{ "id": "jentadueto-xr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "JENTADUETO XR", "generic": "利格列汀/盐酸二甲双胍缓释片", "aliases": [ "Jentadueto XR", "linagliptin and metformin hydrochloride extended-release", "linagliptin metformin XR", "利格列汀二甲双胍缓释片", "利格列汀/盐酸二甲双胍缓释片", "NDA 208026", "0597-0270-73", "0597-0275-33", "BI D2 1000 M", "BI D5 1000 M" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 JENTADUETO XR 当前公开品牌标签（DailyMed SPL v10，2026-08-19 更新、2026-08-27 发布；NDA 208026）。本页精确展示两种标签主面板：2.5 mg/1,000 mg、NDC 0597-0270-73、60 片；5 mg/1,000 mg、NDC 0597-0275-33、30 片。标签另列 180 片与 90 片瓶装，但没有将其包装数量或 NDC 改写成实时供应。", "dosageFormClass": "利格列汀/盐酸二甲双胍薄膜衣缓释片：2.5/1,000 mg、5/1,000 mg（美国当前公开标签）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2016-05-27（FDA NDA 208026 原始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed（NLM）与 FDA 美国公开资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "JENTADUETO XR", "Jentadueto XR", "利格列汀二甲双胍缓释片" ], "excludedProductCues": [ "JENTADUETO immediate-release", "JENTADUETO tablets", "TRADJENTA", "linagliptin tablet", "GLUCOPHAGE", "metformin tablet", "TRIJARDY XR", "GLYXAMBI" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-jentadueto-xr-linagliptin-2-5mg-metformin-1000mg-0597027073", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签 SPL v10（2026-08-19 更新，2026-08-27 发布）；准确展示包装，不代表实时供应", "en": "Current U.S. DailyMed public label SPL v10 (updated 19 Aug and published 27 Aug 2026); exact displayed pack, not real-time availability" }, "dosageForm": { "zh": "JENTADUETO XR 利格列汀/盐酸二甲双胍薄膜衣缓释片", "en": "JENTADUETO XR linagliptin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片应整片吞服", "en": "oral; extended-release tablet is swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0270-73", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利格列汀 2.5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装", "en": "2.5 mg linagliptin + 1,000 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jentadueto-07.jpg&setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利格列汀", "en": "linagliptin" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍缓释成分", "en": "metformin hydrochloride extended-release component" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、薄膜衣片", "en": "oval, film-coated tablet" }, "imprint": "BI symbol / D2 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 2.5 mg/1,000 mg、NDC 0597-0270-73、60 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-jentadueto-xr-linagliptin-5mg-metformin-1000mg-0597027533", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签 SPL v10（2026-08-19 更新，2026-08-27 发布）；准确展示包装，不代表实时供应", "en": "Current U.S. DailyMed public label SPL v10 (updated 19 Aug and published 27 Aug 2026); exact displayed pack, not real-time availability" }, "dosageForm": { "zh": "JENTADUETO XR 利格列汀/盐酸二甲双胍薄膜衣缓释片", "en": "JENTADUETO XR linagliptin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片应整片吞服", "en": "oral; extended-release tablet is swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0275-33", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利格列汀 5 mg + 盐酸二甲双胍 1,000 mg；30 片瓶装", "en": "5 mg linagliptin + 1,000 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jentadueto-08.jpg&setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利格列汀", "en": "linagliptin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍缓释成分", "en": "metformin hydrochloride extended-release component" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、薄膜衣片", "en": "oval, film-coated