{ "id": "atacand", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "ATACAND", "generic": "坎地沙坦酯", "aliases": [ "Atacand", "candesartan cilexetil", "candesartan", "坎地沙坦酯", "坎地沙坦", "坎地沙坦酯片", "必洛斯", "candesartan cilexetil tablets", "NDA 020838", "62559-640-30", "62559-641-30", "62559-642-30", "62559-643-30", "ATACAND 4 mg", "ATACAND 8 mg", "ATACAND 16 mg", "ATACAND 32 mg" ], "marketBrandNames": [ { "name": "ATACAND", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "四个处方 RLD 规格；32 mg 同时为 RS。", "en": "Four prescription RLD strengths; 32 mg is also the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "ATACAND", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada Marketed 数据列出四个坎地沙坦酯 DIN；不外推其他市场供应。", "en": "Health Canada marketed data list four candesartan cilexetil DINs; this does not project supply to another market." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ATACAND 与四个 DIN", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前品牌标签列出 4、8、16、32 mg 四种普通口服片和六个瓶装身份：4/8 mg 各有 30 片瓶，16/32 mg 各有 30 与 90 片瓶；当前主展示图只逐一对应四个 30 片瓶，两个 90 片瓶保留为官方文字身份，不借用图片。FDA Orange Book 将 NDA 020838 四规格均列为处方 RLD，并将 32 mg 列为 RS。Health Canada 的 2026-08-26 Marketed 数据中有四个 ATACAND 坎地沙坦酯 DIN。监管记录、包装图和具体药房实时库存是不同证据层级。", "dosageFormClass": "坎地沙坦酯普通口服片：4 mg、8 mg、16 mg、32 mg；本页不并入 ATACAND HCT／PLUS 复方，也不把有刻痕解释为自行分片许可", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998-06-04（FDA NDA 020838 四规格批准日期）", "archiveSponsorText": "ANI Pharmaceuticals, Inc.（当前美国申请主体）；AstraZeneca 品牌许可历史；加拿大当前记录为 CHEPLAPHARM Arzneimittel GmbH" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ATACAND", "Atacand", "坎地沙坦酯片" ], "excludedProductCues": [ "ATACAND HCT", "ATACAND PLUS", "candesartan cilexetil and hydrochlorothiazide", "坎地沙坦酯氢氯噻嗪" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-atacand-candesartan-cilexetil-4mg-30-tablet-bottle-ndc-6255964030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; 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the score is an identity clue only" }, "imprint": "ACL / 032", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-atacand-candesartan-cilexetil-32mg-90-tablet-bottle-ndc-6255964390", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; revised Jul 2025)" }, "dosageForm": { "zh": "ATACAND 坎地沙坦酯普通口服片", "en": "ATACAND candesartan cilexetil immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-643-90 / NDA 020838 Product 004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片坎地沙坦酯 32 mg；90 片瓶装；FDA RS", "en": "32 mg candesartan cilexetil per tablet; 90-tablet bottle; FDA RS" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坎地沙坦酯", "en": "candesartan cilexetil" }, "value": 32, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分片许可或与另一种 ARB 的换算值", "en": "labelled amount per tablet; not an individual tablet count, splitting permission or conversion to another ARB" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、有刻痕，约 10 mm；刻痕只作身份核对", "en": "round, biconvex and scored, approximately 10 mm; the score is an identity clue only" }, "imprint": "ACL / 032", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-atacand-candesartan-cilexetil-4mg-30-tablet-bottle-ndc-6255964030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-4mg.jpg&setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "alt": "ATACAND 坎地沙坦酯 4 mg、NDC 62559-640-30、30 片瓶装的美国 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5；2025-07 修订", "presentation": "ATACAND 每片坎地沙坦酯 4 mg，白色至类白色圆形有刻痕片，NDC 62559-640-30，30 片瓶装。", "notice": "此图只对应美国 4 mg、NDC 62559-640-30、30 片瓶装；不代表 8/16/32 mg、ATACAND HCT／PLUS、加拿大或其他市场包装、实时库存或个人片数，也不用于鉴定真伪。", "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ATACAND 说明书放大阅读：先分清单方、复方、每片 mg 与完整药单", "en": "ATACAND label reading: separate single ingredient, combinations, mg per tablet and the complete medicine list" }, "summary": { "zh": "4、8、16、32 mg 是每片坎地沙坦酯标示量，30/90 Tablets 是瓶内片数；它们不是个人每次片数。