{ "id": "altace", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "ALTACE", "generic": "雷米普利", "aliases": [ "ALTACE", "ramipril", "雷米普利", "NDA 019901", "Altace 1.25 mg", "Altace 2.5 mg", "Altace 5 mg", "Altace 10 mg", "019901" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 ALTACE（ramipril）NDA 019901 原品牌监管档案与 DailyMed SPL v29 当前公开标签", "dosageFormClass": "ALTACE 雷米普利硬明胶口服胶囊：1.25、2.5、5、10 mg；胶囊无刻痕。当前美国标签对准确 ALTACE 胶囊另有整粒吞服或打开后与指定少量食物/液体混合的说明，本页不把它扩大到其他胶囊或转换为个人剂量方案", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991-01-28（美国 NDA 019901 初始上市记录）", "archiveSponsorText": "美国 NDA 019901 原品牌历史；当前 DailyMed 标签列示 Pfizer Laboratories Div Pfizer Inc；实时供应与其他市场状态须另行核验" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ramipril tablet", "ramipril generic capsule", "generic ramipril", "雷米普利片", "雷米普利通用名胶囊", "other ACE inhibitor", "其他 ACE 抑制剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-altace-ramipril-1-25mg-100-capsule-bottle-ndc-6157011001", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-110-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 1.25 mg；NDC 61570-110-01；100 粒瓶装", "en": "Ramipril 1.25 mg per capsule; 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no score" }, "imprint": "Altace 1 25 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 1.25 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-altace-ramipril-2-5mg-100-capsule-bottle-ndc-6157011101", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-111-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 2.5 mg；NDC 61570-111-01；100 粒瓶装", "en": "Ramipril 2.5 mg per capsule; NDC 61570-111-01; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-06.jpg&archiveid=963585", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷米普利", "en": "ramipril" }, "value": 2.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒", "en": "capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "胶囊形；无刻痕", "en": "capsule-shaped; no score" }, "imprint": "Altace 2 5 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 2.5 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-altace-ramipril-5mg-100-capsule-bottle-ndc-6157011201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-112-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 5 mg；NDC 61570-112-01；100 粒瓶装", "en": "Ramipril 5 mg per capsule; NDC 61570-112-01; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-07.jpg&archiveid=963585", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷米普利", "en": "ramipril" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒", "en": "capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "胶囊形；无刻痕", "en": "capsule-shaped; no score" }, "imprint": "Altace 5 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 5 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-altace-ramipril-10mg-100-capsule-bottle-ndc-6157012001", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-120-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 10 mg；NDC 61570-120-01；100 粒瓶装", "en": "Ramipril 10 mg per capsule; NDC 61570-120-01; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-08.jpg&archiveid=963585", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷米普利", "en": "ramipril" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒", "en": "capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "胶囊形；无刻痕", "en": "capsule-shaped; no score" }, "imprint": "Altace 10 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 10 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-altace-ramipril-5mg-100-capsule-bottle-ndc-6157011201", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-07.jpg&archiveid=963585", "alt": "ALTACE 雷米普利在美国 DailyMed 当前标签中的 5 mg、NDC 61570-112-01、100 粒瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v29（2026-05-19 生效）", "presentation": "ALTACE 雷米普利：每粒 5 mg，NDC 61570-112-01，100 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ALTACE、雷米普利 5 mg、NDC 61570-112-01 与 100 粒瓶装。