{ "id": "tagrisso", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Tagrisso", "generic": "奥希替尼", "aliases": [ "泰瑞沙", "TAGRISSO", "osimertinib", "奥希替尼", "甲磺酸奥希替尼", "osimertinib mesylate" ], "marketBrandNames": [ { "name": "泰瑞沙®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "company_product_page_name_and_strength_cue", "note": { "zh": "阿斯利康中国肿瘤产品页列示“泰瑞沙®（甲磺酸奥希替尼片）80 mg”。该企业页面仅支持核对中文商品名、通用名线索和所列强度；不确认现行批准、包装、供应、可售资格或个人使用。", "en": "AstraZeneca China's oncology product page lists 泰瑞沙® (osimertinib mesylate tablets) 80 mg. This company page supports checking the Chinese trade-name, generic-name cue and listed strength only; it does not establish current authorisation, packaging, supply, sale eligibility or individual use." }, "source": { "id": "src_dd817f06ac5828d2", "label": "阿斯利康中国：肿瘤产品页（泰瑞沙®／甲磺酸奥希替尼片 80 mg）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/oncology.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "mainlandChinaTradeNameCue": { "value": "泰瑞沙®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_dd817f06ac5828d2", "label": "阿斯利康中国：肿瘤产品页（泰瑞沙®／甲磺酸奥希替尼片 80 mg）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/oncology.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed TAGRISSO（osimertinib）有日期公开标签，SPL v36 于 2026-04-22 发布；本档案只展示该标签中可逐一对应的 40 mg、80 mg、各 30 片瓶装面板。阿斯利康中国公开肿瘤产品页列示“泰瑞沙®（甲磺酸奥希替尼片）80 mg”，仅作为中国名称和规格检索线索，不推定现行批准、包装、供应、可得性或个人适用性。", "dosageFormClass": "口服薄膜衣片：40 mg、80 mg（DailyMed SPL v36 所列；本页分别展示两个 30 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2015（DailyMed 当前美国公开标签所列初始批准）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AZD9291 clinical-trial supply", "osimertinib injection", "奥希替尼注射液", "oral suspension", "口服混悬液", "口服混悬" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tagrisso-osimertinib-tablet-40mg-30bottle-ndc-0310-1349-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签 SPL v36（2026-04-22 发布）", "en": "U.S. DailyMed public label, SPL v36 (published 22 Apr 2026)" }, "dosageForm": { "zh": "TAGRISSO 奥希替尼口服薄膜衣片", "en": "TAGRISSO osimertinib film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-1349-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image_08.jpg&setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥希替尼", "en": "osimertinib" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色（标签描述）", "en": "beige (label description)" }, "shape": { "zh": "圆形、双凸片（标签描述）", "en": "round, biconvex tablet (label description)" }, "imprint": "AZ 40 / plain reverse", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tagrisso-osimertinib-tablet-80mg-30bottle-ndc-0310-1350-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签 SPL v36（2026-04-22 发布）", "en": "U.S. DailyMed public label, SPL v36 (published 22 Apr 2026)" }, "dosageForm": { "zh": "TAGRISSO 奥希替尼口服薄膜衣片", "en": "TAGRISSO osimertinib film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-1350-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；30 片瓶装", "en": "80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image_09.jpg&setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥希替尼", "en": "osimertinib" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色（标签描述）", "en": "beige (label description)" }, "shape": { "zh": "椭圆形、双凸片（标签描述）", "en": "oval, biconvex tablet (label description)" }, "imprint": "AZ 80 / plain reverse", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tagrisso-osimertinib-tablet-80mg-30bottle-ndc-0310-1350-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image_09.jpg&setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7&type=img", "alt": "TAGRISSO 奥希替尼在美国 DailyMed 公开标签中的 80 mg、NDC 0310-1350-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v36（2026-04-22 发布）", "presentation": "TAGRISSO 奥希替尼：每片 80 mg，NDC 0310-1350-30，30 片瓶装。", "notice": "此图只对应美国 DailyMed SPL v36 中 TAGRISSO、奥希替尼、每片 80 mg、NDC 0310-1350-30 与 30 片瓶装。