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updated 12 Dec 2025 and published 15 Dec 2025" }, "dosageForm": { "zh": "氨氯地平/缬沙坦/氢氯噻嗪口服薄膜衣片", "en": "amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0563-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 10 mg + 缬沙坦 320 mg + 氢氯噻嗪 25 mg；30 片瓶装", "en": "Per tablet: amlodipine 10 mg + valsartan 320 mg + hydrochlorothiazide 25 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-13.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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": "us-exforge-hct-amlodipine-5mg-valsartan-160mg-hydrochlorothiazide-12-5mg-30-tablet-bottle-ndc-0078-0559-15", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-09.jpg", "alt": "EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪在美国 DailyMed 当前标签中的 5 mg/160 mg/12.5 mg、NDC 0078-0559-15、30 片装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v33（2025-12-12 更新；2025-12-15 发布）", "presentation": "EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪薄膜衣片：每片 5 mg/160 mg/12.5 mg；NDC 0078-0559-15；30 片装包装面板。", "notice": "此图只对应美国当前标签中的 EXFORGE HCT 5 mg/160 mg/12.5 mg、NDC 0078-0559-15、30 片装。它不代表其余四种 EXFORGE HCT 强度、EXFORGE 双成分片、单方成分、其他包装或其他市场；不用于鉴定真伪，也不生成个人片数、加减量、转换或联合方案。", "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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": "EXFORGE HCT 说明书放大阅读：5/160/12.5 是三种成分的每片身份", "en": "EXFORGE HCT label reading: 5/160/12.5 identifies three ingredients in one tablet" }, "summary": { "zh": "本模块用当前美国公开标签帮助核对 EXFORGE HCT、氨氯地平、缬沙坦、氢氯噻嗪、完整三数字、口服薄膜衣片与 NDC。它不决定个人是否需要三种降压成分、每天用几片、能否与其他降压或利尿产品同用，或怎样调整。", "en": "This module uses the current U.S. public label to check EXFORGE HCT, amlodipine, valsartan, hydrochlorothiazide, the complete three-number marking, oral film-coated tablet and NDC. It does not decide whether someone needs all three ingredients, a tablet count, co-use with another antihypertensive/diuretic or an adjustment." }, "checks": [ { "zh": "5/160/12.5、10/160/12.5、5/160/25、10/160/25、10/320/25 mg 都是每片中三种成分的完整标示。不能只看一个数字，也不能从数字推导个人每天几片、加减量，或把单方和复方自行拼成同一产品。", "en": "5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25 and 10/320/25 mg are complete three-ingredient markings per tablet. Do not read only one number, derive a personal tablet count, adjust an amount or self-assemble the product from single-ingredient and combination medicines." }, { "zh": "EXFORGE 只含氨氯地平和缬沙坦；EXFORGE HCT 还含氢氯噻嗪。名称相近、都含氨氯地平或缬沙坦，不能证明可自行叠加、轮换或替代。", "en": "EXFORGE contains amlodipine and valsartan only; EXFORGE HCT also contains hydrochlorothiazide. Similar names or a shared amlodipine/valsartan ingredient do not establish self-combination, alternation or substitution." }, { "zh": "正在使用其他降压药、利尿剂、含缬沙坦/氯沙坦/厄贝沙坦等产品、止痛药、盐替代品、补充剂或多种药物时，应把实际药盒和完整药单交给药师或医生核对。网页不能把“同类”或“共同成分”变成可否合用的个人结论。", "en": "With another antihypertensive, diuretic, a product containing valsartan/losartan/irbesartan, pain medicine, salt substitute, supplement or multiple medicines, have the actual packs and complete list reviewed by a pharmacist or clinician. A webpage cannot turn a shared class or ingredient into an individual co-use conclusion." }, { "zh": "怀孕/计划妊娠、晕厥、明显头晕、胸痛、呼吸困难、面部或咽喉肿胀等情况需要及时联系当地医生或紧急医疗支持；本页不决定是否自行停用、恢复或改用另一种药。", "en": "Pregnancy/planning pregnancy, fainting, marked dizziness, chest pain, breathing trouble, facial or throat swelling or another acute concern needs timely local clinical or urgent support; this page does not decide self-stopping, restarting or changing to another medicine." } ], "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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": "三种成分怎样一起出现：钙通道、血管紧张素 II 受体与噻嗪类利尿路径", "en": "How three ingredients appear together: calcium-channel, angiotensin-II receptor and thiazide-diuretic pathways" }, "summary": { "zh": "当前标签将 EXFORGE HCT 描述为二氢吡啶类钙通道阻滞剂氨氯地平、血管紧张素 II 受体阻滞剂缬沙坦与噻嗪类利尿剂氢氯噻嗪的固定复方。机制帮助理解为什么完整药单核对重要，不预测个人血压、肾功能、电解质、疗效、用量或是否适合换药。", "en": "The current label describes EXFORGE HCT as a fixed combination of the dihydropyridine calcium-channel blocker amlodipine, the angiotensin-II receptor blocker valsartan and the thiazide diuretic hydrochlorothiazide. Mechanism helps explain why complete-list review matters; it does not predict an individual's blood pressure, kidney function, electrolytes, response, amount or whether a switch is suitable." }, "checks": [ { "zh": "三条作用路径不表示可以自行把其他钙通道阻滞剂、ARB、ACE 抑制剂、利尿剂或复方降压药再加一层。任何新增、停用、轮换或替代都要由掌握完整药单和病史的专业人员核对。", "en": "Three pathways do not mean another calcium-channel blocker, ARB, ACE inhibitor, diuretic or combination antihypertensive can be self-added. Any addition, stopping, alternation or substitution needs review by a professional with the complete list and history." }, { "zh": "标签中涉及血容量、肾功能、血钾/血钠或尿酸等词是需要专业复核的线索，不是从家庭血压读数、症状或网络经验自行调整片数的依据。", "en": "Label terms involving volume status, kidney function, potassium/sodium or uric acid are cues for professional review, not grounds to change tablet count from a home blood-pressure reading, symptoms or online experience." }, { "zh": "机制说明不能处理脱水、严重低血压样不适、胸痛、过敏、妊娠相关风险或复杂多药联用。