{ "id": "celebrex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Celebrex", "generic": "塞来昔布", "aliases": [ "celecoxib", "塞来昔布", "塞来昔布胶囊", "西乐葆" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "西乐葆®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_dfb0d45af375cfae", "label": "江阴市人民政府：2025 年常用药品信息中的西乐葆／塞来昔布胶囊记录", "url": "https://www.jiangyin.gov.cn/doc/2025/01/24/1289505.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 FDA 历史标签档案；另有 DailyMed 公开的 100 mg、100 粒瓶装面板（不推定实际可得性）", "dosageFormClass": "口服胶囊；本页精确包装面板仅为 100 mg 胶囊", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（FDA/DailyMed Pfizer 2021 标签档案所列美国初始批准）", "archiveSponsorText": "Pfizer / FDA 历史监管档案；Viatris 的 DailyMed 公开标签面板" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-celebrex-celecoxib-capsule-100mg-100-count-bottle-ndc-58151-083-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2025 包装图稿；页面于 2026-08-23 复核）", "en": "DailyMed public label (2025 package artwork; source checked 23 Aug 2026)" }, "dosageForm": { "zh": "CELEBREX 塞来昔布口服胶囊", "en": "CELEBREX celecoxib oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-083-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒塞来昔布 100 mg；100 粒瓶装", "en": "Celecoxib 100 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=2d6675e4-5859-4be2-8037-a20ce9f707aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "塞来昔布", "en": "celecoxib" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、联用、加减或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 粒瓶装", "en": "100-capsule bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊，胶囊体和帽上有蓝色带；包装标签主展示面", "en": "white capsule with blue bands on body and cap; bottle-label display panel" }, "shape": { "zh": "硬胶囊；印字 7767 / 100", "en": "hard capsule; imprint 7767 / 100" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "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-celebrex-celecoxib-capsule-100mg-100-count-bottle-ndc-58151-083-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=2d6675e4-5859-4be2-8037-a20ce9f707aa&type=img", "alt": "CELEBREX 100 mg 塞来昔布胶囊在美国 DailyMed 公开标签中的 100 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2025 包装图稿）", "presentation": "CELEBREX 塞来昔布 100 mg、100 粒瓶装标签图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 CELEBREX、塞来昔布 100 mg、NDC 58151-083-01、100 粒瓶装的标签图，只帮助核对品牌、通用名、标示强度、胶囊、包装数量与来源；不用于鉴定真伪，也不证明 50 mg、200 mg、400 mg、其他包装、其他市场标签、实际在售、原研身份、目标市场批准或可售资格。", "source": { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "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": "CELEBREX / 塞来昔布说明书放大阅读：先把胶囊、毫克数和同类药分开看", "en": "CELEBREX label reading: keep the capsule, milligram strength and related medicines distinct" }, "summary": { "zh": "本模块以 FDA 和 DailyMed 的 Pfizer 2021 美国 CELEBREX 历史标签档案为阅读入口，帮助核对 CELEBREX、celecoxib、口服胶囊、50/100/200/400 mg 及警告文字；它不提供个人剂量、止痛方案、联用、换药或停药建议。", "en": "This module uses the Pfizer 2021 U.S. FDA and DailyMed CELEBREX label archives as reading entry points. It helps check CELEBREX, celecoxib, oral capsules, 50/100/200/400 mg and warning language; it does not provide an individual dose, pain plan, combination, switch or stopping advice." }, "checks": [ { "zh": "先核对 CELEBREX、celecoxib、口服胶囊、目标市场和每粒标示强度。50、100、200、400 mg 首先是历史标签所列产品身份，不是“今天应吃几粒”的答案；不能据此自行拼量、替代或把别人的处方套用过来。", "en": "First check CELEBREX, celecoxib, oral capsule, target market and stated strength per capsule. 50, 100, 200 and 400 mg first identify products listed in the historical label; they are not an answer to “how many today,” and do not permit self-combining strengths, substitution or use of someone else’s prescription." }, { "zh": "历史标签提示同类 NSAID、水杨酸类和多种药物合用可能需要专业复核。