{ "id": "avalide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "AVALIDE", "generic": "厄贝沙坦/氢氯噻嗪", "aliases": [ "Avalide", "安博诺", "安博诺®", "厄贝沙坦氢氯噻嗪片", "厄贝沙坦/氢氯噻嗪", "irbesartan hydrochlorothiazide", "irbesartan and hydrochlorothiazide", "irbesartan/hydrochlorothiazide", "厄贝沙坦 氢氯噻嗪", "AVALIDE" ], "marketBrandNames": [ { "name": "安博诺®", "market": { "zh": "中国大陆（赛诺菲中国当前产品页）", "en": "Mainland China (current Sanofi China product page)" }, "evidenceStatus": "publication_status_unresolved", "note": { "zh": "赛诺菲中国当前产品页将安博诺®对应为厄贝沙坦氢氯噻嗪片，并列出进口/地产 150 mg/12.5 mg 片剂。这里仅建立中国药盒名称与准确规格的检索入口；美国 AVALIDE 档案另有 150/12.5 mg 和 300/12.5 mg 两种标签产品，不能仅按共同成分、品牌关联或 mg 数字跨市场合并、换算或替代。", "en": "The current Sanofi China product page maps CoAprovel® (安博诺®) to irbesartan/hydrochlorothiazide tablets and lists imported and locally produced 150 mg/12.5 mg tablets. This creates only a China pack-name and exact-strength search route. The U.S. AVALIDE dossier separately contains 150/12.5 mg and 300/12.5 mg labelled products; shared ingredients, brand association or milligram numbers do not merge, convert or substitute products across markets." }, "source": { "id": "src_dace9683647650ef", "label": "赛诺菲中国：安博诺® 厄贝沙坦氢氯噻嗪片当前产品页（150 mg/12.5 mg）", "url": "https://www.sanofi.cn/zh/your-health/products/coaprovel", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "安博诺®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_dace9683647650ef", "label": "赛诺菲中国：安博诺® 厄贝沙坦氢氯噻嗪片当前产品页（150 mg/12.5 mg）", "url": "https://www.sanofi.cn/zh/your-health/products/coaprovel", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：当前 DailyMed 公开标签所列 AVALIDE 薄膜衣口服片与两项准确 30 片瓶装展示面。中国大陆“安博诺®”只作为赛诺菲中国当前产品页约束的药盒名称与 150 mg/12.5 mg 片剂线索；不从任一市场资料推定另一市场的批准、包装、供应、购买资格、原研/仿制关系或可替代性。", "dosageFormClass": "厄贝沙坦/氢氯噻嗪固定组合薄膜衣口服片；所引美国标签展示 150 mg/12.5 mg 与 300 mg/12.5 mg 30 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服（产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1997（所引美国标签列示 Initial U.S. Approval）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC（所引美国 DailyMed 当前公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AVAPRO irbesartan single-ingredient tablet", "单方厄贝沙坦片", "another irbesartan/hydrochlorothiazide product", "其他厄贝沙坦/氢氯噻嗪产品", "other market package", "其他市场包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avalide-irbesartan-hctz-150-12-5mg-30-bottle-ndc-0024-5855-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-26 核验）", "en": "Current U.S. DailyMed public label (verified 26 Aug 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5855-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AVALIDE：每片厄贝沙坦 150 mg / 氢氯噻嗪 12.5 mg，30 片瓶装", "en": "AVALIDE: irbesartan 150 mg / hydrochlorothiazide 12.5 mg per tablet, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0d91895e-c869-4b33-9b83-d55c1ad6317e-09.jpg&setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄贝沙坦（每片）", "en": "Irbesartan (per tablet)" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } }, { "ingredient": { "zh": "氢氯噻嗪（每片）", "en": "Hydrochlorothiazide (per tablet)" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": { "zh": "一面心形图案；另一面 2875", "en": "heart on one side; 2875 on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): AVALIDE 150 mg/12.5 mg, NDC 0024-5855-30, 30-tablet bottle package panel", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-avalide-irbesartan-hctz-300-12-5mg-30-bottle-ndc-0024-5856-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-26 核验）", "en": "Current U.S. DailyMed public label (verified 26 Aug 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5856-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AVALIDE：每片厄贝沙坦 300 mg / 氢氯噻嗪 12.5 mg，30 片瓶装", "en": "AVALIDE: irbesartan 300 mg / hydrochlorothiazide 12.5 mg per tablet, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0d91895e-c869-4b33-9b83-d55c1ad6317e-10.jpg&setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄贝沙坦（每片）", "en": "Irbesartan (per