ATACAND HCT／PLUS 另含氢氯噻嗪，必须作为不同产品核对。", "en": "The 4, 8, 16 and 32 mg figures are labelled candesartan cilexetil amounts per tablet, while 30/90 Tablets are bottle counts; neither is an individual dose. ATACAND HCT/PLUS additionally contains hydrochlorothiazide and must be checked as a different product." }, "checks": [ { "zh": "四种片剂都有刻痕，但刻痕是官方外观身份线索，不是网页允许所有人掰片、拼规格或把两片换成另一强度的许可。", "en": "All four tablets are scored, but a score is an official appearance clue—not web permission for everyone to split, assemble strengths or replace one strength with two tablets." }, { "zh": "标签有胎儿毒性黑框警告。已经怀孕、可能怀孕或计划怀孕时，应尽快联系负责治疗的专业人员核对，不要仅凭网页继续、停用或自行换药。", "en": "The label has a boxed warning for fetal toxicity. If pregnant, possibly pregnant or planning pregnancy, promptly contact the responsible clinician; do not continue, stop or self-switch from a webpage alone." }, { "zh": "糖尿病患者与阿利吉仑同用属于标签禁忌；补钾剂、含钾代盐、保钾利尿药、锂、NSAID 止痛药及另一种影响肾素-血管紧张素系统的药物都应按完整药单、肾功能和血钾核对。网页不自动判断能否同服或如何错开。", "en": "Co-use with aliskiren is contraindicated in patients with diabetes. Potassium supplements or salt substitutes, potassium-sparing diuretics, lithium, NSAID pain medicines and another renin-angiotensin-system medicine require review of the complete list, kidney function and potassium. The site does not decide co-use or invent a separation interval." }, { "zh": "面、唇、舌或喉部突然肿胀，呼吸或吞咽困难，晕厥或其他严重急性表现可能是急症，应立即使用当地急救服务并带上全部药盒。", "en": "Sudden swelling of the face, lips, tongue or throat, trouble breathing or swallowing, fainting or another severe acute feature may be an emergency. Use local emergency services immediately and take every medicine pack." } ], "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "坎地沙坦酯怎样起作用：前药转化后阻断血管紧张素 II 的 AT1 受体", "en": "How candesartan cilexetil works: a prodrug converted to an angiotensin-II AT1-receptor blocker" }, "summary": { "zh": "坎地沙坦酯在胃肠道吸收过程中转化为坎地沙坦，选择性阻断血管紧张素 II 的 AT1 受体作用。这个机制解释为何血压、肾功能、血钾和完整药单重要，但不能从机制或一次血压读数推导个人片数、加量、停药或换药。", "en": "Candesartan cilexetil is converted to candesartan during gastrointestinal absorption and selectively blocks angiotensin-II activity at the AT1 receptor. This explains why blood pressure, kidney function, potassium and the full medicine list matter, but neither the mechanism nor one reading determines an individual's tablets, increase, stop or switch." }, "checks": [ { "zh": "同为 ARB 不表示 ATACAND、COZAAR、DIOVAN、BENICAR、AVAPRO 或 MICARDIS 可以按 mg 一对一换算、轮换或叠加。", "en": "Sharing the ARB class does not make ATACAND, COZAAR, DIOVAN, BENICAR, AVAPRO or MICARDIS one-to-one milligram conversions or medicines to alternate or combine." }, { "zh": "头晕或血压读数变化不能单独证明过量、漏服或需要补服。严重胸痛、呼吸困难、晕厥或神经系统急症表现应立即使用当地急救；其他新症状及时联系负责团队。", "en": "Dizziness or a blood-pressure change alone does not prove overdose, a missed dose or a need to make up use. Severe chest pain, breathing difficulty, fainting or neurologic emergency features require immediate local emergency care; contact the responsible team promptly for other new symptoms." }, { "zh": "ATACAND HCT／PLUS 把坎地沙坦酯与氢氯噻嗪放在同一片中；共同品牌词根不表示能用两盒单方自行拼成复方或拆分复方方案。", "en": "ATACAND HCT/PLUS combines candesartan cilexetil and hydrochlorothiazide in one tablet. A shared brand stem does not permit self-assembling the combination from two packs or dismantling a combination regimen." } ], "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ATACAND", "generic": "坎地沙坦酯", "dosageFormClass": "坎地沙坦酯普通口服片：4 mg、8 mg、16 mg、32 mg；本页不并入 ATACAND HCT／PLUS 复方，也不把有刻痕解释为自行分片许可" }, "labelSource": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_767379654dd27819", "label": "FDA Drugs@FDA：ATACAND NDA 020838 申请档案", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "2026-09-02", "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": "ATACAND 是坎地沙坦酯单方口服片，属于 ARB。