{ "id": "bisoprolol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "康忻® / CONCOR® / CARDICOR", "generic": "比索洛尔", "aliases": [ "Bisoprolol", "bisoprolol fumarate", "比索洛尔富马酸盐", "康忻", "Concor", "Cardicor", "比索洛尔", "富马酸比索洛尔", "68788-8671-1", "29300-126" ], "marketBrandNames": [ { "name": "康忻® / Concor®", "market": { "zh": "中国大陆及跨市场企业品牌页", "en": "Mainland China and cross-market company brand page" }, "evidenceStatus": "company_product_page_name_and_strength_cue", "note": { "zh": "默克中国企业页面将康忻®／Concor®列为比索洛尔产品家族。本条只用于核对药盒文字与通用名线索；不确认任何具体国家或地区的现行批准、持有人、准确规格/包装、供应、可售资格、真伪或与其他比索洛尔产品可替代。", "en": "Merck China's company page identifies 康忻®/Concor® as a bisoprolol product family. This entry is only for checking pack text and the generic-name cue; it does not establish current authorisation, holder, exact strength/package, supply, sale eligibility, authenticity or interchangeability with another bisoprolol product in any country or region." }, "source": { "id": "src_cf1b33adecdebf99", "label": "默克中国：康忻® / Concor® 比索洛尔产品家族页面", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/concor-concorcor.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "CONCOR / CONCOR COR", "market": { "zh": "欧洲多国有日期授权清单", "en": "Dated authorisation list across multiple European countries" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "EMA 的 2020 年 PSUSA 国家授权清单列出多个由 Merck 实体持有的 Concor／Concor COR 规格。本条证明该清单时点的品牌与授权记录，不证明 2026 年任一国家的现行供应、准确包装、可售资格或可替代性。", "en": "The EMA's 2020 PSUSA national-authorisation list includes multiple Concor/Concor COR strengths held by Merck entities. This establishes brand and authorisation records at that dated list, not current 2026 supply, exact packaging, sale eligibility or interchangeability in any country." }, "source": { "id": "src_056081cbddfa3b1f", "label": "EMA：比索洛尔国家授权产品清单（PSUSA/00000419/201909）", "url": "https://www.ema.europa.eu/documents/psusa/bisoprolol-list-nationally-authorised-medicinal-products-psusa/00000419/202009_.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "CARDICOR", "market": { "zh": "英国公开药品信息", "en": "UK public medicine information" }, "evidenceStatus": "dated_public_product_label", "note": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC/PIL 合并列出六种薄膜衣片强度；内容最后更新 2020-11-17。它是英国产品资料入口，不替代中国大陆康忻或其他市场现行说明书。", "en": "The currently accessible UK emc Merck Cardicor SmPC/PIL jointly lists six film-coated tablet strengths; its content was last updated on 17 Nov 2020. It is a UK product-information route and does not replace the current label for Concor in Mainland China or another market." }, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "默克中国企业页面将康忻®／Concor®列为比索洛尔产品家族；EMA 2020 年 PSUSA 国家授权清单列有多个 Merck 的 Concor／Concor COR 产品；英国 eMC 当前可访问的 Merck Cardicor SmPC／PIL 合并列出 1.25、2.5、3.75、5、7.5、10 mg 薄膜衣片（文件内容最后更新 2020-11-17）。美国另列 DailyMed 2026-03-20 更新的再包装通用药标签。各来源只约束其市场、时间和准确文件，不互相证明现行供应、包装、可售资格或可替代性。", "dosageFormClass": "富马酸比索洛尔薄膜衣口服片：英国 Cardicor 1.25、2.5、3.75、5、7.5、10 mg；美国再包装标签 5、10 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "欧盟 2020 年 PSUSA 授权清单与现行可访问品牌资料均为来源节点；初始批准年份不在本页推定", "archiveSponsorText": "Merck 品牌家族资料／EMA 国家授权清单／英国 eMC Merck Cardicor 说明书；另列美国再包装通用药标签作比较" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-bisoprolol-fumarate-tablets-5-and-10mg-repackaged-label-ndc-68788-8671-1", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-03-20 更新；再包装标签）", "en": "Current