{ "id": "advair-diskus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "ADVAIR DISKUS", "generic": "丙酸氟替卡松/沙美特罗", "aliases": [ "fluticasone propionate/salmeterol", "氟替卡松/沙美特罗", "fluticasone propionate", "salmeterol", "salmeterol xinafoate" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "舒利迭®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_feba1443d106a6bf", "label": "GSK 中国产品列表：Seretide／舒利迭（沙美特罗替卡松）", "url": "https://www.gsk-china.com/zh-cn/products/product-list/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "干粉吸入器（DISKUS）；双成分预装泡罩", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2000", "archiveSponsorText": "GlaxoSmithKline LLC（美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ADVAIR HFA", "fluticasone propionate salmeterol aerosol", "fluticasone propionate/salmeterol aerosol" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-advair-diskus-100-50-60-blister-ndc-0173-0695-00", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2026-03-30 发布；2026-03 修订）", "en": "DailyMed SPL v32 (published 30 Mar 2026; revised Mar 2026)" }, "dosageForm": { "zh": "ADVAIR DISKUS 双成分干粉吸入器", "en": "ADVAIR DISKUS two-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0695-00", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "100/50 mcg／标签每次吸入；1 个 DISKUS 吸入器（60 个泡罩）", "en": "100/50 mcg per labelled inhalation; one DISKUS inhaler (60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-16.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "丙酸氟替卡松", "en": "fluticasone propionate" }, "value": 100, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "沙美特罗", "en": "salmeterol" }, "value": 50, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "DISKUS 干粉吸入器", "en": "DISKUS dry-powder inhaler" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "泡罩/吸入器", "en": "blisters per inhaler" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "diskus_dry_powder_inhaler", "name": { "zh": "DISKUS 吸入器", "en": "DISKUS inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器/纸盒（60 个泡罩）", "en": "inhaler per carton (60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 当前美国公开标签（GSK；SPL v32，2026-03-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-advair-diskus-250-50-60-blister-ndc-0173-0696-00", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2026-03-30 发布；2026-03 修订）", "en": "DailyMed SPL v32 (published 30 Mar 2026; revised Mar 2026)" }, "dosageForm": { "zh": "ADVAIR DISKUS 双成分干粉吸入器", "en": "ADVAIR DISKUS two-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0696-00", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "250/50 mcg／标签每次吸入；1 个 DISKUS 吸入器（60 个泡罩）", "en": "250/50 mcg per labelled inhalation; one DISKUS inhaler (60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-17.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "丙酸氟替卡松", "en": "fluticasone propionate" }, "value": 250, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "沙美特罗", "en": "salmeterol" }, "value": 50, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "DISKUS 干粉吸入器", "en": "DISKUS dry-powder inhaler" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "泡罩/吸入器", "en": "blisters per inhaler" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "diskus_dry_powder_inhaler", "name": { "zh": "DISKUS 吸入器", "en": "DISKUS inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器/纸盒（60 个泡罩）", "en": "inhaler per carton (60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 当前美国公开标签（GSK；SPL v32，2026-03-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-advair-diskus-500-50-60-blister-ndc-0173-0697-00", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2026-03-30 发布；2026-03 修订）", "en": "DailyMed SPL v32 (published 30 Mar 2026; revised Mar 2026)" }, "dosageForm": { "zh": "ADVAIR DISKUS 双成分干粉吸入器", "en": "ADVAIR DISKUS two-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0697-00", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "500/50 mcg／标签每次吸入；1 个 DISKUS 吸入器（60 个泡罩）", "en": "500/50 mcg per labelled inhalation; one DISKUS inhaler (60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-18.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "丙酸氟替卡松", "en": "fluticasone propionate" }, "value": 500, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "沙美特罗", "en": "salmeterol" }, "value": 50, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "DISKUS 干粉吸入器", "en": "DISKUS dry-powder inhaler" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "泡罩/吸入器", "en": "blisters per inhaler" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "diskus_dry_powder_inhaler", "name": { "zh": "DISKUS 吸入器", "en": "DISKUS inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器/纸盒（60 个泡罩）", "en": "inhaler per carton (60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 当前美国公开标签（GSK；SPL v32，2026-03-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-16.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "alt": "ADVAIR DISKUS 丙酸氟替卡松/沙美特罗在美国 DailyMed GSK 公开标签中的 100/50、60 泡罩吸入装置包装图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（GlaxoSmithKline，2026-03 更新）", "presentation": "ADVAIR DISKUS 丙酸氟替卡松/沙美特罗吸入粉剂：100/50、60 泡罩 DISKUS 装置包装图（DailyMed GSK 公开标签所列）。", "notice": "此为美国 DailyMed GSK 公开标签中明确对应 ADVAIR DISKUS、100/50、60 泡罩吸入装置的包装图，只帮助核对品牌、两个成分、标示量、装置、泡罩数量和来源；不用于鉴定真伪，也不证明其他强度、其他装置、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GlaxoSmithKline，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ADVAIR DISKUS 说明书放大阅读：双成分数字与吸入装置必须一起看", "en": "ADVAIR DISKUS label reading: read the two ingredient numbers together with the inhaler device" }, "summary": { "zh": "本模块以美国 DailyMed 2026-03 公开标签为阅读入口，帮助核对 ADVAIR DISKUS、丙酸氟替卡松、沙美特罗、双成分标示、干粉吸入装置和经口吸入途径。