{ "id": "avastin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Avastin", "generic": "贝伐珠单抗", "aliases": [ "bevacizumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2025-01 更新；两个准确单剂量瓶包装身份）", "dosageFormClass": "静脉用注射液：100 mg/4 mL 与 400 mg/16 mL（25 mg/mL）单剂量瓶", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "2004（美国公开标签所列初始批准）", "archiveSponsorText": "Genentech / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avastin-bevacizumab-100mg-4ml-single-dose-vial-5024206001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 更新）", "en": "DailyMed U.S. public label (Genentech; updated Jan 2025)" }, "dosageForm": { "zh": "AVASTIN 贝伐珠单抗静脉用注射液", "en": "AVASTIN bevacizumab injection for intravenous use" }, "route": { "zh": "稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-060-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含贝伐珠单抗 100 mg/4 mL（25 mg/mL）；每盒 1 瓶", "en": "Bevacizumab 100 mg/4 mL (25 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avastin-10.jpg&setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "贝伐珠单抗", "en": "bevacizumab" }, "value": 100, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、稀释、联用或停药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution, combination or stopping plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶；未用部分须丢弃", "en": "preservative-free single-dose vial; discard unused portion" }, "fill": { "value": 4, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至轻微乳光、无色至淡棕色溶液（标签描述）", "en": "clear to slightly opalescent, colourless to pale-brown solution (label description)" }, "shape": { "zh": "4 mL 单剂量玻璃瓶及纸盒", "en": "4 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 100 mg/4 mL 单剂量瓶美国公开标签面板（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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-avastin-bevacizumab-400mg-16ml-single-dose-vial-5024206101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 更新）", "en": "DailyMed U.S. public label (Genentech; updated Jan 2025)" }, "dosageForm": { "zh": "AVASTIN 贝伐珠单抗静脉用注射液", "en": "AVASTIN bevacizumab injection for intravenous use" }, "route": { "zh": "稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-061-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含贝伐珠单抗 400 mg/16 mL（25 mg/mL）；每盒 1 瓶", "en": "Bevacizumab 400 mg/16 mL (25 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avastin-11.jpg&setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "贝伐珠单抗", "en": "bevacizumab" }, "value": 400, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、稀释、联用或停药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution, combination or stopping plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶；未用部分须丢弃", "en": "preservative-free single-dose vial; discard unused portion" }, "fill": { "value": 16, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至轻微乳光、无色至淡棕色溶液（标签描述）", "en": "clear to slightly opalescent, colourless to pale-brown solution (label description)" }, "shape": { "zh": "16 mL 单剂量玻璃瓶及纸盒", "en": "16 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 400 mg/16 mL 单剂量瓶美国公开标签面板（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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-avastin-bevacizumab-100mg-4ml-single-dose-vial-5024206001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avastin-10.jpg&setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e&type=img", "alt": "AVASTIN 贝伐珠单抗在美国 DailyMed Genentech 公开标签中的 100 mg/4 mL 单剂量瓶纸盒正面图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Genentech，2025-01 更新）", "presentation": "AVASTIN 注射液：100 mg/4 mL（25 mg/mL），静脉用单剂量瓶纸盒正面图（DailyMed Genentech 公开标签所列）。", "notice": "此为美国 DailyMed Genentech 公开标签中明确对应 AVASTIN、贝伐珠单抗 100 mg/4 mL（25 mg/mL）单剂量瓶的纸盒图，只帮助核对品牌、通用名、剂型、标示浓度、静脉用与来源；不用于鉴定真伪，也不证明 400 mg/16 mL 或其他规格、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_5caab32ce3a2a660", "label": "DailyMed（NLM）：AVASTIN 公开标签（Genentech，2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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": "AVASTIN 说明书放大阅读：25 mg/mL 只帮助识别静脉输注瓶", "en": "AVASTIN label reading: 25 mg/mL only helps identify an intravenous-infusion vial" }, "summary": { "zh": "以 DailyMed 当前 AVASTIN 美国公开标签为阅读入口，核对贝伐珠单抗、100 mg/4 mL 与 400 mg/16 mL（25 mg/mL）单剂量瓶和目标市场；不把浓度、瓶数或抗肿瘤方案变成个人输注、联用或停药决定。", "en": "Using the current U.S. DailyMed public label for AVASTIN as an entry point, this checks bevacizumab, 100 mg/4 mL and 400 mg/16 mL (25 mg/mL) single-dose vials and target market; it does not turn concentration, vial count or an oncology regimen into an individual infusion, combination or stopping decision." }, "checks": [ { "zh": "100 mg/4 mL 和 25 mg/mL 