{ "id": "spiriva-handihaler", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Spiriva HandiHaler", "generic": "噻托溴铵", "aliases": [ "tiotropium", "tiotropium bromide", "思力华" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "吸入粉雾剂胶囊及专用装置（FDA 2025 标签及 DailyMed 2025-11 公开标签所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2004（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SPIRIVA RESPIMAT", "RESPIMAT", "tiotropium inhalation spray", "STIOLTO RESPIMAT", "COMBIVENT RESPIMAT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-spiriva-handihaler-tiotropium-bromide-inhalation-powder-capsule-18mcg-ndc-0597-0075-41", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v28（2025-11-10 生效）", "en": "DailyMed SPL v28 (effective 10 Nov 2025)" }, "dosageForm": { "zh": "SPIRIVA HANDIHALER 噻托溴铵吸入粉雾剂胶囊＋专用 HandiHaler 装置", "en": "SPIRIVA HANDIHALER tiotropium bromide inhalation powder capsule + dedicated HandiHaler device" }, "route": { "zh": "仅可通过 HandiHaler 经口吸入；不可吞服", "en": "oral inhalation through the HandiHaler only; do not swallow" }, "routeCodes": [ "inhalation" ], "productCode": "NDC 0597-0075-41", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation_capsule", "primaryDisplay": { "zh": "每粒吸入用胶囊含噻托溴铵 18 mcg；30 粒＋1 个 HandiHaler 装置（仅供吸入，不可吞服）", "en": "Tiotropium bromide 18 mcg per inhalation capsule; 30 capsules + 1 HandiHaler device (for inhalation only, not swallowing)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=spiriva-29.jpg&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "噻托溴铵（每粒吸入用胶囊）", "en": "tiotropium bromide (per inhalation capsule)" }, "value": 18, "unit": "mcg", "basisCode": "per_inhalation_capsule", "basisLabel": { "zh": "每粒吸入用胶囊的标签标示量；不是口服剂量、个人胶囊数或操作指令", "en": "Labelled amount per inhalation capsule; not an oral dose, individual's capsule count or device instruction" } } ], "concentration": null, "container": { "typeCode": "carton_with_device", "typeLabel": { "zh": "纸盒：泡罩胶囊＋专用装置", "en": "carton: blister capsules + dedicated device" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒吸入用胶囊", "en": "inhalation capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒吸入用胶囊／盒；含 1 个 HandiHaler 装置", "en": "inhalation capsules per carton; includes 1 HandiHaler device" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 18 mcg 吸入粉雾剂胶囊、30 粒与 HandiHaler 装置当前美国公开标签（SPL v28）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "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=spiriva-29.jpg&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9&type=img", "alt": "SPIRIVA HANDIHALER 美国公开标签的 18 mcg、30 粒胶囊与 1 个 HandiHaler 装置纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v28，2025-11-10 生效", "presentation": "18 mcg 吸入粉雾剂胶囊、30 粒（3 板各 10 粒）与 1 个 HandiHaler 装置纸盒，NDC 0597-0075-41。", "notice": "此为勃林格殷格翰在美国 DailyMed 现行公开标签中的准确展示面，只帮助核对品牌、噻托溴铵、18 mcg 吸入用胶囊、30 粒/3 板、HandiHaler 装置和 NDC；胶囊不是吞服用。不用于鉴定真伪，也不证明其他包装、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 公开标签（2025-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "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": "SPIRIVA HANDIHALER 说明书放大阅读：胶囊是吸入用，不是吞服用", "en": "SPIRIVA HANDIHALER label reading: the capsule is for inhalation, not swallowing" }, "summary": { "zh": "本模块以 FDA 2025 美国标签为阅读入口，解释该产品的胶囊、粉雾和 HandiHaler 装置之间的关系；它不替代个人吸入技术培训或急性呼吸症状处置。", "en": "This module uses the 2025 U.S. FDA label as a reading entry point, explaining the relationship between its capsule, powder and HandiHaler device; it does not replace individual inhaler-technique training or management of acute breathing symptoms." }, "checks": [ { "zh": "FDA 标签明确说明：SPIRIVA 胶囊只用于通过 HandiHaler 装置经口吸入，不应吞服。看到“18 mcg 胶囊”不能把它理解成口服药片或与任何口服胶囊互换。", "en": "The FDA label explicitly says SPIRIVA capsules are only for oral inhalation through the HandiHaler device and must not be swallowed. Seeing an “18 mcg capsule” does not make it an oral medicine or interchangeable with any swallowed capsule." }, { "zh": "标签列有产品特定的装置操作信息；本页不复述或生成具体吸入次数、装置步骤或个人操作。不要把其他吸入器、雾化器或“相似胶囊”的操作套用到这个产品；请药师或临床人员面对实际装置示范。", "en": "The label contains product-specific device information. This page does not repeat or generate an inhalation count, device steps or individual-use instructions. Do not apply steps for another inhaler, nebuliser or “similar capsule” to this product; ask a pharmacist or clinician to demonstrate with the actual device." }, { "zh": "该标签明确其为长期维持治疗，不用于缓解急性支气管痉挛。