{ "id": "yaz", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "YAZ", "generic": "屈螺酮/炔雌醇", "aliases": [ "YAZ", "Yaz", "drospirenone", "ethinyl estradiol", "屈螺酮", "炔雌醇", "屈螺酮炔雌醇片", "NDA 021676", "50419-405-03", "DS", "DP", "drospirenone and ethinyl estradiol", "NDC 50419-405-03" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "生殖健康", "sourceArchiveMarket": "美国当前公开标签与 FDA 产品记录：YAZ 3 mg/0.02 mg 复方口服片，24 片活性片＋4 片无活性片，每外包装 3 板；不外推其他市场批准、包装、供应或商品名", "dosageFormClass": "YAZ 屈螺酮/炔雌醇组合包装：每板 24 片浅粉色活性薄膜衣片＋4 片白色无活性薄膜衣片；每外包装 3 板", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2006-03-16（FDA Drugs@FDA 所列 NDA 021676 原始批准日期）", "archiveSponsorText": "Bayer HealthCare Pharmaceuticals Inc. / FDA 与 DailyMed 当前公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "YASMIN", "BEYAZ", "SAFYRAL", "SLYND", "NEXTSTELLIS", "drospirenone-only tablets", "屈螺酮单方", "其他 21+7 或 24+4 复方避孕片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-yaz-drospirenone-3mg-ethinyl-estradiol-0-02mg-24-active-4-inert-three-blister-packs-ndc-5041940503", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-05-29 更新；SPL v21）", "en": "Current U.S. DailyMed public label (updated 29 May 2025; SPL v21)" }, "dosageForm": { "zh": "YAZ 屈螺酮/炔雌醇薄膜衣口服片组合包装", "en": "YAZ drospirenone/ethinyl estradiol film-coated oral-tablet kit" }, "route": { "zh": "口服（组合包装身份字段）", "en": "oral (kit product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-405-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_active_tablet", "primaryDisplay": { "zh": "每板 24 片浅粉色活性片（每片屈螺酮 3 mg / 炔雌醇 0.02 mg）＋4 片白色无活性片；每外包装 3 板", "en": "Each blister has 24 light-pink active tablets (drospirenone 3 mg / ethinyl estradiol 0.02 mg per tablet) plus 4 white inert tablets; three blisters per outer pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0ed216ab-0c5e-4e77-8170-114a2c530ae7-06.jpg&setid=065f33e4-b587-4e66-b896-ca9ab7b7c876&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "屈螺酮", "en": "drospirenone" }, "value": 3, "unit": "mg", "basisCode": "per_active_tablet", "basisLabel": { "zh": "每片浅粉色活性片的第一种成分；不能与 0.02 mg 相加，也不是个人应服片数", "en": "first ingredient per light-pink active tablet; not to be added to 0.02 mg and not an individual tablet count" } }, { "ingredient": { "zh": "炔雌醇", "en": "ethinyl estradiol" }, "value": 0.02, "unit": "mg", "basisCode": "per_active_tablet", "basisLabel": { "zh": "每片浅粉色活性片的第二种成分；白色无活性片不含这两种激素", "en": "second ingredient per light-pink active tablet; the white inert tablets do not contain these two hormones" } } ], "concentration": null, "container": { "typeCode": "three_blister_pack_kit", "typeLabel": { "zh": "三板组合外包装", "en": "three-blister outer pack" }, "fill": null, "countPerPackage": 3, "countUnit": { "zh": "板/外包装；每板 28 片", "en": "blisters per outer pack; 28 tablets per blister" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 3, "unit": { "zh": "板/外包装", "en": "blisters per outer pack" } }, "physicalClues": { "color": { "zh": "浅粉色活性片与白色无活性片", "en": "light-pink active and white inert tablets" }, "shape": { "zh": "圆形、无刻痕薄膜衣片", "en": "round, unscored film-coated tablets" }, "imprint": { "zh": "活性片 DS；无活性片 DP（均位于正六边形内）", "en": "DS on active tablets; DP on inert tablets (each within a regular