{ "id": "procardia-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Procardia XL", "generic": "硝苯地平", "aliases": [ "拜新同", "nifedipine", "nifedipine GITS", "nifedipine extended release", "硝苯地平控释片", "硝苯地平" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "拜新同®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_a92ef31704391cdb", "label": "烟台市人民政府：2024 年药品规格及价格记录中的拜新同／硝苯地平控释片 30 mg 记录", "url": "https://www.yantai.gov.cn/art/2023/12/29/art_67240_3168957.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服控释片（GITS；30、60、90 mg；DailyMed 2025 标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989（DailyMed 美国标签档案列示 NDA019684 的起始日期）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "nifedipine immediate release", "immediate release nifedipine", "procardia capsule", "nifedipine capsule", "硝苯地平普通片", "硝苯地平胶囊", "硝苯地平速释" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-procardia-xl-gits-tablet-30mg-ndc-0069-2650-66", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19，2025-12-16 更新；2025-12-17 发布", "en": "DailyMed SPL v19, updated 16 Dec 2025 and published 17 Dec 2025" }, "dosageForm": { "zh": "PROCARDIA XL 硝苯地平 GITS 控释口服片", "en": "PROCARDIA XL nifedipine GITS controlled-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-2650-66", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片标示 30 mg；每片实际含 33 mg；100 片瓶装（GITS 控释片）", "en": "30 mg labelled strength; 33 mg tablet content; 100-tablet bottle (GITS controlled-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示给药强度；不是个人片数或换算规则", "en": "labelled delivery strength per tablet; not an individual tablet-count or conversion rule" } }, { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 33, "unit": "mg", "basisCode": "tablet_content", "basisLabel": { "zh": "标签说明的每片实际含量；与标示给药强度分开阅读", "en": "tablet content stated by the label; read separately from labelled delivery strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "玫瑰粉色", "en": "rose-pink" }, "shape": { "zh": "圆形、双凸薄膜衣控释片", "en": "round biconvex film-coated controlled-release tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 硝苯地平 30 mg GITS、100 片瓶装（Pfizer；SPL v19，2025-12-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-procardia-xl-gits-tablet-60mg-ndc-0069-2660-66", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19，2025-12-16 更新；2025-12-17 发布", "en": "DailyMed SPL v19, updated 16 Dec 2025 and published 17 Dec 2025" }, "dosageForm": { "zh": "PROCARDIA XL 硝苯地平 GITS 控释口服片", "en": "PROCARDIA XL nifedipine GITS controlled-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-2660-66", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片标示 60 mg；每片实际含 66 mg；100 片瓶装（GITS 控释片）", "en": "60 mg labelled strength; 66 mg tablet content; 100-tablet bottle (GITS controlled-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示给药强度；不是个人片数或换算规则", "en": "labelled delivery strength per tablet; not an individual tablet-count or conversion rule" } }, { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 66, "unit": "mg", "basisCode": "tablet_content", "basisLabel": { "zh": "标签说明的每片实际含量；与标示给药强度分开阅读", "en": "tablet content stated by the label; read separately from labelled delivery strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "玫瑰粉色", "en": "rose-pink" }, "shape": { "zh": "圆形、双凸薄膜衣控释片", "en": "round biconvex film-coated controlled-release tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 硝苯地平 60 mg GITS、100 片瓶装（Pfizer；SPL v19，2025-12-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-procardia-xl-gits-tablet-90mg-ndc-0069-2670-66", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19，2025-12-16 更新；2025-12-17 发布", "en": "DailyMed SPL v19, updated 16 Dec 2025 and published 17 Dec 