{ "id": "mobic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Mobic", "generic": "美洛昔康", "aliases": [ "MOBIC", "meloxicam", "美洛昔康", "莫比可", "美洛昔康片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "莫比可®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_c9e0d5ed4526f791", "label": "周口市医疗保障局：2025 年零售药店药品价格信息中的莫比可／美洛昔康片 7.5 mg 记录", "url": "https://ylbzj.zhoukou.gov.cn/sitesources/ybj/page_pc/ztzl/kqzzylfwsfhhcjgzxzlzq/gsgg/article9de15cf3cd994d6b8e2ab0abc9c69b1b.html", "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 MOBIC（meloxicam）历史处方信息，2021-05 修订；FDA 文件明确提示该标签可能不是最新获批版本。本档案不以此推定中国大陆或其他市场的当前批准、供应或可得性。", "dosageFormClass": "口服片：7.5 mg、15 mg（FDA 2021 美国历史标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA 美国公开标签档案（MOBIC）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "meloxicam oral suspension", "美洛昔康口服混悬液", "meloxicam capsule" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mobic-meloxicam-tablet-7-5mg-100-bottle-ndc-0597-0029-01", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史处方信息（2021-05 修订；文件明确可能不是最新获批标签）", "en": "FDA U.S. historical prescribing information (revised May 2021; the document states it may not be the latest approved label)" }, "dosageForm": { "zh": "MOBIC 美洛昔康口服片", "en": "MOBIC meloxicam oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0029-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 7.5 mg；100 片瓶装（美国历史标签）", "en": "7.5 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "美洛昔康", "en": "meloxicam" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "7.5 mg 为每片历史标签标示量；不是个人片数、频率或换算指令", "en": "7.5 mg is the historical labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "pastel yellow" }, "shape": { "zh": "圆形、双凸、无包衣片", "en": "round, biconvex, uncoated tablet" }, "imprint": { "zh": "一面勃林格殷格翰标志；另一面 M", "en": "Boehringer Ingelheim logo on one face; M on the other" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA：MOBIC（meloxicam）美国历史处方信息（2021-05 修订；7.5 mg 100 片瓶装 NDC 与片剂外观）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mobic-meloxicam-tablet-15mg-100-bottle-ndc-0597-0030-01", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史处方信息（2021-05 修订；文件明确可能不是最新获批标签）", "en": "FDA U.S. historical prescribing information (revised May 2021; the document states it may not be the latest approved label)" }, "dosageForm": { "zh": "MOBIC 美洛昔康口服片", "en": "MOBIC meloxicam oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0030-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 15 mg；100 片瓶装（美国历史标签）", "en": "15 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "美洛昔康", "en": "meloxicam" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "15 mg 为每片历史标签标示量；不是个人片数、频率或换算指令", "en": "15 mg is the historical labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "pastel yellow" }, "shape": { "zh": "长圆形、双凸、无包衣片", "en": "oblong, biconvex, uncoated tablet" }, "imprint": { "zh": "一面 15；另一面 M", "en": "15 on one face; M on the other" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA：MOBIC（meloxicam）美国历史处方信息（2021-05 修订；15 mg 100 片瓶装 NDC 与片剂外观）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史标签文字，但未保留可一一对应的官方包装图，故不展示包装图片", "en": "Historical-label text was reviewed, but no one-to-one official package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案只保留 FDA 2021 年美国历史标签中的 MOBIC、美洛昔康、口服片与 7.5 mg／15 mg 文字；该文件明确可能不是最新获批标签。未将零售图、版本不明图、其他市场图或无法对应具体强度的图片呈现为准确原品牌包装，因此页面不展示包装图。", "en": "This dossier retains only MOBIC, meloxicam, oral tablets and 7.5 mg/15 mg wording from the FDA's 2021 U.S. historical label, which explicitly may not be the latest approved label. No retail image, version-uncertain image, another-market image or image without a specific strength match is presented as an exact original-brand pack, so no package visual is shown." }, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA：MOBIC（meloxicam）美国历史处方信息（2021-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MOBIC 说明书放大阅读：7.5、15 mg 是历史片剂身份，不是“该吃几片”", "en": "MOBIC label reading: 7.5 and 15 mg identify historical tablets; they do not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 FDA 2021 年美国历史标签中的 MOBIC、美洛昔康、口服片与每片标示量。该文件明确可能不是最新获批标签；页面不提供个人片数、开始、停用、换药、联用或购买方案。", "en": "This module reads only MOBIC, meloxicam, oral tablets and labelled amounts per tablet in the FDA's 2021 U.S. historical label. The document explicitly may not be the latest approved label; this page provides no individual tablet count, initiation, stopping, switching, co-use or purchase plan." }, "checks": [ { "zh": "把 MOBIC、美洛昔康、口服片、实际强度和目标市场一起核对。7.5、15 mg 是该历史标签中每片的标示量，不是个人每天该用多少片，也不能据此把另一种止痛抗炎药、另一剂型或另一市场产品自行换算。", "en": "Check MOBIC, meloxicam, oral-tablet form, actual strength and target market together. The 7.5 and 15 mg figures are historical labelled amounts per tablet, not how many tablets anyone should use, and they cannot self-convert another anti-inflammatory pain medicine, form or market product." }, { "zh": "该标签提示避免把 MOBIC 与其他 NSAID 或水杨酸盐类产品自行并用，因为这类组合需要专业评估。