{ "id": "zocor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Zocor", "generic": "辛伐他汀", "aliases": [ "simvastatin", "辛伐他汀", "辛伐他汀片", "舒降之" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "舒降之®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_ef150bc5f3a1f961", "label": "石家庄市人民政府：2026 年连锁药店价格信息中的舒降之／辛伐他汀片 20 mg 记录", "url": "https://www.sjz.gov.cn/columns/b250993e-f71f-4ba2-989e-18825c22f01a/202607/22/e0b20329-21d7-449a-ac68-1d287d2501c6.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 DailyMed 有日期公开标签（SPL v11，2025-03 更新/2025-04-03 发布；本档案分别展示三个准确包装面板）", "dosageFormClass": "辛伐他汀口服薄膜衣片：10 mg、20 mg、40 mg（DailyMed SPL v11 所列；分别展示三个 30 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（DailyMed 2025 美国公开标签所列初始批准）", "archiveSponsorText": "Organon LLC / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "VYTORIN", "ezetimibe and simvastatin", "simvastatin and ezetimibe", "ezetimibe/simvastatin", "simvastatin/ezetimibe" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zocor-simvastatin-tablet-10mg-7820618001", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "en": "DailyMed SPL v11, updated Mar 2025 and published 3 Apr 2025" }, "dosageForm": { "zh": "ZOCOR 辛伐他汀口服薄膜衣片", "en": "ZOCOR simvastatin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-180-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片瓶装", "en": "10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&name=zocor-02.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位用量瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "MSD 735", "scoreStatus": "no_score", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f3fc1892ba72b506", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀 10 mg、30 片瓶装美国公开标签面板（Organon；SPL v11，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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-zocor-simvastatin-tablet-20mg-7820618101", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "en": "DailyMed SPL v11, updated Mar 2025 and published 3 Apr 2025" }, "dosageForm": { "zh": "ZOCOR 辛伐他汀口服薄膜衣片", "en": "ZOCOR simvastatin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-181-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；30 片瓶装", "en": "20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&name=zocor-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位用量瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄褐色", "en": "tan" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "MSD 740", "scoreStatus": "no_score", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f3fc1892ba72b506", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀 20 mg、30 片瓶装美国公开标签面板（Organon；SPL v11，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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-zocor-simvastatin-tablet-40mg-7820618201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "en": "DailyMed SPL v11, updated Mar 2025 and published 3 Apr 2025" }, "dosageForm": { "zh": "ZOCOR 辛伐他汀口服薄膜衣片", "en": "ZOCOR simvastatin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-182-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&name=zocor-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位用量瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "砖红色", "en": "brick red" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "MSD 749", "scoreStatus": "no_score", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f3fc1892ba72b506", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀 40 mg、30 片瓶装美国公开标签面板（Organon；SPL v11，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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-zocor-simvastatin-tablet-20mg-7820618101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zocor-03.jpg&setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&type=img", "alt": "ZOCOR 辛伐他汀 20 mg 片剂在美国 DailyMed Organon 公开标签中的 30 片包装面板图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "presentation": "ZOCOR（辛伐他汀）20 mg、NDC 78206-181-01、30 片瓶装包装面板图。", "notice": "此图只对应美国 DailyMed Organon 公开标签中的 ZOCOR、辛伐他汀 20 mg、NDC 78206-181-01 和 30 片瓶装。它仅帮助核对品牌、通用名、每片标示量、口服薄膜衣片、包装数量和来源；不用于鉴定真伪，也不证明 10 mg、40 mg、VYTORIN 等复方、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的联用、开始、停用、换药或片数方案。", "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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": "ZOCOR 说明书放大阅读：10、20、40 mg 是片剂身份，不是他汀换算表", "en": "ZOCOR label reading: 10, 20 and 40 mg identify tablets, not a statin conversion table" }, "summary": { "zh": "本模块以美国 DailyMed 2025-03 ZOCOR 公开标签为阅读入口，帮助核对 ZOCOR、辛伐他汀、10/20/40 mg 口服片、包装和标签中关于肌肉相关风险及相互作用的文字。