{ "id": "rituximab-rituxan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-15", "status": "published_traceable_archive" }, "names": { "brand": "RITUXAN", "generic": "利妥昔单抗", "aliases": [ "美罗华", "rituximab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "美罗华®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_405ac20ea088ffca", "label": "NMPA：利妥昔单抗注射液生物类似药临床试验指导原则（含中国商品名“美罗华”历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/wPvN1870taWudeiyeTSusn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "静脉输注用注射剂", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "1997", "archiveSponsorText": "Genentech（FDA 1997 年历史批准信所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rituxan-rituximab-100mg-10ml-single-dose-vial-5024205121", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 页面更新）", "en": "DailyMed U.S. public label (Genentech; page updated Jan 2025)" }, "dosageForm": { "zh": "RITUXAN 利妥昔单抗静脉输注用注射液", "en": "RITUXAN rituximab injection for intravenous infusion" }, "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 50242-051-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含利妥昔单抗 100 mg/10 mL（10 mg/mL）；每盒 1 瓶", "en": "Rituximab 100 mg/10 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rituxan-04.jpg&setid=b172773b-3905-4a1c-ad95-bab4b6126563&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利妥昔单抗", "en": "rituximab" }, "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、稀释或输注方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution or infusion plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶", "en": "preservative-free single-dose vial" }, "fill": { "value": 10, "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、无色溶液（标签描述）", "en": "clear, colourless solution (label description)" }, "shape": { "zh": "10 mL 单剂量玻璃瓶及纸盒", "en": "10 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_165ab4011d15d5dd", "label": "DailyMed（NLM）：RITUXAN 100 mg/10 mL 单剂量瓶美国公开标签（Genentech）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "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-rituxan-rituximab-500mg-50ml-single-dose-vial-5024205306", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 页面更新）", "en": "DailyMed U.S. public label (Genentech; page updated Jan 2025)" }, "dosageForm": { "zh": "RITUXAN 利妥昔单抗静脉输注用注射液", "en": "RITUXAN rituximab injection for intravenous infusion" }, "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 50242-053-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含利妥昔单抗 500 mg/50 mL（10 mg/mL）；每盒 1 瓶", "en": "Rituximab 500 mg/50 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rituxan-05.jpg&setid=b172773b-3905-4a1c-ad95-bab4b6126563&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利妥昔单抗", "en": "rituximab" }, "value": 500, "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、稀释或输注方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution or infusion plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶", "en": "preservative-free single-dose vial" }, "fill": { "value": 50, "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、无色溶液（标签描述）", "en": "clear, colourless solution (label description)" }, "shape": { "zh": "50 mL 单剂量玻璃瓶及纸盒", "en": "50 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_165ab4011d15d5dd", "label": "DailyMed（NLM）：RITUXAN 500 mg/50 mL 单剂量瓶美国公开标签（Genentech）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "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": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rituxan-04.jpg&setid=b172773b-3905-4a1c-ad95-bab4b6126563&type=img", "alt": "RITUXAN 利妥昔单抗在美国 DailyMed Genentech 公开标签中的 100 mg/10 mL 单剂量瓶纸盒图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Genentech，2025-01 更新）", "presentation": "RITUXAN 注射液：100 mg/10 mL（10 mg/mL）、单剂量瓶纸盒图（DailyMed Genentech 公开标签所列）。", "notice": "此为美国 DailyMed Genentech 公开标签中明确对应 RITUXAN、利妥昔单抗 100 mg/10 mL（10 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、单剂量瓶和来源；不用于鉴定真伪，也不证明其他规格、其他给药形式、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_4f99c2e1cf1d1ffd", "label": "DailyMed（NLM）：RITUXAN 公开标签（Genentech，2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "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": "RITUXAN 说明书放大阅读：10 mg/mL 单剂量瓶不是家庭输注或分装用量", "en": "RITUXAN label reading: a 10 mg/mL single-dose vial is not for home infusion or dose sharing" }, "summary": { "zh": "本模块以 Genentech 的美国 DailyMed 2025-01 RITUXAN 公开标签为阅读入口，帮助核对 RITUXAN、利妥昔单抗、静脉用注射剂、100 mg/10 mL 或 500 mg/50 mL（均为 10 mg/mL）单剂量瓶及目标市场；它不把浓度、瓶数、输注顺序或任何疾病名称变成个人方案。", "en": "This module uses Genentech's January 2025 U.S. DailyMed public label for RITUXAN as a reading entry point. It helps check RITUXAN, rituximab, injection for intravenous use, 100 mg/10 mL or 500 mg/50 mL (both 10 mg/mL) single-dose vials and target market; it does not turn concentration, vial count, infusion sequence or a disease name into an individual plan." }, "checks": [ { "zh": "100 mg/10 mL 与 500 mg/50 mL 是两种单剂量瓶的产品身份线索，10 mg/mL 是浓度；这些数字不等于“自己该用几瓶”、可以把余量留到下次或可分给他人。RITUXAN 标签明确它仅能由具备处理严重输注反应医疗支持的专业人员静脉输注，实际配制、输注和剩余处置必须由治疗机构负责。", "en": "100 mg/10 mL and 500 mg/50 mL are product-identity clues for two single-dose vials, and 10 mg/mL is a concentration; these numbers are not “how many vials to use,” permission to save leftovers or share product. The RITUXAN label states it is to be given intravenously only by professionals with medical support for severe infusion reactions; actual preparation, infusion and remaining-product handling belong to the treating facility." }, { "zh": "同为“单抗”、CD20 相关治疗或静脉用药，不表示 RITUXAN 能与另一种利妥昔单抗产品、化疗、免疫抑制剂、激素或其他生物制剂自行叠加、轮换或替代。