{ "id": "pradaxa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Pradaxa", "generic": "达比加群酯", "aliases": [ "达比加群酯", "dabigatran etexilate", "dabigatran" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服胶囊：75 mg、110 mg、150 mg（FDA 2025 标签所列；口服颗粒不并入本胶囊档案）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2010（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim / FDA 与 DailyMed 公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PRADAXA oral pellets", "PRADAXA pellets", "dabigatran etexilate pellets", "达比加群酯口服颗粒" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-pradaxa-capsule-75mg-0597-0355-09", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "en": "DailyMed SPL v48 (updated 25 Jun 2025; published 30 Jun 2025)" }, "dosageForm": { "zh": "达比加群酯口服胶囊", "en": "dabigatran etexilate oral capsule" }, "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 0597-0355-09", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 75 mg；60 粒瓶装", "en": "75 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-10.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达比加群酯", "en": "dabigatran etexilate" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊标签标示量；不是个人服用数量或换算指令", "en": "labelled amount per capsule; not an individual capsule count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_bottle", "typeLabel": { "zh": "原瓶（使用单位瓶装）", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "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": 60, "unit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明帽与白色不透明体", "en": "white opaque cap and white opaque body" }, "shape": { "zh": "硬胶囊", "en": "hard capsule" }, "imprint": "R75", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "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-pradaxa-capsule-110mg-0597-0108-54", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "en": "DailyMed SPL v48 (updated 25 Jun 2025; published 30 Jun 2025)" }, "dosageForm": { "zh": "达比加群酯口服胶囊", "en": "dabigatran etexilate oral capsule" }, "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 0597-0108-54", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 110 mg；60 粒瓶装", "en": "110 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-09.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达比加群酯", "en": "dabigatran etexilate" }, "value": 110, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊标签标示量；不是个人服用数量或换算指令", "en": "labelled amount per capsule; not an individual capsule count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_bottle", "typeLabel": { "zh": "原瓶（使用单位瓶装）", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "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": 60, "unit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色不透明帽与浅蓝色不透明体", "en": "light-blue opaque cap and light-blue opaque body" }, "shape": { "zh": "硬胶囊", "en": "hard capsule" }, "imprint": "R110", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "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-pradaxa-capsule-150mg-0597-0360-55", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "en": "DailyMed SPL v48 (updated 25 Jun 2025; published 30 Jun 2025)" }, "dosageForm": { "zh": "达比加群酯口服胶囊", "en": "dabigatran etexilate oral capsule" }, "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 0597-0360-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 150 mg；60 粒瓶装", "en": "150 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-11.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达比加群酯", "en": "dabigatran etexilate" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊标签标示量；不是个人服用数量或换算指令", "en": "labelled amount per capsule; not an individual capsule count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_bottle", "typeLabel": { "zh": "原瓶（使用单位瓶装）", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "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": 60, "unit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色不透明帽与白色不透明体", "en": "light-blue opaque cap and white opaque body" }, "shape": { "zh": "硬胶囊", "en": "hard capsule" }, "imprint": "R150", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "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-pradaxa-capsule-110mg-0597-0108-54", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-09.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "alt": "PRADAXA 达比加群酯在美国 DailyMed 公开标签中的 110 mg、60 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "presentation": "PRADAXA 达比加群酯 110 mg、60 粒胶囊瓶装标签图（DailyMed 公开标签所列）。", "notice": "此图只对应美国 DailyMed SPL v48 中 PRADAXA 110 mg、NDC 0597-0108-54、60 粒原瓶标签图，只帮助核对品牌、通用名、标示强度、胶囊剂型、包装数量与来源；不用于鉴定真伪，也不证明 75 mg、150 mg、泡罩、口服颗粒、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "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": "PRADAXA / 达比加群酯说明书放大阅读：胶囊、原瓶防潮与不能自行换算", "en": "PRADAXA label reading: capsules, original-container storage and no self-conversion" }, "summary": { "zh": "本模块以 FDA 与 DailyMed 的 2025 美国公开标签为阅读入口，帮助识别 PRADAXA、达比加群酯、胶囊、标示强度和储存提示。它不生成个人服用数量、补服、停用、联用、换药或操作前后安排。", "en": "This module uses 2025 U.S. FDA and DailyMed public labels as a reading entry point for PRADAXA, dabigatran etexilate, capsules, stated strength and storage wording. It does not generate an individual capsule count, missed-dose, stopping, combination, switching or procedure plan." }, "checks": [ { "zh": "先同时核对 PRADAXA、达比加群酯、胶囊、每粒标示强度和目标市场。