{ "id": "opdivo", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Opdivo", "generic": "纳武利尤单抗", "aliases": [ "nivolumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2026-05 更新；四个准确单剂量瓶包装身份）", "dosageFormClass": "静脉输注用注射剂：40 mg/4 mL、100 mg/10 mL、120 mg/12 mL、240 mg/24 mL 单剂量瓶", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "2014（美国公开标签所列初始批准）", "archiveSponsorText": "Bristol Myers Squibb / 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-opdivo-nivolumab-40mg-4ml-single-dose-vial-0003377211", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3772-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 40 mg/4 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 40 mg/4 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-40mg-4ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "value": 40, "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、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "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": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow 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_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 40 mg/4 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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-opdivo-nivolumab-100mg-10ml-single-dose-vial-0003377412", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3774-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 100 mg/10 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 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=opdivo-100mg-10ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "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、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "single-dose vial; discard unused portion" }, "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": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow 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_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 100 mg/10 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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-opdivo-nivolumab-120mg-12ml-single-dose-vial-0003375614", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3756-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 120 mg/12 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 120 mg/12 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-120mg-12ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "value": 120, "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、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "single-dose vial; discard unused portion" }, "fill": { "value": 12, "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": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow solution (label description)" }, "shape": { "zh": "12 mL 单剂量玻璃瓶及纸盒", "en": "12 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 120 mg/12 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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-opdivo-nivolumab-240mg-24ml-single-dose-vial-0003373413", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3734-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 240 mg/24 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 240 mg/24 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-240mg-24ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "value": 240, "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、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "single-dose vial; discard unused portion" }, "fill": { "value": 24, "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": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow solution (label description)" }, "shape": { "zh": "24 mL 单剂量玻璃瓶及纸盒", "en": "24 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 240 mg/24 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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-opdivo-nivolumab-40mg-4ml-single-dose-vial-0003377211", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-40mg-4ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "alt": "OPDIVO 纳武利尤单抗在美国 DailyMed Bristol Myers Squibb 公开标签中的 40 mg/4 mL 纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Bristol Myers Squibb，2026-05 更新）", "presentation": "OPDIVO 注射液：40 mg/4 mL（10 mg/mL）单剂量瓶纸盒展开图（DailyMed Bristol Myers Squibb 公开标签所列）。", "notice": "此为美国 DailyMed Bristol Myers Squibb 公开标签中明确对应 OPDIVO、纳武利尤单抗 40 mg/4 mL（10 mg/mL）单剂量瓶的纸盒展开图，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_4c881dfa94de0be6", "label": "DailyMed（NLM）：OPDIVO 公开标签（Bristol Myers Squibb，2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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": "OPDIVO 说明书放大阅读：单剂量瓶的 mg/mL 只用于核对输注产品身份", "en": "OPDIVO label reading: mg/mL on a single-dose vial only helps identify an infusion product" }, "summary": { "zh": "本模块以 FDA 2026-05 OPDIVO 美国标签为阅读入口，帮助核对 OPDIVO、纳武利尤单抗、静脉用注射剂、单剂量瓶及目标市场；它不把瓶身的 10 mg/mL、不同瓶装规格、治疗间隔、联合方案或标签风险文字变成个人输注、居家处理或换药方案。", "en": "This module uses the FDA May 2026 U.S. OPDIVO label as a reading entry point. It helps check OPDIVO, nivolumab, injection for intravenous use, single-dose vials and target market; it does not turn a vial's 10 mg/mL, different vial presentations, treatment intervals, combination regimens or label risk wording into an individual infusion, home-handling or switching plan." }, "checks": [ { "zh": "标签列示的 40 mg/4 mL、100 mg/10 mL、120 mg/12 mL、240 mg/24 mL 都是 10 mg/mL 单剂量瓶的产品身份线索。