它只帮助核对品牌、通用名、每片标签量、片剂、包装数量和来源；不用于鉴定真伪，也不证明 40 mg、其他 NDC、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、疗程、联用、换药或停药方案。", "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TAGRISSO／泰瑞沙说明书放大阅读：40、80 mg 先是准确片剂身份", "en": "TAGRISSO label reading: 40 and 80 mg identify exact tablets first" }, "summary": { "zh": "本模块只阅读 DailyMed 美国公开标签中 TAGRISSO、奥希替尼、40/80 mg 口服薄膜衣片和两个 30 片包装面板。它不根据包装数字、肿瘤名称、基因词或网页信息决定任何人的片数、疗程、联用、停用、换药或是否适合治疗。", "en": "This module reads only TAGRISSO, osimertinib, 40/80 mg film-coated oral tablets and two 30-tablet package panels in the U.S. DailyMed public label. It does not use package numbers, cancer wording, genetic terms or website content to decide any person's tablet count, course, co-use, stopping, switching or treatment suitability." }, "checks": [ { "zh": "先把完整商品名、通用名、每片 40 或 80 mg、口服薄膜衣片、实际 NDC、包装和目标市场一起核对。40 mg 与 80 mg 是两个准确片剂的身份字段，不是网页可换算成个人片数、减量、补用或疗程的规则。", "en": "Check the full trade name, generic name, 40 or 80 mg per tablet, film-coated oral-tablet form, actual NDC, package and target market together. 40 mg and 80 mg identify two exact tablets; they are not a web rule for individual tablet count, reduction, make-up use or treatment course." }, { "zh": "该美国标签列出片剂可按特定标签说明分散于水中、但不应压碎。这个产品特定的标签文字并不表示另一种口服抗肿瘤药、另一市场包装或任何有吞咽困难者都可按同样方式处理；应由药师或开方团队核对实际产品和处方。", "en": "The U.S. label states that these tablets may be dispersed in water under its specific instructions but should not be crushed. This product-specific wording does not mean another oral oncology medicine, another-market pack or any swallowing difficulty can be handled the same way; have a pharmacist or prescriber review the actual product and prescription." }, { "zh": "标签中的 EGFR 突变、检测和疾病阶段文字用于界定所引美国标签的适用人群；它不等于每位肺部疾病患者都应做同一检测，也不让网页解释个人检测结果、决定治疗或自行调整药物。带原始检测报告、病理资料和完整药单请肿瘤团队解释。", "en": "EGFR-mutation, testing and disease-stage wording in the label defines the populations in that U.S. document. It does not mean every person with lung disease should have the same test, and it does not let a webpage interpret an individual's result, decide treatment or direct self-adjustment. Bring the original testing report, pathology material and full medicine list to the oncology team." }, { "zh": "标签列出间质性肺病/肺炎、QTc 间期延长、心肌病、角膜炎及皮肤反应等需及时评估的安全信息。呼吸困难、胸痛、晕厥、明显心悸、突发视力问题或其他急性严重不适应优先使用当地紧急医疗渠道；不要仅凭网页自行继续、停用、补用或改用其他抗肿瘤药。", "en": "The label includes safety information requiring timely assessment for interstitial lung disease/pneumonitis, QTc prolongation, cardiomyopathy, keratitis and skin reactions. Breathing difficulty, chest pain, fainting, marked palpitations, sudden visual problems or another acute severe concern require local urgent medical care first; do not use a webpage to continue, stop, make up or change an anticancer medicine." } ], "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥希替尼怎样起作用：标签描述其为与特定突变 EGFR 不可逆结合的激酶抑制剂", "en": "How osimertinib works: the label describes an irreversible kinase inhibitor of certain mutant EGFR forms" }, "summary": { "zh": "美国标签将奥希替尼描述为 EGFR 激酶抑制剂，并说明其可与某些突变形式的 EGFR 不可逆结合。