{ "id": "symbicort", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Symbicort", "generic": "布地奈德/福莫特罗", "aliases": [ "budesonide", "formoterol", "formoterol fumarate", "budesonide formoterol" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开处方药历史标签档案", "dosageFormClass": "复方定量吸入气雾剂；80/4.5 与 160/4.5（本档案所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2006（美国公开历史标签所列初始批准）", "archiveSponsorText": "DailyMed（NLM）公开历史标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-symbicort-budesonide-80mcg-formoterol-4-5mcg-120-inhalations-0186037220", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2024-11-20 发布）", "en": "DailyMed SPL v31 (published 20 Nov 2024)" }, "dosageForm": { "zh": "SYMBICORT 布地奈德/富马酸福莫特罗二水合物定量吸入气雾剂", "en": "SYMBICORT budesonide/formoterol fumarate dihydrate metered-dose inhalation aerosol" }, "route": { "zh": "经口吸入（标签产品身份字段）", "en": "oral inhalation (label product-identity field)" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0186-0372-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "每次吸入：布地奈德 80 mcg + 福莫特罗 4.5 mcg；120 次定量吸入", "en": "Per inhalation: budesonide 80 mcg + formoterol 4.5 mcg; 120 metered inhalations" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-17.jpg&setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "布地奈德", "en": "budesonide" }, "value": 80, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第一种标签成分；不是个人吸入次数", "en": "first labelled ingredient in the same inhalation; not an individual's inhalation count" } }, { "ingredient": { "zh": "福莫特罗（按富马酸福莫特罗二水合物计）", "en": "formoterol (as formoterol fumarate dihydrate)" }, "value": 4.5, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第二种标签成分；两个数字不能相加为个人用量", "en": "second labelled ingredient in the same inhalation; the two numbers must not be added as an individual amount" } } ], "concentration": null, "container": { "typeCode": "metered_dose_inhaler", "typeLabel": { "zh": "红色塑料驱动器、白色口含器、灰色防尘盖，带计数器", "en": "red plastic actuator, white mouthpiece, gray dust cap and counter" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "次定量吸入/吸入器", "en": "metered inhalations per inhaler" } }, "physicalClues": { "color": { "zh": "红色驱动器、白色口含器、灰色防尘盖", "en": "red actuator, white mouthpiece and gray dust cap" }, "shape": { "zh": "带剂量计数器的定量吸入器与纸盒", "en": "metered-dose inhaler with counter and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 当前美国公开标签（AstraZeneca；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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-symbicort-budesonide-160mcg-formoterol-4-5mcg-120-inhalations-0186037020", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2024-11-20 发布）", "en": "DailyMed SPL v31 (published 20 Nov 2024)" }, "dosageForm": { "zh": "SYMBICORT 布地奈德/富马酸福莫特罗二水合物定量吸入气雾剂", "en": "SYMBICORT budesonide/formoterol fumarate dihydrate metered-dose inhalation aerosol" }, "route": { "zh": "经口吸入（标签产品身份字段）", "en": "oral inhalation (label product-identity field)" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0186-0370-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "每次吸入：布地奈德 160 mcg + 福莫特罗 4.5 mcg；120 次定量吸入", "en": "Per inhalation: budesonide 160 mcg + formoterol 4.5 mcg; 120 metered inhalations" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-16.jpg&setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "布地奈德", "en": "budesonide" }, "value": 160, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第一种标签成分；不是个人吸入次数", "en": "first labelled ingredient in the same inhalation; not an individual's inhalation count" } }, { "ingredient": { "zh": "福莫特罗（按富马酸福莫特罗二水合物计）", "en": "formoterol (as formoterol fumarate dihydrate)" }, "value": 4.5, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第二种标签成分；两个数字不能相加为个人用量", "en": "second labelled ingredient in the same inhalation; the two numbers must not be added as an individual amount" } } ], "concentration": null, "container": { "typeCode": "metered_dose_inhaler", "typeLabel": { "zh": "红色塑料驱动器、白色口含器、灰色防尘盖，带计数器", "en": "red plastic actuator, white mouthpiece, gray dust cap and counter" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "次定量吸入/吸入器", "en": "metered inhalations per inhaler" } }, "physicalClues": { "color": { "zh": "红色驱动器、白色口含器、灰色防尘盖", "en": "red actuator, white mouthpiece and gray dust cap" }, "shape": { "zh": "带剂量计数器的定量吸入器与纸盒", "en": "metered-dose inhaler with counter and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 当前美国公开标签（AstraZeneca；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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=image-16.jpg&setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "alt": "SYMBICORT 布地奈德/福莫特罗 160/4.5 定量吸入气雾剂在美国 DailyMed AstraZeneca 公开历史标签中的 120 次吸入纸盒图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开历史标签（AstraZeneca，2017-12 修订）", "presentation": "SYMBICORT 160/4.5、120 次吸入定量气雾剂纸盒图（DailyMed 公开历史标签所列；AstraZeneca 文件）。", "notice": "此图仅作公开历史标签的产品身份阅读线索，不用于鉴定真伪、确认当前批准或推断其他强度、包装、市场或个人用法。", "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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": "SYMBICORT 说明书放大阅读：80/4.5 与 160/4.5 是两个成分加一个装置的身份信息", "en": "SYMBICORT label reading: 80/4.5 and 160/4.5 identify two ingredients in one device" }, "summary": { "zh": "本模块以美国 DailyMed 公开历史标签和包装图为阅读入口，帮助核对 SYMBICORT、布地奈德、福莫特罗、每次喷射的双数字、定量吸入包装和经口吸入途径。它不提供任何人的喷数、增量、替换或急性呼吸处理方案。", "en": "This module uses the U.S. DailyMed public historical label and package image to check SYMBICORT, budesonide, formoterol, the two per-actuation numbers, metered-inhalation package and oral-inhalation route. It does not provide an individual's puff count, escalation, substitution or acute-breathing plan." }, "checks": [ { "zh": "先把 SYMBICORT、布地奈德/福莫特罗、准确的 80/4.5 或 160/4.5 标示、每次喷射、包装所示吸入次数和目标市场一起核对。页面中的数字是这一个产品身份字段，不是网页给任何人计算今天应喷几次的答案。", "en": "Check SYMBICORT, budesonide/formoterol, the exact 80/4.5 or 160/4.5 wording, each actuation, stated inhalation count and target market together. These numbers are identity fields for one product, not a web answer to how many times anyone should use it today." }, { "zh": "80/4.5 与 160/4.5 的第一个数字对应复方中的布地奈德标示；不能只比第一个数字，就自行换强度、把两盒拼用，或把另一种吸入药按相似数字换算。", "en": "In 80/4.5 and 160/4.5, the first number is the budesonide marking within the combination. Do not compare only that number to self-change strength, combine packs or convert another inhaler by a similar-looking number." }, { "zh": "这份历史标签将该产品与急性支气管痉挛的即时缓解区分开来。突然或加重的呼吸困难、咳嗽或喘鸣，应按当地紧急医疗和既有照护指引及时处理，而不要据网页自行连续补喷、叠加装置或借用他人产品。", "en": "This historical label distinguishes the product from immediate relief of acute bronchospasm. Sudden or worsening breathing difficulty, cough or wheeze needs timely action through local emergency and existing care guidance, not repeated self-dosing, device stacking or borrowing another person's product from a webpage." }, { "zh": "现有吸入药、其他哮喘或过敏药、β 受体阻滞剂、利尿剂、部分抗抑郁药以及全部非处方产品和补充剂，都应与实际装置和完整药单一起交由药师或医生核对。