突然或加重的呼吸困难不适合通过自行多用、换用或等待网页回复处理，应按当地急救和医疗团队指引处置。", "en": "The label describes long-term maintenance treatment and says it is not for relief of acute bronchospasm. Sudden or worsening breathing difficulty is not a situation for self-escalation, substitution or waiting for a webpage; follow local emergency and care-team guidance." }, { "zh": "胶囊颜色、泡罩、装置外观和“18 mcg”仅是本产品的核对线索，不能验证真伪、判断是否为 RESPIMAT 或其他噻托溴铵产品，也不能证明可替代性。应把实际包装、装置、商品名和目标市场一起交由药师核对。", "en": "Capsule colour, blister, device appearance and “18 mcg” are only identification clues for this product. They cannot authenticate it, show it is RESPIMAT or another tiotropium product, or prove interchangeability. Have a pharmacist check the actual pack, device, brand name and target market together." } ], "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "噻托溴铵怎样起作用：它在气道平滑肌阻断 M3 毒蕈碱受体", "en": "How tiotropium works: it blocks M3 muscarinic receptors in airway smooth muscle" }, "summary": { "zh": "FDA 标签将噻托溴铵描述为长效抗毒蕈碱药。在气道中，它通过抑制平滑肌上的 M3 受体发挥支气管扩张相关作用；吸入后的这一作用主要发生在局部。机制解释的是作用路径，不能决定个人是否适用、吸入技术、装置操作、是否需要急救药或呼吸困难时应如何处理。", "en": "The FDA label describes tiotropium as a long-acting antimuscarinic agent. In the airways, it has bronchodilation-related effects through inhibition of M3 receptors on smooth muscle, and this effect after inhalation is predominantly local. Mechanism explains an action pathway; it cannot determine individual suitability, inhalation technique, device operation, whether a rescue medicine is needed or what to do with breathing difficulty." }, "checks": [ { "zh": "“抗胆碱能”或“支气管扩张”不表示 SPIRIVA HANDIHALER 能与另一种吸入器、雾化液、口服胶囊或其他同类药自行叠加、替换或按微克数换算。产品、装置、给药途径和完整药单必须一起核对。", "en": "“Anticholinergic” or “bronchodilation” does not make SPIRIVA HANDIHALER self-combinable, substitutable or convertible by micrograms with another inhaler, nebuliser solution, swallowed capsule or related medicine. Product, device, route and the complete medicine list must be checked together." }, { "zh": "M3 受体机制不会把“胶囊”变成口服用药，也不会说明可以把粉末倒出、改用其他装置或凭经验改变操作。该产品的胶囊、粉末与 HandiHaler 是同一个给药系统的一部分；需要现场示范或核对时，应带实际装置咨询药师或临床人员。", "en": "An M3-receptor mechanism does not turn a “capsule” into a swallowed medicine, or show that powder can be emptied, another device used or operation changed from experience. The capsule, powder and HandiHaler are parts of one delivery system; with a need for demonstration or checking, take the actual device to a pharmacist or clinician." }, { "zh": "机制不能把维持治疗产品变成突然气促、喘鸣或胸闷时的自行加量方案。出现急性或加重的呼吸困难，应按所在地的急救与医疗渠道及时处理，而不是等待网页给出装置或药物调整。", "en": "Mechanism cannot turn a maintenance product into a self-escalation plan for sudden breathlessness, wheeze or chest tightness. For acute or worsening breathing difficulty, use local emergency and medical pathways promptly rather than wait for a webpage device or medicine adjustment." } ], "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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": "Spiriva HandiHaler", "generic": "噻托溴铵", "dosageFormClass": "吸入粉雾剂胶囊及专用装置（FDA 2025 标签及 DailyMed 2025-11 公开标签所列）" }, "labelSource": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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." } }, { "source": { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 公开标签（2025-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "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": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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": "FDA 的 SPIRIVA HANDIHALER（tiotropium bromide）2025 美国标签将其列为通过专用 HandiHaler 装置使用的吸入粉雾剂胶囊。它不是口服吞咽胶囊；产品形式和装置必须作为完整身份一起核对。", "history": "“胶囊”一词不等于所有产品都经口吞服。吸入装置、使用方法与急性症状处置均不能仅凭外观、药名或上一种吸入产品推断。", "sourceDocuments": [ { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 公开标签（2025-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "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 021395", "approvalTimeline": [ { "date": "2004", "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: 2004。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: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA: SPIRIVA HANDIHALER prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025 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 2025 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_3cae0a2e7f3979e2", "label": "FDA: SPIRIVA HANDIHALER prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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/spiriva-handihaler/", "en": "https://origindrug.com/en/drugs/spiriva-handihaler/" }, "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." ] }