它只帮助核对商品名、通用名、每粒标示量、胶囊、包装数量、刻印和来源；不用于鉴定真伪，也不证明其他规格、其他包装、其他市场、实时库存、原研身份、可替代性，或任何个人的粒数、频率、打开胶囊、停药、联用或换药方案。", "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 5 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ALTACE／雷米普利说明书放大阅读：先看每粒毫克数，再看胶囊能否打开", "en": "ALTACE/ramipril label reading: check milligrams per capsule, then the exact capsule-opening boundary" }, "summary": { "zh": "当前美国标签把 ALTACE 列为雷米普利 1.25、2.5、5、10 mg 硬明胶胶囊。mg 是每粒标示量，不是网页给出的个人粒数。胶囊没有可供“掰半”的刻痕；标签对准确 ALTACE 胶囊另有打开后混合的产品专属说明，但不能据此推断其他雷米普利或其他胶囊也能打开。", "en": "The current U.S. label lists ALTACE as hard gelatin ramipril capsules in 1.25, 2.5, 5 and 10 mg strengths. mg is the labelled amount per capsule, not a personal capsule count generated by the site. A capsule has no score to split in half. The label has a product-specific opening-and-mixing option for exact ALTACE capsules, which does not establish that another ramipril or another capsule may be opened." }, "checks": [ { "zh": "同时核对 ALTACE、雷米普利、口服胶囊、1.25/2.5/5/10 mg、NDC、颜色、刻印和目标市场。不要把雷米普利片、通用名胶囊、依那普利、卡托普利、赖诺普利或沙坦类当成同一产品。", "en": "Check ALTACE, ramipril, oral capsule, 1.25/2.5/5/10 mg, NDC, colour, imprint and target market together. Do not treat a ramipril tablet, generic capsule, enalapril, captopril, lisinopril or an ARB as the same product." }, { "zh": "1.25、2.5、5、10 mg 都表示每粒标示量；个人用量还需结合处方、适应症、血压、肾功能、钾、年龄、脱水和完整药单。网页不能把一个规格换算成几粒或一日总量。", "en": "1.25, 2.5, 5 and 10 mg each state the labelled amount per capsule. Individual use also depends on the prescription, indication, blood pressure, kidney function, potassium, age, volume status and complete medicine list; the site cannot convert a strength into a capsule count or daily total." }, { "zh": "当前标签一般写整粒吞服，也允许准确 ALTACE 胶囊打开后把全部内容与约 4 oz 苹果酱、120 mL 水或苹果汁混合并全部摄入。此处只解释标签原文：吞咽困难、喂养管、储存、其他品牌或儿童使用仍须先让药师核对，不能把胶囊内容目测分半。", "en": "The current label generally says to swallow the capsule whole and also permits the exact ALTACE capsule to be opened, with all contents mixed into about 4 oz of applesauce or 120 mL of water or apple juice and consumed in full. This only explains the source label. Swallowing difficulty, feeding tubes, storage, another brand or paediatric use still require pharmacist review, and capsule contents must not be divided by eye." }, { "zh": "把利尿药、补钾、含钾盐替代品、布洛芬/萘普生等 NSAIDs、锂、其他 ACE 抑制剂、沙坦类、阿利吉仑和沙库巴曲/缬沙坦放在同一张药单复核；不要自行叠加、错开、轮换、停用或替换。", "en": "Place diuretics, potassium supplements, potassium-containing salt substitutes, NSAIDs such as ibuprofen/naproxen, lithium, other ACE inhibitors, ARBs, aliskiren and sacubitril/valsartan on one list for review. Do not self-combine, separate, alternate, stop or substitute." }, { "zh": "面部、嘴唇、舌头或喉部肿胀，呼吸或吞咽困难，昏厥或其他严重急性问题需要立即使用当地急救服务；不要等待网页判断。怀孕或可能怀孕也应尽快联系开方团队，因为美国标签含胎儿毒性加框警示。", "en": "Swelling of the face, lips, tongue or throat, breathing or swallowing difficulty, fainting or another severe acute problem requires immediate local emergency help; do not wait for a website decision. Pregnancy or possible pregnancy also requires prompt contact with the prescribing team because the U.S. label carries a boxed warning for fetal toxicity." } ], "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "雷米普利怎样起作用：前体药转化为雷米普利拉，再抑制 ACE", "en": "How ramipril works: a prodrug converted to ramiprilat, then ACE inhibition" }, "summary": { "zh": "当前标签说明雷米普利经酯酶水解为活性代谢物雷米普利拉。