hexagon)" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签与三板组合包装（SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-yaz-drospirenone-3mg-ethinyl-estradiol-0-02mg-24-active-4-inert-three-blister-packs-ndc-5041940503", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0ed216ab-0c5e-4e77-8170-114a2c530ae7-06.jpg&setid=065f33e4-b587-4e66-b896-ca9ab7b7c876&type=img", "alt": "YAZ 屈螺酮/炔雌醇 NDC 50419-405-03 三板组合包装在 DailyMed 当前美国标签中的展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-05-29 更新；SPL v21）", "presentation": "YAZ 每板 24 片浅粉色活性片＋4 片白色无活性片、每外包装 3 板、NDC 50419-405-03 展示面", "notice": "此图只帮助核对所引美国标签中的 YAZ、两种成分、24+4 片结构、三板外包装和 NDC；不用于鉴定真伪，也不证明其他市场品牌、批准、供应、可售资格、可替代性或任何个人使用方案。", "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签与包装图（SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "YAZ 说明书放大阅读：先分清两种成分、活性片与无活性片", "en": "YAZ label reading: first separate the two ingredients and active versus inert tablets" }, "summary": { "zh": "这一标签最容易读错的不是一个数字，而是数字所属层级：每片两种成分、每板 24+4 片、每盒三板。网页帮助逐层核对，但不生成个人开始、漏服、补服、停用、换药或避孕方案。", "en": "The main reading risk is not one number but the layer it belongs to: two ingredients per active tablet, 24+4 tablets per blister and three blisters per box. The page helps separate those layers but does not generate an individual start, missed-use, make-up, stopping, switching or contraceptive plan." }, "checks": [ { "zh": "每片浅粉色活性片含屈螺酮 3 mg 和炔雌醇 0.02 mg；白色片是无活性片。3 与 0.02 不能相加成一个可比较强度，24、4、28 与三板也不是个人应服片数。", "en": "Each light-pink active tablet contains drospirenone 3 mg and ethinyl estradiol 0.02 mg; the white tablets are inert. The 3 and 0.02 figures are not added into one comparable strength, and 24, 4, 28 and three blisters are not an individual's tablet count." }, { "zh": "标签黑框警告指出，35 岁以上吸烟者不应使用 YAZ，吸烟会增加复方口服避孕药相关严重心血管事件风险。胸痛、呼吸困难、单侧腿部肿痛、突发神经症状或其他急性严重表现应立即使用当地急救渠道，而不是等待网页判断。", "en": "The boxed warning states that women over 35 who smoke should not use YAZ and that smoking increases serious cardiovascular-event risk with combined oral contraceptives. Chest pain, breathing difficulty, one-sided leg swelling or pain, sudden neurologic symptoms or another acute serious concern requires immediate local emergency help, not a web decision." }, { "zh": "屈螺酮具有抗盐皮质激素活性；肾上腺、肾脏或肝脏问题，以及补钾、保钾利尿剂、螺内酯、ACEI、ARB、醛固酮拮抗剂、肝素或长期每日 NSAID 等同在药单时，要优先核对血钾和完整药单。网页不生成停药或错开方案。", "en": "Drospirenone has antimineralocorticoid activity. Adrenal, kidney or liver problems, or co-listing potassium, potassium-sparing diuretics, spironolactone, an ACE inhibitor, ARB, aldosterone antagonist, heparin or long-term daily NSAID use requires priority review of potassium and the complete medicine list. The page does not create a stop or separation plan." }, { "zh": "YASMIN、BEYAZ、SAFYRAL、SLYND 和其他 21+7 或 24+4 产品可能成分、雌激素、叶酸、活性片数或标签不同；不能按商品名、颜色、片数或共同的屈螺酮自行替换、拼接或轮换。", "en": "YASMIN, BEYAZ, SAFYRAL, SLYND and other 21+7 or 24+4 products can differ in ingredients, oestrogen, folate, active-tablet count or label. Brand, colour, tablet count or shared drospirenone does not permit self-substitution, assembly or alternation." } ], "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签——黑框警告、包装、禁忌、血钾与相互作用", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：抑制排卵是主要机制，不等于可自行选用或替换", "en": "Mechanism reading: ovulation suppression is primary, not permission to self-select or switch" }, "summary": { "zh": "当前标签把复方口服避孕药的主要作用描述为抑制排卵，并说明宫颈黏液和子宫内膜变化也可能参与。屈螺酮还具有抗盐皮质激素和抗雄激素活性。