{ "id": "propecia-finasteride", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "PROPECIA", "generic": "非那雄胺 1 mg 片", "aliases": [ "Propecia", "finasteride", "finasteride 1 mg", "非那雄胺", "非那雄胺片", "保法止", "finasteride tablets", "非那雄胺 1 mg", "PROPECIA", "NDA 020788", "78206-152-01", "stylized P", "PROPECIA 1 mg" ], "marketBrandNames": [ { "name": "PROPECIA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 020788、1 mg 口服片，当前处方 RLD／RS；实际供应仍须在当地核对。", "en": "NDA 020788, 1 mg oral tablet, currently prescription RLD/RS; actual supply still requires local checking." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 FDA Orange Book 当前把 PROPECIA 非那雄胺 1 mg 片、NDA 020788 Product 001 列为处方 RLD 与 RS；DailyMed 公开标签列出 NDC 78206-152-01 的 30 片瓶装。监管在册、准确包装、实际库存、购买资格和个人适用性属于不同证据层级。", "dosageFormClass": "非那雄胺 1 mg 薄膜衣口服片。PROSCAR 是非那雄胺 5 mg 的另一品牌与另一准确产品身份；同一成分不等于可按 5:1 自行切片、拼片、轮换或替换。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997-12-19（FDA NDA 020788 批准日期）", "archiveSponsorText": "Organon LLC（美国 NDA 当前申请持有人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "PROPECIA", "Propecia finasteride 1 mg", "保法止", "非那雄胺 1 mg 片" ], "excludedProductCues": [ "PROSCAR", "finasteride 5 mg", "非那雄胺 5 mg", "dutasteride", "AVODART" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-propecia-finasteride-tablet-1mg-30-bottle-ndc-78206-152-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开品牌标签（处方信息 2022-08 修订；患者信息 2023-11 修订）", "en": "Current U.S. DailyMed brand label (prescribing information revised Aug 2022; patient information revised Nov 2023)" }, "dosageForm": { "zh": "PROPECIA 非那雄胺 1 mg 薄膜衣口服片", "en": "PROPECIA finasteride 1 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-152-01", "pouchCode": null, "applicationNumber": "NDA 020788 Product 001", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非那雄胺 1 mg；30 片瓶装", "en": "Finasteride 1 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=propecia-03.jpg&setid=6f904709-65aa-44ce-b144-b4c8a0416e36&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非那雄胺", "en": "finasteride" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是把 PROSCAR 5 mg 切分后的网页换算值", "en": "labelled amount per tablet; not an individual's tablet count or a web conversion made by dividing PROSCAR 5 mg" } } ], "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": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕褐色", "en": "tan" }, "shape": { "zh": "八边形、凸面、薄膜衣片，约 7 mm", "en": "octagonal, convex, film-coated tablet, approximately 7 mm" }, "imprint": "stylized P / PROPECIA", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-propecia-finasteride-tablet-1mg-30-bottle-ndc-78206-152-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=propecia-03.jpg&setid=6f904709-65aa-44ce-b144-b4c8a0416e36&type=img", "alt": "PROPECIA 非那雄胺 1 mg、NDC 78206-152-01、30 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开品牌标签", "presentation": "每片非那雄胺 1 mg；棕褐色八边形凸面薄膜衣片，无刻痕，一面为 stylized P、一面为 PROPECIA；NDC 78206-152-01，30 片瓶装。", "notice": "此图只对应美国 NDC 78206-152-01 的 30 片瓶装，不代表其他国家包装、PROSCAR 5 mg、仿制品或实时库存，也不用于鉴定真伪。", "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROPECIA 说明书放大阅读：先分清 1 mg、30 片瓶装、PROSCAR 5 mg 与孕期接触边界", "en": "PROPECIA enlarged label: separate 1 mg, the 30-tablet bottle, PROSCAR 5 mg and pregnancy-handling boundaries" }, "summary": { "zh": "1 mg 是每片非那雄胺标示量，30 Tablets 是整瓶片数，不是个人一次片数。