U.S. DailyMed public label (updated 20 Mar 2026; repackaged label)" }, "dosageForm": { "zh": "富马酸比索洛尔口服片", "en": "bisoprolol fumarate oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 68788-8671-1 (source NDC 29300-126)", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "5 mg、10 mg 每片标示量（美国标签）", "en": "5 mg and 10 mg labelled per tablet (U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "5 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "5 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } }, { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "10 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "10 mg labelled per tablet; 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current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 5 mg（英国说明书文字身份）", "en": "Cardicor 5 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "黄白色", "en": "yellowish white" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "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": "gb-cardicor-bisoprolol-fumarate-7-5mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 7.5 mg（英国说明书文字身份）", "en": "Cardicor 7.5 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅黄色", "en": "pale yellow" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "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": "gb-cardicor-bisoprolol-fumarate-10mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 10 mg（英国说明书文字身份）", "en": "Cardicor 10 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅橙色至淡橙色", "en": "pale orange to light orange" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "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": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "Cardicor 已核验文字外观、美国资料为再包装标签；均不冒充准确原品牌包装图", "en": "Cardicor text appearance is verified and the U.S. record is repackaged; neither is presented as an exact original-brand package image" }, "summary": { "zh": "英国 Cardicor SmPC 提供六种片剂的颜色、形状与刻痕文字，但未提供可与单一强度、单一包装逐一对应的公开精确药盒图；美国 DailyMed 页面则明确是再包装标签。为避免把说明书文字、再包装图或其他市场零售图误读为康忻／Concor／Cardicor 的准确原品牌药盒，本页以文字身份卡展示外观和强度，并保留原始说明书链接供放大阅读。", "en": "The UK Cardicor SmPC provides colour, shape and score wording for six tablets but no public exact pack image matched one to one to a single strength and package; the U.S. DailyMed page is explicitly repackaged. To avoid treating label text, a repackaged image or another-market retail image as an exact Concor/Cardicor original-brand pack, the page uses text identity cards for appearance and strength and retains primary label links for enlarged reading." }, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "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": "康忻 / Concor / Cardicor 说明书放大阅读：先分清品牌、市场、每片 mg 和刻痕", "en": "Concor / Cardicor label reading: first separate brand, market, mg per tablet and score status" }, "summary": { "zh": "本模块同时提供默克中国品牌家族、EMA 有日期授权清单、英国 eMC Merck Cardicor SmPC/PIL 和美国再包装通用药标签入口。它帮助核对品牌、富马酸比索洛尔、薄膜衣片、每片强度、外观和文件市场；不能给出任何人的片数、服用时间、漏用处理、分片、停用、换药或联用答案。", "en": "This module links the Merck China brand family, a dated EMA authorisation list, UK emc Merck Cardicor SmPC/PIL and a U.S. repackaged generic label. It helps check brand, bisoprolol fumarate, film-coated tablet, per-tablet strength, appearance and document market; it cannot provide anyone's tablet count, timing, missed-use handling, splitting, stopping, switching or combination plan." }, "checks": [ { "zh": "先把康忻／Concor／Cardicor 或实际商品名、富马酸比索洛尔、薄膜衣口服片、每片 mg、实际包装和目标市场一起核对。