{ "id": "colcrys", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "COLCRYS", "generic": "秋水仙碱", "aliases": [ "COLCRYS", "colchicine", "秋水仙碱" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 COLCRYS 秋水仙碱有日期历史公开标签（2025-07 修订；公开产品记录列示 2026-04-30 美国营销结束）。本页只保留一个 0.6 mg、NDC 64764-119-07、30 片瓶装展示面。", "dosageFormClass": "口服片：每片秋水仙碱 0.6 mg（历史标签的 30 片瓶装展示面）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1961（美国公开历史标签所列 Initial U.S. Approval）", "archiveSponsorText": "Takeda Pharmaceuticals America, Inc. / DailyMed（NLM）有日期历史公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "colchicine injection", "秋水仙碱注射剂", "COLCRYS MITIGARE", "MITIGARE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-colcrys-colchicine-tablet-0-6mg-30-count-bottle-ndc-64764-119-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "en": "Dated U.S. DailyMed historical public label (Takeda; revised Jul 2025; product record lists marketing end 30 Apr 2026)" }, "dosageForm": { "zh": "COLCRYS 秋水仙碱口服片", "en": "COLCRYS colchicine oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-119-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 0.6 mg；30 片瓶装", "en": "0.6 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=colcrys-03.jpg&archiveid=902339", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "秋水仙碱", "en": "colchicine" }, "value": 0.6, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签量；不是个人片数、开始、停用、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, start, stop, co-use or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "紫色", "en": "purple" }, "shape": { "zh": "椭圆/胶囊形片；有刻痕", "en": "oval/capsule-shaped tablet; scored" }, "imprint": "AR 374", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-colcrys-colchicine-tablet-0-6mg-30-count-bottle-ndc-64764-119-07", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=colcrys-03.jpg&archiveid=902339", "alt": "COLCRYS 秋水仙碱美国 DailyMed 有日期历史公开标签中的 0.6 mg、NDC 64764-119-07、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "2025-07 修订；公开产品记录列示 2026-04-30 美国营销结束", "presentation": "COLCRYS 秋水仙碱：每片 0.6 mg，NDC 64764-119-07，30 片瓶装历史标签展示面。", "notice": "此图只对应美国 DailyMed 有日期历史标签中的 COLCRYS、秋水仙碱 0.6 mg、NDC 64764-119-07 与 30 片瓶装；公开产品记录列示该美国记录的营销结束日期为 2026-04-30。它只帮助核对品牌、通用名、每片历史标签量、口服片、包装数量、外形线索与来源；不用于鉴定真伪，也不证明当前在售、库存、购买、其他包装、其他市场、原研身份、可替代性或任何个人使用方案。标签所列刻痕与毫克数不是网页给个人的掰开、片数、开始、停用、联用或换药指令。", "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COLCRYS 历史标签放大阅读：0.6 mg、NDC 与 30 片瓶装只先核对历史身份", "en": "COLCRYS historical-label reading: 0.6 mg, NDC and a 30-tablet bottle first identify a historical product" }, "summary": { "zh": "本模块只阅读一份美国有日期历史公开标签中的 COLCRYS、秋水仙碱、每片 0.6 mg、NDC 64764-119-07、30 片瓶装和外形文字线索。该记录列示美国营销结束日期为 2026-04-30；页面不提供个人片数、开始、停用、补用、掰开、联用、换药或购买方案。", "en": "This module reads only COLCRYS, colchicine, 0.6 mg per tablet, NDC 64764-119-07, a 30-tablet bottle and appearance text in one dated U.S. historical public label. The record lists a U.S. marketing end date of 30 Apr 2026; this page provides no individual tablet count, initiation, stopping, make-up use, splitting, co-use, switching or purchase plan." }, "checks": [ { "zh": "先把 COLCRYS、秋水仙碱、0.6 mg、实际 NDC、30 片瓶装、口服片和目标市场一起核对。0.6 mg 是这个准确历史片剂的标签量，不是任何人该吃几片或是否可以换到另一种产品的答案。", "en": "Check COLCRYS, colchicine, 0.6 mg, the actual NDC, the 30-tablet bottle, oral-tablet form and target market together. 0.6 mg is the labelled amount for this exact historical tablet, not an answer to how many tablets anyone should use or whether another product can be exchanged." }, { "zh": "紫色、AR 374、椭圆/胶囊形与刻痕均是历史标签中这一准确片剂的身份线索。它们不能鉴定照片真伪，也不是自行掰开、补用、加减、停用或换药的许可。