tablet)" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } }, { "ingredient": { "zh": "氢氯噻嗪（每片）", "en": "Hydrochlorothiazide (per tablet)" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": { "zh": "一面心形图案；另一面 2876", "en": "heart on one side; 2876 on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): AVALIDE 300 mg/12.5 mg, NDC 0024-5856-30, 30-tablet bottle package panel", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-avalide-irbesartan-hctz-150-12-5mg-30-bottle-ndc-0024-5855-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0d91895e-c869-4b33-9b83-d55c1ad6317e-09.jpg&setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "alt": "AVALIDE 厄贝沙坦/氢氯噻嗪在美国 DailyMed 当前公开标签中的 150 mg/12.5 mg、NDC 0024-5855-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2026-08-26 核验）", "presentation": "AVALIDE：每片厄贝沙坦 150 mg/氢氯噻嗪 12.5 mg，NDC 0024-5855-30，30 片瓶装展示面（当前 DailyMed 公开标签所列）。", "notice": "此图只对应所引美国 DailyMed 当前标签中的 AVALIDE、每片厄贝沙坦 150 mg/氢氯噻嗪 12.5 mg、NDC 0024-5855-30 与 30 片瓶装。它只帮助核对准确标签身份与来源；不用于鉴定真伪，也不证明其他强度、包装、市场、当前可得性、可替代性或任何人的用药方案。", "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide label (150 mg/12.5 mg, NDC 0024-5855-30 package panel)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AVALIDE 说明书放大阅读：两组 mg 先是固定组合片的身份", "en": "AVALIDE label reading: two milligram values identify a fixed-combination tablet first" }, "summary": { "zh": "本模块用所引美国 DailyMed 当前公开标签核对 AVALIDE、厄贝沙坦/氢氯噻嗪、两种每片标示量、口服片、NDC、包装和外观。两组 mg 共同描述一片准确的固定组合产品；本页不从网页决定任何人的片数、开始、停用、替换、错开、联用或购买方案。", "en": "This module uses the cited current U.S. DailyMed public label to check AVALIDE, irbesartan/hydrochlorothiazide, two labelled amounts per tablet, oral-tablet form, NDC, pack and appearance. The two milligram values together describe one exact fixed-combination product; this page does not decide anyone's tablet count, start, stop, replacement, separation, co-use or purchase plan." }, "checks": [ { "zh": "先将 AVALIDE、两种活性成分、每片两组 mg、薄膜衣口服片、NDC、30 片瓶装、刻印和目标市场作为一组核对。150/12.5 与 300/12.5 不是网页上的个人剂量计算式，也不能据此把单方厄贝沙坦片、另一固定组合或另一市场包装当作可自行替换的同一产品。", "en": "Check AVALIDE, both active ingredients, both labelled milligram values per tablet, film-coated oral-tablet form, NDC, 30-tablet bottle, imprint and target market together. 150/12.5 and 300/12.5 are not web formulas for an individual dose and do not make a single-ingredient irbesartan tablet, another fixed combination or another-market pack self-replaceable." }, { "zh": "所引美国标签将两项展示面均描述为桃色双凸椭圆片，并以心形图案及 2875 或 2876 区分。颜色、形状、数字和照片只可协助定位候选标签；不能确认真伪、当前可得性、完整成分或可替代性。", "en": "The cited U.S. label describes both displayed presentations as peach biconvex oval tablets and distinguishes them with a heart plus 2875 or 2876. Colour, shape, numbers and a photograph can only help locate a candidate label; they cannot authenticate a product, confirm current availability, establish full ingredients or establish interchangeability." }, { "zh": "这是固定组合产品。若实际药盒、处方、药单、妊娠相关情况、既往反应或其他药物与网页记录不一致，应携带准确包装和完整药单请药师或开方团队按当前官方文件逐项核对；不要据本页自行加减、停用、叠加、拆分或替换。", "en": "This is a fixed-combination product. If the actual pack, prescription, medicine list, pregnancy-related circumstances, prior reactions or other medicines differ from the web record, bring the exact pack and complete medicine list to a pharmacist or prescriber for item-by-item review against current official documents; do not self-adjust, stop, stack, split or replace based on this page." }, { "zh": "出现呼吸困难、昏厥、面唇舌喉肿胀、严重皮疹或其他急性严重不适时，应优先使用当地紧急与医疗渠道；不要等待网页检索，也不要试图用另一盒药自行抵消或处理。", "en": "For breathing difficulty, fainting, swelling of the face, lips, tongue or throat, a severe rash or another acute serious concern, use local urgent and medical pathways first; do not wait for a web search or attempt to self-counteract or manage it with another pack." } ], "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "厄贝沙坦/氢氯噻嗪怎样起作用：固定组合的机制阅读，不是个人方案", "en": "How irbesartan/hydrochlorothiazide works: reading a fixed combination, not an individual plan" }, "summary": { "zh": "所引美国标签将 AVALIDE 描述为厄贝沙坦（血管紧张素 II 受体拮抗剂）和氢氯噻嗪（噻嗪类利尿剂）的固定组合。