{ "id": "ofev", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "OFEV", "generic": "尼达尼布", "aliases": [ "OFEV", "nintedanib", "nintedanib esylate", "尼达尼布" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 DailyMed 当前 OFEV（nintedanib）口服胶囊标签，SPL v21，2025-11-20 生效。该记录只对应美国标签所列产品，不推定中国大陆或其他市场的当前批准、供应或可得性。", "dosageFormClass": "口服胶囊：100 mg、150 mg（DailyMed 当前美国公开标签所列；各 60 粒瓶装/纸盒记录）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2014（DailyMed 当前美国公开标签所列初始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "nintedanib tablet", "尼达尼布片", "nintedanib injection", "尼达尼布注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ofev-nintedanib-150mg-60capsule-bottle-carton-ndc-0597-0145-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2025-05 修订）", "en": "Current U.S. DailyMed public label (revised May 2025)" }, "dosageForm": { "zh": "口服软胶囊", "en": "oral soft capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0145-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "OFEV 尼达尼布 150 mg；60 粒瓶装纸盒（NDC 0597-0145-60）", "en": "OFEV nintedanib 150 mg; 60-capsule bottle carton (NDC 0597-0145-60)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ofev-09.jpg&setid=da1c9f37-779e-4682-816f-93d0faa4cfc9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "尼达尼布", "en": "nintedanib" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊的标签量；不是个人用量或换算", "en": "labelled amount per capsule; not an individual amount or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "带儿童安全封口的 HDPE 瓶", "en": "HDPE bottle with child-resistant closure" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶装纸盒", "en": "capsules per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒胶囊/瓶装纸盒", "en": "capsules per bottle carton" } }, "physicalClues": { "color": { "zh": "棕色不透明（标签描述）", "en": "brown, opaque (label description)" }, "shape": { "zh": "长圆形软胶囊（标签描述）", "en": "oblong soft capsule (label description)" }, "imprint": "Boehringer Ingelheim company symbol / 150", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed（NLM）：OFEV 尼达尼布当前美国公开标签（Boehringer Ingelheim；2025-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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-ofev-nintedanib-100mg-60capsule-bottle-carton-ndc-0597-0143-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2025-05 修订）", "en": "Current U.S. DailyMed public label (revised May 2025)" }, "dosageForm": { "zh": "口服软胶囊", "en": "oral soft capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0143-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "OFEV 尼达尼布 100 mg；60 粒瓶装纸盒（NDC 0597-0143-60）", "en": "OFEV nintedanib 100 mg; 60-capsule bottle carton (NDC 0597-0143-60)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ofev-10.jpg&setid=da1c9f37-779e-4682-816f-93d0faa4cfc9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "尼达尼布", "en": "nintedanib" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊的标签量；不是个人用量或换算", "en": "labelled amount per capsule; not an individual amount or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "带儿童安全封口的 HDPE 瓶", "en": "HDPE bottle with child-resistant closure" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶装纸盒", "en": "capsules per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒胶囊/瓶装纸盒", "en": "capsules per bottle carton" } }, "physicalClues": { "color": { "zh": "桃色不透明（标签描述）", "en": "peach, opaque (label description)" }, "shape": { "zh": "长圆形软胶囊（标签描述）", "en": "oblong soft capsule (label description)" }, "imprint": "Boehringer Ingelheim company symbol / 100", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed（NLM）：OFEV 尼达尼布当前美国公开标签（Boehringer Ingelheim；2025-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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-ofev-nintedanib-150mg-60capsule-bottle-carton-ndc-0597-0145-60", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ofev-09.jpg&setid=da1c9f37-779e-4682-816f-93d0faa4cfc9&type=img", "alt": "OFEV 尼达尼布在美国 DailyMed 当前标签中的 150 mg、NDC 0597-0145-60、60 粒瓶装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2025-05 修订）", "presentation": "OFEV 尼达尼布：每粒 150 mg，NDC 0597-0145-60，60 粒瓶装纸盒。", "notice": "此图只对应美国 DailyMed 当前标签中的 OFEV、尼达尼布、每粒 150 mg、NDC 0597-0145-60 与 60 粒瓶装纸盒。它只帮助核对品牌、通用名、每粒标签量、包装数量和来源；不用于鉴定真伪，也不证明 100 mg 产品、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的胶囊数量、时间、开始、停用、联用或换药方案。", "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed（NLM）：OFEV 尼达尼布当前美国公开标签（Boehringer Ingelheim；2025-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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": "OFEV 说明书放大阅读：100、150 mg 是胶囊身份，不是“该吃几粒”", "en": "OFEV label reading: 100 and 150 mg identify capsules; they do not answer “how many capsules”" }, "summary": { "zh": "本模块只阅读 DailyMed 当前美国标签中的 OFEV、尼达尼布、口服胶囊和每粒标示量。它把标签的产品身份和安全核对线索放在一起，但不提供个人用量、开始、停用、换药、联用或购买方案。", "en": "This module reads only OFEV, nintedanib, oral capsules and labelled amount per capsule in the current U.S. DailyMed label. It places product identity and safety-review cues together, but provides no individual use, initiation, stopping, switching, co-use or purchase plan." }, "checks": [ { "zh": "把 OFEV、尼达尼布、口服胶囊、每粒 100 或 150 mg、实际包装和目标市场一起核对。mg 是每一粒准确胶囊的标签量，不是网页可以换算成个人每天该用多少粒的规则，也不能据此把另一种药、另一市场产品或另一剂型自行互换。", "en": "Check OFEV, nintedanib, oral-capsule form, the stated 100 or 150 mg per capsule, the actual pack and target market together. Mg is the labelled amount in an exact capsule, not a web rule for how many capsules an individual should use, and it cannot self-convert another medicine, market product or form." }, { "zh": "该美国标签写明胶囊应整粒吞服，不应咀嚼、打开或压碎；这是这个准确胶囊产品的标签文字，不能外推为其他胶囊或片剂的操作结论。