{ "id": "avodart", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Avodart", "generic": "度他雄胺", "aliases": [ "dutasteride", "度他雄胺" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 AVODART 当前公开标签（DailyMed SPL v4，2025-03-12 生效）", "dosageFormClass": "口服软明胶胶囊：每粒 0.5 mg；本档案精确展示 NDC 80725-712-04 的 90 粒瓶装；不并入 JALYN 复方或其他市场产品", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "Waylis Therapeutics LLC / DailyMed 当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "JALYN", "dutasteride and tamsulosin", "dutasteride/tamsulosin", "度他雄胺坦索罗辛", "度他雄胺/坦索罗辛" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avodart-dutasteride-softgel-capsule-0-5mg-90count-ndc-80725-712-04", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2025-03-12 生效）", "en": "DailyMed SPL v4 (effective 12 Mar 2025)" }, "dosageForm": { "zh": "AVODART 度他雄胺口服软明胶胶囊", "en": "AVODART dutasteride oral soft gelatin capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-712-04", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒度他雄胺 0.5 mg；90 粒瓶装", "en": "Dutasteride 0.5 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avodart-spl-image-09.jpg&setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度他雄胺", "en": "dutasteride" }, "value": 0.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人胶囊数、频率或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, frequency or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "暗黄色", "en": "dull yellow" }, "shape": { "zh": "长椭圆形软明胶胶囊", "en": "oblong oval soft gelatin capsule" }, "imprint": "GX CE2", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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-avodart-dutasteride-softgel-capsule-0-5mg-90count-ndc-80725-712-04", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avodart-spl-image-09.jpg&setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "alt": "AVODART 度他雄胺 0.5 mg 口服软明胶胶囊在美国 DailyMed 公开标签中的 90 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4（2025-03-12 生效）", "presentation": "AVODART 度他雄胺 0.5 mg、NDC 80725-712-04、90 粒瓶装标签图（DailyMed 当前公开标签所列）。", "notice": "此图只对应美国 DailyMed 当前标签中的 AVODART、度他雄胺 0.5 mg、NDC 80725-712-04 与 90 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、软明胶胶囊、包装数量和来源；不用于鉴定真伪，也不证明 JALYN、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的胶囊数、联用、开始、停用或换药方案。", "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "AVODART / 度他雄胺说明书放大阅读：0.5 mg 是每粒胶囊的身份，不是自行调整胶囊数的公式", "en": "AVODART label reading: 0.5 mg identifies each capsule; it is not a formula for self-adjusting capsule count" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 AVODART、度他雄胺、每粒 0.5 mg、口服软明胶胶囊和准确瓶装。它不决定个人胶囊数、是否与坦索罗辛或其他泌尿用药同服、何时停用或怎样换药。", "en": "This module uses the current U.S. DailyMed public label to check AVODART, dutasteride, 0.5 mg per capsule, oral soft gelatin capsules and the exact bottle. It does not decide an individual's capsule count, use with tamsulosin or another urological medicine, stopping time or switching." }, "checks": [ { "zh": "先同时核对 AVODART、度他雄胺、每粒 0.5 mg、NDC 80725-712-04、口服软明胶胶囊、实际包装和目标市场。JALYN 虽含度他雄胺，却是与坦索罗辛组成的复方产品；相同成分、相近名称或毫克数字都不能证明可以自行互换、叠加或按比例换算。", "en": "Check AVODART, dutasteride, 0.5 mg per capsule, NDC 80725-712-04, oral soft gelatin capsule, actual pack and target market together. Although JALYN contains dutasteride, it is a combination product with tamsulosin; a shared ingredient, similar name or milligram number does not establish self-directed substitution, combination or proportional conversion." }, { "zh": "标签将 AVODART 列为有前列腺增大的男性症状性 BPH 的产品；相同的“排尿”或“前列腺”文字，不能证明它与非那雄胺、坦索罗辛、草本或其他泌尿产品可自行叠加、替换或轮换。", "en": "The label identifies AVODART for symptomatic BPH in men with an enlarged prostate. Shared urinary or prostate wording does not establish that it can be self-combined, substituted or alternated with finasteride, tamsulosin, herbs or another urological product." }, { "zh": "美国标签写明软明胶胶囊应整粒吞服，不应咀嚼或打开。该句属于这一准确产品的标签信息；因吞咽困难、包装损坏、外观相近或听到他人经验而需要改变处理方式时，应先由药师或医生核对实际产品。", "en": "The U.S. label says the soft gelatin capsules should be swallowed whole and not chewed or opened. This is label information for this exact product; if swallowing difficulty, package damage, a similar appearance or someone else's experience raises a question about handling, have a pharmacist or clinician check the actual product first." }, { "zh": "美国标签将妊娠列为禁忌，并对孕妇或可能怀孕者接触渗漏胶囊给出专门警示。