共同写有“比索洛尔”或相同数字，不证明另一强度、另一品牌、另一种 β 受体阻断剂或另一市场产品可以自行替换、叠加或轮换。", "en": "Check Concor, Cardicor or the actual trade name, bisoprolol fumarate, film-coated oral tablet, mg per tablet, actual pack and target market together. A shared bisoprolol name or number does not prove that another strength, brand, beta-blocker or another-market product can be self-substituted, combined or alternated." }, { "zh": "英国 Cardicor SmPC 合并列出 1.25、2.5、3.75、5、7.5、10 mg；美国再包装标签列 5、10 mg。它们是各自文件中区分准确片剂的每片标示量，不是网页可转成“每天几颗”、把两种规格相加、改时点或漏用后补用的公式。", "en": "The UK Cardicor SmPC jointly lists 1.25, 2.5, 3.75, 5, 7.5 and 10 mg; the U.S. repackaged label lists 5 and 10 mg. These distinguish exact tablets in their own documents, not a webpage formula for how many per day, adding strengths, changing timing or making up missed use." }, { "zh": "标签将比索洛尔描述为 β1 选择性（心脏选择性）肾上腺素能受体阻断剂，并提醒这种选择性并非绝对。看到心率、血压、呼吸不适、晕厥、明显头晕，或准备手术/牙科操作时，应使用当地医疗与开方团队渠道；不要据此页面自行增减、骤停或改用另一种心血管药。", "en": "The label describes bisoprolol as a beta1-selective (cardioselective) adrenoceptor blocker and notes that this selectivity is not absolute. With heart-rate or blood-pressure concerns, breathing difficulty, fainting, marked dizziness, or a planned surgical/dental procedure, use local medical and prescribing-team channels; do not self-adjust, abruptly stop or change to another cardiovascular medicine from this page." }, { "zh": "英国 Cardicor SmPC 说明 2.5–10 mg 的所列刻痕片可以等分，但这是该准确 Cardicor 文件的产品特异文字，不自动适用于康忻、Concor、美国通用药或其他厂家的片剂，也不代表任何人应掰片。是否分片必须结合实际包装、现行本地说明书、处方和药师/开方团队核对。", "en": "The UK Cardicor SmPC says the listed scored 2.5–10 mg tablets can be divided into equal doses, but that is product-specific wording for the exact Cardicor document. It does not automatically apply to Concor, a U.S. generic or another maker's tablet, and does not mean anyone should split a tablet. Splitting requires the actual pack, current local label, prescription and pharmacist/prescriber review." }, { "zh": "若药单还有美托洛尔、卡维地洛、地高辛、可乐定、维拉帕米、地尔硫卓、胺碘酮、降糖药、滴眼液中的 β 受体阻断剂、非处方药或补充剂，应将每一种实际药盒和完整药单一起交给药师或开方团队核对。不要因都写“心脏”“血压”或“β 受体阻断剂”就自行合并、错开或替换。", "en": "If the list also includes metoprolol, carvedilol, digoxin, clonidine, verapamil, diltiazem, amiodarone, glucose-lowering medicines, a beta-blocker eye drop, OTC product or supplement, take every actual pack and the complete medicine list to a pharmacist or prescriber. Do not self-combine, time-separate or substitute products merely because they mention the heart, blood pressure or beta blockade." } ], "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；说明书放大阅读入口）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "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": "比索洛尔怎样起作用：β1 选择性解释的是路径，不是个人方案", "en": "How bisoprolol works: beta1 selectivity explains a pathway, not an individual plan" }, "summary": { "zh": "该美国公开标签将富马酸比索洛尔描述为合成的 β1 选择性（心脏选择性）肾上腺素能受体阻断剂；高剂量时其选择性并非绝对。这个机制帮助读者理解类别与为何需审核完整药单，不能预测个人心率、血压、呼吸情况、适用性或任何联合用药方案。", "en": "The U.S. public label describes bisoprolol fumarate as a synthetic beta1-selective (cardioselective) adrenoceptor blocker; at higher doses its selectivity is not absolute. This mechanism helps explain the class and why a complete medicine list needs review; it cannot predict individual heart rate, blood pressure, breathing, suitability or any combination plan." }, "checks": [ { "zh": "“β1 选择性”描述的是受体作用的相对倾向，不是凭网页判断某个人一定适合、一定耐受，或能否与另一种心率/血压相关药一起使用的结论。