这个机制帮助读者理解标签中的药理语言，不预测个人疗效、风险、耐受性、剂量、联用或是否适合治疗。", "en": "The U.S. label describes osimertinib as an EGFR kinase inhibitor that binds irreversibly to certain mutant EGFR forms. This mechanism helps read the label's pharmacology; it does not predict an individual's benefit, risk, tolerance, dose, co-use or treatment suitability." }, "checks": [ { "zh": "“EGFR 激酶抑制剂”是作用路径用语，不表示任何 EGFR 检测阳性、肺癌、同类靶向药或不同市场的奥希替尼产品可以自行互换、叠加或按 mg 换算。", "en": "“EGFR kinase inhibitor” is pathway wording; it does not mean any positive EGFR test, lung cancer, related targeted medicine or another-market osimertinib product can be self-switched, combined or milligram-converted." }, { "zh": "检测名称、突变名称和药品名称都只是需要专业人员一起核对的证据片段。它们不能取代病理、影像、器官功能、既往治疗、当前说明书、完整药单或肿瘤团队的个体化判断。", "en": "Test names, mutation names and medicine names are only evidence fragments that need professional review together. They do not replace pathology, imaging, organ function, prior treatment, the current label, the complete medicine list or individual assessment by an oncology team." }, { "zh": "机制解释不能替代药物警戒或相互作用核对。出现新的呼吸、心律、视觉、皮肤或其他令人担忧的症状，或准备加入处方药、非处方药、补充剂或草本时，应让肿瘤团队和药师审阅实际产品与完整药单。", "en": "A mechanism explanation does not replace pharmacovigilance or interaction review. With new respiratory, rhythm, visual, skin or other concerning symptoms, or before adding a prescription, OTC product, supplement or herb, have the oncology team and pharmacist review the actual product and complete medicine list." } ], "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tagrisso", "generic": "奥希替尼", "dosageFormClass": "口服薄膜衣片：40 mg、80 mg（DailyMed SPL v36 所列；本页分别展示两个 30 片瓶装面板）" }, "labelSource": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "productRoutes": [ { "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "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": "2026-08-22", "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": "2026-08-22", "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 的 TAGRISSO（osimertinib）美国公开标签列出 40 mg、80 mg 口服薄膜衣片。本页把商品名、通用名、每片标示量、准确 NDC、包装外观和原始说明书入口并列，帮助读者看清“每片多少 mg”是产品身份，不把它转换成个人片数、联用、换药、停用或购买结论。", "history": "该美国公开标签列示 Initial U.S. Approval: 2015，且当前 SPL 记录为 v36、2026-04-22 发布。本页只锚定该美国文件和两个对应 30 片瓶装面板；中国页面中的“泰瑞沙®”仅用于中文名称检索，其他市场产品、不同 NDC、不同包装、其他剂型与个体化治疗均须按实际产品和所在市场现行资料另行核对。", "sourceDocuments": [ { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, { "id": "src_dd817f06ac5828d2", "label": "阿斯利康中国：肿瘤产品页（泰瑞沙®／甲磺酸奥希替尼片 80 mg）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/oncology.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } ], "applicationNumber": "NDA 208065", "approvalTimeline": [ { "date": "2015", "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: 2015。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: 2015. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed: TAGRISSO osimertinib U.S. public label, SPL v36", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "DailyMed SPL v36, published 2026-04-22", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v36, published 2026-04-22 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 DailyMed SPL v36, published 2026-04-22 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_de01b0b37d6ccdaf", "label": "DailyMed: TAGRISSO osimertinib U.S. public label, SPL v36", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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/tagrisso/", "en": "https://origindrug.com/en/drugs/tagrisso/" }, "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." ] }