{ "id": "lialda-mesalamine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-05", "status": "published_traceable_archive" }, "names": { "brand": "LIALDA", "generic": "美沙拉秦延迟释放片", "aliases": [ "Lialda", "mesalamine", "mesalazine", "mesalamine delayed-release tablets", "美沙拉秦", "美沙拉秦延迟释放片", "美沙拉嗪", "美沙拉嗪延迟释放片", "NDA 022000", "NDC 54092-476-12", "LIALDA", "54092-476-12", "S476" ], "marketBrandNames": [ { "name": "LIALDA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；监管记录不证明实时库存、价格或个人适用。", "en": "Current brand label; a regulatory record does not prove live stock, price or individual suitability." }, "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "本页只建立美国 LIALDA 当前品牌标签档案：NDA 022000、每片 1.2 g、NDC 54092-476-12、120 片瓶装。美国记录不外推中国大陆或其他市场的批准、商品名、参比身份、供应、价格、购买资格或个人适用性。", "dosageFormClass": "LIALDA 是美沙拉秦延迟释放片，其包衣在约 pH 6.8 或以上开始分解，随后延长释放。ASACOL HD、PENTASA、APRISO、DELZICOL、栓剂、灌肠剂以及不同厂牌属于不同准确产品，不能只按共同成分或总毫克数自行互换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007-01-16（LIALDA NDA 022000 初始批准；标签中的 1987 是美沙拉秦美国初始批准信息）", "archiveSponsorText": "Takeda Pharmaceuticals America, Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LIALDA", "LIALDA mesalamine", "mesalamine delayed-release tablets", "美沙拉秦延迟释放片" ], "excludedProductCues": [ "ASACOL HD", "PENTASA", "APRISO", "DELZICOL", "CANASA", "ROWASA", "generic mesalamine", "mesalamine suppository", "mesalamine enema" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lialda-mesalamine-delayed-release-tablet-1-2g-120-bottle-ndc-5409247612", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v49；2026-03-24）", "en": "Current U.S. DailyMed brand label (SPL v49; 24 March 2026)" }, "dosageForm": { "zh": "LIALDA 美沙拉秦延迟释放片", "en": "LIALDA mesalamine delayed-release tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54092-476-12", "pouchCode": null, "applicationNumber": "NDA 022000", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片美沙拉秦 1.2 g；120 片瓶装", "en": "Mesalamine 1.2 g per tablet; 120-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lialda-02.jpg&setid=3098a080-be86-4265-9818-7fc4beab77b7&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "美沙拉秦", "en": "mesalamine" }, "value": 1.2, "unit": "g", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或与其他美沙拉秦制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion to another mesalamine product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红棕色", "en": "red-brown" }, "shape": { "zh": "椭圆形片", "en": "ellipsoidal tablet" }, "imprint": "S476", "scoreStatus": "label_says_do_not_split_or_crush", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lialda-mesalamine-delayed-release-tablet-1-2g-120-bottle-ndc-5409247612", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lialda-02.jpg&setid=3098a080-be86-4265-9818-7fc4beab77b7&type=img", "alt": "LIALDA 美沙拉秦 1.2 g、NDC 54092-476-12、120 片瓶装的 DailyMed 官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v49；2026-03-24", "presentation": "红棕色椭圆片，S476；每片 1.2 g，120 片瓶装。", "notice": "只对应所引美国当前准确包装。外观与刻印不用于鉴定真伪，也不能证明实时库存；标签要求整片吞服，不因可见刻痕或总毫克数推导掰片、换药或个人用法。", "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LIALDA 说明书放大阅读：每片含量、整片吞服、肾功能与相互作用", "en": "LIALDA enlarged label: per-tablet amount, swallowing whole, kidney function and interactions" }, "summary": { "zh": "包装的 1.2 g 是每片美沙拉秦含量，120 Tablets 是瓶内片数。