{ "id": "arcoxia", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "ARCOXIA", "generic": "依托考昔", "aliases": [ "ARCOXIA", "Arcoxia", "etoricoxib", "依托考昔", "ARTG 131797", "ARTG 81456", "ARTG 204147", "ARTG 81458" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "澳大利亚：TGA 当前 ARTG 公开记录分别列示 ARCOXIA etoricoxib 30 mg、60 mg、90 mg、120 mg tablet blister pack，Licence status 均为 A，并提供 Product Information（PI）和 Consumer Medicine Information（CMI）入口。本页不从澳大利亚记录推定中国大陆、美国、欧盟、日本或其他市场的批准、商品名、包装、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "依托考昔 30 mg、60 mg、90 mg、120 mg 薄膜衣口服片；TGA ARTG 所列泡罩包装", "dosageFormClassCode": "oral_solid", "route": "口服（产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2002-10-11（澳大利亚 TGA 60 mg、120 mg ARTG 登记日期；30 mg 为 2008-04-11，90 mg 为 2013-11-05）", "archiveSponsorText": "ORGANON PHARMA PTY LTD（四项 TGA ARTG 当前公开记录所列 sponsor）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "celecoxib", "塞来昔布", "meloxicam", "美洛昔康", "ibuprofen", "布洛芬", "naproxen", "萘普生", "other etoricoxib product", "其他依托考昔产品", "other market package", "其他市场包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "au-arcoxia-etoricoxib-30mg-tablet-blister-artg-131797", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 131797（2026-08-28 核验）", "en": "TGA ARTG 131797 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 131797", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 30 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 30 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-arcoxia-etoricoxib-60mg-tablet-blister-artg-81456", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 81456（2026-08-28 核验）", "en": "TGA ARTG 81456 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 81456", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 60 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 60 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-arcoxia-etoricoxib-90mg-tablet-blister-artg-204147", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 204147（2026-08-28 核验）", "en": "TGA ARTG 204147 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 204147", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 90 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 90 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 90, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-arcoxia-etoricoxib-120mg-tablet-blister-artg-81458", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 81458（2026-08-28 核验）", "en": "TGA ARTG 81458 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 81458", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 120 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 120 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_103e8f7bd192a28f", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 120 mg 片泡罩包装（ARTG 81458）", "url": "https://www.tga.gov.au/resources/artg/81458", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验四项 TGA 产品级记录与官方电子说明书，但未保留可与单一强度、单一包装一一对应的官方包装图，故不展示包装图片", "en": "Four TGA product-level records and official electronic leaflets were reviewed, but no official package image matching one exact strength and pack was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 TGA ARTG 中 ARCOXIA、依托考昔 30／60／90／120 mg 片、四个 ARTG 编号、泡罩包装、当前 sponsor 及 PI/CMI 入口。此次没有保留可与单一强度和单一泡罩包装逐一对应的官方原品牌图片；为避免把零售图、版本不明图、其他市场图或另一种依托考昔/NSAID 产品误作准确 ARCOXIA 包装，页面不展示包装图片，只保留官方文字身份和电子说明书供放大阅读。", "en": "This dossier retains ARCOXIA, etoricoxib 30/60/90/120 mg tablets, four ARTG numbers, blister packaging, the current sponsor and PI/CMI routes from TGA ARTG records. No official original-brand image was retained that can be matched one-to-one to a single strength and blister pack; to avoid treating a retail image, version-uncertain image, another-market image or another etoricoxib/NSAID product as the exact ARCOXIA pack, the page withholds package imagery and retains official text identity and electronic leaflets for enlarged reading." }, "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797；四项档案入口之一）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ARCOXIA 说明书放大阅读：30、60、90、120 mg 是四种准确片剂身份", "en": "ARCOXIA label reading: 30, 60, 90 and 120 mg identify four exact tablet presentations" }, "summary": { "zh": "本模块以四项 TGA ARTG 记录及其官方 PI/CMI 入口为边界，帮助核对 ARCOXIA、依托考昔、每片标示量、口服片、泡罩包装与 ARTG 编号。