实际包装、处方或市场与页面不同时，应带着药盒请药师或开方团队核对。", "en": "Purple colour, AR 374, the oval/capsule shape and scoring are identity clues for this exact historical labelled tablet. They cannot authenticate a photo and are not permission to self-split, make up, adjust, stop or switch. If the actual pack, prescription or market differs, take the pack to a pharmacist or prescribing team." }, { "zh": "历史标签特别提示强 P-gp 或 CYP3A4 抑制剂相关相互作用风险，并要求把所有处方药、非处方药、补充剂与近期新增抗菌药等一起核对。肾脏或肝脏问题、年长、多病共存或多药并用时，更不应从网页自行开始、增加、重复、停用或换药；应由药师或医生结合准确产品与完整药单复核。", "en": "The historical label flags interaction risk with strong P-gp or CYP3A4 inhibitors and calls for review of every prescription medicine, OTC product, supplement and recent addition such as an antibacterial. With kidney or liver problems, older age, multiple conditions or multiple medicines, do not self-start, increase, repeat, stop or switch from a webpage; a pharmacist or clinician should review the exact product and complete medicine list." }, { "zh": "出现严重腹泻或呕吐、明显无力、肌肉疼痛或无力、麻木刺痛、异常出血/瘀斑、发热、感染样表现、呼吸困难或其他急性严重不适时，应及时使用当地紧急医疗渠道；不要根据网页自行判断原因或调整药物。", "en": "With severe diarrhoea or vomiting, marked weakness, muscle pain or weakness, numbness or tingling, unusual bleeding/bruising, fever, infection-like symptoms, breathing difficulty or another acute serious concern, promptly use local urgent medical care; do not use a webpage to determine the cause or adjust medicine." } ], "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Warnings, Drug Interactions and Patient Counseling；Takeda；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "秋水仙碱怎样在标签中被描述：与微管蛋白结合的作用路径，不是个人用药规则", "en": "How colchicine is described in the label: a tubulin-binding pathway, not an individual-use rule" }, "summary": { "zh": "这份有日期历史标签在临床药理部分描述秋水仙碱与微管蛋白结合，并影响微管聚合与炎症过程中的细胞活动。它帮助理解标签用语中的作用路径，不诊断关节痛、炎症或其他症状，也不决定任何人的片数、开始、停用、联用或换药。", "en": "In Clinical Pharmacology, this dated historical label describes colchicine binding to tubulin and affecting microtubule polymerisation and cell activity in inflammatory processes. It helps explain a label term, not diagnose joint pain, inflammation or another symptom, and it does not determine anyone's tablet count, initiation, stopping, co-use or switching." }, "checks": [ { "zh": "“与微管蛋白结合”是标签中的机制描述，不表示网页能够判断某个疼痛、红肿、腹泻、肌肉症状或化验变化是否由这款药、痛风或其他原因造成。", "en": "“Binds to tubulin” is a mechanism description in the label; it does not mean a webpage can decide whether pain, redness, diarrhoea, muscle symptoms or a laboratory change is caused by this medicine, gout or another cause." }, { "zh": "同样涉及炎症、关节痛、尿酸或细胞过程的药物，不能因为名称、用途或机制词相近就自行叠加、轮换、替代或按 mg 换算。请将全部实际药盒、处方和补充剂交由药师或开方团队逐项核对。", "en": "Medicines that also involve inflammation, joint pain, uric acid or cell processes cannot be self-combined, alternated, substituted or milligram-converted because their names, uses or mechanism terms seem similar. Have a pharmacist or prescribing team review every actual pack, prescription and supplement item by item." }, { "zh": "机制说明不能决定何时开始、持续多久、是否漏用补回、是否停用或怎样处理急性症状。任何现实使用问题必须回到准确产品的现行目标市场资料和专业人员。", "en": "A mechanism explanation cannot decide when to start, how long to continue, whether to make up a missed use, whether to stop or how to handle an acute symptom. Any real-use question must return to current target-market information for the exact product and a professional." } ], "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Clinical Pharmacology；Takeda；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "COLCRYS", "generic": "秋水仙碱", "dosageFormClass": "口服片：每片秋水仙碱 0.6 mg（历史标签的 30 片瓶装展示面）" }, "labelSource": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 COLCRYS 历史公开标签列示秋水仙碱口服片，每片 0.6 mg，并有一个 NDC 64764-119-07、30 片瓶装展示面。