{ "id": "stelara", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Stelara", "generic": "乌司奴单抗", "aliases": [ "ustekinumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2026-07 更新；四个准确皮下/静脉包装身份）", "dosageFormClass": "皮下注射：45 mg/0.5 mL 单剂量瓶、45 mg/0.5 mL 与 90 mg/mL 预充式注射器；静脉输注：130 mg/26 mL 单剂量瓶", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下 / 静脉输注", "routeCode": "subcutaneous", "historicalApprovalEntry": "2009（美国公开标签所列初始批准）", "archiveSponsorText": "Janssen Biotech / 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-stelara-ustekinumab-45mg-0-5ml-single-dose-vial-subcutaneous-5789406002", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2026-07 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; 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updated Jul 2026)" }, "dosageForm": { "zh": "STELARA 乌司奴单抗单剂量预充式注射器", "en": "STELARA ustekinumab single-dose prefilled syringe" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 57894-060-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "每个单剂量预充式注射器含乌司奴单抗 45 mg/0.5 mL；每盒 1 个", "en": "Ustekinumab 45 mg/0.5 mL per single-dose prefilled syringe; one per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=45mg+PFS+CArton.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乌司奴单抗", "en": "ustekinumab" }, "value": 45, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每个单剂量预充式注射器的标签总量；不是个人注射/输注量、频次、转换或换药方案", "en": "labelled total per single-dose prefilled syringe; not an individual's injection/infusion amount, frequency, conversion or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "带 27G、1/2 英寸固定针和安全护套的单剂量预充式注射器", "en": "single-dose prefilled syringe with fixed 27-gauge, 1/2-inch needle and safety guard" }, "fill": { "value": 0.5, "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": "个单剂量预充式注射器/盒", "en": "single-dose prefilled syringe per carton" } }, "physicalClues": { "color": { "zh": "无色至淡黄色溶液，可见少量半透明或白色小颗粒（标签描述）", "en": "colourless to light-yellow solution that may contain a few small translucent or white particles (label description)" }, "shape": { "zh": "单剂量预充式注射器及独立纸盒", "en": "individually packaged single-dose prefilled syringe and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 45 mg/0.5 mL 单剂量预充式注射器美国公开标签面板（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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-stelara-ustekinumab-90mg-1ml-prefilled-syringe-5789406103", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2026-07 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)" }, "dosageForm": { "zh": "STELARA 乌司奴单抗单剂量预充式注射器", "en": "STELARA ustekinumab single-dose prefilled syringe" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 57894-061-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "每个单剂量预充式注射器含乌司奴单抗 90 mg/1 mL；每盒 1 个", "en": "Ustekinumab 90 mg/1 mL per single-dose prefilled syringe; one per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=90mg+PFS+Carton.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乌司奴单抗", "en": "ustekinumab" }, "value": 90, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每个单剂量预充式注射器的标签总量；不是个人注射/输注量、频次、转换或换药方案", "en": "labelled total per single-dose prefilled syringe; not an individual's injection/infusion amount, frequency, conversion or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "带 27G、1/2 英寸固定针和安全护套的单剂量预充式注射器", "en": "single-dose prefilled syringe with fixed 27-gauge, 1/2-inch needle and safety guard" }, "fill": { "value": 1, "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": "个单剂量预充式注射器/盒", "en": "single-dose prefilled syringe per carton" } }, "physicalClues": { "color": { "zh": "无色至淡黄色溶液，可见少量半透明或白色小颗粒（标签描述）", "en": "colourless to light-yellow solution that may contain a few small translucent or white particles (label description)" }, "shape": { "zh": "单剂量预充式注射器及独立纸盒", "en": "individually packaged