出现急性或严重担忧时应优先使用当地医疗支持。", "en": "A mechanism explanation cannot manage dehydration, severe low-blood-pressure-like symptoms, chest pain, allergy, pregnancy-related risk or complex polypharmacy. With an acute or serious concern, prioritise local medical support." } ], "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Clinical Pharmacology；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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": "Exforge HCT", "generic": "氨氯地平/缬沙坦/氢氯噻嗪", "dosageFormClass": "口服薄膜衣片：氨氯地平/缬沙坦/氢氯噻嗪 5/160/12.5、10/160/12.5、5/160/25、10/160/25、10/320/25 mg（当前美国标签所列）" }, "labelSource": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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 当前 EXFORGE HCT 标签将其列为氨氯地平、缬沙坦和氢氯噻嗪的固定剂量三成分口服片，列有五种完整三数字标示。本页帮助核对品牌、全部三种成分、完整三数字、实际包装、标签版本和目标市场；不从任一数字生成个人片数、加减量、联用、换药或停药方案。", "history": "当前美国标签列示 Initial U.S. Approval: 2009，SPL v33 的 Updated 日期为 2025-12-12、DailyMed Published 日期为 2025-12-15。EXFORGE 仅含氨氯地平与缬沙坦；EXFORGE HCT 多出氢氯噻嗪。品牌名相近或共享成分都不建立自行替代、叠加或轮换关系。", "sourceDocuments": [ { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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" } ], "applicationNumber": "NDA 022314", "approvalTimeline": [ { "date": "2009-04-30", "title": { "zh": "NDA 022314 原始申请批准", "en": "NDA 022314 original application approval" }, "detail": { "zh": "FDA Drugs@FDA 公开记录将 EXFORGE HCT 的原始申请（ORIG 1）标为 2009-04-30 获批；该美国监管节点不建立其他市场的批准、供应或个人适用性。", "en": "The FDA Drugs@FDA public record lists EXFORGE HCT original application (ORIG 1) as approved on 30 Apr 2009. This U.S. regulatory node does not establish approval, supply or individual suitability in another market." }, "source": { "id": "src_bb60774a7963f6b6", "label": "FDA: EXFORGE HCT NDA 022314 original approval letter (2009-04-30)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022314s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2009", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 EXFORGE HCT 标签列示 Initial U.S. Approval: 2009；该年份不自动说明其他市场的产品状态。", "en": "The current EXFORGE HCT label lists Initial U.S. Approval: 2009; it does not establish product status in another market." }, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed: current EXFORGE HCT public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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": "2025-12-12", "title": { "zh": "当前 SPL v33 更新日期", "en": "Current SPL v33 updated date" }, "detail": { "zh": "DailyMed 当前标签的 Updated 日期为 2025-12-12；该日期与公开日期分开记录。", "en": "The current DailyMed label's updated date is 12 Dec 2025; it remains separate from publication." }, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed: current EXFORGE HCT public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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": "2025-12-15", "title": { "zh": "DailyMed 公开当前 SPL v33", "en": "DailyMed published current SPL v33" }, "detail": { "zh": "DailyMed 将当前 v33 的 Published Date 列为 2025-12-15；页面不把它解释成个人治疗建议。", "en": "DailyMed lists 15 Dec 2025 as the current v33 Published Date; this page does not interpret it as individual-treatment advice." }, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed: current EXFORGE HCT public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "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": "已链接当前三成分标签与一个精确包装展示", "en": "Current three-ingredient label and one exact package panel linked" }, "detail": { "zh": "展示图只对应 5 mg/160 mg/12.5 mg、NDC 0078-0559-15、30 片装；不据此建立实际在售、库存或其他规格状态。", "en": "The image corresponds only to the 5 mg/160 mg/12.5 mg, NDC 0078-0559-15, 30-tablet panel; it does not establish actual marketing, stock or another-strength status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、规格、供应、原研关系或可替代性。", "en": "No local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5/160/12.5 mg 是不是只看其中一个数字即可？", "en": "Can 5/160/12.5 mg be read as just one of its three numbers?" }, "answer": { "zh": "不能。它表示这一准确复方片中氨氯地平、缬沙坦和氢氯噻嗪的三组标示量。页面不把它变成个人片数、调整或与单方药的换算。", "en": "No. It identifies the three labelled ingredient amounts in this exact fixed-combination tablet. The page does not turn it into an individual tablet count, adjustment or conversion to single-ingredient medicines." } }, { "question": { "zh": "EXFORGE 与 EXFORGE HCT 能否自行互换？", "en": "Can EXFORGE and EXFORGE HCT be self-switched?" }, "answer": { "zh": "不能。EXFORGE HCT 另含氢氯噻嗪，是三成分产品。相近品牌名不建立可自行互换关系；请带实际药盒和完整药单咨询药师或开方团队。", "en": "No. EXFORGE HCT additionally contains hydrochlorothiazide and is a three-ingredient product. Similar brand names do not establish self-interchangeability; take the actual packs and complete medicine list to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/exforge-hct/", "en": "https://origindrug.com/en/drugs/exforge-hct/" }, "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." ] }