{ "id": "entresto", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Entresto", "generic": "沙库巴曲/缬沙坦", "aliases": [ "ENTRESTO", "诺欣妥", "诺欣妥®", "沙库巴曲缬沙坦", "沙库巴曲缬沙坦钠片", "sacubitril valsartan", "sacubitril", "valsartan" ], "marketBrandNames": [ { "name": "诺欣妥®", "market": { "zh": "中国大陆（诺华中国有日期公开资料）", "en": "Mainland China (dated Novartis China public record)" }, "evidenceStatus": "first_party_brand_history", "note": { "zh": "诺华中国有日期公开资料将诺欣妥®对应为沙库巴曲缬沙坦（后续公开资料写作沙库巴曲缬沙坦钠片）。该资料建立中国商品名与通用名线索，但不在本页建立准确中国包装规格。美国 ENTRESTO 档案的 24/26、49/51、97/103 mg 片剂及两种 SPRINKLE 颗粒是美国标签产品身份，不能从“诺欣妥/ENTRESTO”或总毫克数直接跨市场换算。", "en": "A dated Novartis China public record maps Entresto® (诺欣妥®) to sacubitril/valsartan; later first-party material describes sacubitril/valsartan sodium tablets. This establishes a China trade-name and generic-name cue, not an exact Chinese package strength here. The U.S. ENTRESTO dossier's 24/26, 49/51 and 97/103 mg tablets and two SPRINKLE pellet products are U.S.-label identities and cannot be converted across markets from the names or a total milligram number." }, "source": { "id": "src_c9674ad892b8bc2c", "label": "诺华中国：诺欣妥®（沙库巴曲缬沙坦）中国获批公开资料（2021）", "url": "https://www.novartis.com.cn/news/nuoxintuo-was-approved-for-the-indication-of-high-blood-pressure-breaking-through-the-dilemma-of-no-new-drug-for-high-blood-pressure-in-the-past-10-years", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "诺欣妥®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_c9674ad892b8bc2c", "label": "诺华中国：诺欣妥®（沙库巴曲缬沙坦）中国获批公开资料（2021）", "url": "https://www.novartis.com.cn/news/nuoxintuo-was-approved-for-the-indication-of-high-blood-pressure-breaking-through-the-dilemma-of-no-new-drug-for-high-blood-pressure-in-the-past-10-years", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v25，2026-07-07 发布；不代表供应）。中国大陆“诺欣妥®”只作为诺华中国有日期公开资料约束的商品名/通用名线索；本页不据此建立准确中国包装规格、当前供应、购买资格或跨市场换算。", "dosageFormClass": "美国标签复方薄膜衣片：沙库巴曲/缬沙坦 24 mg/26 mg、49 mg/51 mg、97 mg/103 mg；另有装于胶囊壳内的口服颗粒 6 mg/6 mg、15 mg/16 mg，属于不同产品形态。中国名称线索不改变这些美国标签产品身份。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2015（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed（NLM）公开标签档案；中国大陆名称线索来自诺华中国有日期公开资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-entresto-sacubitril-24mg-valsartan-26mg-60-tablet-bottle-ndc-0078-0659-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; 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not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-entresto-sacubitril-49mg-valsartan-51mg-60-tablet-bottle-ndc-0078-0777-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; 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not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-entresto-sacubitril-97mg-valsartan-103mg-60-tablet-bottle-ndc-0078-0696-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; 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not an individual's capsule count, conversion or administration instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊帽", "en": "white capsule cap" }, "shape": { "zh": "胶囊壳内装口服颗粒", "en": "capsule shell containing oral pellets" }, "imprint": "04", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO / ENTRESTO SPRINKLE 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-entresto-sprinkle-sacubitril-15mg-valsartan-16mg-60-capsule-bottle-ndc-0078-1238-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; effective/updated 6 Jul 2026 and published 7 Jul 2026" }, "dosageForm": { "zh": "ENTRESTO SPRINKLE 沙库巴曲/缬沙坦口服颗粒（装于胶囊壳内）", "en": "ENTRESTO SPRINKLE sacubitril/valsartan oral pellets in a capsule shell" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1238-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒所含颗粒：沙库巴曲 15 mg + 缬沙坦 16 mg；60 粒瓶装", "en": "Pellets in each capsule: sacubitril 15 mg + valsartan 16 mg; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&name=ENTRESTO-22.