是准确单剂量瓶的总含量与浓度线索，不是需要几瓶、余量可否保存或家庭输注说明。", "en": "100 mg/4 mL and 25 mg/mL are total-content and concentration clues for the exact single-dose vial, not a number of vials, permission to save leftovers or home-infusion instructions." }, { "zh": "同为抗血管生成或静脉抗肿瘤药，不表示可自行与化疗、其他靶向药、免疫治疗、抗凝药或补充剂组合、轮换或替代。", "en": "Being an anti-angiogenic or intravenous anticancer medicine does not permit self-combination, alternation or substitution with chemotherapy, another targeted medicine, immunotherapy, anticoagulation or supplements." }, { "zh": "明显出血、突发胸痛或呼吸不适、严重腹痛、伤口异常、严重头痛/神经变化或其他急性问题，应及时使用当地紧急医疗支持并联系治疗团队。", "en": "With marked bleeding, sudden chest pain or breathing trouble, severe abdominal pain, an unusual wound problem, severe headache/neurologic change or another acute concern, use local urgent medical support promptly and contact the treatment team." } ], "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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": "贝伐珠单抗怎样起作用：标签描述其结合 VEGF 并抑制血管生成信号", "en": "How bevacizumab works: the label describes binding VEGF and inhibiting angiogenesis signalling" }, "summary": { "zh": "DailyMed 的 AVASTIN 当前公开标签描述贝伐珠单抗可结合 VEGF，阻止其与血管内皮细胞表面受体结合，从而抑制血管生成。它解释一条肿瘤生物学路径，不判断个人肿瘤是否适用、是否联合化疗、输注剂量或开始、暂停和停用。", "en": "The current DailyMed public label for AVASTIN describes bevacizumab as binding VEGF and preventing its binding to endothelial-cell receptors, thereby inhibiting angiogenesis. It explains one tumour-biology pathway, not individual suitability, chemotherapy combination, infusion dose or a start/hold/stop decision." }, "checks": [ { "zh": "“抗血管生成”不是凭肿瘤名称、影像报告或网络资料自行判断用药的依据。疾病类型、病理/分子资料、既往治疗、手术计划、出血或血栓风险和完整药单须由肿瘤团队整体评估。", "en": "“Anti-angiogenesis” is not a basis for treatment decisions from a tumour name, imaging report or online information. Disease type, pathology/molecular information, prior therapy, surgical plans, bleeding/thrombosis risk and complete medicine list need oncology-team assessment." }, { "zh": "共同影响 VEGF 或都为抗体药物，不表示 AVASTIN 可与另一种靶向药、生物制剂、抗凝药或其他治疗自行叠加、轮换或替代。", "en": "A shared VEGF effect or antibody class does not make AVASTIN self-combinable, alternatable or substitutable with another targeted therapy, biologic, anticoagulant or other treatment." }, { "zh": "标签含有出血、胃肠穿孔、伤口愈合、高血压和其他严重风险警示。出现出血、剧烈腹痛、胸痛、呼吸困难、神经系统异常或其他急性问题时，应立即使用当地肿瘤团队或紧急医疗渠道。", "en": "The label contains warnings about bleeding, GI perforation, wound healing, hypertension and other serious risks. With bleeding, severe abdominal pain, chest pain, breathing trouble, neurologic change or another acute concern, use the local oncology team or emergency pathway immediately." } ], "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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": "Avastin", "generic": "贝伐珠单抗", "dosageFormClass": "静脉用注射液：100 mg/4 mL 与 400 mg/16 mL（25 mg/mL）单剂量瓶" }, "labelSource": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 贝伐珠单抗当前美国公开标签（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 贝伐珠单抗当前美国公开标签（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_21b7725287c2a9f6", "label": "FDA：AVASTIN 2014 美国历史标签（BLA 125085）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "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 AVASTIN（bevacizumab）当前美国公开标签列示 100 mg/4 mL 与 400 mg/16 mL 两个 25 mg/mL 单剂量瓶。本页把浓度、总体积、NDC、包装与来源分开呈现；不把浓度或瓶数变成个人输注、联用、停药或购买结论。", "history": "两个单剂量瓶共享浓度但总体积与总毫克数不同；不能只看品牌或 25 mg/mL 就视作同一包装。市场记录、配制与给药条件须按目标市场现行文件逐项复核。", "sourceDocuments": [ { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 贝伐珠单抗当前美国公开标签（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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_21b7725287c2a9f6", "label": "FDA：AVASTIN 2014 美国历史标签（BLA 125085）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125085", "approvalTimeline": [ { "date": "DailyMed 当前公开标签，2025-01 更新", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 DailyMed 当前公开标签，2025-01 更新 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated DailyMed 当前公开标签，2025-01 更新 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed: current AVASTIN U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "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": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "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": "不从美国公开标签推定当地批准、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. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "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": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/avastin/", "en": "https://origindrug.com/en/drugs/avastin/" }, "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." ] }