它不将包装信息变成个人的吸入次数、加量、替代或急性呼吸处理规则。", "en": "This module uses the March 2026 U.S. DailyMed label as a reading entry point. It helps check ADVAIR DISKUS, fluticasone propionate, salmeterol, the two-ingredient marking, dry-powder inhaler device and oral-inhalation route. It does not turn package information into an individual's inhalation count, escalation, substitution or acute-breathing rule." }, "checks": [ { "zh": "先把商品名、两个成分、每次吸入的完整双数字、DISKUS 干粉装置和目标市场一起核对。不要只看其中一个数字，或把包装标示理解为网页给任何人计算的每日吸入次数。", "en": "Check the brand, both ingredients, the complete two-number marking per inhalation, the DISKUS dry-powder device and target market together. Do not read only one number or treat a package marking as a web-calculated daily inhalation count." }, { "zh": "这份标签把 ADVAIR DISKUS 描述为经口吸入粉剂。名称相似、共同含有一个成分，或都是吸入药，并不能证明另一种气雾剂、雾化液、胶囊吸入剂或不同装置可以自行替换。", "en": "This label describes ADVAIR DISKUS as an oral-inhalation powder. A similar name, one shared ingredient or the fact that both are inhalers does not establish that another aerosol, nebulised solution, inhalation capsule or device can be self-substituted." }, { "zh": "标签把维持治疗与突发气道痉挛的即时缓解区分开来。突发或加重的呼吸困难、咳嗽或喘鸣，应按当地紧急医疗服务和已有照护计划及时处理，而不是根据网页自行连续补吸、叠加装置或借用他人药品。", "en": "The label distinguishes maintenance treatment from immediate relief of acute bronchospasm. Sudden or worsening breathing difficulty, cough or wheeze needs timely action through local emergency services and an existing care plan, not repeated self-use, device stacking or borrowing another person's medicine from a webpage." }, { "zh": "所有正在使用的吸入药、处方药、非处方药、补充剂和草本都应随实际装置一起交给药师或医生核对。复方中的一个成分相同，不表示两种产品可以自行叠加、交替或替换。", "en": "All current inhalers, prescription medicines, OTC products, supplements and herbs should be reviewed with the actual device by a pharmacist or clinician. Sharing one ingredient in a combination product does not mean two products can be self-combined, alternated or substituted." } ], "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "丙酸氟替卡松/沙美特罗怎样起作用：标签描述两个不同类别成分的组合", "en": "How fluticasone propionate/salmeterol works: the label describes a combination of two medicine classes" }, "summary": { "zh": "这份公开标签将该产品描述为含皮质激素成分与长效 β2 受体激动剂成分的复方。机制只解释成分角色，不决定某个人应使用哪种装置、何时使用、是否能合用或是否适合转换。", "en": "The public label describes this as a combination of a corticosteroid ingredient and a long-acting beta2-agonist ingredient. Mechanism explains ingredient roles; it does not decide which device a person should use, when to use it, whether products can be combined or whether a switch is suitable." }, "checks": [ { "zh": "复方含有两个作用路径，不等于可以把任一成分单独拆出来与另一装置的相似成分相加。机制名称和共同成分都不是自行合并或替换的依据。", "en": "A combination has two action pathways; that does not permit separating one ingredient and adding it to a similar ingredient in another device. Mechanism names and shared ingredients are not a basis for self-combination or substitution." }, { "zh": "标签对含长效 β2 受体激动剂的联用另列使用边界。任何新增吸入器、心血管药、利尿剂、抗抑郁药或补充剂，均应连同准确产品和完整药单交由专业人员复核。", "en": "The label separately sets boundaries for co-use involving long-acting beta2-agonists. Any new inhaler, cardiovascular medicine, diuretic, antidepressant or supplement needs review of the exact product and complete medicine list by a professional." }, { "zh": "理解“一个抗炎成分加一个支气管舒张成分”有助于读标签，但不能把机制写成个人疗效承诺、急性症状处理方案或产品之间的等量换算公式。", "en": "Understanding “an anti-inflammatory ingredient plus a bronchodilator ingredient” can help read a label, but does not turn mechanism into a personal efficacy promise, an acute-symptom plan or an equal-conversion formula between products." } ], "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新；临床药理/相互作用）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ADVAIR DISKUS", "generic": "丙酸氟替卡松/沙美特罗", "dosageFormClass": "干粉吸入器（DISKUS）；双成分预装泡罩" }, "labelSource": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "2026-08-20", "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": "美国 DailyMed 2026-03 标签将 ADVAIR DISKUS 列为经口吸入的丙酸氟替卡松/沙美特罗复方干粉吸入器，初始美国批准年份为 2000。此页只帮助把两个成分、每次吸入的双数字、DISKUS 装置和目标市场标签放在一起阅读；不提供个人吸入次数、急性症状处理、换药或联用方案。", "history": "同一品牌、相似的双数字、相同的一个成分或一张包装照片，都不足以证明可与另一种吸入器、另一强度或另一市场产品互换。该档案的官方来源明确将产品呈现为经口吸入粉剂，并分别展示 100/50、250/50、500/50 三个 60 泡罩 DISKUS 包装面板。", "sourceDocuments": [ { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "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 021077", "approvalTimeline": [ { "date": "2000", "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: 2000。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: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed: ADVAIR DISKUS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03 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 2026-03 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_c264f3fb8b6629af", "label": "DailyMed: ADVAIR DISKUS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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/advair-diskus/", "en": "https://origindrug.com/en/drugs/advair-diskus/" }, "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." ] }