{ "id": "ventolin-hfa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Ventolin HFA", "generic": "沙丁胺醇", "aliases": [ "albuterol", "albuterol sulfate", "salbutamol" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开处方药标签档案", "dosageFormClass": "定量吸入气雾剂；带计数器的吸入器（本档案所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "1981（美国公开标签所列初始批准）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ventolin-hfa-albuterol-90mcg-actuation-200-inhalation-ndc-0173-0682-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-04-26 更新）", "en": "Current U.S. DailyMed public label (updated 26 Apr 2024)" }, "dosageForm": { "zh": "VENTOLIN HFA 沙丁胺醇定量吸入气雾剂", "en": "VENTOLIN HFA albuterol 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 0173-0682-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_actuation_from_mouthpiece", "primaryDisplay": { "zh": "每次从口含器喷出相当于沙丁胺醇碱 90 mcg（硫酸沙丁胺醇 108 mcg）；蓝色带计数器吸入器；200 次定量吸入，18 g", "en": "Each actuation from the mouthpiece delivers 90 mcg albuterol base (equivalent to 108 mcg albuterol sulfate); blue inhaler with counter; 200 metered inhalations, 18 g" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ventolinhfa-spl-graphic-15.jpg&setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙丁胺醇碱（每次从口含器喷出）", "en": "albuterol base (per actuation from mouthpiece)" }, "value": 90, "unit": "mcg", "basisCode": "per_actuation_from_mouthpiece", "basisLabel": { "zh": "每次定量喷射的标签标示量；不是个人吸入次数", "en": "labelled amount per metered actuation; not an individual inhalation count" } }, { "ingredient": { "zh": "硫酸沙丁胺醇（等量盐形式）", "en": "albuterol sulfate (equivalent salt form)" }, "value": 108, "unit": "mcg", "basisCode": "per_actuation_from_mouthpiece", "basisLabel": { "zh": "与 90 mcg 沙丁胺醇碱为同一次喷射的等量口径，不能相加", "en": "equivalent to 90 mcg albuterol base in the same actuation; do not add the values" } } ], "concentration": null, "container": { "typeCode": "metered_dose_inhaler", "typeLabel": { "zh": "蓝色带计数器定量吸入器", "en": "blue metered-dose inhaler with counter" }, "fill": { "value": 18, "unit": "g" }, "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": 200, "unit": { "zh": "次定量吸入/吸入器", "en": "metered inhalations per inhaler" } }, "physicalClues": { "color": { "zh": "蓝色吸入器与蓝色防尘盖", "en": "blue inhaler with blue cap" }, "shape": { "zh": "带剂量计数器的定量吸入器", "en": "metered-dose inhaler with dose counter" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂当前美国公开标签（2024-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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=ventolinhfa-spl-graphic-15.jpg&setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "alt": "VENTOLIN HFA 沙丁胺醇定量吸入气雾剂在美国 DailyMed 公开标签中的 200 次定量吸入包装文字图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（GSK；2024-04 版本）", "presentation": "VENTOLIN HFA / 沙丁胺醇，90 mcg 每次喷射、200 次定量吸入包装文字图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 VENTOLIN HFA / 沙丁胺醇、每次喷射 90 mcg、200 次定量吸入的包装文字图，只帮助核对品牌、通用名、标示量、计数器、经口吸入途径和来源；不用于鉴定真伪，也不证明其他喷数、其他装置、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 200 次定量吸入包装文字图（GSK 公开标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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": "VENTOLIN HFA 说明书放大阅读：每喷 mcg、计数器和吸入器部件要一起看", "en": "VENTOLIN HFA label reading: read micrograms, counter and inhaler parts together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签和包装图为阅读入口，帮助区分 VENTOLIN HFA、沙丁胺醇、每次喷射的标示量、计数器和经口吸入途径。它不提供任何人的喷数、补喷、加量、换药或急性呼吸处理方案。", "en": "This module uses the U.S. DailyMed public label and package image to distinguish VENTOLIN HFA, albuterol, stated amount per actuation, the counter and oral-inhalation route. It does not provide an individual's puff count, extra-dose, escalation, switching or acute-breathing plan." }, "checks": [ { "zh": "先把 VENTOLIN HFA、沙丁胺醇、经口吸入、每次喷射标示量、包装所示计数器和目标市场一起核对。90 mcg 是这一个产品每次喷射的标示身份信息，不是网页给任何人计算今天应喷几次的答案。", "en": "Check VENTOLIN HFA, albuterol, oral inhalation, the stated amount per actuation, the package counter and target market together. The 90 mcg wording identifies one actuation of this product; it is not a web answer to how many times anyone should use it today." }, { "zh": "该标签提示此金属罐只应与 VENTOLIN HFA 执行器配合，执行器也不应与另一种吸入器的药罐混用。