{ "id": "jardiance", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Jardiance", "generic": "恩格列净", "aliases": [ "empagliflozin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前公开处方药标签（2026-01-30 生效）与 FDA 历史监管档案", "dosageFormClass": "恩格列净口服薄膜衣片：10 mg、25 mg；各精确展示 30 片泡罩板纸盒（3 板 × 10 片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2014（FDA 标签所列美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim / FDA 与 DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SYNJARDY", "GLYXAMBI", "JARDIANCE DUO", "empagliflozin metformin", "empagliflozin linagliptin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-jardiance-empagliflozin-tablet-10mg-0597015237", "marketCode": "US", "labelVersion": { "zh": "2026-01-30 生效；DailyMed 当前公开标签", "en": "effective 30 Jan 2026; current DailyMed public label" }, "dosageForm": { "zh": "恩格列净口服薄膜衣片", "en": "empagliflozin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0152-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片纸盒（3 板 × 10 片）", "en": "10 mg per tablet; 30-tablet carton (3 blister cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&name=jardiance-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_card_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/泡罩板", "en": "tablets per blister card" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板 × 10 片）", "en": "tablets per carton (3 blister cards × 10 tablets)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净 10 mg、30 片泡罩板纸盒当前美国公开标签面板（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-jardiance-empagliflozin-tablet-25mg-0597015337", "marketCode": "US", "labelVersion": { "zh": "2026-01-30 生效；DailyMed 当前公开标签", "en": "effective 30 Jan 2026; current DailyMed public label" }, "dosageForm": { "zh": "恩格列净口服薄膜衣片", "en": "empagliflozin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0153-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；30 片纸盒（3 板 × 10 片）", "en": "25 mg per tablet; 30-tablet carton (3 blister cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&name=jardiance-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_card_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/泡罩板", "en": "tablets per blister card" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板 × 10 片）", "en": "tablets per carton (3 blister cards × 10 tablets)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净 25 mg、30 片泡罩板纸盒当前美国公开标签面板（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-jardiance-empagliflozin-tablet-25mg-0597015337", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jardiance-10.jpg&setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=img", "alt": "JARDIANCE 25 mg 在美国 DailyMed 公开标签中的包装标签图", "archiveMarket": "美国", "labelVersion": "2026-01-30 生效；DailyMed 当前公开标签", "presentation": "JARDIANCE（恩格列净）25 mg、30 片泡罩板纸盒（3 板 × 10 片；NDC 0597-0153-37；DailyMed 当前美国公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 JARDIANCE、恩格列净 25 mg、NDC 0597-0153-37、30 片泡罩板纸盒（3 板 × 10 片）；只帮助核对来源与产品身份，不用于鉴定真伪，也不证明 10 mg、其他 NDC、复方产品、其他市场标签、原研身份、当前可得性、目标市场批准或可替代性。", "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JARDIANCE 说明书放大阅读：25 mg 先是包装所示的产品强度", "en": "JARDIANCE label reading: 25 mg first identifies the packaged product strength" }, "summary": { "zh": "本模块以美国 DailyMed 2026-01 当前标签为公开阅读入口，帮助读者核对 JARDIANCE、10 mg 或 25 mg、每片强度与 30 片泡罩板纸盒；它不把包装强度或包装数量转成个人用药方案。", "en": "This module uses the current Jan 2026 U.S. DailyMed label as a public reading entry point, helping readers check JARDIANCE, 10 mg or 25 mg, strength per tablet and the 30-tablet blister-card carton; it does not turn strength or package count into an individual treatment plan." }, "checks": [ { "zh": "先把商品名 JARDIANCE、通用名恩格列净（empagliflozin）、“25 mg”、口服片剂和目标市场一起核对。包装上的 25 mg 是该图所示产品强度，不是任何人每天应服几片的答案。", "en": "Check JARDIANCE, the generic name empagliflozin, “25 mg”, oral-tablet form and target market together. The 25 mg on this package is the illustrated product strength, not an answer to how many tablets any person should take." }, { "zh": "糖尿病、心力衰竭或慢性肾病等词语不能自行推导为“这盒药适合我”。是否适用、何时用、能否换规格或停用，都需要回到具体病情、处方和目标市场的现行标签。", "en": "Terms such as diabetes, heart failure or chronic kidney disease cannot be used to conclude that this pack is suitable for a particular person. Suitability, timing, a strength change or stopping all require the individual clinical context, prescription and current label in the target market." }, { "zh": "若同时使用利尿剂、胰岛素或其他降糖产品，或在生病、进食饮水异常、手术前后出现用药疑问，应带上完整药品清单请开方团队或药师核对；不要仅凭网页或包装自行加减、补服或替换。", "en": "If diuretics, insulin or other glucose-lowering products are also used, or questions arise around illness, unusual eating or drinking, or surgery, bring the complete medicine list to the prescribing team or pharmacist. Do not add, reduce, make up or replace doses from a webpage or package alone." }, { "zh": "外观图和文字仅是核对起点。