应整片吞服，不能掰开或压碎；个人片数、频次、疗程及能否改用其他美沙拉秦产品，不能从包装数字或网页推导。", "en": "The 1.2 g figure is mesalamine per tablet and 120 Tablets is the bottle count. Swallow tablets whole; do not split or crush them. Individual tablet count, frequency, course and any switch to other mesalamine products cannot be inferred from pack numbers or this page." }, "checks": [ { "zh": "开始前及使用期间需按专业安排评估肾功能；既往肾病、老人、脱水或同时使用可能损害肾脏的药物时更要主动核对。出现尿量明显变化、肿胀或严重不适应及时就医，不要自行停换。", "en": "Kidney function requires professional assessment before and during treatment. Prior kidney disease, older age, dehydration or concurrent nephrotoxic medicines needs extra review. Marked urine change, swelling or severe illness needs prompt care; do not self-stop or switch." }, { "zh": "NSAID 等肾毒性药物可能增加肾脏不良反应风险；不要只在网页上把药错开，应把处方药、非处方止痛药、中草药和补充剂一次性交给医生或药师核对。", "en": "NSAIDs and other nephrotoxic medicines may increase renal adverse-reaction risk. Do not merely separate them using a webpage; give prescriptions, OTC pain medicines, herbs and supplements together to a doctor or pharmacist." }, { "zh": "与硫唑嘌呤或 6-巯基嘌呤同用可能增加血液病风险，需要专业核对全血细胞计数和血小板；发热、异常瘀青、出血或明显乏力不应用网页自行判断。", "en": "Azathioprine or 6-mercaptopurine may increase blood-dyscrasia risk and requires professional review of complete blood counts and platelets. Fever, unusual bruising, bleeding or marked fatigue cannot be self-assessed on a webpage." }, { "zh": "65 岁及以上人群标签报告血液病发生率较高；老年人还常有肾功能变化和多药使用，应把实际药盒、处方和化验一起复核，而不是按年龄自行减片。", "en": "The label reports a higher incidence of blood dyscrasias in people aged 65 and older. Kidney change and polypharmacy are also common; review actual packs, prescriptions and tests together rather than self-reducing by age." }, { "zh": "急性不耐受综合征、严重皮肤反应、胸痛、呼吸困难、明显腹痛/血便加重或其他急性异常需要及时医疗评估；网页不作停药或急症排除决定。", "en": "Acute intolerance syndrome, severe skin reactions, chest pain, breathing difficulty, marked worsening abdominal pain/bloody stool or another acute change requires prompt medical assessment; this page does not decide stopping or exclude emergencies." } ], "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "释放结构阅读：pH 依赖包衣不等于所有美沙拉秦制剂可互换", "en": "Release design: a pH-dependent coat does not make mesalamine products interchangeable" }, "summary": { "zh": "LIALDA 片剂采用 pH 依赖聚合物包衣；标签描述包衣在 pH 6.8 或以上、通常到达末端回肠时开始分解，之后美沙拉秦延迟并延长释放。该机制用于理解准确产品，不能生成掰片、压碎、加减片数或改用其他制剂的方案。", "en": "LIALDA uses a pH-dependent polymer coat. The label describes breakdown at pH 6.8 or above, normally in the terminal ileum, followed by delayed and extended mesalamine release. This explains the exact product but creates no plan to split, crush, change tablet count or switch formulation." }, "checks": [ { "zh": "共同成分不等于相同释放位置、剂型、规格、辅料或标签；ASACOL HD、PENTASA、APRISO、DELZICOL 及直肠制剂要分别核对。", "en": "A shared ingredient does not mean the same release site, form, strength, excipients or label. ASACOL HD, PENTASA, APRISO, DELZICOL and rectal products require separate checks." }, { "zh": "看到完整或部分片壳样物质、吞咽困难或新包装时，应保存包装并询问专业人员；不要自行压碎、浸泡或改用另一剂型。", "en": "If intact or partial tablet-shell material is seen, swallowing is difficult or a new pack arrives, keep the pack and ask a professional; do not crush, soak or switch form yourself." }, { "zh": "疾病活动、症状变化、检查结果与肾功能由临床团队综合判断；释放原理不能替代复诊，也不能决定个人片数、疗程或停换药。", "en": "Disease activity, symptom change, test results and kidney function require integrated clinical review. Release design does not replace follow-up or determine an individual's tablet count, course, stopping or switching." } ], "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LIALDA", "generic": "美沙拉秦延迟释放片", "dosageFormClass": "LIALDA 是美沙拉秦延迟释放片，其包衣在约 pH 6.8 或以上开始分解，随后延长释放。