它不提供个人片数、频率、疗程、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module is bounded by four TGA ARTG records and their official PI/CMI routes. It helps check ARCOXIA, etoricoxib, the labelled amount per tablet, oral-tablet form, blister packaging and ARTG number. It provides no individual tablet count, frequency, course, missed-use action, start, stop, co-use, switch or purchase plan." }, "checks": [ { "zh": "先把 ARCOXIA、依托考昔、每片 30／60／90／120 mg、口服片、泡罩包装、ARTG 编号和目标市场作为一组核对。四个数字分别识别不同的准确片剂，不是从网页推算个人片数、把多片拼成另一强度或自行换药的公式。", "en": "Check ARCOXIA, etoricoxib, 30/60/90/120 mg per tablet, oral-tablet form, blister pack, ARTG number and target market together. The four numbers identify different exact tablets; they are not a web formula for an individual's tablet count, assembling another strength from several tablets or self-switching." }, { "zh": "依托考昔属于 NSAID/选择性 COX-2 抑制剂类别。类别文字首先是核对重复和风险的线索，不表示可以与 ADVIL、ALEVE、MOBIC、CELEBREX、阿司匹林、感冒止痛药或另一依托考昔产品自行叠加、错开、轮换或按 mg 换算。请将所有处方药、非处方药、草本和补充剂连同实际药盒交给药师或开方团队核对。", "en": "Etoricoxib is in the NSAID/selective COX-2 inhibitor class. Class wording is first a cue to check duplication and risk; it does not permit self-combining, separating, alternating or milligram-converting it with ADVIL, ALEVE, MOBIC, CELEBREX, aspirin, cold/pain products or another etoricoxib product. Have a pharmacist or prescriber review every prescription, OTC product, herb and supplement together with the actual packs." }, { "zh": "30、60、120 mg 的 TGA 页面链接一项有效至 2026-11-10 的 Section 14 consent，涉及包装上 sponsor 旧联系信息。本页不会把这一行政合规记录误写成产品失效、假药或疗效变化；若实际包装联系信息与当前记录不一致，请使用 TGA 当前 ARTG、PI/CMI 或当前 sponsor 渠道核实。", "en": "The TGA pages for 30, 60 and 120 mg link a Section 14 consent effective until 10 November 2026 concerning former sponsor contact details on packaging. This administrative compliance record is not presented here as product failure, falsification or changed efficacy. If contact details on the actual pack differ from the current record, verify through the current TGA ARTG, PI/CMI or sponsor route." }, { "zh": "出现急性、严重或迅速进展的不适时，应优先使用当地紧急医疗渠道；不要等待网页检索，也不要依据本页自行加药、停药、换药或用另一盒止痛药抵消。", "en": "With an acute, serious or rapidly worsening concern, use local urgent medical pathways first; do not wait for a web search or self-add, stop, switch or counteract with another pain medicine based on this page." } ], "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 官方 Product Information / Consumer Medicine Information 入口", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依托考昔怎样起作用：选择性 COX-2 抑制是机制线索，不是个人选择规则", "en": "How etoricoxib works: selective COX-2 inhibition is a mechanism cue, not a personal selection rule" }, "summary": { "zh": "TGA 的公开审议记录将依托考昔描述为非甾体抗炎药（NSAID）和选择性环氧合酶-2（COX-2）抑制剂。该术语只解释一种药理分类与作用路径；它不判断个人疼痛原因、心血管或胃肠风险、是否适用、片数、疗程、联用、停用或替代。", "en": "A TGA public scheduling record describes etoricoxib as a non-steroidal anti-inflammatory drug (NSAID) and selective cyclo-oxygenase-2 (COX-2) inhibitor. This wording explains a pharmacologic class and pathway only; it does not determine an individual's pain cause, cardiovascular or gastrointestinal risk, suitability, tablet count, course, co-use, stopping or replacement." }, "checks": [ { "zh": "“选择性 COX-2”不是“对所有人更安全”或“可以与其他 NSAID 同服”的同义词。专业评估仍需结合实际产品、当前说明书、既往反应、心血管/胃肠/肾脏相关情况和完整药单。", "en": "“Selective COX-2” is not synonymous with “safer for everyone” or permission to combine with another NSAID. Professional review still requires the actual product, current leaflet, prior reactions, cardiovascular/gastrointestinal/kidney context and complete medicine list." }, { "zh": "共同类别、共同用途或相近 mg 数字不能证明 ARCOXIA 与 CELEBREX、MOBIC、ADVIL、ALEVE 或另一依托考昔产品等效、可自行替代或可以叠加。剂型、强度、市场、标签版本和其他成分都要逐项核对。", "en": "A shared class, purpose or nearby milligram number does not establish that ARCOXIA is equivalent to, self-substitutable for or combinable with CELEBREX, MOBIC, ADVIL, ALEVE or another etoricoxib product. Dosage form, strength, market, label version and other ingredients all require item-by-item review." }, { "zh": "机制说明不能替代药物警戒、相互作用或症状评估。若新增处方、非处方止痛/感冒药、抗凝药、草本或补充剂，或出现新的严重不适，请带准确药盒和完整药单联系药师或医疗团队；急性严重情况优先使用当地紧急医疗渠道。", "en": "A mechanism explanation does not replace pharmacovigilance, interaction review or symptom assessment. When a prescription, OTC pain/cold medicine, anticoagulant, herb or supplement is added, or a new serious concern occurs, take the exact pack and full medicine list to a pharmacist or care team; use local urgent-care channels first for an acute serious concern." } ], "source": { "id": "src_e92c0e02a7bea8a6", "label": "澳大利亚 TGA：依托考昔列入处方药类别的公开审议记录（2003；历史监管文件）", "url": "https://www.tga.gov.au/sites/default/files/ndpsc-record-37.