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙库巴曲", "en": "sacubitril" }, "value": 15, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒内颗粒的标签量；不是个人粒数、换算或给药操作规则", "en": "labelled amount in the pellets of each capsule; not an individual's capsule count, conversion or administration instruction" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 16, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒内颗粒的标签量；不是个人粒数、换算或给药操作规则", "en": "labelled amount in the pellets of each capsule; not an individual's capsule count, conversion or administration instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "黄色胶囊帽", "en": "yellow capsule cap" }, "shape": { "zh": "胶囊壳内装口服颗粒", "en": "capsule shell containing oral pellets" }, "imprint": "10", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO / ENTRESTO SPRINKLE 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-entresto-sacubitril-24mg-valsartan-26mg-60-tablet-bottle-ndc-0078-0659-20", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ENTRESTO-06.jpg&setid=000dc81d-ab91-450c-8eae-8eb74e72296f&type=img", "alt": "ENTRESTO 沙库巴曲/缬沙坦在美国 DailyMed Novartis 公开标签中的 24 mg/26 mg、60 片装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Novartis，2026-07 版本）", "presentation": "ENTRESTO 沙库巴曲/缬沙坦薄膜衣片：每片 24 mg/26 mg、60 片装包装面板（NDC 0078-0659-20；DailyMed Novartis 公开标签所列）。", "notice": "此为美国 DailyMed Novartis 公开标签中明确对应 ENTRESTO、沙库巴曲/缬沙坦 24 mg/26 mg、60 片装的包装面板，只帮助核对品牌、两个成分、每片的两组标示量、口服薄膜衣片、包装数量和来源；不用于鉴定真伪，也不证明 49 mg/51 mg、97 mg/103 mg、ENTRESTO SPRINKLE 口服颗粒、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ENTRESTO 说明书放大阅读：24/26、49/51、97/103 是两个成分的产品身份", "en": "ENTRESTO label reading: 24/26, 49/51 and 97/103 identify two ingredients in one product" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签和 Novartis 包装图为阅读入口，帮助核对 ENTRESTO、沙库巴曲/缬沙坦、每片的双数字、薄膜衣片、包装与目标市场。它不提供任何人的片数、联用、转换或症状处理方案。", "en": "This module uses the U.S. DailyMed public label and Novartis package image to check ENTRESTO, sacubitril/valsartan, the two numbers per tablet, film-coated tablet, package and target market. It does not provide an individual's tablet count, combination, switching or symptom-management plan." }, "checks": [ { "zh": "24 mg/26 mg、49 mg/51 mg、97 mg/103 mg 分别是沙库巴曲和缬沙坦两种成分的标示量。不能把其中一个数字、总毫克数，或另一种缬沙坦产品的数字，当作可自行拼量、减半或替换的依据。", "en": "24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg state the labelled amounts of two ingredients: sacubitril and valsartan. Neither one number, a total milligram number nor the number on another valsartan product is a basis for self-combining, halving or substituting." }, { "zh": "美国标签把口服薄膜衣片与 ENTRESTO SPRINKLE 口服颗粒分开列出。口服颗粒的包装文字还明确要求打开胶囊壳给药、不要整粒吞服、不要咀嚼或压碎颗粒；这不表示薄膜衣片也能按同样方式处理。任何掰开、研碎、打开或换剂型的问题都要由准确产品的现行标签和药师确认。", "en": "The U.S. label lists film-coated tablets separately from ENTRESTO SPRINKLE oral pellets. Pellet packaging states that the capsule shell is opened for administration and the pellets are not swallowed whole, chewed or crushed; that does not establish the same handling for the film-coated tablet. Any splitting, crushing, opening or dosage-form switch must be confirmed from the current label for the exact product and a pharmacist." }, { "zh": "标签明确列出与 ACE 抑制剂、其他 ARB、含钾补充剂/代盐、保钾利尿剂、NSAIDs、锂盐等的关键核对事项。正在服用降压、心衰、利尿、止痛或补充剂产品时，应把完整药单和实际包装交由医生或药师核对；不要因名称相近自行叠加、停用或替换。", "en": "The label identifies important checks involving ACE inhibitors, other ARBs, potassium supplements/salt substitutes, potassium-sparing diuretics, NSAIDs and lithium. With blood-pressure, heart-failure, diuretic, pain or supplement products, have a clinician or pharmacist review the complete medicine list and actual packs; do not self-add, stop or substitute based on similar names." }, { "zh": "该标签对与 ACE 抑制剂转换和部分既往反应有明确限制，并含妊娠相关警示。