它抑制 ACE，减少血管紧张素 II 的形成并降低醛固酮分泌，帮助理解为什么血压、肾功能、钾、脱水和相互作用需要一起看；该机制不能预测个人反应或决定用量。", "en": "The current label explains that ramipril is hydrolysed by esterases to the active metabolite ramiprilat. ACE inhibition reduces formation of angiotensin II and lowers aldosterone secretion, helping explain why blood pressure, kidney function, potassium, volume status and interactions need review together; the mechanism cannot predict individual response or determine an amount." }, "checks": [ { "zh": "同属 ACE 抑制剂不表示雷米普利可与依那普利、卡托普利或赖诺普利自行合用、按毫克换算或隔日轮换；与沙坦类或沙库巴曲/缬沙坦也必须按准确药物和现行标签核对。", "en": "Sharing the ACE-inhibitor class does not make ramipril self-combinable, milligram-convertible or alternate-day interchangeable with enalapril, captopril or lisinopril; ARBs and sacubitril/valsartan also require exact medicine- and current-label review." }, { "zh": "干咳、头晕、乏力、排尿变化或检查异常不能仅凭机制归因，也不能成为自行停药、补服或换另一种降压药的理由；请带实际药盒和完整药单联系专业人员。", "en": "Dry cough, dizziness, weakness, urine change or an abnormal test cannot be attributed from mechanism alone and is not a reason to self-stop, redose or change to another blood-pressure medicine; take the actual pack and complete medicine list to a professional." }, { "zh": "机制词不能替代血压、肾功能、电解质、妊娠状态和完整药单的临床判断；若有面舌喉肿胀、呼吸困难、昏厥或其他严重急性问题，应立即使用当地急救支持。", "en": "Mechanism terms do not replace clinical review of blood pressure, kidney function, electrolytes, pregnancy status and the complete medicine list. Face/tongue/throat swelling, breathing difficulty, fainting or another severe acute problem requires immediate local emergency support." } ], "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 当前美国公开标签（临床药理与作用机制）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ALTACE", "generic": "雷米普利", "dosageFormClass": "ALTACE 雷米普利硬明胶口服胶囊：1.25、2.5、5、10 mg；胶囊无刻痕。当前美国标签对准确 ALTACE 胶囊另有整粒吞服或打开后与指定少量食物/液体混合的说明，本页不把它扩大到其他胶囊或转换为个人剂量方案" }, "labelSource": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（Pfizer；SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（Pfizer；SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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_a1437b72a96c9176", "label": "FDA Drugs@FDA：ALTACE（ramipril）NDA 019901 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019901", "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": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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": "2026-08-28", "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": "ALTACE 是雷米普利的美国原品牌档案。当前美国公开标签列出 1.25、2.5、5、10 mg 四种口服硬明胶胶囊。页面优先帮助老人分清品牌、通用名、每粒毫克数、胶囊能否打开的产品专属边界，以及与其他 ACE 抑制剂、沙坦、沙库巴曲/缬沙坦、利尿药、补钾、锂和 NSAIDs 的药单核对；不生成个人粒数、频率、停药、联用或换药方案。", "history": "DailyMed 当前标签把 ALTACE 的初始美国批准记录为 1991，并在产品数据中列出 NDA019901 与 1991-01-28 的营销起始日期。SPL v29 于 2026-05-19 生效，列示 Pfizer、四种 100 粒瓶装展示面和 2026 年修订的血管性水肿警示。网页把原始批准历史、当前标签、具体 NDC 的历史营销日期和实时供应严格分开。", "sourceDocuments": [ { "id": "src_a1437b72a96c9176", "label": "FDA Drugs@FDA：ALTACE（ramipril）NDA 019901 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019901", "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": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（Pfizer；SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 019901（ALTACE / ramipril；美国原品牌监管档案）", "approvalTimeline": [ { "date": "1991-01-28", "title": { "zh": "ALTACE 胶囊美国初始上市记录", "en": "Initial U.S. marketing record for ALTACE capsules" }, "detail": { "zh": "DailyMed 当前 NDA 品牌标签把 ALTACE 的初始美国批准列为 1991，并在产品数据中把 NDA019901 与 1991-01-28 的营销起始日期连接。该历史节点只建立美国产品史，不自动建立其他市场的品牌、批准、供应或可替代性。", "en": "The current DailyMed NDA brand label lists ALTACE's initial U.S. approval as 1991 and links NDA019901 to a marketing start date of 28 Jan 1991 in its product data. This historical node establishes U.S. product history only and does not automatically establish another market's brand, approval, supply or interchangeability." }, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（初始批准与产品数据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-05-19", "title": { "zh": "当前美国 ALTACE SPL v29 生效", "en": "Current U.S. ALTACE SPL v29 effective" }, "detail": { "zh": "当前 DailyMed 标签列示 ALTACE、NDA019901、Pfizer、1.25/2.5/5/10 mg 硬明胶胶囊、准确 NDC、颜色、刻印和四种瓶装展示面，并更新血管性水肿警示。