机制只解释药理路径，不判断个人适用性、血栓风险、是否需要化验或应选哪一款。", "en": "The current label describes suppression of ovulation as the primary action of combined oral contraceptives, with cervical-mucus and endometrial changes also possibly contributing. Drospirenone also has antimineralocorticoid and antiandrogenic activity. Mechanism explains pharmacology; it does not decide individual suitability, clot risk, testing needs or product choice." }, "checks": [ { "zh": "“都能抑制排卵”不能把不同复方避孕药变成可一比一替换产品；激素种类、每片含量、活性/无活性片结构、相互作用与目标市场标签都要逐项核对。", "en": "‘Both suppress ovulation’ does not make different combined contraceptives one-for-one substitutes. Hormone identities, per-tablet amounts, active/inert structure, interactions and the target-market label all require separate review." }, { "zh": "抗盐皮质激素活性解释了为什么血钾与相关联用药需要关注，但不能从机制推算个人是否安全、需要何种化验或如何调整其他药。", "en": "Antimineralocorticoid activity explains why potassium and related co-medications need attention, but mechanism cannot calculate individual safety, testing or adjustment of another medicine." }, { "zh": "本页不把机制扩展为常规全基因筛查建议。是否适用要结合吸烟、年龄、偏头痛、血栓史、肝肾与肾上腺情况、完整药单和现行标签，由负责团队判断。", "en": "This page does not extend mechanism into routine whole-genome screening advice. Suitability requires smoking status, age, migraine, clot history, hepatic, renal and adrenal status, the complete medicine list and current label, assessed by the responsible team." } ], "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签——临床药理与作用机制", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "YAZ", "generic": "屈螺酮/炔雌醇", "dosageFormClass": "YAZ 屈螺酮/炔雌醇组合包装：每板 24 片浅粉色活性薄膜衣片＋4 片白色无活性薄膜衣片；每外包装 3 板" }, "labelSource": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签（2025-05-29 更新；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签（2025-05-29 更新；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "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": "2026-09-04", "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_11400c4c99f4c228", "label": "FDA Drugs@FDA：YAZ NDA 021676 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021676", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "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": "2026-09-04", "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": "YAZ 是屈螺酮/炔雌醇复方口服片的美国品牌监管档案。每板含 24 片浅粉色活性片，每片分别含屈螺酮 3 mg 和炔雌醇 0.02 mg，另有 4 片白色无活性片；每个 NDC 50419-405-03 外包装含三板。两个 mg 数字属于同一片中的两种成分，24、4、28 和 3 属于不同包装层级，不能相加或改写为个人应服片数、漏服处理、换药或避孕方案。", "history": "FDA Drugs@FDA 记录 NDA 021676 于 2006-03-16 原始批准，并把当前 3 mg/0.02 mg 口服片列为 RLD 与 RS。DailyMed 当前公开标签（2025-05-29 更新，SPL v21）由 Bayer 发布，列示 NDC 50419-405-03、三板包装、24 片活性片和 4 片无活性片。标签同时写有 Initial U.S. Approval: 2001，这是复方所依托产品历史表述，不能替代 NDA 021676 的原始批准日期。YASMIN、BEYAZ、SAFYRAL、SLYND 及其他市场产品均不能并入这一准确包装。", "sourceDocuments": [ { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签（2025-05-29 更新；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_11400c4c99f4c228", "label": "FDA Drugs@FDA：YAZ NDA 021676 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021676", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_862034bf7cd36bc3", "label": "FDA：YAZ NDA 021676 原始批准函（2006-03-16）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021676s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 021676（YAZ；drospirenone/ethinyl estradiol tablets）", "approvalTimeline": [ { "date": "2006-03-16", "title": { "zh": "FDA 原始批准 YAZ NDA 021676", "en": "FDA original approval of YAZ NDA 021676" }, "detail": { "zh": "Drugs@FDA 的申请历史把该日期列为 ORIG-1 Approval；这是美国监管历史节点，不是其他市场批准、供应或个人适用性结论。", "en": "The Drugs@FDA application history lists this date as the ORIG-1 approval. It is a U.S. regulatory-history point, not another market's approval, supply or individual-suitability conclusion." }, "source": { "id": "src_11400c4c99f4c228", "label": "FDA Drugs@FDA：YAZ NDA 021676 产品与申请历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021676", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-05-29", "title": { "zh": "当前 DailyMed SPL v21 更新", "en": "Current DailyMed SPL v21 updated" }, "detail": { "zh": "本页的准确 NDC、三板包装、活性/无活性片、外观、黑框警告和相互作用阅读均以该公开标签为主要来源；标签更新日期不等于渠道库存。", "en": "The exact NDC, three-blister pack, active/inert tablet distinction, appearance, boxed warning and interaction reading use this public label as the primary source. A label-update date is not channel stock." }, "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签（SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NDA 021676 当前产品记录与公开标签已建立", "en": "Current product record and public label established under NDA 021676" }, "detail": { "zh": "3 mg/0.02 mg 口服片在 Drugs@FDA 当前表中为处方 RLD 与 RS；本页只记录准确公开标签和包装身份，不声称实时供应或购买资格。", "en": "The 3 mg/0.02 mg oral tablet is currently listed by Drugs@FDA as a prescription RLD and RS. This page records the exact public label and pack identity, not real-time supply or purchase eligibility." } }, { "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": "现行品牌、批准、包装和参比关系待逐市场核验", "en": "Current brand, approval, pack and reference status not yet established market by market" }, "detail": { "zh": "不从美国 YAZ 商品名、NDA、RLD/RS、NDC、24+4 结构或颜色推定当地产品身份、批准、供应、可售资格或可替代性。", "en": "No local product identity, approval, supply, sale eligibility or interchangeability is inferred from the U.S. YAZ name, NDA, RLD/RS status, NDC, 24+4 structure or colours." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "3 mg、0.02 mg、24、4、28 和 3 分别是什么意思？", "en": "What do 3 mg, 0.02 mg, 24, 4, 28 and 3 each mean?" }, "answer": { "zh": "3 mg 与 0.02 mg 是每片浅粉色活性片中两种不同成分的标示量；每板有 24 片活性片和 4 片白色无活性片，共 28 片；外包装有 3 板。这些数字不能相加，也不能单独回答某个人怎么吃。", "en": "3 mg and 0.02 mg are the labelled amounts of two different ingredients in each light-pink active tablet. Each blister has 24 active and 4 white inert tablets, 28 total, and the outer pack has three blisters. These numbers are not added and do not by themselves answer how an individual should use the product." } }, { "question": { "zh": "漏了一片或拿错颜色，网页能直接告诉我补几片吗？", "en": "Can the page tell me how many to make up after a missed or wrong-colour tablet?" }, "answer": { "zh": "不能。活性片与无活性片、漏了几片、处于哪一段、是否呕吐腹泻及其他用药都会改变需要核对的标签路径。请立即查手中准确包装的患者说明并联系药师或开方团队；不要按网上通用表自行补服。", "en": "No. Active versus inert tablet, how many were missed, cycle position, vomiting or diarrhoea and other medicines change which exact-label path applies. Check the patient information for the pack in hand and contact a pharmacist or prescribing team promptly; do not self-make-up from a generic online chart." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/yaz/", "en": "https://origindrug.com/en/drugs/yaz/" }, "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." ] }