{ "id": "bystolic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "BYSTOLIC", "generic": "盐酸奈必洛尔片", "aliases": [ "Bystolic", "nebivolol", "nebivolol hydrochloride", "奈必洛尔", "盐酸奈必洛尔", "盐酸奈必洛尔片", "nebivolol tablets", "NDA 021742", "0456-1402-30", "0456-1405-90", "0456-1410-90", "0456-1420-90", "BYSTOLIC 2.5 mg", "BYSTOLIC 5 mg", "BYSTOLIC 10 mg", "BYSTOLIC 20 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 BYSTOLIC 品牌标签列出 2.5、5、10、20 mg 四种口服片及四个准确瓶装面板；FDA Orange Book 将 NDA 021742 四个规格均列为处方 RLD，并将 20 mg 列为 RS。加拿大：Health Canada DPD 当前将 BYSTOLIC 2.5、5、10、20 mg 均列为 Marketed。监管在册、官方包装图与具体渠道实时库存属于不同证据层级。", "dosageFormClass": "盐酸奈必洛尔口服片：2.5 mg、5 mg、10 mg、20 mg；四种三角形无刻痕片与准确美国瓶装身份", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007-12-17（FDA NDA 021742 的 2.5／5／10 mg 原始批准；20 mg 于 2008-10-08 批准）", "archiveSponsorText": "Allergan Sales LLC / AbbVie（美国 FDA 监管资料）；AbbVie Corporation（加拿大 DPD）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "BYSTOLIC", "Bystolic", "盐酸奈必洛尔片" ], "excludedProductCues": [ "BYVALSON", "nebivolol and valsartan", "nebivolol/valsartan", "奈必洛尔缬沙坦" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-bystolic-nebivolol-2-5mg-30-tablet-bottle-ndc-0456140230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1402-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 2.5 mg（以盐酸盐形式）；30 片瓶装", "en": "2.5 mg nebivolol per tablet (as hydrochloride); 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-03.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "三角形、无刻痕片，约 8 mm", "en": "triangular, unscored tablet, approximately 8 mm" }, "imprint": "2;1;2;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-bystolic-nebivolol-5mg-90-tablet-bottle-ndc-0456140590", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1405-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 5 mg（以盐酸盐形式）；90 片瓶装", "en": "5 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-04.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "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": "2026-08-30", "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": "米色至浅棕色", "en": "beige to light brown" }, "shape": { "zh": "三角形、无刻痕片，约 10 mm", "en": "triangular, unscored tablet, approximately 10 mm" }, "imprint": "5;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-bystolic-nebivolol-10mg-90-tablet-bottle-ndc-0456141090", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1410-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 10 mg（以盐酸盐形式）；90 片瓶装", "en": "10 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-05.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "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": "2026-08-30", "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": "紫色", "en": "purple" }, "shape": { "zh": "三角形、无刻痕片，约 10 mm", "en": "triangular, unscored tablet, approximately 10 mm" }, "imprint": "10;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-bystolic-nebivolol-20mg-90-tablet-bottle-ndc-0456142090", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1420-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 20 mg（以盐酸盐形式）；90 片瓶装；FDA RS", "en": "20 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle; FDA RS" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-06.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "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": "2026-08-30", "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": "蓝色", "en": "blue" }, "shape": { "zh": "三角形、无刻痕片，约 10 mm", "en": "triangular, unscored tablet, approximately 10 mm" }, "imprint": "20;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-bystolic-nebivolol-2-5mg-30-tablet-bottle-ndc-0456140230", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-03.