本段只解释标签对两种成分的分类；它不判断任何人的血压、体液状况、是否适用、片数、联用、暂停或替代。", "en": "The cited U.S. label describes AVALIDE as a fixed combination of irbesartan (an angiotensin II receptor antagonist) and hydrochlorothiazide (a thiazide diuretic). This section explains the label's classification of the two ingredients only; it does not determine anyone's blood pressure, fluid status, suitability, tablet count, co-use, pausing or substitution." }, "checks": [ { "zh": "“固定组合”意味着两种标签成分共同构成这一准确片剂身份；它不表示可把任意单方产品、其他品牌、其他强度或其他市场包装按网页自行凑成、拆开或换算成同一方案。", "en": "“Fixed combination” means two labelled ingredients together form this exact tablet identity; it does not mean arbitrary single-ingredient products, other brands, strengths or market packs can be self-assembled, separated or converted from a webpage into the same plan." }, { "zh": "“血管紧张素 II 受体拮抗剂”与“噻嗪类利尿剂”是作用路径分类，不足以解释个人头晕、血压读数、口渴、浮肿或其他症状的原因，也不替代专业人员对准确产品与完整药单的核对。", "en": "“Angiotensin II receptor antagonist” and “thiazide diuretic” are pathway classifications. They cannot explain the cause of an individual's dizziness, blood-pressure reading, thirst, swelling or another symptom, and they do not replace professional review of the exact product and complete medicine list." }, { "zh": "如担心同时使用的处方药、非处方药、补充剂、草本、既往反应或特殊生理情况，最有用的下一步是携带完整药单与实际药盒联系药师或医生；机制介绍不能替代这一核对。", "en": "For concerns about prescription products, OTC products, supplements, herbs, prior reactions or a special physiological circumstance, the most useful next step is to bring the complete medicine list and actual pack to a pharmacist or clinician; a mechanism introduction cannot replace that review." } ], "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label (Clinical Pharmacology)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AVALIDE", "generic": "厄贝沙坦/氢氯噻嗪", "dosageFormClass": "厄贝沙坦/氢氯噻嗪固定组合薄膜衣口服片；所引美国标签展示 150 mg/12.5 mg 与 300 mg/12.5 mg 30 片瓶装" }, "labelSource": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "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": "2026-08-26", "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_022ec20a49fca6de", "label": "FDA Drugs@FDA: AVALIDE 2025 U.S. prescribing information PDF", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020758s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "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": "2026-08-26", "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": "2026-08-26", "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": "这是一份美国 AVALIDE 的可追溯身份档案。所引 DailyMed 当前公开标签可核对 AVALIDE、厄贝沙坦/氢氯噻嗪、两种每片标示量、口服薄膜衣片、NDC、30 片瓶装、桃色椭圆外观和官方电子说明书。它帮助先辨认准确产品；不把两组 mg、瓶数、药名或照片变成个人服用片数、开始、停用、替换、联用或购买结论。", "history": "所引美国 DailyMed 当前公开标签列示 AVALIDE 的 Initial U.S. Approval 为 1997，并列 Sanofi-Aventis U.S. LLC。这里的时间和主体只锚定该美国公开标签；不据此断言其他市场的批准历史、当前供应、商标归属、原研身份、仿制关系或任何产品之间的相等性。", "sourceDocuments": [ { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_022ec20a49fca6de", "label": "FDA Drugs@FDA: AVALIDE 2025 U.S. prescribing information PDF", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020758s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } ], "applicationNumber": "NDA 020758", "approvalTimeline": [ { "date": "1997", "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: 1997。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: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed: AVALIDE current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "current DailyMed public label verified 2026-08-26", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 current DailyMed public label verified 2026-08-26 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 current DailyMed public label verified 2026-08-26 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_42edcc338c51a5ef", "label": "DailyMed: AVALIDE current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "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/avalide/", "en": "https://origindrug.com/en/drugs/avalide/" }, "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." ] }