tablet" }, "imprint": "BI symbol / D5 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 5 mg/1,000 mg、NDC 0597-0275-33、30 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-jentadueto-xr-linagliptin-2-5mg-metformin-1000mg-0597027073", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jentadueto-07.jpg&setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa&type=img", "alt": "JENTADUETO XR 利格列汀 2.5 mg/盐酸二甲双胍 1,000 mg、NDC 0597-0270-73、60 片瓶装的美国 DailyMed 标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v10；2026-08-19 更新，2026-08-27 发布", "presentation": "JENTADUETO XR 每片利格列汀 2.5 mg/盐酸二甲双胍 1,000 mg，NDC 0597-0270-73，60 片瓶装标签展示面。", "notice": "此图只对应当前美国标签中的 2.5 mg/1,000 mg、NDC 0597-0270-73、60 片瓶装；不代表 180 片瓶装、5 mg/1,000 mg、JENTADUETO 普通片、TRADJENTA、其他市场包装或当前可得性，不用于鉴定真伪，也不生成个人片数。", "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 2.5 mg/1,000 mg、NDC 0597-0270-73、60 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JENTADUETO XR 说明书放大阅读：一片两种成分，XR 缓释片不得掰开、压碎、溶解或咀嚼", "en": "JENTADUETO XR label reading: two ingredients in one tablet; do not split, crush, dissolve or chew the XR tablet" }, "summary": { "zh": "美国标签列两种强度。先确认准确 NDC 和两个成分数字，不要相加、按外观估算后掰片，或再自行加用 TRADJENTA、利格列汀、GLUCOPHAGE 或二甲双胍产品。", "en": "The U.S. label lists two strengths. Confirm the exact NDC and both ingredient figures; do not add the numbers, estimate and split from appearance, or self-add TRADJENTA/linagliptin, GLUCOPHAGE or metformin products." }, "checks": [ { "zh": "例如“2.5 mg/1,000 mg”表示每片含利格列汀 2.5 mg 和盐酸二甲双胍 1,000 mg；它不是 1,002.5 mg 的可比强度，也不是两个服用时间。", "en": "For example, 2.5 mg/1,000 mg means 2.5 mg linagliptin and 1,000 mg metformin HCl per tablet. It is not a comparable 1,002.5 mg strength or two times of day." }, { "zh": "标签要求整片吞服，并明确不得掰开、压碎、溶解或咀嚼。网页不根据标签中的专业方案替任何人选择频次、片数或转换方法。", "en": "The label requires swallowing whole and says not to split, crush, dissolve or chew. The site does not use clinician-facing regimens in the label to choose an individual's frequency, tablet count or transition method." }, { "zh": "黑框警示涉及二甲双胍相关乳酸性酸中毒；肾功能、65 岁及以上、含碘造影、手术、缺氧状态、过量饮酒和肝功能问题都是标签列出的优先核对边界。", "en": "The boxed warning covers metformin-associated lactic acidosis. Kidney function, age 65 or older, iodinated contrast, surgery, hypoxic states, excessive alcohol and hepatic impairment are label-listed priority review boundaries." }, { "zh": "严重虚弱、呼吸困难、持续呕吐、明显意识变化、严重腹痛或其他急性重症需要立即使用当地急救渠道并带上全部药盒；不要等待网页判断是否停药或补服。", "en": "Severe weakness, breathing difficulty, persistent vomiting, marked altered awareness, severe abdominal pain or another acute serious concern requires local emergency help with every medicine pack. Do not wait for a webpage to decide interruption or make-up use." } ], "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开标签与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样配合：利格列汀减慢肠促胰岛素失活，二甲双胍影响肝糖生成与胰岛素敏感性", "en": "How the ingredients work: linagliptin slows incretin inactivation, while metformin affects hepatic glucose production and insulin sensitivity" }, "summary": { "zh": "标签把利格列汀列为 DPP-4 抑制剂，把二甲双胍列为双胍类。标签还说明该片由二甲双胍缓释核心和利格列汀即时释放外层组成。