2025" }, "dosageForm": { "zh": "PROCARDIA XL 硝苯地平 GITS 控释口服片", "en": "PROCARDIA XL nifedipine GITS controlled-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-2670-66", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片标示 90 mg；每片实际含 99 mg；100 片瓶装（GITS 控释片）", "en": "90 mg labelled strength; 99 mg tablet content; 100-tablet bottle (GITS controlled-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 90, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示给药强度；不是个人片数或换算规则", "en": "labelled delivery strength per tablet; not an individual tablet-count or conversion rule" } }, { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 99, "unit": "mg", "basisCode": "tablet_content", "basisLabel": { "zh": "标签说明的每片实际含量；与标示给药强度分开阅读", "en": "tablet content stated by the label; read separately from labelled delivery strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "玫瑰粉色", "en": "rose-pink" }, "shape": { "zh": "圆形、双凸薄膜衣控释片", "en": "round biconvex film-coated controlled-release tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 硝苯地平 90 mg GITS、100 片瓶装（Pfizer；SPL v19，2025-12-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-procardia-xl-gits-tablet-30mg-ndc-0069-2650-66", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-03.jpg", "alt": "PROCARDIA XL 30 mg GITS 硝苯地平控释片在美国 DailyMed 公开标签中的 Pfizer 100 片瓶装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2025-12 更新；包装图稿标注 2023-11）", "presentation": "PROCARDIA XL 30 mg GITS、100 片瓶装主展示图（DailyMed 公开标签所列；Pfizer 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PROCARDIA XL 30 mg GITS、100 片瓶装的 Pfizer 包装文字图，只帮助核对品牌、通用名、标示强度、控释片、包装数量和来源；不用于鉴定真伪，也不证明 60 mg/90 mg、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROCARDIA XL / 硝苯地平控释片说明书放大阅读：缓释外壳、30/60/90 mg 与“不能掰开”", "en": "PROCARDIA XL label reading: controlled-release shell, 30/60/90 mg and why tablets are not split" }, "summary": { "zh": "本模块以 FDA 2021 和 DailyMed 2025 美国公开标签为阅读入口，帮助核对 PROCARDIA XL、硝苯地平、GITS 控释片、30/60/90 mg 和包装文字；它不把这些信息转换为个人开始、加减、联用、换药或停药方案。", "en": "This module uses the 2021 FDA and 2025 U.S. DailyMed public labels as reading entry points. It helps check PROCARDIA XL, nifedipine, GITS controlled-release tablets, 30/60/90 mg and package text; it does not convert them into an individual start, adjustment, combination, switch or stop plan." }, "checks": [ { "zh": "30、60、90 mg 是标签所列控释片的标示强度，不是可以按经验相加、对半或用另一种硝苯地平产品换算的片数规则。任何产品变更必须同时核对准确处方、剂型、市场和现行标签。", "en": "30, 60 and 90 mg are labelled strengths for controlled-release tablets, not rules for adding, halving or converting tablet counts by experience with another nifedipine product. Any product change requires the exact prescription, dosage form, market and current label to be checked together." }, { "zh": "DailyMed 标签明确写明控释片应整片吞服，不咀嚼、不掰分、不压碎。这里的“不能掰开”来自此准确控释产品的释放设计，不能被泛化为其他片剂的操作结论。", "en": "The DailyMed label explicitly states that the controlled-release tablet should be swallowed whole, not chewed, divided or crushed. This ‘do not split’ statement comes from the release design of this exact product and cannot be generalised to another tablet." }, { "zh": "标签说明，药物释放完成后，偶尔在粪便中看到看似药片的空壳不必据此自行补服、停用或改变方案；任何担忧都应与实际包装和完整药单一并交由药师或开方团队确认。", "en": "The label explains that, after release is complete, something that looks like a tablet shell may occasionally be seen in stool. That is not a reason to self-dose again, stop or change the plan; bring any concern, the actual package and the complete medicine list to a pharmacist or prescribing team." }, { "zh": "同类降压药、β 受体阻滞剂、其他心血管药、葡萄柚制品或多药并用都可能带来需要专业人员核对的问题。