公开产品记录同时列示该美国记录的营销结束日期为 2026-04-30；因此本页只帮助读者核对历史产品身份和原始文件，不将其描述为当前在售、可购买或可替代产品，也不把毫克数、刻痕、相互作用或不良反应文字转成个人片数、开始、停用、联用或换药建议。", "history": "这份有日期的美国公开标签列示 Initial U.S. Approval: 1961，并在公开产品记录中列示 NDA 022352、美国营销起始日期 2009-09-01 与营销结束日期 2026-04-30。上述是所引历史记录的定位信息，不能替代任何市场的现行标签；同一通用名的其他品牌、胶囊、其他包装、其他强度或其他市场产品都需按准确包装和当地现行资料分别核对。", "sourceDocuments": [ { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 022352（有日期历史公开产品记录）", "approvalTimeline": [ { "date": "1961", "title": { "zh": "历史标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the historical label" }, "detail": { "zh": "这份 COLCRYS 有日期历史公开标签列示 Initial U.S. Approval: 1961。它只定位所引美国历史档案，不建立其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "This dated COLCRYS historical public label lists Initial U.S. Approval: 1961. It locates only the cited U.S. historical archive and does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-07", "title": { "zh": "有日期历史标签修订", "en": "Dated historical-label revision" }, "detail": { "zh": "所引 DailyMed 标签标示 2025-07 修订。这个日期只说明所引文件版本，不能代表当前标签、当前安全结论、库存、购买资格或其他市场状态。", "en": "The cited DailyMed label is marked revised July 2025. The date identifies only the cited document version; it does not represent current labeling, current safety conclusions, stock, purchase eligibility or another-market status." }, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2026-04-30", "title": { "zh": "历史产品记录列示美国营销结束日期", "en": "U.S. marketing-end date listed in historical product data" }, "detail": { "zh": "所引公开产品记录列示 2026-04-30 为美国营销结束日期。因此本页不把 COLCRYS 表述为当前在售、可购、可替代或仍在美国供应；任何现行产品问题须回到目标市场的现行官方资料和专业人员。", "en": "The cited public product data list 30 Apr 2026 as the U.S. marketing-end date. This page therefore does not describe COLCRYS as currently marketed, purchasable, interchangeable or still supplied in the United States; current-product questions require current target-market official material and a professional." }, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史产品记录列示营销结束日期 2026-04-30", "en": "Historical product data list a marketing-end date of 30 Apr 2026" }, "detail": { "zh": "本页只保留 COLCRYS 0.6 mg、NDC 64764-119-07、30 片瓶装的历史标签身份和原始文件入口；不建立当前在售、库存、购买、换用或供应结论。", "en": "This page retains only the historical label identity and primary-document entry point for COLCRYS 0.6 mg, NDC 64764-119-07 and a 30-tablet bottle; it does not establish current marketing, stock, purchase, switching or supply." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, 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": "不从这份美国历史标签推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场都须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this U.S. historical label; each market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "COLCRYS 0.6 mg、NDC 和 30 片瓶装是否意味着可以自行开始、加减、掰开或换到其他秋水仙碱产品？", "en": "Do COLCRYS 0.6 mg, an NDC and a 30-tablet bottle mean a person can self-start, adjust, split or change to another colchicine product?" }, "answer": { "zh": "不能。这些文字只识别所引美国历史标签中的准确片剂和瓶装。共同通用名、相近毫克数、包装照片或刻痕均不建立自行开始、增加、重复、掰开、停用、联用、轮换或替换关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These details only identify the exact tablet and bottle in the cited U.S. historical label. A shared generic name, nearby milligram number, package photo or score does not establish self-initiation, increase, repetition, splitting, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team." } } ], "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/colcrys/", "en": "https://origindrug.com/en/drugs/colcrys/" }, "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." ] }