single-dose prefilled syringe and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 90 mg/1 mL 单剂量预充式注射器美国公开标签面板（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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-stelara-ustekinumab-130mg-26ml-single-dose-vial-intravenous-5789405427", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2026-07 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)" }, "dosageForm": { "zh": "STELARA 乌司奴单抗单剂量瓶", "en": "STELARA ustekinumab single-dose vial" }, "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 57894-054-27", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含乌司奴单抗 130 mg/26 mL（5 mg/mL）；每盒 1 个", "en": "Ustekinumab 130 mg/26 mL (5 mg/mL) per single-dose vial; one per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=130mg+vial+carton+%281%29.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乌司奴单抗", "en": "ustekinumab" }, "value": 130, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人注射/输注量、频次、转换或换药方案", "en": "labelled total per single-dose vial; not an individual's injection/infusion amount, frequency, conversion or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "静脉输注用单剂量瓶", "en": "single-dose vial for intravenous infusion" }, "fill": { "value": 26, "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": "无色至淡黄色溶液，可见少量半透明或白色小颗粒（标签描述）", "en": "colourless to light-yellow solution that may contain a few small translucent or white particles (label description)" }, "shape": { "zh": "单剂量瓶及独立纸盒", "en": "individually packaged single-dose vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 130 mg/26 mL 单剂量瓶美国公开标签面板（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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-stelara-ustekinumab-130mg-26ml-single-dose-vial-intravenous-5789405427", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=130mg+vial+carton+%281%29.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "alt": "STELARA 乌司奴单抗在美国 DailyMed Janssen Biotech 公开标签中的 130 mg/26 mL 静脉输注单剂量瓶纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Janssen Biotech，2026-07 更新）", "presentation": "STELARA 注射液：130 mg/26 mL（5 mg/mL），静脉输注用单剂量瓶纸盒展开图（DailyMed Janssen Biotech 公开标签所列）。", "notice": "此为美国 DailyMed Janssen Biotech 公开标签中明确对应 STELARA、乌司奴单抗 130 mg/26 mL（5 mg/mL）静脉输注用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、静脉输注用与来源；不用于鉴定真伪，也不证明皮下注射预充式注射器、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_4bdbc9d18f29966d", "label": "DailyMed（NLM）：STELARA 公开标签（Janssen Biotech，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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": "STELARA 说明书放大阅读：静脉制剂和皮下制剂不能凭同名互推", "en": "STELARA label reading: intravenous and subcutaneous products cannot be inferred from a shared name" }, "summary": { "zh": "以 DailyMed 当前 STELARA 美国公开标签为阅读入口，核对乌司奴单抗、静脉或皮下给药途径、包装与目标市场；不把同名产品、毫克数字、输注或注射文字变成个人剂量、居家操作或转换方案。", "en": "Using the current U.S. DailyMed public label for STELARA as an entry point, this checks ustekinumab, intravenous or subcutaneous route, package and target market; it does not turn a shared name, mg marking, infusion or injection wording into an individual dose, home handling or conversion plan." }, "checks": [ { "zh": "标签所列 130 mg/26 mL（5 mg/mL）静脉用瓶是该准确静脉制剂的身份线索，并不证明皮下产品、另一市场包装或不同规格相同。", "en": "The label's 130 mg/26 mL (5 mg/mL) IV vial is an identity clue for that exact IV product; it does not establish that a subcutaneous product, another-market pack or another presentation is the same." }, { "zh": "同为免疫相关药、生物制剂或治疗相近疾病，不表示可与其他生物制剂、免疫抑制药、激素、疫苗或感染治疗自行组合、轮换或替代。", "en": "Being an immune-related medicine, biologic or treatment for a related disease does not permit self-combination, alternation or substitution with another biologic, immunosuppressant, steroid, vaccine or infection treatment." }, { "zh": "高热、呼吸困难、严重腹痛、异常神经症状、广泛皮疹或其他急性问题时，应及时联系当地治疗团队或紧急医疗支持。", "en": "With high fever, breathing trouble, severe abdominal pain, unusual neurologic symptoms, widespread rash or another acute concern, contact the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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": "乌司奴单抗怎样起作用：标签描述其结合 IL-12 与 IL-23 共用的 p40 亚基", "en": "How ustekinumab works: the label describes binding the p40 subunit shared by IL-12 and IL-23" }, "summary": { "zh": "FDA 的 STELARA 标签描述乌司奴单抗可特异性结合 IL-12 和 IL-23 共用的 p40 蛋白亚基，干扰这些细胞因子与共同受体链的相互作用。