75、110、150 mg 是标签所列单粒强度线索，不是个人应服用几粒或如何换算的答案。", "en": "First check PRADAXA, dabigatran etexilate, capsule form, stated strength per capsule and target market together. 75, 110 and 150 mg are labelled per-capsule strength clues, not an answer to how many capsules an individual should take or convert." }, { "zh": "FDA 公开标签写明胶囊应整粒吞服；不要咀嚼、掰开或打开胶囊颗粒。该标签还提示，PRADAXA 胶囊不能与其他达比加群酯剂型按 mg 对 mg 自行互换。", "en": "The FDA public label says capsules should be swallowed whole; do not chew, break or open the capsule pellets. It also states that PRADAXA capsules are not to be self-substituted milligram-for-milligram with other dabigatran etexilate dosage forms." }, { "zh": "该美国标签提示将胶囊保留在原瓶或原泡罩中以防潮；不要为方便而转入分药盒。若使用原瓶，标签还列出开瓶后的使用期限；此为美国标签阅读提示，实际产品和当地说明书必须由药师核对。", "en": "The U.S. label says to keep capsules in the original bottle or blister packaging to protect from moisture; do not move them into a pill organizer merely for convenience. It also lists an in-use period after opening a bottle; this is a U.S.-label reading point, and the actual product and local leaflet require pharmacist review." }, { "zh": "抗凝药不能因为漏服担心、出血担心、检查/手术、拿到不同包装或他人建议而自行停用、加量、补双份、叠加或换成其他抗凝/抗血小板药。出现严重或难以控制的出血、昏厥、呼吸困难、突发神经系统症状等紧急情况，应立即使用当地紧急医疗服务。", "en": "An anticoagulant must not be self-stopped, increased, doubled, combined or switched to another anticoagulant or antiplatelet medicine because of a missed-dose concern, bleeding concern, a procedure, a different pack or someone else’s advice. With severe or uncontrolled bleeding, fainting, breathing difficulty or sudden neurological symptoms, seek local emergency care immediately." } ], "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "达比加群酯怎样起作用：它是直接凝血酶抑制剂", "en": "How dabigatran etexilate works: it is a direct thrombin inhibitor" }, "summary": { "zh": "FDA 2025 公开标签将达比加群列为直接凝血酶抑制剂。这个机制只解释作用路径，不判断个人是否需要抗凝，也不决定个人胶囊数量、联用、换用、停用或检查/手术安排。", "en": "The 2025 FDA public label describes dabigatran as a direct thrombin inhibitor. This explains a pathway only; it does not determine whether an individual needs anticoagulation or decide an individual capsule count, combination, switching, stopping or procedure plan." }, "checks": [ { "zh": "“直接凝血酶抑制剂”不是自行判断血栓风险、出血风险或治疗是否合适的工具；诊断、肾功能、年龄、其他疾病、完整药单和现行标签都可能影响专业判断。", "en": "“Direct thrombin inhibitor” is not a tool for self-judging clot risk, bleeding risk or whether treatment is appropriate; diagnosis, kidney function, age, other conditions, the full medicine list and current label can all affect professional assessment." }, { "zh": "相同的“抗凝”目的或类似机制，不使 PRADAXA 与华法林、阿哌沙班、利伐沙班或抗血小板药可自行叠加、轮换、替换或按 mg 换算。任何改变必须由开方医生或药师用实际产品和完整药单核对。", "en": "A shared anticoagulation purpose or related mechanism does not make PRADAXA self-combinable, interchangeable or milligram-convertible with warfarin, apixaban, rivaroxaban or an antiplatelet medicine. Any change requires the prescriber or pharmacist to review the actual products and full medicine list." }, { "zh": "机制页面也不能决定是否暂停、何时恢复、漏服后怎样处理或围手术期怎样安排。对上述问题或出现出血、不适、跌倒/外伤后担忧时，请及时联系当地医疗团队；紧急情况使用当地急救服务。", "en": "A mechanism page also cannot decide whether to pause, when to resume, how to handle a missed dose or how to plan around a procedure. For those questions, bleeding, feeling unwell or concern after a fall or injury, contact the local care team promptly; use emergency services for emergencies." } ], "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "Pradaxa", "generic": "达比加群酯", "dosageFormClass": "口服胶囊：75 mg、110 mg、150 mg（FDA 2025 标签所列；口服颗粒不并入本胶囊档案）" }, "labelSource": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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." } }, { "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 公开标签（Boehringer Ingelheim，2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "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." } } ], "recordRoute": { "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." } }, "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": "FDA 与 DailyMed 的 PRADAXA（dabigatran etexilate）2025 美国公开标签将其列为口服胶囊，并列示 75 mg、110 mg、150 mg 与美国初始批准年份 2010。本页仅建立这一美国公开标签的阅读入口；不据此推定任何市场的当前批准、持有人、规格、适应症、供应、原研关系或可售资格。", "history": "抗凝药包装上的 mg、胶囊数量和品牌名都只是产品身份线索，不能变成自行开始、停用、补服、叠加、换药或围手术期安排的指令。尤其在同时使用多种药物时，应让医生或药师以实际包装、完整药单和目标市场的现行文件逐项核对。", "sourceDocuments": [ { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 公开标签（Boehringer Ingelheim，2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "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" } ], "applicationNumber": "NDA 022512", "approvalTimeline": [ { "date": "2010", "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: 2010。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: 2010. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA: PRADAXA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-06", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-06 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 2025-06 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_dc1a1cae5d73a14a", "label": "FDA: PRADAXA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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/pradaxa/", "en": "https://origindrug.com/en/drugs/pradaxa/" }, "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." ] }