用于核对准确产品身份，不转换为个人片数、开始、停用、联用、换药或购买结论。", "history": "该美国公开标签列示 Initial U.S. Approval: 1979，页面更新日期为 2026-02-09。其黑框警告涉及迟发性运动障碍；本页只锚定这一美国文件和两个对应 100 片瓶装展示面。不同剂型、不同包装、不同市场或同通用名产品均须按实际药盒和所在市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA (current DailyMed label; application number not asserted in this dossier)", "approvalTimeline": [ { "date": "1979", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1979。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1979. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed: current REGLAN metoclopramide U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2026-02-09", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-02-09 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-02-09 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed: current REGLAN metoclopramide U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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/reglan/", "en": "https://origindrug.com/en/drugs/reglan/" }, "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." ] }