它们不是可自行换算的“几瓶”、可留存的余量或家庭输注指示；配制、稀释、输注和剩余处置应由治疗机构按现行标签与处方执行。", "en": "The label's 40 mg/4 mL, 100 mg/10 mL, 120 mg/12 mL and 240 mg/24 mL are product-identity clues for 10 mg/mL single-dose vials. They are not self-convertible “number of vials,” saved leftovers or home-infusion instructions; preparation, dilution, infusion and remaining-product handling belong to the treating facility under the current label and prescription." }, { "zh": "与 KEYTRUDA 或其他 PD-1/PD-L1 药有相近靶点，或同为静脉用药，不表示可以自行叠加、交替、漏用后补回、由一支换成另一支，或与化疗、伊匹木单抗、靶向药、激素和补充剂随意合用。具体肿瘤、检查、既往方案、器官功能和完整药单必须由肿瘤团队核对。", "en": "A related target to KEYTRUDA or another PD-1/PD-L1 medicine, or being an intravenous product, does not permit self-combination, alternation, catch-up use, vial-to-vial substitution or casual co-use with chemotherapy, ipilimumab, targeted therapy, steroids or supplements. Exact tumour, testing, prior regimen, organ function and the full medicine list require oncology-team review." }, { "zh": "标签提示免疫介导反应可累及肺、肠道、肝脏、内分泌器官、肾脏和皮肤，并有输注相关反应的提示。新的或加重的呼吸困难、持续腹泻、黄疸样变化、异常乏力/意识变化、尿量变化、严重皮疹、发热寒战或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持。", "en": "The label notes immune-mediated reactions that may involve lungs, bowel, liver, endocrine organs, kidneys and skin, and warns about infusion-related reactions. New or worsening breathing difficulty, persistent diarrhoea, jaundice-like changes, unusual fatigue/mental-status change, changed urine output, severe rash, fever/chills or another acute concern needs prompt contact with the treatment team or local urgent medical support." }, { "zh": "PD-L1、MSI-H、dMMR、EGFR、ALK 等术语在某些疾病场景和标签条件中出现，但不构成自行选择 OPDIVO 或推断联合方案的依据。检测样本、方法、疾病阶段、具体适应症与目标市场现行标签必须由团队解释。", "en": "Terms such as PD-L1, MSI-H, dMMR, EGFR and ALK appear in some disease settings and label conditions, but do not support self-selecting OPDIVO or inferring a combination plan. Test specimen, method, disease stage, exact indication and the current target-market label require team interpretation." } ], "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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": "纳武利尤单抗怎样起作用：标签描述其阻断 PD-1 与 PD-L1/PD-L2 的相互作用", "en": "How nivolumab works: the label describes blocking PD-1 interactions with PD-L1/PD-L2" }, "summary": { "zh": "DailyMed 的 OPDIVO 当前公开标签描述纳武利尤单抗与 PD-1 受体结合，阻断 PD-1 与 PD-L1/PD-L2 的相互作用，从而解除对 T 细胞反应的抑制。它是机制概述，不判断个人疾病是否适用、联合方案、输注安排或治疗持续时间。", "en": "The current DailyMed public label for OPDIVO describes nivolumab as binding PD-1 and blocking PD-1 interaction with PD-L1/PD-L2, releasing inhibition of T-cell responses. It is a mechanism overview, not a decision about individual suitability, combination, infusion schedule or duration." }, "checks": [ { "zh": "与 KEYTRUDA 或其他 PD-1/PD-L1 药物有相近靶点，不表示可以在同一疗程自行叠加、交替、换算或从一种产品直接改为另一种。", "en": "A related target to KEYTRUDA or another PD-1/PD-L1 medicine does not permit self-combination, alternation, conversion or direct switching within a course." }, { "zh": "机制不能预测哪位患者会获益，也不能替代对免疫相关不良反应、既往自身免疫问题、感染风险、器官功能和完整药单的评估。", "en": "Mechanism cannot predict who will benefit or replace assessment of immune-related adverse reactions, prior autoimmune concerns, infection risk, organ function and the complete medicine list." }, { "zh": "出现新的或加重的呼吸困难、腹泻、黄疸、严重皮疹、内分泌相关症状、视力/神经变化或其他急性问题时，应及时联系当地治疗团队或紧急医疗支持。", "en": "With new or worsening breathing trouble, diarrhoea, jaundice, severe rash, endocrine-related symptoms, visual/neurologic change or another acute concern, contact the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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": "Opdivo", "generic": "纳武利尤单抗", "dosageFormClass": "静脉输注用注射剂：40 mg/4 mL、100 mg/10 mL、120 mg/12 mL、240 mg/24 mL 单剂量瓶" }, "labelSource": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 纳武利尤单抗当前美国公开标签（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 纳武利尤单抗当前美国公开标签（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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_7a8d917cc8b41800", "label": "FDA：OPDIVO 2026 美国标签（BLA 125554）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125554s136lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "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 OPDIVO（nivolumab）当前美国公开标签列示 10 mg/mL 静脉输注用注射剂，并列出四个单剂量瓶包装。本页把商品名、通用名、浓度、总体积、NDC、包装图和来源分别对应；不把瓶身数字变成个人输注量、配制、间隔、联用、停药或购买结论。", "history": "当前美国公开标签与 2026 FDA 标签共同提供阅读入口；适应症、给药、风险、市场状态与实际供应仍须以目标市场当日文件和负责团队核对。", "sourceDocuments": [ { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 纳武利尤单抗当前美国公开标签（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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_7a8d917cc8b41800", "label": "FDA：OPDIVO 2026 美国标签（BLA 125554）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125554s136lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_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 125554", "approvalTimeline": [ { "date": "DailyMed SPL v18，2026-05 发布", "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 SPL v18，2026-05 发布 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 SPL v18，2026-05 发布 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_ff06f39a33bac3c6", "label": "DailyMed: current OPDIVO U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "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/opdivo/", "en": "https://origindrug.com/en/drugs/opdivo/" }, "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." ] }