既往反应、呼吸病史、检查结果、完整药单和准确产品标签都需要专业人员一起核对。", "en": "‘Beta1 selectivity’ describes a relative receptor tendency; it is not a webpage conclusion that a person is definitely suitable, will definitely tolerate it, or can use it with another heart-rate/blood-pressure-related medicine. Prior reactions, respiratory history, tests, the complete medicine list and the exact product label all need professional review." }, { "zh": "药物类别或机制相近，不建立比索洛尔与美托洛尔、卡维地洛或其他 β 受体阻断剂之间的个人换算、同日叠加、隔天轮换或互换关系。名称、盐型、强度、剂型、市场标签和处方都是产品身份的一部分。", "en": "A similar class or mechanism does not establish personal conversion, same-day combination, alternate-day use or interchangeability between bisoprolol, metoprolol, carvedilol or another beta-blocker. Name, salt, strength, dosage form, market label and prescription are all part of product identity." }, { "zh": "老年人或多药并用时，机制解释尤其不能代替逐项核对：请带上所有药盒、处方标签、非处方药和补充剂，并记下实际服用时间和不适，交由药师或开方团队阅读。", "en": "For older people or people using multiple medicines, a mechanism explanation especially cannot replace item-by-item review: bring all packs, prescription labels, OTC products and supplements, and note actual timing and symptoms for a pharmacist or prescribing team to review." } ], "source": { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；Clinical Pharmacology；2026-03-20 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "康忻® / CONCOR® / CARDICOR", "generic": "比索洛尔", "dosageFormClass": "富马酸比索洛尔薄膜衣口服片：英国 Cardicor 1.25、2.5、3.75、5、7.5、10 mg；美国再包装标签 5、10 mg" }, "labelSource": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "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_9bf2e9f496055438", "label": "英国 eMC：Merck Cardicor 患者说明书 PIL（产品 7765）", "url": "https://www.medicines.org.uk/emc/product/7765/pil", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "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_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；2026-03-20 更新；再包装标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "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": "康忻®／Concor®／Cardicor 与比索洛尔属于同一默克品牌家族线索，但不同国家、商品名、适应范围、强度和包装必须分别核对。英国 Cardicor 资料列有六种每片强度，美国资料则是再包装通用药标签。本页把品牌、通用名、盐型、每片 mg、外观和文件市场并列，帮助老人和家属先认清手中药；不把任何 mg 或刻痕写成个人片数、开始/停用、掰片、换药或联用方案。", "history": "默克中国品牌页、EMA 2020 年国家授权清单和英国 eMC Merck Cardicor SmPC/PIL 共同提供跨市场品牌与文件线索；美国 DailyMed 标签明确是再包装通用药资料。它们不能混成一张‘全球统一药盒’，也不能从 Cardicor 的刻痕说明推到康忻、Concor、美国通用药或其他厂家的片剂。", "sourceDocuments": [ { "id": "src_cf1b33adecdebf99", "label": "默克中国：康忻® / Concor® 比索洛尔产品家族页面", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/concor-concorcor.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_056081cbddfa3b1f", "label": "EMA：比索洛尔国家授权产品清单（PSUSA/00000419/201909；有日期历史监管清单）", "url": "https://www.ema.europa.eu/documents/psusa/bisoprolol-list-nationally-authorised-medicinal-products-psusa/00000419/202009_.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_9bf2e9f496055438", "label": "英国 eMC：Merck Cardicor 患者说明书 PIL（产品 7765）", "url": "https://www.medicines.org.uk/emc/product/7765/pil", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；2026-03-20 更新；再包装标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "跨市场来源：EMA PSUSA/00000419/201909 国家授权清单；UK eMC product 7765 Cardicor；DailyMed SPL setid c0e309f3-82c3-4629-b790-fb8538b87369（美国再包装标签）", "approvalTimeline": [ { "date": "2020-09", "title": { "zh": "EMA 比索洛尔国家授权产品清单", "en": "EMA national-authorisation list for bisoprolol" }, "detail": { "zh": "EMA 的 PSUSA/00000419/201909 清单列出多个由 Merck 实体持有的 Concor、Concor COR、Cardicor 等国家授权产品与强度。