不要因为包装都写“止痛”“消炎”或同属一类就自行叠加、隔日轮换或加用阿司匹林；带实际包装和完整药单请药师或医生逐项核对。", "en": "The historical label flags questions that can require professional review with related NSAIDs, salicylates and multiple medicines. Do not self-combine, alternate or add aspirin merely because packages say “pain” or “inflammation” or belong to a related class; bring actual packages and the complete medicine list for item-by-item pharmacist or clinician review." }, { "zh": "FDA/DailyMed 历史标签包含严重心血管与胃肠道风险警示，且写明老年人与既往消化道溃疡或出血史者的严重胃肠道事件风险更高。黑便、呕血、胸部不适、呼吸困难、晕厥或其他急性严重不适，应及时使用当地紧急医疗支持，而不是根据网页自行增减或换药。", "en": "The historical FDA/DailyMed labels contain serious cardiovascular and gastrointestinal warnings and state that older people and those with a prior peptic-ulcer or GI-bleeding history are at higher risk for serious GI events. With black stools, vomiting blood, chest discomfort, breathing trouble, fainting or another acute severe concern, use timely local urgent medical support rather than self-adjusting or switching from a webpage." }, { "zh": "胶囊能否打开、撒在食物上、混合、漏服后如何处理，必须只按准确产品与目标市场的现行标签、实际包装和药师建议逐项确认。即使历史标签记载过某一胶囊处理方式，也不能把它泛化到其他强度、其他品牌、其他胶囊或其他市场产品。", "en": "Whether a capsule may be opened, sprinkled on food, mixed, or managed after a missed dose must be confirmed item by item from the exact product, target market’s current label, actual pack and pharmacist advice. Even if a historical label records one capsule-handling method, it cannot be generalised to another strength, brand, capsule or market product." } ], "source": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "塞来昔布怎样起作用：标签将其列为选择性 COX-2 抑制剂", "en": "How celecoxib works: the label describes a selective COX-2 inhibitor" }, "summary": { "zh": "DailyMed 的 CELEBREX 历史标签将 celecoxib 描述为一种非甾体抗炎药（NSAID），并指向其选择性抑制环氧合酶-2（COX-2）的药理作用。这解释药理路径，不预测个人是否适用、疼痛原因、用量、联用、换药或停药。", "en": "The DailyMed CELEBREX historical label describes celecoxib as a nonsteroidal anti-inflammatory drug (NSAID) and points to selective inhibition of cyclooxygenase-2 (COX-2). This explains a pharmacologic pathway; it does not predict individual suitability, cause of pain, amount, combination, switching or stopping." }, "checks": [ { "zh": "“选择性 COX-2”或“NSAID”不是自行判断某种疼痛能否用药、该选哪一种止痛药或能否同日叠加的工具。病因、既往病史、全部药物、剂型和现行标签都需要专业人员一起判断。", "en": "“Selective COX-2” or “NSAID” is not a tool for deciding whether a pain problem needs medicine, which pain medicine to select or whether products can be combined on the same day. Cause, history, all medicines, dosage form and current label need professional review together." }, { "zh": "共同的抗炎或止痛路径不使 CELEBREX 与其他 NSAID、含水杨酸类成分的产品或复方感冒止痛产品可自行相加、轮换或替代。机制页面不能完成相互作用核对。", "en": "A shared anti-inflammatory or pain pathway does not make CELEBREX self-combinable, alternatable or substitutable with another NSAID, a salicylate-containing product or a combination cold/pain product. A mechanism page cannot complete an interaction review." }, { "zh": "机制不能把 50、100、200、400 mg 胶囊变成个人的加减量、长期使用或停用规则。考虑改变方案、使用多种药物，或出现新症状时，应带实际包装和完整药单取得当地药师、医生或紧急支持。", "en": "Mechanism cannot turn 50, 100, 200 or 400 mg capsules into a personal increase, decrease, long-term-use or stopping rule. With a contemplated change, multiple medicines or a new symptom, bring actual packages and the complete medicine list to local pharmacist, clinician or urgent support." } ], "source": { "id": "src_cb5d7c49b51c80d5", "label": "DailyMed（NLM）：CELEBREX 公开历史标签档案（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226&version=36", "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": "Celebrex", "generic": "塞来昔布", "dosageFormClass": "口服胶囊；本页精确包装面板仅为 100 mg 胶囊" }, "labelSource": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.