PROPECIA 1 mg 与 PROSCAR 5 mg 是两个准确产品身份，不能把共同成分变成自行切片或换算许可。", "en": "The 1 mg figure is labelled finasteride per tablet, while 30 Tablets is the bottle count—not an individual tablet count. PROPECIA 1 mg and PROSCAR 5 mg are separate exact product identities; a shared ingredient is not permission to split or convert them yourself." }, "checks": [ { "zh": "标签把 PROPECIA 限定在男性型脱发的男性使用场景，并明确不适用于女性。网页不根据脱发照片、年龄或症状替个人判断适用性。", "en": "The label limits PROPECIA to the male-pattern-hair-loss setting in men and states that it is not indicated for women. The site does not determine suitability from hair photographs, age or symptoms." }, { "zh": "怀孕或可能怀孕者不得接触压碎或破损的 PROPECIA 片；完整包衣片在正常拿取时可减少皮肤接触，但发现破损应避免接触并按现行说明书与医疗团队处理。", "en": "A person who is or may be pregnant must not handle crushed or broken PROPECIA tablets. The coating limits skin contact during normal handling of intact tablets, but damaged tablets require avoidance and handling according to the current label and clinical advice." }, { "zh": "非那雄胺可能影响 PSA 结果。就诊、筛查或解释 PSA 时，应主动告诉医生正在或曾经使用的准确产品、强度和时间；网页不根据一次化验值判断停药或疾病。", "en": "Finasteride may affect PSA results. Tell the clinician the exact product, strength and timing when PSA is measured or interpreted. The site does not infer interruption or disease from one test result." }, { "zh": "标签列出的不良反应与上市后报告需要结合个人情况解释；出现乳房变化、严重过敏、明显情绪变化或其他持续困扰时，应及时联系医疗团队，不要自行加量、减量或换成 5 mg 产品。", "en": "Labelled adverse reactions and postmarketing reports require individual interpretation. Breast changes, serious allergy, marked mood changes or another persistent concern needs timely clinical contact; do not self-increase, reduce or switch to a 5 mg product." } ], "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "非那雄胺怎样起作用：抑制 II 型 5α-还原酶，降低睾酮向 DHT 的转化", "en": "How finasteride works: type II 5α-reductase inhibition reduces conversion of testosterone to DHT" }, "summary": { "zh": "标签说明非那雄胺抑制 II 型 5α-还原酶，降低睾酮转化为二氢睾酮（DHT）。这个机制解释了它与毛囊、前列腺及妊娠接触警示的联系，但不能从机制推导个人是否需要用药、多久见效或是否可以换成 PROSCAR。", "en": "The label explains that finasteride inhibits type II 5α-reductase and reduces conversion of testosterone to dihydrotestosterone (DHT). This links the medicine to hair follicles, the prostate and pregnancy-handling warnings, but cannot determine whether an individual needs treatment, when benefit will appear or whether PROSCAR can replace it." }, "checks": [ { "zh": "PROPECIA 与 PROSCAR 共享非那雄胺成分，但强度、标签用途和准确产品身份不同；同一机制不建立 5:1 的家庭切片规则。", "en": "PROPECIA and PROSCAR share finasteride but differ in strength, labelled use and exact product identity. A shared mechanism does not create a household 5:1 tablet-splitting rule." }, { "zh": "PROPECIA 也不是度他雄胺（AVODART）。同属 5α-还原酶抑制相关药物，不代表可以按毫克数轮换、叠加或替换。", "en": "PROPECIA is not dutasteride (AVODART). A related 5α-reductase-inhibitor class does not permit milligram rotation, combination or substitution." }, { "zh": "机制和基因信息都不能单独回答个人是否适合。请结合诊断、完整药单、生育/妊娠接触情境、PSA 与既往反应，由负责团队判断。", "en": "Mechanism and genetic information alone cannot answer individual suitability. Diagnosis, the complete medicine list, reproductive/pregnancy exposure context, PSA and prior response require review by the responsible clinical team." } ], "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PROPECIA", "generic": "非那雄胺 1 mg 片", "dosageFormClass": "非那雄胺 1 mg 薄膜衣口服片。PROSCAR 是非那雄胺 5 mg 的另一品牌与另一准确产品身份；同一成分不等于可按 5:1 自行切片、拼片、轮换或替换。" }, "labelSource": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "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": "2026-09-02", "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": "PROPECIA 是非那雄胺 1 mg 的美国品牌档案，用于男性型脱发的标签场景；它不是 PROSCAR 5 mg 的网页切片方案。1 mg 是每片标示量，30 Tablets 是整瓶数量。