该清单只证明文件时点的授权记录，不证明 2026 年任何国家的现行供应、准确包装、可售资格、真伪或可替代性。", "en": "The EMA PSUSA/00000419/201909 list records multiple nationally authorised Concor, Concor COR, Cardicor and related strengths held by Merck entities. It establishes records at the document date, not current 2026 supply, exact packaging, sale eligibility, authenticity or interchangeability in any country." }, "source": { "id": "src_056081cbddfa3b1f", "label": "EMA：比索洛尔国家授权产品清单（PSUSA/00000419/201909）", "url": "https://www.ema.europa.eu/documents/psusa/bisoprolol-list-nationally-authorised-medicinal-products-psusa/00000419/202009_.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020-11-17", "title": { "zh": "英国 Cardicor SmPC 内容更新节点", "en": "UK Cardicor SmPC content-update node" }, "detail": { "zh": "英国 eMC 的 Merck Cardicor SmPC 合并列出 1.25、2.5、3.75、5、7.5、10 mg 薄膜衣片、外观和刻痕说明。页面在 2026-08-30 仍可公开访问，但内容最后更新日期为 2020-11-17；因此本档案把它作为有日期的英国说明书来源，不把它写成实时库存或全球通用标签。", "en": "The UK emc Merck Cardicor SmPC jointly lists 1.25, 2.5, 3.75, 5, 7.5 and 10 mg film-coated tablets, appearance and score wording. The page remained publicly accessible on 30 Aug 2026, but its content was last updated on 17 Nov 2020; this dossier therefore treats it as dated UK product information, not live stock or a globally uniform label." }, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-03-20", "title": { "zh": "DailyMed 当前美国公开标签更新", "en": "Current U.S. DailyMed public label updated" }, "detail": { "zh": "DailyMed 将该 BISOPROLOL FUMARATE 口服片公开标签的 Updated 日期列为 2026-03-20，包装方为 Preferred Pharmaceuticals Inc.，并明确其为再包装标签。该节点仅定位 5 mg／10 mg 片剂、NDC 68788-8671-1 与来源 NDC 29300-126 的美国标签；不建立原品牌、实际在售、库存、购买、个人片数、分片、联用或换药结论。", "en": "DailyMed lists 20 Mar 2026 as the Updated date for this BISOPROLOL FUMARATE oral-tablet public label, identifies Preferred Pharmaceuticals Inc. as packager, and explicitly marks it repackaged. This node only locates the U.S. label for 5 mg/10 mg tablets, NDC 68788-8671-1 and source NDC 29300-126; it does not establish an original brand, actual availability, stock, purchase, individual tablet count, splitting, co-use or switching." }, "source": { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；2026-03-20 更新；再包装标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开再包装标签；未展示为原品牌包装", "en": "Current repackaged public label linked; not displayed as an original-brand package" }, "detail": { "zh": "本页只链接该美国标签的比索洛尔富马酸盐 5 mg／10 mg 口服片、NDC 68788-8671-1 和来源 NDC 29300-126。标签虽含包装图片，但已明确为再包装资料，因而不用于本页原品牌外观；也不建立实际在售、库存、购买、真伪、个人片数、频率、停用、换药或可替代性。", "en": "This page links only the U.S. label's bisoprolol fumarate 5 mg/10 mg oral tablets, NDC 68788-8671-1 and source NDC 29300-126. Although the label contains a package image, it is explicitly repackaged and is not used here as original-brand appearance; it also does not establish actual availability, stock, purchase, authenticity, individual tablet count, frequency, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆品牌线索", "en": "Mainland China brand cue" }, "status": { "zh": "已链接默克中国康忻®／Concor®产品家族页；现行批准与包装仍需监管记录", "en": "Merck China Concor brand-family page linked; current