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_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.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." } }, { "source": { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "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_cb5d7c49b51c80d5", "label": "DailyMed（NLM）：CELEBREX 公开历史标签档案（Pfizer，2021-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226&version=36", "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." } } ], "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": [ { "id": "fda-2020-nsaid-pregnancy-20-weeks-celecoxib-safety-communication", "issuedAt": "2020-10-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：含塞来昔布的 NSAIDs 在妊娠约 20 周后的风险沟通", "en": "FDA Drug Safety Communication: NSAID risk communication in pregnancy at about 20 weeks or later, including celecoxib" }, "summary": { "zh": "FDA 于 2020-10-15 发布 NSAIDs 药物安全通讯，公告的产品表明确列出 celecoxib／Celebrex。该公告说明，妊娠约 20 周或之后使用 NSAIDs 可能与胎儿肾功能问题及羊水过少有关，并说明美国处方信息的相应更新方向；它是美国、特定日期的类别监管沟通，不代表任何人已发生问题，也不提供自行开始、停止、换药、减少剂量或以其他止痛药替代的结论。妊娠、疑似妊娠或镇痛用药问题，应连同准确产品、所在市场现行说明书和完整用药清单由开方团队或药师核对。", "en": "On 2020-10-15, FDA issued an NSAID Drug Safety Communication whose product table explicitly lists celecoxib/Celebrex. It says NSAID use at about 20 weeks of pregnancy or later may be associated with fetal kidney problems and low amniotic fluid, and describes related U.S. prescribing-information updates. This is a dated U.S. class regulatory communication; it does not establish that any person has a problem or support self-starting, stopping, switching, reducing, or replacing pain medicine. Pregnancy, suspected pregnancy, or pain-medicine questions require review of the exact product, current label for the relevant market, and complete medicine list with the prescribing team or pharmacist." }, "source": { "id": "src_a2dd38c41a9b7aa8", "label": "FDA：2020-10-15 NSAIDs 在妊娠约 20 周后使用的药物安全通讯（明确列出 celecoxib／Celebrex）", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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": "FDA 与 DailyMed 的 CELEBREX（celecoxib）历史美国标签档案列示口服胶囊及美国初始批准年份 1998。本页另建立 DailyMed 公开标签中一款准确的 100 mg、100 粒瓶装面板，帮助核对品牌、通用名、每粒标示量、NDC 与包装；不据此推定其他强度、其它包装、现行市场供应、其它市场批准、原研关系、价格或可售资格。", "history": "止痛或抗炎字样、同为 NSAID、相同通用名或相近 mg 都不足以建立可互换关系。品牌、通用名、胶囊剂型、标示强度、目标市场、标签版本和完整药单必须一起核对；不能从一张包装图或历史档案自行叠加、轮换、换药或调整。", "sourceDocuments": [ { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "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_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.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_cb5d7c49b51c80d5", "label": "DailyMed（NLM）：CELEBREX 公开历史标签档案（Pfizer，2021-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226&version=36", "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_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": "NDA 020998", "approvalTimeline": [ { "date": "1998", "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: 1998。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: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA: CELEBREX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.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": "2021", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021 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 2021 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_4ceafb56ba5ca7ea", "label": "FDA: CELEBREX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.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": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/celebrex/", "en": "https://origindrug.com/en/drugs/celebrex/" }, "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." ] }