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_decision_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ARCOXIA", "generic": "依托考昔", "dosageFormClass": "依托考昔 30 mg、60 mg、90 mg、120 mg 薄膜衣口服片；TGA ARTG 所列泡罩包装" }, "labelSource": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "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_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "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_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "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_103e8f7bd192a28f", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 120 mg 片泡罩包装（ARTG 81458）", "url": "https://www.tga.gov.au/resources/artg/81458", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "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_3924715f5abefd1b", "label": "澳大利亚 TGA eBS：ARCOXIA Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2009-PI-00309-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "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": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "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": "这是一份澳大利亚 ARCOXIA 的可追溯产品档案。四项 TGA ARTG 当前公开记录可分别核对依托考昔 30、60、90、120 mg 每片标示量、片剂、泡罩包装、ARTG 编号、当前 sponsor 和官方 PI/CMI 入口。页面帮助先辨认准确产品和来源；不会把四个 mg 数字、NSAID/COX-2 类别或包装文字转换为个人片数、频率、疗程、开始、停用、联用、换药或购买结论。", "history": "TGA ARTG 将 ARCOXIA 60 mg（ARTG 81456）与 120 mg（ARTG 81458）的登记日期列为 2002-10-11，将 30 mg（ARTG 131797）列为 2008-04-11，将 90 mg（ARTG 204147）列为 2013-11-05；四项当前公开记录均列 ORGANON PHARMA PTY LTD。30、60、120 mg 页面另链接一项截至 2026-11-10 的 Section 14 consent，内容针对包装上的 sponsor 旧联系信息；本页只把它作为包装联系信息的合规线索，不把它扩写为疗效、成分、真伪或产品质量结论。", "sourceDocuments": [ { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_103e8f7bd192a28f", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 120 mg 片泡罩包装（ARTG 81458）", "url": "https://www.tga.gov.au/resources/artg/81458", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_3924715f5abefd1b", "label": "澳大利亚 TGA eBS：ARCOXIA Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2009-PI-00309-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_81fbb06bcb263647", "label": "澳大利亚 TGA eBS：ARCOXIA Consumer Medicine Information（CMI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2009-CMI-00310-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_9b6fc3045338f690", "label": "澳大利亚 TGA：ARCOXIA 30 mg Section 14 consent（sponsor 旧联系信息；有效至 2026-11-10）", "url": "https://www.tga.gov.au/resources/section-14-consents/arcoxia-etoricoxib-30mg-tablet-blister-pack-organon-pharma-pty-ltd-con-1408", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_compliance_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_e92c0e02a7bea8a6", "label": "澳大利亚 TGA：依托考昔列入处方药类别的公开审议记录（2003；历史监管文件）", "url": "https://www.tga.gov.au/sites/default/files/ndpsc-record-37.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_decision_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "澳大利亚 TGA ARTG 131797／81456／204147／81458（ARCOXIA etoricoxib 30／60／90／120 mg tablet blister pack）", "approvalTimeline": [ { "date": "2002-10-11", "title": { "zh": "ARCOXIA 60 mg 与 120 mg 的 TGA ARTG 登记日期", "en": "TGA ARTG dates for ARCOXIA 60 mg and 120 mg" }, "detail": { "zh": "TGA 将 ARTG 81456（60 mg）与 ARTG 81458（120 mg）的 ARTG Date 均列为 2002-10-11。该日期只锚定两项澳大利亚监管产品记录，不建立其他强度、市场、供应、个人片数或疗程。", "en": "TGA lists 11 Oct 2002 as the ARTG date for ARTG 81456 (60 mg) and ARTG 81458 (120 mg). The date anchors two Australian regulatory product records only; it does not establish another strength, market, supply, individual tablet count or course." }, "source": { "id": "src_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2008-04-11", "title": { "zh": "ARCOXIA 30 mg 的 TGA ARTG 登记日期", "en": "TGA ARTG date for ARCOXIA 30 mg" }, "detail": { "zh": "TGA 将 ARTG 131797 的产品名列为 ARCOXIA etoricoxib 30mg tablet blister pack，ARTG Date 为 2008-04-11。