ASACOL HD、PENTASA、APRISO、DELZICOL、栓剂、灌肠剂以及不同厂牌属于不同准确产品，不能只按共同成分或总毫克数自行互换。" }, "labelSource": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "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": "2026-09-05", "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_21a6177cab38ae20", "label": "FDA Drugs@FDA：LIALDA NDA 022000 产品与监管记录入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022000", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "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": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "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": "LIALDA 是美沙拉秦延迟释放口服片的美国品牌档案。1.2 g 是每片含量，不是个人片数；120 Tablets 才是整瓶片数，也不是个人应该吃多少片。片剂应整片吞服，不能掰开或压碎；不同美沙拉秦制剂的释放位置、剂型、强度和标签不同，不能只按同成分或总毫克数自行替换。肾功能、完整药单和老年人的血象风险需由医生或药师结合实际情况核对。", "history": "FDA 资料记录 LIALDA 于 2007-01-16 以 NDA 022000 获批，用于轻至中度溃疡性结肠炎的相关适应证。当前 DailyMed SPL v49 于 2026-03-24 生效，列出 1.2 g 延迟释放片和 120 片瓶装；1987 是标签中的美沙拉秦美国初始批准年份，不应误写为 LIALDA 品牌获批年份。", "sourceDocuments": [ { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_f1258d364bfd2ffa", "label": "FDA：LIALDA NDA 022000 审评资料，记录 2007-01-16 初始批准历史", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_21a6177cab38ae20", "label": "FDA Drugs@FDA：LIALDA NDA 022000 产品与监管记录入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022000", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } ], "applicationNumber": "NDA 022000", "approvalTimeline": [ { "date": "2007-01-16", "title": { "zh": "LIALDA 美国初始批准", "en": "Initial U.S. approval of LIALDA" }, "detail": { "zh": "FDA 审评资料记录 NDA 022000 于该日初始获批；与标签所示美沙拉秦 1987 年初始批准年份分开。", "en": "FDA review material records initial approval of NDA 022000 on this date; this is distinct from the label's 1987 initial U.S. approval year for mesalamine." }, "source": { "id": "src_f1258d364bfd2ffa", "label": "FDA：LIALDA NDA 022000 审评资料，记录 2007-01-16 初始批准历史", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2026-03-24", "title": { "zh": "当前 DailyMed 标签版本生效", "en": "Current DailyMed label effective" }, "detail": { "zh": "SPL v49 列出 1.2 g 延迟释放片、精确 NDC 和 120 片瓶装。", "en": "SPL v49 lists the 1.2 g delayed-release tablet, exact NDC and 120-tablet bottle." }, "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "展示一个准确 120 片瓶装；不证明实时供应。", "en": "One exact 120-tablet bottle is displayed; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、商品名、参比、包装和供应尚未逐市场确认", "en": "Local approval, brand, reference, pack and supply not yet established market by market" }, "detail": { "zh": "不从美国 NDA、NDC 或包装推定其他市场状态。", "en": "No other-market status is inferred from the U.S. NDA, NDC or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1.2 g 是每次吃一片吗？", "en": "Does 1.2 g mean one tablet each time?" }, "answer": { "zh": "不是。1.2 g 只说明每片含量；个人片数、频次与疗程必须以准确处方和专业复核为准。", "en": "No. 1.2 g is only the amount per tablet; tablet count, frequency and course require the exact prescription and professional review." } }, { "question": { "zh": "其他美沙拉秦也是同成分，能按总毫克直接换吗？", "en": "Can another mesalamine product be switched by total milligrams?" }, "answer": { "zh": "不能自行换。释放设计、剂型、规格和标签可能不同，应带两盒实物或官方说明书由医生或药师逐项核对。", "en": "Do not self-switch. Release design, form, strength and labelling may differ; have a doctor or pharmacist compare both actual packs or official labels." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lialda-mesalamine/", "en": "https://origindrug.com/en/drugs/lialda-mesalamine/" }, "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." ] }