不要因为含有其中一个成分而自行加用、拆分或更换复方产品。", "en": "Existing inhalers, other asthma or allergy medicines, beta blockers, diuretics, some antidepressants, OTC products and supplements should be reviewed with the actual device and complete medicine list by a pharmacist or clinician. Do not add, split or change a combination product yourself because it shares one ingredient." } ], "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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": "布地奈德/福莫特罗怎样起作用：标签描述一个抗炎皮质激素成分与一个长效 β2 受体激动剂成分", "en": "How budesonide/formoterol works: the label describes an anti-inflammatory corticosteroid ingredient and a long-acting beta2-agonist ingredient" }, "summary": { "zh": "DailyMed 历史标签将布地奈德描述为糖皮质激素成分，将福莫特罗描述为长效 β2 肾上腺素能受体激动剂成分。它们的机制文字用于理解复方的两条作用路径；不用于判断个人症状原因、急性风险、吸入技术、喷数、联用或是否应更换产品。", "en": "The DailyMed historical label describes budesonide as a glucocorticosteroid ingredient and formoterol as a long-acting beta2-adrenergic agonist ingredient. The mechanism text helps explain two action pathways in a combination; it does not determine the cause of an individual's symptoms, acute risk, inhaler technique, puff count, combination or switching." }, "checks": [ { "zh": "“抗炎”“长效 β2 激动剂”是标签的机制语言，不会把任何咳嗽、胸闷、喘鸣或心悸自动归入同一种疾病，也不能替代诊断。", "en": "“Anti-inflammatory” and “long-acting beta2 agonist” are label mechanism terms. They do not attribute every cough, chest symptom, wheeze or palpitation to one disease and cannot replace diagnosis." }, { "zh": "“长效”不表示该产品可作为急性症状的网页自助方案，也不表示它与 VENTOLIN HFA 或任何其他吸入产品可凭机制名称、颜色或喷数互换。", "en": "“Long-acting” does not turn the product into a web-guided plan for acute symptoms, nor establish interchangeability with VENTOLIN HFA or another inhaler from a mechanism name, colour or puff count." }, { "zh": "复方机制也不支持把布地奈德、福莫特罗或其他吸入产品自行另加、拆分、轮换或改变强度。出现呼吸急剧加重、面部或口腔肿胀、晕厥、明显心悸或其他急性严重不适时，应优先使用当地紧急医疗支持。", "en": "Combination mechanism does not support self-adding, separating, alternating or changing the strength of budesonide, formoterol or another inhaled product. With rapidly worsening breathing, face or mouth swelling, fainting, marked palpitations or another acute serious concern, prioritise local emergency care." } ], "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗公开历史标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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": "Symbicort", "generic": "布地奈德/福莫特罗", "dosageFormClass": "复方定量吸入气雾剂；80/4.5 与 160/4.5（本档案所列）" }, "labelSource": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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": "DailyMed 的 SYMBICORT（budesonide/formoterol fumarate）美国公开历史标签列示为经口吸入的复方定量气雾剂；标签包含 80/4.5 与 160/4.5 两种每次喷射标示，以及 60 次或 120 次定量吸入包装。页面帮助读者把双成分、成分各自的数字、装置、包装次数和目标市场一起核对；不据此生成个人喷数、加量、急性症状处理或换药方案。", "history": "“80/4.5”“160/4.5”不是一个可单独比较或自行换算的总量数字，而是同一复方装置中两个成分的每次喷射标示。另一种强度、另一种吸入器、另一个市场或另一份标签都需要重新逐项核对，不能凭品牌、颜色、相似数字或共同成分推定可以互换。", "sourceDocuments": [ { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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 021929", "approvalTimeline": [ { "date": "2006", "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: 2006。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: 2006. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed: SYMBICORT public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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": "2017-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2017-12 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 2017-12 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_7ed5285b16c9aa47", "label": "DailyMed: SYMBICORT public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "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/symbicort/", "en": "https://origindrug.com/en/drugs/symbicort/" }, "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." ] }