两条作用路径和特定释放结构解释固定复方，但不能推导个人该选哪种强度、是否适合或能否与其他降糖药联合。", "en": "The label identifies linagliptin as a DPP-4 inhibitor and metformin as a biguanide. It also describes a metformin extended-release core coated with immediate-release linagliptin. These pathways and the specific release structure explain the fixed combination but cannot determine an individual's strength, suitability or combination with another glucose-lowering medicine." }, "checks": [ { "zh": "“两种机制互补”不是把 TRADJENTA 和二甲双胍自行拼成 JENTADUETO XR 的许可；缓释核心、即时释放包衣、成分量、标签和监测边界属于准确产品。", "en": "“Complementary mechanisms” do not permit self-assembling JENTADUETO XR from TRADJENTA and metformin. The extended-release core, immediate-release coating, ingredient amounts, label and monitoring boundaries belong to the exact product." }, { "zh": "共同写有利格列汀或二甲双胍，不表示 JENTADUETO、JENTADUETO XR、单方药和其他复方可以按毫克数自行叠加、轮换或替换。剂型、释放方式、肾功能和完整药单必须一起核对。", "en": "A shared linagliptin or metformin name does not make JENTADUETO, JENTADUETO XR, single-ingredient products and other combinations self-combinable, alternatable or substitutable by milligrams. Dosage form, release design, kidney function and the complete medicine list require joint review." }, { "zh": "基因筛查不是网页替个人选择这款药的默认答案。个体适用性要结合诊断、肾功能、完整药单、既往反应和目标市场现行说明书，由负责团队判断。", "en": "Genetic screening is not the site's default answer for choosing this medicine. Individual suitability requires diagnosis, kidney function, the complete medicine list, prior response and the current target-market label, reviewed by the treating team." } ], "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开标签（产品结构与 12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "JENTADUETO XR", "generic": "利格列汀/盐酸二甲双胍缓释片", "dosageFormClass": "利格列汀/盐酸二甲双胍薄膜衣缓释片：2.5/1,000 mg、5/1,000 mg（美国当前公开标签）" }, "labelSource": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开品牌标签、两种展示包装与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开品牌标签、两种展示包装与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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": "2026-08-30", "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": "JENTADUETO XR 一片同时含利格列汀和盐酸二甲双胍缓释成分。包装上的两个 mg 数字分别属于两种成分，不是相加后的总强度，也不是服用时间。它与 JENTADUETO 普通片、TRADJENTA 单方、GLUCOPHAGE 或其他含共同成分的产品不是可以按名称或毫克数自行拼接的同一盒药。当前美国标签列两种强度，并要求缓释片整片吞服，不得掰开、压碎、溶解或咀嚼。网页帮助认清准确产品、成分、每片标示量和官方说明书，不生成个人片数、频次、联用、换药、补服或停药方案。", "history": "FDA 于 2016-05-27 批准 JENTADUETO XR NDA 208026。当前标签所写 Initial U.S. Approval: 2012 是利格列汀/二甲双胍品牌组合的历史节点，不应误写成 XR 产品在 2012 年获批。FDA 公开审评还将 JENTADUETO 普通片 NDA 201281 与 JENTADUETO XR NDA 208026 分开比较；共同品牌词根和共同成分不能建立自行互换关系。", "sourceDocuments": [ { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开品牌标签、两种展示包装与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_df2bf5960258fdd2", "label": "FDA：JENTADUETO XR NDA 208026 原始批准函（2016-05-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208026Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_22af408a91cd305e", "label": "FDA：JENTADUETO XR NDA 208026 临床药理审评（普通片与 XR 产品边界）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA：JENTADUETO XR NDA 208026 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FDA NDA 208026（JENTADUETO XR；利格列汀/盐酸二甲双胍缓释片）", "approvalTimeline": [ { "date": "2016-05-27", "title": { "zh": "FDA 批准 JENTADUETO XR NDA 208026", "en": "FDA approved JENTADUETO XR NDA 208026" }, "detail": { "zh": "FDA 原始批准函确认两种缓释片规格获批。该节点建立美国 NDA 产品史，不等于其他市场的批准或当前供应。", "en": "The FDA original approval letter confirms approval of two extended-release tablet strengths. This establishes U.S. NDA product history, not another market's approval or current supply." }, "source": { "id": "src_df2bf5960258fdd2", "label": "FDA：JENTADUETO XR NDA 208026 原始批准函（2016-05-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208026Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-19", "title": { "zh": "DailyMed SPL v10 当前标签更新", "en": "Current DailyMed SPL v10 label updated" }, "detail": { "zh": "当前标签于 2026-08-27 公开发布。