药片无刻痕，且怀孕或可能怀孕者不得接触压碎或破损的片剂；网页不会根据脱发程度、PSA、年龄或照片替个人决定是否使用。", "history": "FDA Orange Book 记录 PROPECIA NDA 020788 于 1997-12-19 获批，当前 1 mg 产品仍列为处方 RLD 与 RS。DailyMed 页面保留 2022-08 修订的处方信息、2023-11 修订的患者信息及一个准确 30 片瓶装面板。标签所写 1992 年美国初始批准指非那雄胺活性成分的初始批准历史，不等于 PROPECIA 产品在 1992 年获批。", "sourceDocuments": [ { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "NDA 020788 Product 001", "approvalTimeline": [ { "date": "1997-12-19", "title": { "zh": "FDA 批准 PROPECIA 1 mg 片", "en": "FDA approved PROPECIA 1 mg tablets" }, "detail": { "zh": "Orange Book 当前数据把 NDA 020788、1 mg、RLD／RS 与该批准日期相连。", "en": "Current Orange Book data connect NDA 020788, 1 mg, RLD/RS status and this approval date." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-08", "title": { "zh": "美国处方信息修订", "en": "U.S. prescribing information revised" }, "detail": { "zh": "DailyMed 当前公开页面所列处方信息修订日期。", "en": "Revision date shown for the prescribing information on the current DailyMed public page." }, "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2023-11", "title": { "zh": "美国患者信息修订", "en": "U.S. patient information revised" }, "detail": { "zh": "患者信息提供用途、接触警示、常见风险与就医沟通的通俗入口。", "en": "Patient information provides a plain-language entry to use, handling warnings, common risks and clinical communication." }, "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD／RS", "en": "Current prescription RLD/RS" }, "detail": { "zh": "NDA 020788 Product 001；监管在册不等于实时库存。", "en": "NDA 020788 Product 001; regulatory listing is not live stock." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地批准、商品名、包装或供应", "en": "Local approval, brand, pack and supply are not established by this dossier" }, "detail": { "zh": "“保法止”等名称须结合当地药监记录和手中现行说明书逐项核对。", "en": "Names such as Propecia/保法止 require market-specific checking against the local regulator and current leaflet in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "PROSCAR 5 mg 能切成五份当 PROPECIA 1 mg 吗？", "en": "Can a PROSCAR 5 mg tablet be cut into five parts to make PROPECIA 1 mg?" }, "answer": { "zh": "网页不能支持这种做法。PROPECIA 1 mg 是独立处方产品，药片无刻痕；PROSCAR 5 mg 具有不同标签用途与产品身份。不要凭算术自行切片、拼片或替换，请让医生或药师按准确产品与个人情况核对。", "en": "The site cannot support that practice. PROPECIA 1 mg is a separate prescription product and its tablet is unscored; PROSCAR 5 mg has a different labelled use and product identity. Do not use arithmetic to split, assemble or substitute tablets; have a clinician or pharmacist review the exact products and personal context." } }, { "question": { "zh": "1 mg 是一次吃一颗吗？", "en": "Does 1 mg mean one tablet for me?" }, "answer": { "zh": "1 mg 只说明每片含多少非那雄胺，不是网页给出的个人片数。个人是否适合、如何使用和何时复评必须以本人处方、现行说明书和负责团队判断为准。", "en": "The 1 mg figure only states finasteride per tablet; it is not a personal tablet count from this site. Suitability, use and reassessment require the individual's prescription, current label and responsible clinical team." } }, { "question": { "zh": "看到棕褐色八边形 P／PROPECIA 就能判真伪吗？", "en": "Does a tan octagonal P/PROPECIA tablet prove authenticity?" }, "answer": { "zh": "不能。外观只能作为核对线索，还需核对市场、NDC、批号、有效期、完整包装、来源渠道和当地监管记录；网页与照片识别都不作真伪结论。", "en": "No. Appearance is only a comparison clue. Market, NDC, lot, expiry, intact packaging, supply source and local regulatory record still require checking; neither this site nor photo recognition authenticates a medicine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/propecia-finasteride/", "en": "https://origindrug.com/en/drugs/propecia-finasteride/" }, "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." ] }