这里不把标签要求变成个人转换时间表或治疗决定；开始、停用、转换、漏服或任何新不适，都应按开方团队、药师和目标市场现行标签处理。", "en": "The label contains explicit restrictions for switching with ACE inhibitors and for some prior reactions, as well as pregnancy-related warnings. This page does not turn those label requirements into an individual transition schedule or treatment decision; starting, stopping, switching, missed doses or any new concern must be addressed with the prescribing team, pharmacist and current target-market label." } ], "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "沙库巴曲/缬沙坦怎样起作用：标签描述两条同时存在的药理路径", "en": "How sacubitril/valsartan works: the label describes two simultaneous pharmacologic pathways" }, "summary": { "zh": "DailyMed 标签将 ENTRESTO 描述为脑啡肽酶抑制剂沙库巴曲与血管紧张素 II 受体阻断剂缬沙坦的复方；标签进一步说明其通过沙库巴曲活性代谢物抑制脑啡肽酶，并由缬沙坦阻断 AT1 受体。这解释标签中的药理路径，不判断个人心衰原因、是否适合使用、片数、联用或转换方案。", "en": "The DailyMed label describes ENTRESTO as a combination of the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker valsartan; it further states that sacubitril's active metabolite inhibits neprilysin while valsartan blocks the AT1 receptor. This explains label-described pharmacology, not an individual's cause of heart failure, suitability, tablet count, combination or switching plan." }, "checks": [ { "zh": "“两条作用路径”不表示可从机制推导个人该选哪种心脏药、是否需要加药，或自行把 ENTRESTO 与 ACE 抑制剂、ARB 或其他降压药叠加。完整病史、血压、肾功能、化验、既往反应和全部用药必须由专业人员一起核对。", "en": "“Two pathways” does not let a mechanism page choose a person's heart medicine, decide whether to add a medicine or self-combine ENTRESTO with an ACE inhibitor, ARB or another blood-pressure medicine. History, blood pressure, kidney function, tests, prior reactions and all medicines require professional review together." }, { "zh": "复方中的缬沙坦与单成分缬沙坦产品共享一个成分，不表示可以凭包装数字、机制或名称自行互换、补用、轮换或并用；完整产品、剂型和现行标签必须分别核对。", "en": "Valsartan in the combination shares an ingredient with single-ingredient valsartan products, but package numbers, mechanism or names do not establish self-interchangeability, catch-up use, alternation or co-use; the complete product, dosage form and current label must be checked separately." }, { "zh": "机制页面也不能判断头晕、晕厥、面部或咽喉肿胀、呼吸困难、明显乏力或其他不适的原因。出现急性或严重不适时，应优先使用当地紧急医疗支持；不要依据机制文字自行继续、停用或更改方案。", "en": "A mechanism page cannot determine the cause of dizziness, fainting, face or throat swelling, breathing difficulty, marked weakness or another symptom. With an acute or severe concern, prioritise local urgent medical support; do not self-continue, stop or change treatment from mechanism wording." } ], "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦公开标签（Clinical Pharmacology，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Entresto", "generic": "沙库巴曲/缬沙坦", "dosageFormClass": "美国标签复方薄膜衣片：沙库巴曲/缬沙坦 24 mg/26 mg、49 mg/51 mg、97 mg/103 mg；另有装于胶囊壳内的口服颗粒 6 mg/6 mg、15 mg/16 mg，属于不同产品形态。中国名称线索不改变这些美国标签产品身份。" }, "labelSource": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ENTRESTO（sacubitril/valsartan）美国公开标签将其列为复方口服薄膜衣片，分别标示沙库巴曲/缬沙坦 24 mg/26 mg、49 mg/51 mg、97 mg/103 mg；同一标签还列有口服颗粒产品。页面帮助读者把两个成分、两组标示量、准确剂型、包装与目标市场一起核对；不据此生成个人服用数量、加减量、联用、转换或停药方案。", "history": "“24/26”“49/51”“97/103”是两个活性成分各自的标示量，不是一个可自行相加、拆分或与其他缬沙坦产品互换的单一数字。美国标签还把口服薄膜衣片与 ENTRESTO SPRINKLE 口服颗粒分开列示；共享品牌或成分不表示两种产品可按 mg 对 mg 自行替换。", "sourceDocuments": [ { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 207620 / 218591", "approvalTimeline": [ { "date": "2015", "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: 2015。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: 2015. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed: ENTRESTO public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-07 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 2026-07 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_e4242a4ad9626c06", "label": "DailyMed: ENTRESTO public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "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/entresto/", "en": "https://origindrug.com/en/drugs/entresto/" }, "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." ] }