本页的两种展示包装、整片吞服、双成分、肾功能、含碘造影与乳酸性酸中毒等阅读边界均以该标签为主要来源。", "en": "The current label was publicly released on 27 Aug 2026. This page uses it as the primary source for the two displayed packs, whole-tablet handling, both ingredients, kidney function, iodinated contrast and lactic-acidosis reading boundaries." }, "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR SPL v10 当前美国公开品牌标签（2026-08-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签与两种准确主展示包装已建立", "en": "Current public brand label and two exact principal-display packages established" }, "detail": { "zh": "逐一记录每片双成分量、NDC、瓶装数量、颜色、形状、刻印和官方标签面板；不表示具体渠道库存、购买资格、真伪或个人片数。", "en": "Records both per-tablet ingredient amounts, NDC, bottle count, colour, shape, imprint and official label panel. It does not establish channel stock, purchasing eligibility, authenticity or an individual tablet count." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, European Union, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product records not established" }, "detail": { "zh": "不从美国商品名、共同成分、NDA 或包装推定当地批准、持有人、规格、供应、原研/参比关系或可替代性。", "en": "No local approval, holder, strength, supply, originator/reference relationship or interchangeability is inferred from the U.S. trade name, shared ingredients, NDA or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "2.5 mg/1,000 mg 是 1,002.5 mg，还是两个服用时间？", "en": "Does 2.5 mg/1,000 mg mean 1,002.5 mg, or two dosing times?" }, "answer": { "zh": "都不是。它表示一片分别含利格列汀 2.5 mg 和盐酸二甲双胍 1,000 mg。两个数字属于两种成分，不能相加后与其他药比较，也不能推导个人频次或片数。", "en": "Neither. One tablet contains 2.5 mg linagliptin and 1,000 mg metformin HCl. The figures belong to two ingredients and cannot be added for comparison with another medicine or used to derive an individual's frequency or tablet count." } }, { "question": { "zh": "药片太大，可以掰半、压碎或溶在水里吗？", "en": "Can a large tablet be halved, crushed or dissolved in water?" }, "answer": { "zh": "当前美国标签要求整片吞服，并明确不得掰开、压碎、溶解或咀嚼。吞咽困难时请带准确药盒联系开方团队或药师讨论其他可行产品，不要自行破坏缓释结构。", "en": "The current U.S. label requires swallowing whole and explicitly says not to split, crush, dissolve or chew. If swallowing is difficult, take the exact pack to the prescriber or pharmacist to discuss another appropriate product rather than damaging the extended-release design." } }, { "question": { "zh": "已经使用 JENTADUETO XR，还能再用 TRADJENTA 或二甲双胍吗？", "en": "Can TRADJENTA or metformin be added when JENTADUETO XR is already used?" }, "answer": { "zh": "网页不能决定联用。JENTADUETO XR 已含利格列汀和盐酸二甲双胍；药单中再出现共同成分必须优先核对，不能自行叠加、轮换或停掉其中一盒。", "en": "A webpage cannot decide combination use. JENTADUETO XR already contains linagliptin and metformin HCl. Another shared ingredient on the medicine list requires priority review, not self-combination, alternation or stopping a pack." } }, { "question": { "zh": "JENTADUETO 普通片和 JENTADUETO XR 是一样的吗？", "en": "Are JENTADUETO immediate-release and JENTADUETO XR the same?" }, "answer": { "zh": "不是同一剂型。FDA 审评资料把普通片 NDA 201281 与缓释片 NDA 208026 分开。共同品牌词根不能用来自行换算、替换或把旧药与新药一起使用。", "en": "They are not the same dosage form. FDA review material separates immediate-release NDA 201281 from extended-release NDA 208026. A shared brand stem cannot support self-conversion, substitution or using old and new supplies together." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/jentadueto-xr/", "en": "https://origindrug.com/en/drugs/jentadueto-xr/" }, "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." ] }