吞咽困难、漏用、包装不一致或想改变使用方式时，应先带实际药盒和完整药单请药师或开方团队核对。", "en": "The U.S. label says the capsules should be swallowed whole and not chewed, opened or crushed. This is label wording for this exact capsule product and cannot be generalised to another capsule or tablet. For swallowing difficulty, missed use, a mismatched pack or a contemplated change in use, first have a pharmacist or prescribing team review the actual pack and complete medicine list." }, { "zh": "标签列出肝功能、胃肠道问题、出血风险、动脉血栓事件及多药并用等需要专业复核的线索。它们不是网页可以决定“能不能同时用、谁先停、怎样错开”的答案；出现呕血、黑便、胸部不适、呼吸困难、晕厥或其他急性严重不适时，应优先使用当地紧急医疗渠道。", "en": "The label identifies liver context, gastrointestinal problems, bleeding risk, arterial thromboembolic events and multiple medicines as review cues. They are not a webpage answer to whether products can be used together, which should stop first or how to space them; vomiting blood, black stools, chest discomfort, breathing difficulty, fainting or another acute serious concern require local urgent medical care first." }, { "zh": "若同时有抗凝药、抗血小板药、非处方止痛药、草本或补充剂，或正在接受其他处方治疗，应把所有实际包装、开始/变更时间和不适一起交给药师或医疗团队核对。不要仅按“肺部用药”“纤维化”或相近毫克数字自行叠加、轮换或替代。", "en": "If anticoagulants, antiplatelet medicines, OTC pain products, herbs or supplements, or other prescriptions are also present, have a pharmacist or care team review every actual pack, start/change timing and concerns together. Do not self-combine, alternate or substitute based only on words such as “lung medicine,” “fibrosis” or similar milligram figures." } ], "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20; capsule identity and warnings)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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": "尼达尼布怎样起作用：标签将其描述为激酶抑制剂", "en": "How nintedanib works: the label identifies it as a kinase inhibitor" }, "summary": { "zh": "DailyMed 当前标签将 OFEV 描述为激酶抑制剂。这个机制词帮助理解标签的药理分类，却不预测个人病因、肺功能变化、耐受性、胶囊数量、是否适合、联用方案或是否需要换药。", "en": "The current DailyMed label describes OFEV as a kinase inhibitor. This mechanism term helps explain the label's pharmacologic classification; it does not predict an individual's cause, lung-function change, tolerance, capsule count, suitability, co-use plan or whether to switch." }, "checks": [ { "zh": "“激酶抑制剂”是药理路径用语，不表示所有同类药、相近用途产品或不同市场的尼达尼布产品可以自行互换、叠加或按 mg 对等换算。", "en": "“Kinase inhibitor” is pharmacologic-pathway wording; it does not establish that all related medicines, products with similar uses or nintedanib products from different markets can be self-interchanged, combined or milligram-converted." }, { "zh": "同样出现“肺纤维化”“间质性肺疾病”或“激酶”文字，也不能证明两盒药适用于同一疾病、同一人或同一市场。应先核对准确商品名、通用名、胶囊强度、目标市场标签和完整药单。", "en": "Shared words such as “pulmonary fibrosis,” “interstitial lung disease” or “kinase” do not establish that two packs apply to the same condition, person or market. First check the exact brand, generic name, capsule strength, target-market label and complete medicine list." }, { "zh": "机制解释不能替代标签、药物警戒或完整药单核对。涉及新增药物、出血或胃肠道相关不适、肝功能问题、漏用、掰开/打开胶囊或改变治疗时，应由了解实际产品和目标市场标签的专业人员审阅。", "en": "A mechanism explanation does not replace label, pharmacovigilance or complete-medicine-list review. Adding a medicine, bleeding or gastrointestinal concerns, liver questions, missed use, opening a capsule or changing treatment requires professional review of the actual product and target-market label." } ], "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21; Clinical Pharmacology)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "OFEV", "generic": "尼达尼布", "dosageFormClass": "口服胶囊：100 mg、150 mg（DailyMed 当前美国公开标签所列；各 60 粒瓶装/纸盒记录）" }, "labelSource": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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": "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": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国公开标签将 OFEV 列为尼达尼布口服胶囊，并列出 100 mg、150 mg 两种每粒标示量。本页帮助读者把商品名、通用名、胶囊、每粒标示量、美国标签和药物警戒入口逐项对应；它不把毫克数字变成个人每次/每天用量、开始、停用、联用、换药或购买建议。", "history": "DailyMed 标签列示 OFEV 的美国初始批准为 2014，且页面标示 NDA 205832。该档案仅定位这一美国公开标签：同一通用名的其他厂商、其他市场、其他包装或不同标签版本，均必须按实际药盒和目标市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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_5618be3b3fbcbdcf", "label": "FDA: OFEV nintedanib orphan-drug designation and approval record for IPF (2014)", "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=344511", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 205832", "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_4976d8d99a5c79b5", "label": "DailyMed: current OFEV nintedanib U.S. public label, SPL v21", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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" } }, { "date": "2025-11-20", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-11-20 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 2025-11-20 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_4976d8d99a5c79b5", "label": "DailyMed: current OFEV nintedanib U.S. public label, SPL v21", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "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" } } ], "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/ofev/", "en": "https://origindrug.com/en/drugs/ofev/" }, "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." ] }