外观相近、同为蓝色或都写沙丁胺醇，不能证明部件可互换。", "en": "The label says this metal canister is to be used only with the VENTOLIN HFA actuator, and that actuator is not to be used with another inhaler's canister. Similar appearance, a blue colour or shared albuterol wording does not prove components are interchangeable." }, { "zh": "该标签将突然或加重的呼吸困难、咳嗽或喘鸣列为需及时医疗评估的问题；如果原本的产品不再缓解症状或需要比平时更频繁使用，应按当地医疗渠道及时寻求帮助，而不要从网页自行加量或借用他人吸入器。", "en": "The label identifies sudden or worsening breathing difficulty, cough or wheeze as reasons for prompt medical assessment. If the usual product no longer helps or is needed more often than usual, seek timely help through local care channels rather than self-escalating from a webpage or borrowing another person's inhaler." }, { "zh": "吸入药、哮喘药、β 受体阻滞剂、利尿剂、地高辛、部分抗抑郁药以及全部非处方产品和补充剂都可能影响需要核对的事项。开始、停用、联用或更换任何吸入产品前，应带完整药单与实际装置请药师或医生逐项确认。", "en": "Other inhaled or asthma medicines, beta blockers, diuretics, digoxin, some antidepressants, OTC products and supplements can all affect what requires review. Before starting, stopping, combining or changing an inhaled product, ask a pharmacist or clinician to check the complete medicine list and actual device." } ], "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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": "沙丁胺醇怎样起作用：标签描述其优先作用于气道平滑肌的 β2 肾上腺素能受体", "en": "How albuterol works: the label describes preferential action at beta2-adrenergic receptors in airway smooth muscle" }, "summary": { "zh": "DailyMed 标签描述沙丁胺醇优先作用于 β2 肾上腺素能受体；气道平滑肌受体被激活后涉及 cAMP 信号并导致平滑肌松弛。这个机制解释一条作用路径，但不能判断个人喘鸣原因、急性风险、吸入技术、喷数、联用或是否应更换产品。", "en": "The DailyMed label describes albuterol as acting preferentially at beta2-adrenergic receptors; activation in airway smooth muscle involves cAMP signalling and relaxation. This explains an action pathway, not the cause of an individual's wheeze, acute risk, inhaler technique, puff count, combination or a need to change product." }, "checks": [ { "zh": "“β2 受体”“气道放松”是标签的机制语言，不是把任何胸闷、咳嗽、气短或心悸自动归为同一疾病，也不替代诊断。", "en": "“Beta2 receptor” and “airway relaxation” are label mechanism terms. They do not attribute every chest symptom, cough, shortness of breath or palpitation to one disease and cannot replace diagnosis." }, { "zh": "标签也提示 β2 受体相关作用可能伴随心率、血压或其他心血管影响；机制名称不能用于自行判断个人能否加用、加量、与其他吸入药同服或换用另一种产品。", "en": "The label also notes that beta2-receptor-related action may be accompanied by pulse, blood-pressure or other cardiovascular effects. A mechanism name cannot decide whether an individual may add, increase, combine with another inhaler or change product." }, { "zh": "如果出现突然加重的呼吸问题、面部/口腔肿胀、晕厥、明显心悸或其他急性严重不适，应优先使用当地紧急医疗支持，而不是继续试验不同药物或装置。", "en": "With suddenly worsening breathing, swelling of the face or mouth, fainting, marked palpitations or another acute serious concern, prioritise local emergency care rather than experimenting with different medicines or devices." } ], "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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": "Ventolin HFA", "generic": "沙丁胺醇", "dosageFormClass": "定量吸入气雾剂；带计数器的吸入器（本档案所列）" }, "labelSource": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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 VENTOLIN HFA（albuterol sulfate）美国公开标签列示为经口吸入的定量气雾剂；主展示图标示每次喷射 90 mcg 沙丁胺醇（按沙丁胺醇碱计）与 200 次定量吸入。页面帮助读者把品牌、通用名、每喷标示、计数器、吸入途径与目标市场一起核对；不据此生成个人喷数、用药间隔、急性症状处理或换药方案。", "history": "“每喷 90 mcg”“200 次”“蓝色吸入器”都是这一个美国公开标签下的产品身份线索，不能据此确认其他国家包装、其他沙丁胺醇装置、个人用法或可替代性。喷雾罐与塑料执行器的匹配、标签版本和计数器状态也应与实际产品一起核对。", "sourceDocuments": [ { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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 020983", "approvalTimeline": [ { "date": "1981", "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: 1981。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: 1981. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed: VENTOLIN HFA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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": "2024-04", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-04 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 2024-04 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_4939b25c2c864e50", "label": "DailyMed: VENTOLIN HFA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "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/ventolin-hfa/", "en": "https://origindrug.com/en/drugs/ventolin-hfa/" }, "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." ] }