authorisation and packaging still require regulatory records" }, "detail": { "zh": "默克中国企业页确认康忻®／Concor®与比索洛尔产品家族的关系，但不把企业品牌介绍替代为现行批准说明书、准确包装、供应或可售资格结论。", "en": "The Merck China company page confirms the relationship between Concor and the bisoprolol product family, but a company brand page does not replace a current approved label or establish exact packaging, supply or sale eligibility." } }, { "market": { "zh": "英国及欧洲有日期资料", "en": "Dated UK and European material" }, "status": { "zh": "已链接 Cardicor SmPC/PIL 与 EMA 国家授权清单", "en": "Cardicor SmPC/PIL and EMA national-authorisation list linked" }, "detail": { "zh": "页面建立 Cardicor 六种薄膜衣片的文字身份卡，并链接 EMA 的有日期国家授权清单。二者只在各自文件范围内提供品牌、强度、外观与授权线索，不证明 2026 年实时供应或跨市场替代。", "en": "The page builds text identity cards for six Cardicor film-coated tablets and links the dated EMA national-authorisation list. Each source provides brand, strength, appearance or authorisation cues only within its own document scope; neither proves real-time 2026 supply or cross-market substitution." } }, { "market": { "zh": "日本及其他市场", "en": "Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从中国、英国、EMA 或美国资料推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from Chinese, UK, EMA or U.S. material; every market requires separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签有 5 mg、10 mg，我能不能靠掰开、两种规格相加或换另一种 β 受体阻断剂来自己调整？", "en": "The label has 5 mg and 10 mg. Can I adjust myself by splitting, adding strengths or switching to another beta-blocker?" }, "answer": { "zh": "不能。5 mg、10 mg 是这个美国标签中准确片剂的身份字段；它们不建立个人片数、是否可掰、补用、加减、同日叠加、隔天轮换或与另一种 β 受体阻断剂换算的规则。请带着实际药盒、现行处方和完整药单交给药师或开方团队核对。", "en": "No. 5 mg and 10 mg are identity fields for exact tablets in this U.S. label; they do not establish individual tablet count, splitting, make-up use, adjustment, same-day combination, alternate-day use or conversion with another beta-blocker. Take the actual pack, current prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "英国 Cardicor 说明书说刻痕片可以等分，我手里的康忻或比索洛尔也能照做吗？", "en": "The UK Cardicor label says scored tablets can be divided equally. Can I apply that to my Concor or bisoprolol tablet?" }, "answer": { "zh": "不能跨产品照搬。该文字只约束英国 Cardicor 文件列出的准确片剂；康忻、Concor、美国通用药或其他厂家的处方、刻痕功能、辅料、片型和本地说明书可能不同。是否分片必须由实际药盒、现行本地说明书、处方和药师/开方团队共同确认。", "en": "Do not carry that wording across products. It applies only to the exact tablets listed in the UK Cardicor document; the prescription, functional score, excipients, tablet design and local label may differ for Concor, a U.S. generic or another maker. Splitting requires confirmation using the actual pack, current local label, prescription and pharmacist/prescriber review." } }, { "question": { "zh": "为什么页面不展示这份美国标签里的包装照片？", "en": "Why does the page not display the package photo in this U.S. label?" }, "answer": { "zh": "该 DailyMed 页面明确标为再包装标签。为了不把再包装图误读成原研、原品牌或其他市场的准确外观，本页保留可阅读的原始标签链接，却不把该图展示为原品牌包装。", "en": "This DailyMed page is explicitly identified as a repackaged label. To avoid reading a repackaged image as an originator, original-brand or another-market exact appearance, this page retains the readable primary-label link but does not display that image as an original-brand package." } } ], "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/bisoprolol/", "en": "https://origindrug.com/en/drugs/bisoprolol/" }, "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." ] }