它解释免疫信号路径，不决定个人的诊断、是否适合使用、静脉诱导与皮下注射维持如何衔接、剂量或换药。", "en": "The FDA STELARA label describes ustekinumab as specifically binding the p40 protein subunit shared by IL-12 and IL-23, disrupting their interaction with a shared receptor chain. It explains an immune-signalling pathway, not an individual's diagnosis, suitability, how intravenous induction and subcutaneous maintenance are sequenced, dose or medicine switch." }, "checks": [ { "zh": "“IL-12/23”或“靶向炎症因子”不是自行判断皮肤、关节或肠道症状原因，或决定开始、停用、改期、加量或换药的工具。诊断、感染筛查、疾病活动度、完整药单和现行标签须由专科团队一并评估。", "en": "“IL-12/23” or “targets inflammatory cytokines” is not a tool for identifying the cause of skin, joint or bowel symptoms, or deciding start, stop, delay, dose change or switching. Diagnosis, infection screening, disease activity, complete medicine list and current label need specialist assessment together." }, { "zh": "皮下制剂、静脉制剂、其他乌司奴单抗产品或不同市场规格不能因共同机制自行换算、互换或叠加。给药途径、浓度、一次性输注安排和维持方案必须核对准确产品的现行标签。", "en": "Subcutaneous products, intravenous products, another ustekinumab product or a different-market strength cannot be self-converted, interchanged or combined because of a shared mechanism. Route, concentration, one-time infusion plan and maintenance plan must be checked against the current label for the exact product." }, { "zh": "标签含有感染、过敏和其他风险信息。发热、持续咳嗽、呼吸困难、全身皮疹、晕厥或其他急性严重不适时，应及时联系当地治疗团队或紧急医疗支持。", "en": "The label contains information about infection, allergy and other risks. With fever, persistent cough, breathing trouble, widespread rash, fainting or another acute severe concern, contact the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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": "Stelara", "generic": "乌司奴单抗", "dosageFormClass": "皮下注射：45 mg/0.5 mL 单剂量瓶、45 mg/0.5 mL 与 90 mg/mL 预充式注射器；静脉输注：130 mg/26 mL 单剂量瓶" }, "labelSource": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 乌司奴单抗当前美国公开标签（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 乌司奴单抗当前美国公开标签（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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_9368420c3c9534f8", "label": "FDA：STELARA 2016 美国历史标签（BLA 761044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.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 STELARA（ustekinumab）当前美国公开标签同时列示皮下注射与静脉输注包装。本页将四个准确包装的给药途径、容器、浓度/总体积、NDC 与来源分开呈现；共同商品名不能证明可自行换算、配制、注射、转换或替代。", "history": "皮下单剂量瓶、皮下预充式注射器与静脉单剂量瓶是不同产品身份；不能仅按通用名、商品名或照片建立等同性。具体标签版本、规格、市场状态和实际供应均须逐项核验。", "sourceDocuments": [ { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 乌司奴单抗当前美国公开标签（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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_9368420c3c9534f8", "label": "FDA：STELARA 2016 美国历史标签（BLA 761044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.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 761044", "approvalTimeline": [ { "date": "DailyMed SPL v22，2026-07 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 v22，2026-07 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 v22，2026-07 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_19dc277142d47a4d", "label": "DailyMed: current STELARA U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "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/stelara/", "en": "https://origindrug.com/en/drugs/stelara/" }, "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." ] }