疾病场景、既往疗程、感染风险、疫苗、完整药单和目标市场标签需要由开方团队一起核对。", "en": "Being called an antibody, a CD20-related treatment or an intravenous medicine does not make RITUXAN self-combinable, alternatable or substitutable with another rituximab product, chemotherapy, immunosuppressant, steroid or biologic. Disease setting, prior course, infection risk, vaccinations, the full medicine list and the target-market label need integrated review by the prescribing team." }, { "zh": "标签对严重输注反应、严重皮肤/黏膜反应、乙肝病毒再激活、进行性多灶性白质脑病、感染及其他风险有明确警示。输注期间或之后出现呼吸困难、胸部不适、明显皮疹/黏膜损害、发热感染征象、黄疸样变化、意识/神经变化、严重腹痛或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持。", "en": "The label carries explicit warnings about severe infusion reactions, severe skin/mucosal reactions, hepatitis B virus reactivation, progressive multifocal leukoencephalopathy, infection and other risks. With breathing difficulty, chest symptoms, marked rash/mucosal injury, fever or infection signs, jaundice-like changes, mental/neurologic change, severe abdominal pain or another acute concern during or after infusion, contact the treatment team promptly or use local urgent medical support." }, { "zh": "“CD20 阳性”、淋巴瘤、关节炎或自身免疫病等词汇不能由网页自行转成适用结论。相关检测、病理、感染/乙肝记录、既往治疗和现行标签必须由相应专科团队解释；不要因同名或相似适应症自行启动、暂停或更换。", "en": "Terms such as “CD20-positive,” lymphoma, arthritis or autoimmune disease cannot be turned into a suitability conclusion by a webpage. Relevant testing, pathology, infection/hepatitis B record, prior treatment and current label require interpretation by the appropriate specialty team; do not self-start, pause or switch because names or indications look similar." } ], "source": { "id": "src_4f99c2e1cf1d1ffd", "label": "DailyMed（NLM）：RITUXAN 公开标签（Genentech，2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "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": "利妥昔单抗怎样起作用：标签描述其与 B 细胞表面的 CD20 结合", "en": "How rituximab works: the label describes binding to CD20 on B cells" }, "summary": { "zh": "FDA 的 RITUXAN 标签将利妥昔单抗描述为可与成熟 B 淋巴细胞和前 B 淋巴细胞表面的 CD20 抗原结合的单克隆抗体；标签还描述其可通过补体依赖细胞毒、抗体依赖细胞毒和直接凋亡诱导等途径参与作用。这解释作用路径，不判断个人疾病是否适用、感染风险、疫苗安排、联合治疗或给药时间。", "en": "The FDA RITUXAN label describes rituximab as a monoclonal antibody that binds CD20 on mature and pre-B lymphocytes; it also describes complement-dependent cytotoxicity, antibody-dependent cytotoxicity and direct apoptosis induction as possible pathways. This explains action pathways, not individual disease suitability, infection risk, vaccine planning, combination treatment or timing." }, "checks": [ { "zh": "“作用于 B 细胞”不表示可以根据病名、化验单片段或机制自行判断是否需要治疗，或与其他免疫抑制、抗肿瘤、激素或生物制剂自行叠加、轮换或停用。", "en": "“Acts on B cells” does not permit a treatment decision from a diagnosis name, partial laboratory result or mechanism, nor self-combination, alternation or stopping with another immunosuppressant, anticancer medicine, steroid or biologic." }, { "zh": "RITUXAN、其他利妥昔单抗产品、生物类似药及不同给药设置必须按准确产品、给药途径、标签、输注方案和目标市场记录逐项核对；共同的 CD20 机制不等于可自行互换。", "en": "RITUXAN, another rituximab product, a biosimilar and different administration settings must be checked item by item for exact product, route, label, infusion plan and target-market record; a shared CD20 mechanism does not mean self-interchangeability." }, { "zh": "标签含有严重输注反应、感染与其他风险警示。发热、寒战、呼吸困难、皮疹、意识改变或其他急性不适时，应及时联系当地治疗团队或紧急医疗支持；不能以机制页面替代风险评估。", "en": "The label contains warnings about serious infusion reactions, infections and other risks. With fever, chills, breathing trouble, rash, mental-status change or another acute concern, contact the local treatment team or urgent medical support promptly; a mechanism page cannot replace risk assessment." } ], "source": { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 2019 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RITUXAN", "generic": "利妥昔单抗", "dosageFormClass": "静脉输注用注射剂" }, "labelSource": { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.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" }, "productRoutes": [ { "source": { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.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": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "以 FDA 历史批准信与标签为入口的静脉输注档案；不得按通用名、照片或历史资料将其与皮下、口服或贴剂产品直接等同。", "history": "FDA 的 RITUXAN 公开历史批准信和标签可用于阅读静脉输注这一给药途径。历史文件和标签可能不是最新版本；任何市场的当前持有人、标签、输注条件和可得性必须另行核验。", "sourceDocuments": [ { "id": "src_dbae68351375fb09", "label": "FDA：Rituximab 历史批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ritugen112697l.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.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", "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 103705", "approvalTimeline": [ { "date": "1997", "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: 1997。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: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_0d2b93571c630223", "label": "FDA: RITUXAN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2019", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2019 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 2019 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_0d2b93571c630223", "label": "FDA: RITUXAN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rituximab-rituxan/", "en": "https://origindrug.com/en/drugs/rituximab-rituxan/" }, "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." ] }