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "alt": "BYSTOLIC 奈必洛尔 2.5 mg、NDC 0456-1402-30、30 片瓶装的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v31；标签正文 2024-08 修订", "presentation": "BYSTOLIC 每片奈必洛尔 2.5 mg，蓝色三角形无刻痕片，NDC 0456-1402-30，30 片瓶装。", "notice": "此图只对应当前美国标签中的 2.5 mg、NDC 0456-1402-30、30 片瓶装；不代表 5、10、20 mg、加拿大或其他市场包装、实时库存或个人片数，不用于鉴定真伪。", "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BYSTOLIC 说明书放大阅读：先核对脉搏、突然停药与重复 β 受体阻滞剂", "en": "BYSTOLIC label reading: review pulse, abrupt withdrawal and duplicate beta blockers first" }, "summary": { "zh": "先核对 BYSTOLIC、奈必洛尔、准确强度、NDC 与目标市场，再把低脉搏、头晕/晕厥、胸痛、呼吸症状、糖尿病和完整药单放在一起核对。四个 mg 数字不是与另一种 β 受体阻滞剂换算的比例。", "en": "Check BYSTOLIC, nebivolol, exact strength, NDC and target market, then review low pulse, dizziness/fainting, chest pain, breathing symptoms, diabetes and the complete medicine list together. The four milligram figures are not conversion ratios to another beta blocker." }, "checks": [ { "zh": "2.5、5、10、20 mg 分别是每片奈必洛尔标示量；30 或 90 Tablets 是瓶内片数，不是每次服用量。无刻痕只是身份线索，不能从网页推导自行掰片许可。", "en": "2.5, 5, 10 and 20 mg are labelled nebivolol amounts per tablet. '30' or '90 Tablets' is the bottle count, not the amount per dose. An unscored appearance is an identity clue and does not let the site infer self-splitting permission." }, { "zh": "标签警告不要突然停止 BYSTOLIC，尤其是冠心病患者；突然停用 β 受体阻滞剂可能使心绞痛或心肌梗死风险加重。不要因一次脉搏或血压读数自行停药，胸痛或严重急性症状使用当地急救。", "en": "The label warns against abruptly stopping BYSTOLIC, especially with coronary artery disease, because abrupt beta-blocker withdrawal may worsen angina or myocardial-infarction risk. Do not stop from one pulse or blood-pressure reading; use local emergency care for chest pain or another severe acute symptom." }, { "zh": "药单中若同时出现另一种 β 受体阻滞剂（如 TOPROL-XL、LOPRESSOR、美托洛尔、比索洛尔、TENORMIN、INDERAL LA、COREG），或地高辛、地尔硫䓬/维拉帕米、可乐定，应优先让药师或开方团队核对重复作用、心率、传导与低血压风险。", "en": "If another beta blocker (such as TOPROL-XL, LOPRESSOR/metoprolol, bisoprolol, TENORMIN, INDERAL LA or COREG), digoxin, diltiazem/verapamil or clonidine appears on the list, ask a pharmacist or prescriber to prioritise duplicate effects, heart rate, conduction and hypotension risk." }, { "zh": "标签提示奈必洛尔可能掩盖低血糖的一些警示表现；糖尿病患者不要只靠心跳加快判断低血糖。明显晕厥、严重心动过缓、呼吸困难、面唇舌喉肿胀或持续胸痛需要及时医疗评估，严重急性表现使用当地急救。", "en": "The label says nebivolol may mask some warning features of hypoglycaemia; a person with diabetes should not rely only on a racing heart to detect low glucose. Fainting, severe bradycardia, breathing difficulty, swelling of the face/lips/tongue/throat or persistent chest pain requires prompt medical assessment; severe acute features require local emergency care." } ], "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "BYSTOLIC 怎样起作用：以 β1 受体阻滞为主，并有一氧化氮相关血管舒张线索", "en": "How BYSTOLIC works: primarily beta-1 blockade with nitric-oxide-associated vasodilation" }, "summary": { "zh": "当前标签描述奈必洛尔在较低浓度下以 β1 选择性阻滞为主，并提示奈必洛尔及其代谢物与内皮来源一氧化氮相关血管舒张有关。机制帮助理解它为什么会影响心率与血压，但不能决定个人剂量、能否与另一种减慢心率药联用或何时停换。", "en": "The current label describes nebivolol as predominantly beta-1 selective at lower concentrations and notes nitric-oxide-associated vasodilation involving nebivolol and its metabolites. This helps explain effects on heart rate and blood pressure but cannot determine an individual's dose, combination with another rate-slowing medicine or withdrawal/switching." }, "checks": [ { "zh": "“同为 β 受体阻滞剂”不表示 BYSTOLIC、美托洛尔、比索洛尔、阿替洛尔、普萘洛尔和卡维地洛可以按 mg 一对一换算或轮换服用。