页面把标签版本、具体 NDC 的历史营销日期与实时库存和购买严格分开。", "en": "The current DailyMed label lists ALTACE, NDA019901, Pfizer, hard gelatin 1.25/2.5/5/10 mg capsules, exact NDCs, colours, imprints and four bottle display panels, and updates the angioedema warning. The page keeps label version and historical NDC marketing dates separate from live stock and purchase." }, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 品牌标签和四种 100 粒瓶装展示面已链接；实时供应未建立", "en": "Current NDA brand label and four 100-capsule bottle panels linked; live supply not established" }, "detail": { "zh": "分别记录 1.25、2.5、5、10 mg 的 NDC、颜色、ALTACE/MP 刻印、无刻痕和来源。DailyMed 产品数据还列有不同 NDC 的历史营销结束日期，因此本页不把“当前标签”写成“当前有货”，也不用于鉴定真伪、购买或决定个人粒数、频率、打开胶囊、停药、联用或换药。", "en": "The dossier separately records NDC, colour, ALTACE/MP imprint, no-score status and source for 1.25, 2.5, 5 and 10 mg. DailyMed product data also lists historical marketing end dates for individual NDCs, so a current label is not described as current stock. The record does not authenticate, sell or decide an individual's capsule count, frequency, capsule opening, stopping, co-use or switching." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product record not established" }, "detail": { "zh": "不从美国 ALTACE 名称、NDA、共同通用名、NDC、毫克数、胶囊颜色、刻印或包装图推定当地商品名、批准、包装、供应、原研/参比关系或可替代性；每个市场须按当地现行监管资料逐产品核对。", "en": "No local trade name, approval, package, supply, originator/reference relationship or interchangeability is inferred from the U.S. ALTACE name, NDA, shared generic name, NDC, milligram value, capsule colour, imprint or package image; each product requires current local regulatory review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ALTACE、雷米普利、依那普利和卡托普利是一回事吗？", "en": "Are ALTACE, ramipril, enalapril and captopril the same thing?" }, "answer": { "zh": "ALTACE 是所引美国雷米普利产品的商品名，雷米普利是通用名；依那普利和卡托普利是不同成分。即使都属于 ACE 抑制剂，也不能据此自行叠加、轮换、按毫克换算或替代。请用实际药盒、处方和完整药单由药师或开方团队核对。", "en": "ALTACE is the trade name of the cited U.S. ramipril product, while ramipril is the generic name; enalapril and captopril are different ingredients. Even though all are ACE inhibitors, that does not support self-combining, alternating, milligram conversion or substitution. Have a pharmacist or prescriber review the actual packs, prescription and complete medicine list." } }, { "question": { "zh": "ALTACE 是胶囊，能否打开或分成一半？", "en": "ALTACE is a capsule; can it be opened or divided in half?" }, "answer": { "zh": "当前美国标签对准确 ALTACE 胶囊有整粒吞服或打开后把全部内容与指定少量食物/液体混合并全部摄入的说明，但这不等于可以目测分半，也不适用于其他雷米普利胶囊、其他品牌、其他剂型、喂养管或个人情况。先核对手中准确产品和处方，再请药师确认。", "en": "The current U.S. label for the exact ALTACE capsule describes swallowing whole or opening it and mixing all contents with a specified small amount of food or liquid for complete consumption. That does not permit division by eye and does not apply automatically to another ramipril capsule, brand, dosage form, feeding tube or individual context. Check the exact product and prescription, then confirm with a pharmacist." } }, { "question": { "zh": "药单里已有缬沙坦、沙库巴曲/缬沙坦、利尿药、布洛芬或补钾，可以一起用吗？", "en": "Can ALTACE be used with valsartan, sacubitril/valsartan, a diuretic, ibuprofen or potassium?" }, "answer": { "zh": "网页不能判断个人能否同用。这些名称提示需要把全部处方药、非处方止痛药、补充剂、含钾盐替代品、血压、肾功能和电解质一起交给药师或开方团队逐项核对；不要自行叠加、错开、隔日轮换、停用或替换。", "en": "The site cannot decide individual co-use. These names signal that all prescriptions, OTC pain medicines, supplements, potassium-containing salt substitutes, blood pressure, kidney function and electrolytes need item-by-item review by a pharmacist or prescriber; do not self-combine, separate, alternate by day, stop or substitute." } } ], "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/altace/", "en": "https://origindrug.com/en/drugs/altace/" }, "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." ] }