若手上还有阿司匹林、布洛芬、塞来昔布、感冒止痛药、抗凝药、草本或补充剂，应把全部实际包装和完整药单交给药师或开方团队核对，而不是只按“止痛”字样判断。", "en": "The label flags that MOBIC should not be self-combined with other NSAIDs or salicylate products because such combinations require professional assessment. If aspirin, ibuprofen, celecoxib, cold/pain products, anticoagulants, herbs or supplements are also present, have a pharmacist or prescriber review every actual pack and the full medicine list rather than deciding from the word “pain.”" }, { "zh": "FDA 标签对严重心血管和胃肠道风险设有黑框警告，并提示高龄者发生严重胃肠道事件的风险更高。这些警示不能转成网页上的个人停药或换药指令；出现胸痛、呼吸困难、异常虚弱、言语不清、呕血、黑便或其他急性严重不适时，应使用当地紧急医疗渠道。", "en": "The FDA label carries boxed warnings about serious cardiovascular and gastrointestinal risks and notes a higher risk of serious gastrointestinal events in older people. These warnings cannot become an individual stop-or-switch instruction on a webpage; chest pain, shortness of breath, unusual weakness, slurred speech, vomiting blood, black stools or another acute serious concern require local urgent medical care." }, { "zh": "历史标签还列出肾功能、肝功能、既往溃疡或出血、心血管情况及多药并用等需专业复核的情形。它不取代手上准确产品的现行说明书；涉及掰开、漏用、调整或更换时，应先请药师或开方团队结合实际药盒和完整药单核对。", "en": "The historical label also identifies kidney and liver context, prior ulcer or bleeding, cardiovascular context and multiple medicines as situations needing professional review. It does not replace the current leaflet for the exact product in hand; for splitting, missed use, adjustment or switching, first have a pharmacist or prescribing team review the actual pack and full medicine list." } ], "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; tablet identity, boxed warnings and interactions)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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": "美洛昔康怎样起作用：它影响前列腺素生成相关的 COX 路径", "en": "How meloxicam works: it affects COX pathways involved in prostaglandin production" }, "summary": { "zh": "FDA 2021 年标签说明，美洛昔康与其他 NSAID 一样，作用机制并未完全明确，但涉及抑制 COX-1 和 COX-2，并影响前列腺素合成。该机制解释一条药理路径，不判断个人疼痛原因、疗效、片数、联用、停用或替代。", "en": "The FDA's 2021 label says that, like other NSAIDs, meloxicam's mechanism is not completely understood but involves inhibition of COX-1 and COX-2 and affects prostaglandin synthesis. This explains one pharmacologic pathway; it does not determine an individual's pain cause, benefit, tablet count, co-use, stopping or replacement." }, "checks": [ { "zh": "“影响 COX/前列腺素”是机制用语，不表示不同 NSAID 可以自行叠加、轮换或按 mg 对等换算。名称、剂型、强度、既往反应、胃肠/心肾情况与完整药单都会影响专业人员的判断。", "en": "“Affects COX/prostaglandins” is mechanism wording; it does not permit self-combining, alternating or milligram-converting different NSAIDs. Name, form, strength, prior reactions, gastrointestinal/cardiac/kidney context and the full medicine list all affect professional review." }, { "zh": "同样是“止痛”或“抗炎”用途，不能说明手中两盒产品可以互换。即使通用名相同，不同市场、剂型、每片标示量和标签版本也应逐项核对。", "en": "A shared “pain” or “anti-inflammatory” purpose does not establish that two packs can be exchanged. Even with the same generic name, market, dosage form, labelled amount per tablet and label version need item-by-item review." }, { "zh": "机制页不替代药物警戒或相互作用核对。加入新处方、非处方止痛/感冒产品、抗凝药、草本或补充剂，或出现不适时，应带完整药单请药师或医疗团队审阅；紧急严重症状优先使用当地紧急医疗渠道。", "en": "A mechanism page does not replace pharmacovigilance or interaction review. When a new prescription, OTC pain/cold product, anticoagulant, herb or supplement is added, or a concerning symptom occurs, have a pharmacist or care team review the full medicine list; use local urgent-care channels first for an acute serious concern." } ], "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; Clinical Pharmacology)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Mobic", "generic": "美洛昔康", "dosageFormClass": "口服片：7.5 mg、15 mg（FDA 2021 美国历史标签所列）" }, "labelSource": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; the document states it may not be the latest approved label)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; the document states it may not be the latest approved label)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 2021 年美国历史标签将 MOBIC 列为美洛昔康口服片，并列出 7.5 mg、15 mg 两种每片标示量及各自 100 片瓶装 NDC。本页帮助读者把商品名、通用名、片剂、每片标示量、历史标签和药物警戒入口逐项对应；它不把毫克数字变成个人片数、开始、停用、联用、换药或购买建议。", "history": "FDA 文件列示 MOBIC 的美国初始批准年份为 2000，且页面明确提示该标签可能不是最新获批版本。该档案只定位这一美国历史文件；不同剂型、不同包装、不同市场或同通用名产品均应按实际药盒和目标市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; the document states it may not be the latest approved label)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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 official lookup entry", "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 020938", "approvalTimeline": [ { "date": "2000", "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: 2000。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: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC historical U.S. prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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": "2021-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021-05 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 2021-05 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_6a23f2af3df82e63", "label": "FDA: MOBIC historical U.S. prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.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/mobic/", "en": "https://origindrug.com/en/drugs/mobic/" }, "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." ] }