每款药的成分、选择性、剂型和标签边界不同。", "en": "Sharing the beta-blocker class does not make BYSTOLIC, metoprolol, bisoprolol, atenolol, propranolol and carvedilol one-to-one milligram conversions or medicines to alternate. Ingredient, selectivity, form and label boundaries differ." }, { "zh": "强 CYP2D6 抑制剂可能增加奈必洛尔暴露，标签举例包括氟西汀和帕罗西汀。用药核对比仅凭商品名或一次血压值更重要，不应自行停用精神科药或降压药。", "en": "Strong CYP2D6 inhibitors may increase nebivolol exposure; the label gives fluoxetine and paroxetine as examples. Medicine-list review is more useful than relying on a brand name or one blood-pressure reading, and neither psychiatric nor blood-pressure medicine should be self-stopped." }, { "zh": "标签讨论 CYP2D6 快/慢代谢者的暴露差异，但同时说明其临床重要性通常低于仅靠母体药物作用的情形，因为活性代谢物也有贡献。这不是网页默认推荐全基因组检测或据基因结果自行换药的依据。", "en": "The label discusses CYP2D6 extensive/poor-metaboliser exposure differences, while noting that clinical importance is usually less than for drugs acting only through the parent compound because active metabolites also contribute. This is not a basis for default whole-genome testing or self-switching from a genetic result." } ], "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BYSTOLIC", "generic": "盐酸奈必洛尔片", "dosageFormClass": "盐酸奈必洛尔口服片：2.5 mg、5 mg、10 mg、20 mg；四种三角形无刻痕片与准确美国瓶装身份" }, "labelSource": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "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_38e20404283186a8", "label": "FDA Drugs@FDA：BYSTOLIC NDA 021742 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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": "2026-08-30", "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": "BYSTOLIC 是奈必洛尔的美国品牌片。它属于 β 受体阻滞剂，但不等于美托洛尔、比索洛尔、阿替洛尔、普萘洛尔或卡维地洛，不能按毫克数自行换算、轮换或叠加。老人查看这款药时，先核对准确强度和药盒，再把静息脉搏过慢、头晕或晕厥、糖尿病低血糖警示、肾肝功能和完整药单带给医生或药师。标签警告不要突然停用；网页不生成个人片数、频次、停换药或补服方案。", "history": "FDA 于 2007-12-17 批准 BYSTOLIC NDA 021742 的 2.5、5、10 mg，20 mg 于 2008-10-08 批准。当前美国标签写有 Initial U.S. Approval: 2007，并保留四个品牌规格。标签还记录该产品曾由 Mylan Laboratories 授权，并涉及 Janssen Pharmaceutica N.V. 的许可历史；当前品牌监管记录由 Allergan Sales LLC / AbbVie 体系维护。加拿大官方 DPD 当前列出四种规格均为 Marketed。上述节点用于追溯产品与市场记录，不等于具体药房库存。", "sourceDocuments": [ { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "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_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 BYSTOLIC 与 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" }, { "id": "src_38e20404283186a8", "label": "FDA Drugs@FDA：BYSTOLIC NDA 021742 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 021742（BYSTOLIC／nebivolol；四规格 RLD；20 mg 为 RS）", "approvalTimeline": [ { "date": "2007-12-17", "title": { "zh": "FDA 批准 BYSTOLIC 2.5／5／10 mg", "en": "FDA approved BYSTOLIC 2.5, 5 and 10 mg" }, "detail": { "zh": "Orange Book 当前数据将三款规格与 NDA 021742、处方 RLD 和该批准日期相连。", "en": "Current Orange Book data connect the three strengths with NDA 021742, prescription RLD status and this approval date." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "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": "2008-10-08", "title": { "zh": "FDA 批准 BYSTOLIC 20 mg", "en": "FDA approved BYSTOLIC 20 mg" }, "detail": { "zh": "Orange Book 当前数据将 20 mg 列为 RLD 与 RS。RS 只是一项美国参比标准监管字段，不是个人优选药结论。", "en": "Current Orange Book data list 20 mg as both RLD and RS. RS is a U.S. regulatory reference-standard field, not an individual preferred-medicine conclusion." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "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": "2024-08", "title": { "zh": "美国品牌标签修订", "en": "U.S. brand label revised" }, "detail": { "zh": "当前 DailyMed SPL v31 保留四种规格和处方信息；本页据此更新包装、禁忌、停药、相互作用和老人阅读边界。", "en": "Current DailyMed SPL v31 retains four strengths and prescribing information; this page uses it for package, contraindication, withdrawal, interaction and older-reader boundaries." }, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD 规格当前在册；20 mg 为 RS", "en": "Four prescription RLD strengths currently listed; 20 mg is the RS" }, "detail": { "zh": "当前标签逐一建立四个准确瓶装面板；监管在册和标签面板不代表具体药房实时库存或购买资格。", "en": "The current label establishes four exact bottle panels. Regulatory listing and label panels do not establish live pharmacy stock or purchasing eligibility." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "四个规格当前均列为 Marketed", "en": "All four strengths currently listed as Marketed" }, "detail": { "zh": "Health Canada DPD 列出 DIN 02398990、02399008、02399016、02399024 与 AbbVie Corporation；不把加拿大状态外推美国或其他市场。", "en": "Health Canada's DPD lists DIN 02398990, 02399008, 02399016 and 02399024 with AbbVie Corporation. Canadian status is not projected onto the United States or another market." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立准确现行监管产品记录", "en": "Exact current regulatory product records not established" }, "detail": { "zh": "不从美国/加拿大商品名、通用名、mg 数字或包装颜色推定当地批准、品牌、供应、原研/参比关系或可替代性。", "en": "No local approval, brand, supply, originator/reference relationship or interchangeability is inferred from U.S./Canadian names, milligram figures or pack colours." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BYSTOLIC 和美托洛尔、比索洛尔是一种药吗？", "en": "Is BYSTOLIC the same medicine as metoprolol or bisoprolol?" }, "answer": { "zh": "不是。它们都可能属于 β 受体阻滞剂，但活性成分和产品不同，不能按 mg 自行换算、一天一种轮换或重复叠加。请让药师或开方团队核对准确药盒和目的。", "en": "No. They may share the beta-blocker class, but active ingredients and products differ. Do not self-convert milligrams, alternate by day or duplicate them. Ask the pharmacist or prescriber to review the exact packs and purposes." } }, { "question": { "zh": "脉搏慢或头晕，可以立刻停药吗？", "en": "Can the medicine be stopped immediately for a slow pulse or dizziness?" }, "answer": { "zh": "网页不能决定停药。标签同时提示严重心动过缓等风险和突然停用的冠心病风险。记录症状、脉搏、血压及全部药盒，及时联系负责团队；晕厥、胸痛、呼吸困难或其他严重急性表现使用当地急救。", "en": "A webpage cannot decide withdrawal. The label covers risks such as severe bradycardia and coronary risk from abrupt discontinuation. Record symptoms, pulse, blood pressure and every pack, and contact the responsible team promptly; use local emergency care for fainting, chest pain, breathing difficulty or another severe acute feature." } }, { "question": { "zh": "需要做 CYP2D6 或全基因组检测才能用这款药吗？", "en": "Is CYP2D6 or whole-genome testing required to use this medicine?" }, "answer": { "zh": "当前标签讨论 CYP2D6 暴露差异和强抑制剂相互作用，但没有把全基因组检测写成所有人的默认前提。先核对完整药单、脉搏、肾肝功能、既往反应和临床问题；是否需要特定检测由负责团队判断。", "en": "The current label discusses CYP2D6 exposure differences and strong-inhibitor interactions, but does not make whole-genome testing a default prerequisite for everyone. Review the complete medicine list, pulse, kidney/liver function, prior response and clinical question first; the responsible team decides whether a specific test is needed." } }, { "question": { "zh": "无刻痕片能不能掰开？", "en": "Can an unscored tablet be split?" }, "answer": { "zh": "无刻痕是准确产品外观线索，但网页不会由此单独推断可以或绝对不可以分片。吞咽困难、需更改强度或药片破损时，请带准确药盒让药师核对该产品说明书和可行替代剂型。", "en": "An unscored tablet is an exact-product appearance clue, but the site does not infer splitting permission or prohibition from that fact alone. For swallowing difficulty, strength changes or a damaged tablet, take the exact pack to a pharmacist to review the product label and an appropriate alternative form." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/bystolic/", "en": "https://origindrug.com/en/drugs/bystolic/" }, "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." ] }