不要因为包装都写“降压”或都含硝苯地平就自行叠加、轮换或替代；头晕、胸部不适、晕厥或明显不适时应及时使用当地医疗支持。", "en": "Related blood-pressure medicines, beta blockers, other cardiovascular medicines, grapefruit products or multiple medicines can all raise questions needing professional review. Do not self-combine, alternate or substitute merely because packages mention blood pressure or contain nifedipine; seek timely local medical support for dizziness, chest discomfort, fainting or marked illness." } ], "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（患者信息与产品展示）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硝苯地平控释片怎样起作用：影响钙离子进入血管平滑肌和心肌细胞", "en": "How controlled-release nifedipine works: it affects calcium-ion entry into vascular smooth and cardiac muscle cells" }, "summary": { "zh": "DailyMed 标签将硝苯地平描述为钙离子内流抑制剂（慢通道阻滞剂/钙离子拮抗剂），可选择性抑制钙离子跨细胞膜进入血管平滑肌和心肌细胞。它解释药理路径，不预测个人血压变化、适用性、片数、联用或换药。", "en": "The DailyMed label describes nifedipine as a calcium-ion influx inhibitor (slow-channel blocker/calcium-ion antagonist) that selectively inhibits transmembrane calcium-ion entry into vascular smooth and cardiac muscle cells. It explains a pharmacologic pathway; it does not predict an individual's blood-pressure change, suitability, tablet count, combination or switch." }, "checks": [ { "zh": "“影响钙离子进入”解释了为何硝苯地平属于钙通道阻滞剂，但不能从中推导某个人该选普通片、控释片还是另一种降压药。剂型、既往反应、疾病情况、完整药单和现行标签都需要一起复核。", "en": "‘Affects calcium-ion entry’ explains why nifedipine is a calcium-channel blocker, but cannot determine whether an individual should use an immediate-release tablet, a controlled-release tablet or another blood-pressure medicine. Dosage form, prior reactions, conditions, complete medicine list and current label all need review together." }, { "zh": "与其他降压药有相近目标或共同影响血压，不表示可以自行同日叠加、隔日轮换或从普通制剂改成控释制剂。机制不能替代对具体产品、血压记录和相互作用的专业判断。", "en": "Having a related target or shared effect on blood pressure with another medicine does not permit same-day self-combination, alternate-day rotation or a change from an immediate-release to a controlled-release product. Mechanism cannot replace professional judgment about exact products, blood-pressure records and interactions." }, { "zh": "控释机制也不是个人用药时间表，更不能用来决定何时自行加量、减量或停药。出现头晕、晕厥、胸部不适或其他急性变化，应使用当地急诊与专业支持，而不是根据机制页面自行调整。", "en": "A controlled-release mechanism is not an individual timetable and cannot decide when to self-increase, reduce or stop. With dizziness, fainting, chest discomfort or another acute change, use local urgent and professional support rather than self-adjusting from a mechanism page." } ], "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Procardia XL", "generic": "硝苯地平", "dosageFormClass": "口服控释片（GITS；30、60、90 mg；DailyMed 2025 标签所列）" }, "labelSource": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_40806ef1e083dfd5", "label": "FDA：PROCARDIA XL 2021 美国标签（NDA 019684）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 PROCARDIA XL（nifedipine）2025 美国公开标签将其列为口服控释片（GITS），并列示 30、60、90 mg 规格及 NDA019684 的历史记录。本页用于放大阅读这一美国公开档案；不将其延伸为中国大陆或其他市场的当前批准、中文商品名、持有人、原研关系、供应、价格或可售资格结论。", "history": "中文检索线索“拜新同”与英文名称、硝苯地平、控释/GITS、每片标示强度和目标市场必须一起核对。缓释/控释设计是产品身份的一部分；不能仅凭同一通用名、相近盒子或相同 mg 将其与普通或其他改良释放硝苯地平产品自动等同。", "sourceDocuments": [ { "id": "src_40806ef1e083dfd5", "label": "FDA：PROCARDIA XL 2021 美国标签（NDA 019684）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019684", "approvalTimeline": [ { "date": "1989", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1989。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1989. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_40806ef1e083dfd5", "label": "FDA: PROCARDIA XL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_40806ef1e083dfd5", "label": "FDA: PROCARDIA XL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/procardia-xl/", "en": "https://origindrug.com/en/drugs/procardia-xl/" }, "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." ] }