它不等于 ATACAND HCT／PLUS 复方，也不能与 COZAAR、DIOVAN、BENICAR、AVAPRO、MICARDIS 或其他降压药按 mg 自行换算、轮换或叠加。老人和多药使用者应优先核对完整药单、血压相关症状、肾功能和血钾；网页不生成个人片数、频次、补服、停药或换药方案。", "history": "FDA Orange Book 当前数据记录 ATACAND NDA 020838 的四个普通口服片产品于 1998-06-04 获批。当前美国标签由 ANI Pharmaceuticals 发布，写明 ATACAND 商标属于 AstraZeneca 集团并许可给 ANI，产品在 Takeda Pharmaceutical Company, Ltd. 许可下生产。加拿大当前 Marketed 数据列出四个由 CHEPLAPHARM Arzneimittel GmbH 持有的 ATACAND DIN。", "sourceDocuments": [ { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_767379654dd27819", "label": "FDA Drugs@FDA：ATACAND NDA 020838 申请档案", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ATACAND 与四个 DIN", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "FDA NDA 020838（ATACAND／candesartan cilexetil；四规格 RLD；32 mg 为 RS）", "approvalTimeline": [ { "date": "1998-06-04", "title": { "zh": "FDA 批准 ATACAND 四种口服片", "en": "FDA approved four ATACAND oral-tablet strengths" }, "detail": { "zh": "Orange Book 当前数据把 4/8/16/32 mg 与 NDA 020838、处方 RLD 和该批准日期相连；32 mg 同时为 RS。", "en": "Current Orange Book data connect 4/8/16/32 mg with NDA 020838, prescription RLD status and this approval date; 32 mg is also the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-07", "title": { "zh": "当前美国处方信息修订", "en": "Current U.S. prescribing information revised" }, "detail": { "zh": "DailyMed SPL v5 保留四种规格、准确包装、黑框警告、相互作用与患者信息。", "en": "DailyMed SPL v5 retains four strengths, exact packs, boxed warning, interactions and patient information." }, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD 规格当前在册；32 mg 为 RS", "en": "Four prescription RLD strengths currently listed; 32 mg is the RS" }, "detail": { "zh": "官方包装图与监管在册不等于具体药房实时库存、购买资格或个人适用性。", "en": "Official pack images and regulatory listing do not establish live pharmacy stock, purchasing eligibility or individual suitability." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "四个 ATACAND 坎地沙坦酯 DIN 当前列为 Marketed", "en": "Four ATACAND candesartan cilexetil DINs currently listed as Marketed" }, "detail": { "zh": "加拿大状态不外推美国、中国大陆或其他市场。", "en": "Canadian status is not projected onto the United States, Mainland China or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ATACAND 和 ATACAND HCT／PLUS 是同一种药吗？", "en": "Are ATACAND and ATACAND HCT/PLUS the same medicine?" }, "answer": { "zh": "不是同一产品。ATACAND 是坎地沙坦酯单方；HCT／PLUS 还含氢氯噻嗪。不要按商品名或毫克数自行叠加、替代或拆分。", "en": "They are not the same product. ATACAND is single-ingredient candesartan cilexetil; HCT/PLUS also contains hydrochlorothiazide. Do not self-combine, substitute or dismantle them from names or milligram figures." } }, { "question": { "zh": "ATACAND 有刻痕，可以自己掰半吗？", "en": "ATACAND is scored; can I halve it myself?" }, "answer": { "zh": "刻痕只作为准确产品外观线索。能否分割必须核对手中市场、强度、现行说明书、处方和专业指示；网页不提供通用分片许可。", "en": "The score is an exact-product appearance clue. Splitting requires the market, strength, current label, prescription and professional instruction for the product in hand; the site gives no universal permission." } }, { "question": { "zh": "可以把 ATACAND 和另一种沙坦类药轮换着吃吗？", "en": "Can ATACAND be alternated with another sartan?" }, "answer": { "zh": "不要这样做。不同 ARB 不是按 mg 自动等量的同一种药，同时出现也可能是重复或专业人员有意安排；请让开方团队或药师核对准确药盒与完整药单。", "en": "Do not do this. Different ARBs are not automatically equivalent by milligrams, and co-listing may be duplication or an intentional professional plan. Have the prescriber or pharmacist review the exact packs and complete list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "same-class-is-not-same-medicine", "dose-unit-literacy" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/atacand/", "en": "https://origindrug.com/en/drugs/atacand/" }, "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." ] }