30 mg 是这一准确片剂的每片标示量，不是个人强度选择或片数换算。", "en": "TGA lists ARCOXIA etoricoxib 30mg tablet blister pack as the product name for ARTG 131797 and 11 Apr 2008 as its ARTG date. The 30 mg figure is the labelled amount per exact tablet, not an individual strength selection or tablet-count conversion." }, "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2013-11-05", "title": { "zh": "ARCOXIA 90 mg 的 TGA ARTG 登记日期", "en": "TGA ARTG date for ARCOXIA 90 mg" }, "detail": { "zh": "TGA 将 ARTG 204147 的产品名列为 ARCOXIA etoricoxib 90mg tablet blister pack，ARTG Date 为 2013-11-05。该节点只定位这一澳大利亚产品记录，不表示 90 mg 对任何人适用。", "en": "TGA lists ARCOXIA etoricoxib 90mg tablet blister pack as the product name for ARTG 204147 and 5 Nov 2013 as its ARTG date. The node locates this Australian product record only and does not mean 90 mg is suitable for any individual." }, "source": { "id": "src_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2025-09-15", "title": { "zh": "Section 14 包装联系信息合规记录开始", "en": "Section 14 packaging-contact compliance record commenced" }, "detail": { "zh": "TGA 的 CON-1408 记录说明，部分 ARCOXIA 包装仍标注 sponsor 旧联系信息，相关 consent 有效至 2026-11-10。本页只将其作为包装联系信息的行政合规边界，不据此断言疗效、成分、真伪、产品失效或质量变化。", "en": "TGA CON-1408 states that some ARCOXIA packaging carries former sponsor contact details and that the consent is effective until 10 Nov 2026. This page treats it only as an administrative compliance boundary for packaging contact details and does not infer efficacy, composition, authenticity, product failure or changed quality." }, "source": { "id": "src_9b6fc3045338f690", "label": "澳大利亚 TGA：ARCOXIA 30 mg Section 14 consent（CON-1408）", "url": "https://www.tga.gov.au/resources/section-14-consents/arcoxia-etoricoxib-30mg-tablet-blister-pack-organon-pharma-pty-ltd-con-1408", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_compliance_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "澳大利亚", "en": "Australia" }, "status": { "zh": "已链接四项当前 TGA ARTG 产品记录与 PI/CMI 官方入口", "en": "Four current TGA ARTG product records and official PI/CMI routes linked" }, "detail": { "zh": "本页分别记录 30、60、90、120 mg 每片标示量、四个 ARTG 编号、片剂与泡罩包装文字身份。它不鉴定真伪，也不建立库存、实际供应、购买、个人片数、频率、疗程、联用、停用、换药或可替代性。", "en": "The dossier separately records 30, 60, 90 and 120 mg labelled per tablet, four ARTG numbers, tablet form and blister-pack text identities. It does not authenticate a product or establish stock, actual supply, purchase, individual tablet count, frequency, course, co-use, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆、美国、欧盟、日本及其他市场", "en": "Mainland China, the United States, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从澳大利亚 ARTG 名称、登记日期、sponsor、PI/CMI、COX-2 类别或泡罩包装推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场须按当地现行监管资料逐产品核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the Australian ARTG name, date, sponsor, PI/CMI, COX-2 class or blister packaging; every market requires exact-product review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "30、60、90、120 mg 能否自己换算片数或互相替代？", "en": "Can 30, 60, 90 and 120 mg be converted into tablet counts or substituted for one another?" }, "answer": { "zh": "不能。它们分别是四种准确片剂的每片标示量。网页不生成个人强度、片数、频率、疗程、漏用补量或换药规则；请以实际处方、准确药盒、当前目标市场说明书和药师/开方团队核对为准。", "en": "No. They are labelled amounts per tablet for four exact presentations. The website does not generate an individual's strength, tablet count, frequency, course, missed-use make-up or switching rule; use the actual prescription, exact pack, current target-market leaflet and pharmacist/prescriber review." } }, { "question": { "zh": "包装上的 sponsor 联系信息与网页不同，是否说明是假药或药品有质量问题？", "en": "If sponsor contact details on the pack differ from this page, does that mean the medicine is falsified or defective?" }, "answer": { "zh": "不能这样判断。TGA 当前 Section 14 记录明确涉及部分包装的旧 sponsor 联系信息，并设置了有效期限；这是一项行政合规记录，不等于对真伪、成分、疗效或质量作结论。请用准确 ARTG 编号、当前 PI/CMI 与 TGA 或 sponsor 当前渠道核实，疑似严重问题应联系当地监管或医疗渠道。", "en": "That conclusion cannot be made. The current TGA Section 14 record concerns former sponsor contact details on some packaging and has a defined period; it is an administrative compliance record, not a finding on authenticity, composition, efficacy or quality. Verify the exact ARTG number, current PI/CMI and current TGA or sponsor route; use local regulatory or medical channels for a serious concern." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/arcoxia/", "en": "https://origindrug.com/en/drugs/arcoxia/" }, "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." ] }