它是这份美国标签的安全信息，不是网站为实际接触、破损或任何个人情况提供的处理方案；请尽快联系当地药师、医生或适当的医疗支持。", "en": "The U.S. label lists pregnancy as a contraindication and gives a specific warning about contact with leaking capsules by women who are or may be pregnant. It is safety information from this U.S. label, not a website handling plan for an actual contact, damaged pack or any individual situation; contact a local pharmacist, clinician or appropriate medical support promptly." }, { "zh": "正在使用多种泌尿、心血管、激素、非处方或补充剂产品，或准备做前列腺相关检查时，应带实际药盒和完整药单请药师或医生核对；网页不能把标签文字变成个人诊断、检查解释或用药安排。", "en": "When using several urological, cardiovascular, hormonal, OTC or supplement products, or preparing for a prostate-related evaluation, bring the actual packs and complete medicine list to a pharmacist or clinician. A webpage cannot turn label wording into an individual diagnosis, test interpretation or medicine plan." } ], "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；Warnings and Patient Information）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "度他雄胺怎样起作用：它抑制两种 5α 还原酶，减少睾酮转化为二氢睾酮（DHT）", "en": "How dutasteride works: it inhibits two 5-alpha-reductase types involved in testosterone conversion to DHT" }, "summary": { "zh": "美国 AVODART 标签将度他雄胺描述为 5α 还原酶抑制剂，可抑制 1 型和 2 型 5α 还原酶介导的睾酮转化为二氢睾酮（DHT）。这是作用路径的说明，不判断任何人的排尿症状原因、前列腺大小、检查结果、是否适用、胶囊数或与其他药物的联合方案。", "en": "The U.S. AVODART label describes dutasteride as a 5-alpha-reductase inhibitor that inhibits type 1 and type 2 5-alpha-reductase-mediated conversion of testosterone to dihydrotestosterone (DHT). This explains a pathway, not the cause of anyone's urinary symptoms, prostate size, test result, suitability, capsule count or combination plan." }, "checks": [ { "zh": "“影响 DHT”不等于可从网页判断某人的症状一定来自前列腺增生，或能绕过对其他泌尿、感染、肿瘤或药物相关原因的专业评估。", "en": "“Affects DHT” does not allow a webpage to determine that a person's symptoms are necessarily from BPH or bypass professional assessment of other urinary, infectious, malignant or medicine-related causes." }, { "zh": "同样影响 5α 还原酶或都用于泌尿症状，不使度他雄胺与非那雄胺、坦索罗辛、JALYN 或其他产品可自行叠加、交替、替换或按 mg 换算。", "en": "A related 5-alpha-reductase effect, or use for urinary symptoms, does not make dutasteride self-combinable, alternatable, substitutable or milligram-convertible with finasteride, tamsulosin, JALYN or another product." }, { "zh": "机制不能替代对完整药单、既往反应、检查计划和准确产品标签的核对。考虑开始、停用、换药、打开胶囊或遇到新的明显不适时，应及时联系当地药师或医生。", "en": "Mechanism does not replace review of the complete medicine list, prior reactions, testing plans and the exact product label. For a contemplated start, stop, switch, opening a capsule or a new concerning symptom, contact a local pharmacist or clinician promptly." } ], "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "Avodart", "generic": "度他雄胺", "dosageFormClass": "口服软明胶胶囊：每粒 0.5 mg；本档案精确展示 NDC 80725-712-04 的 90 粒瓶装；不并入 JALYN 复方或其他市场产品" }, "labelSource": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "本页精确建立美国 AVODART（dutasteride）0.5 mg 口服软明胶胶囊、NDC 80725-712-04、90 粒瓶装的标签阅读身份。JALYN 是度他雄胺与坦索罗辛的复方产品；不得因出现相同成分、相近名称或相同毫克数字，就把它们当作可自行替换、叠加或换算。页面不提供个人胶囊数、联合用药、换药或购买建议。", "history": "本页链接的 DailyMed 公开标签列示 AVODART 的美国初始批准年份为 2001，并将本页所列文件标识为 2025-03-12 生效的 SPL v4。它建立的是一个具体美国公开标签的可回溯阅读路径，不推定中国大陆或其他市场的当前批准、持有人、供应、原研关系或可售资格。", "sourceDocuments": [ { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021319（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "2001", "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: 2001。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: 2001. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed: AVODART public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-03-12 SPL v4", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-03-12 SPL v4 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 2025-03-12 SPL v4 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_4eace7970a6c950b", "label": "DailyMed: AVODART public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_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": "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/avodart/", "en": "https://origindrug.com/en/drugs/avodart/" }, "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." ] }