包装不同、市场不同、标签更新或由其他主体分装时，都可能改变外观和标示；照片不能证明真伪或当前获批状态。", "en": "The image and text are only a checking starting point. Packaging can differ by market, label update or repackaging; a photograph cannot establish authenticity or current approval status." } ], "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "恩格列净怎样起作用：它影响肾脏对葡萄糖的重吸收", "en": "How empagliflozin works: it affects renal glucose reabsorption" }, "summary": { "zh": "FDA 公开标签描述：SGLT2 是使肾小球滤过液中的葡萄糖重新回到循环中的主要转运体；恩格列净抑制 SGLT2，从而减少重吸收、降低肾糖阈并增加尿糖排出。这是机制阅读，不是个人能否使用、与其他降糖药怎样组合或如何处理不适的方案。", "en": "The FDA public label describes SGLT2 as the predominant transporter that returns glucose from glomerular filtrate to the circulation. Empagliflozin inhibits SGLT2, reducing reabsorption, lowering the renal glucose threshold and increasing urinary glucose excretion. This is mechanism reading, not a plan for individual use, combination with other glucose-lowering medicines or management of symptoms." }, "checks": [ { "zh": "“让更多葡萄糖经尿液排出”不等于每个人都可凭此判断适合使用，也不能由此自行增加、减少或补服片数。具体疾病、肾功能、饮水进食状况与现行处方必须一起核对。", "en": "“More glucose leaves in urine” does not mean every person can decide from this that the medicine is suitable, or self-increase, decrease or make up tablets. The clinical situation, kidney function, eating and drinking status, and current prescription must be reviewed together." }, { "zh": "共同机制不使 JARDIANCE 与其他 SGLT2 抑制剂、胰岛素、利尿剂或其他降糖药可自行替换或叠加。共同名称、相近数字或他人的方案都不足以决定个人组合。", "en": "A shared mechanism does not make JARDIANCE self-substitutable or self-combinable with other SGLT2 inhibitors, insulin, diuretics or other glucose-lowering medicines. A shared name, a similar number or another person's regimen cannot decide an individual's combination." }, { "zh": "生病、进食饮水异常、手术前后、血糖异常或出现不适时，机制说明不能决定下一步。应带上实际包装和完整药单请开方团队或药师核对。", "en": "During illness, unusual eating or drinking, around surgery, with abnormal glucose readings or symptoms, a mechanism explanation cannot decide the next step. Take the actual pack and complete medicine list to the prescribing team or pharmacist for review." } ], "source": { "id": "src_c367c16b04b8fab7", "label": "FDA：JARDIANCE 2016-07 美国标签档案（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Jardiance", "generic": "恩格列净", "dosageFormClass": "恩格列净口服薄膜衣片：10 mg、25 mg；各精确展示 30 片泡罩板纸盒（3 板 × 10 片）" }, "labelSource": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c367c16b04b8fab7", "label": "FDA：JARDIANCE 2016-07 美国标签档案（NDA 204629）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-faers-sglt2-2023-dka-label-update-listing", "issuedAt": "2023-09-30", "status": "fda_potential_signal_label_update_listing", "title": { "zh": "FDA FAERS 记录：SGLT2 抑制剂相关标签更新线索", "en": "FDA FAERS record: SGLT2-inhibitor labelling-update information" }, "summary": { "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面标示数据截至 2026-03-13）列出 Jardiance（恩格列净）和 Farxiga（达格列净）等 SGLT2 抑制剂，并说明该类产品的“警告和注意事项”已于 2023 年 9 月更新，纳入持续时间延长的糖尿病酮症酸中毒与尿糖信息。该表是监管安全信号与标签更新记录，不可用于判断个人是否发生相关问题；个人情况仍需结合实际产品、症状、检验和专业评估处理。", "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, displayed as current through 2026-03-13, lists Jardiance (empagliflozin) and Farxiga (dapagliflozin) among SGLT2 inhibitors and says their Warnings and Precautions labelling was updated in September 2023 to include prolonged diabetic ketoacidosis and glucosuria information. This is a regulatory safety-signal and labelling-update record; it cannot determine an individual event or support self-stopping, switching or changing treatment." }, "source": { "id": "src_8c74002392ff8c7f", "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（SGLT2 抑制剂标签更新）", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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 的当前 JARDIANCE（empagliflozin）美国公开标签展示 10 mg 与 25 mg 口服薄膜衣片，各为 30 片泡罩板纸盒（3 板 × 10 片）。本页把品牌、通用名、每片标示强度、包装与来源一起核对；不将包装数字变成个人片数、加减、补服、停用、替代或联用方案。", "history": "FDA 的历史资料记录 JARDIANCE 的美国初始批准年份为 2014；当前包装身份以 2026-01-30 生效的 DailyMed 公开标签为准。历史资料与当前标签都不能推定其他市场的注册、持有人、供应、可售资格或原研/仿制关系。", "sourceDocuments": [ { "id": "src_c367c16b04b8fab7", "label": "FDA：JARDIANCE 2016-07 美国标签档案（NDA 204629）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 204629", "approvalTimeline": [ { "date": "2014", "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: 2014。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: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_c367c16b04b8fab7", "label": "FDA: JARDIANCE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2016-07 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 2016-07 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_c367c16b04b8fab7", "label": "FDA: JARDIANCE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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/jardiance/", "en": "https://origindrug.com/en/drugs/jardiance/" }, "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." ] }