它不决定个人片数、是否可在他汀之间转换、是否能联用或怎样停用。", "en": "This module uses the March 2025 U.S. DailyMed public label for ZOCOR as a reading entry point. It helps check ZOCOR, simvastatin, 10/20/40 mg oral tablets, the package, and label language about muscle-related risk and interactions. It does not decide an individual's tablet count, statin switch, combination or stopping plan." }, "checks": [ { "zh": "先把 ZOCOR、辛伐他汀、每片 10、20 或 40 mg、口服片、实际包装和目标市场一起核对。mg 是这一准确片剂的标示强度，不是“今天应吃几片”的网页答案，也不能据此把不同强度拼量或与另一种他汀互换。", "en": "Check ZOCOR, simvastatin, the stated 10, 20 or 40 mg per tablet, oral-tablet form, actual package and target market together. Mg identifies this exact tablet; it is not a web answer to “how many today,” and it does not permit self-combining strengths or interchanging another statin." }, { "zh": "标签对 80 mg 有专门限制文字。该信息不能被简化为自行加量、用剩药补量或由另一种他汀换算到 ZOCOR；任何强度变化都应由了解适应症、现行标签与完整药单的专业人员处理。", "en": "The label contains a specific restriction for 80 mg. It must not be simplified into self-escalation, using leftovers, or converting from another statin to ZOCOR; any strength change needs a professional who knows the indication, current label and complete medicine list." }, { "zh": "标签提示某些药物、葡萄柚汁及其他会影响药物暴露的情况需要核对。所有降脂药、抗感染药、心血管药、非处方药、草本和补充剂应连同实际包装交给药师或医生，不要因为产品名称不同就自行认定没有重复或相互作用。", "en": "The label signals that some medicines, grapefruit juice and other exposure-affecting situations need review. Bring every lipid medicine, anti-infective, cardiovascular medicine, OTC product, herb and supplement with the actual packages to a pharmacist or clinician; different names do not prove the absence of overlap or interactions." }, { "zh": "出现不明原因的肌肉疼痛、压痛或无力，尤其同时有发热、明显乏力或深色尿液等严重不适时，应及时使用当地医疗支持；不要仅凭网页自行停用、改用阿托伐他汀/瑞舒伐他汀或加用另一种降脂产品。", "en": "With unexplained muscle pain, tenderness or weakness—especially with fever, marked fatigue or dark urine or another severe symptom—use timely local medical support. Do not self-stop, change to atorvastatin/rosuvastatin, or add another lipid medicine from a webpage." } ], "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03；标签阅读与警示）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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": "辛伐他汀怎样起作用：它影响胆固醇合成路径中的 HMG-CoA 还原酶", "en": "How simvastatin works: it affects HMG-CoA reductase in the cholesterol-synthesis pathway" }, "summary": { "zh": "DailyMed 的 ZOCOR 标签将辛伐他汀描述为 HMG-CoA 还原酶抑制剂。该机制帮助理解它为何属于他汀类，但不预测个人血脂变化、肌肉反应、适用性、片数或与另一种他汀的组合。", "en": "The DailyMed ZOCOR label describes simvastatin as an HMG-CoA reductase inhibitor. This helps explain its statin class, but does not predict an individual's lipid response, muscle reaction, suitability, tablet count or combination with another statin." }, "checks": [ { "zh": "“同为 HMG-CoA 还原酶抑制剂”解释的是类别，不是阿托伐他汀、瑞舒伐他汀和辛伐他汀可以自行叠加、隔天轮换或按 mg 互相换算的证据。", "en": "“Both are HMG-CoA reductase inhibitors” explains a class; it is not evidence that atorvastatin, rosuvastatin and simvastatin can be self-combined, alternated or converted by mg." }, { "zh": "机制页面不能决定基因筛查、肌肉症状的原因、是否应换药或怎样处理相互作用。已有药物基因检测报告、完整药单、既往反应、肾肝情况与现行标签需要由专业人员一起解释。", "en": "A mechanism page cannot decide genetic screening, the cause of muscle symptoms, whether to switch, or how to manage interactions. Any pharmacogenomic report, complete medicine list, prior reactions, kidney/liver context and the current label need professional interpretation together." }, { "zh": "把机制读成“降脂通路”后，最安全的下一步仍是核对准确产品、强度、剂型、市场和全部用药，而不是据此自行增减、停用或再加一盒同类药。", "en": "After reading a mechanism as a “lipid pathway,” the safest next step is still to check the exact product, strength, dosage form, market and complete medicine list—not to self-adjust, stop or add another same-class pack." } ], "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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": "Zocor", "generic": "辛伐他汀", "dosageFormClass": "辛伐他汀口服薄膜衣片：10 mg、20 mg、40 mg（DailyMed SPL v11 所列；分别展示三个 30 片瓶装面板）" }, "labelSource": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2021-statin-pregnancy-breastfeeding-safety-communication", "issuedAt": "2021-07-20", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：他汀类药物在妊娠与哺乳期的标签变更", "en": "FDA Drug Safety Communication: labelling changes for statins in pregnancy and breastfeeding" }, "summary": { "zh": "FDA 于 2021-07-20 就整个他汀类发布安全通讯，明确列出 Lipitor（阿托伐他汀）和 Crestor（瑞舒伐他汀）。该通讯涉及美国处方信息中妊娠与哺乳相关警语的监管变更和个体化获益/风险判断；它不等于任何个人可以据此自行开始、停止、替换或调整药物。妊娠、疑似妊娠或哺乳相关问题应结合手中产品、目标市场现行说明书和开方团队意见核对。", "en": "On 2021-07-20, FDA issued a class Drug Safety Communication that explicitly lists Lipitor (atorvastatin) and Crestor (rosuvastatin). It concerns U.S. prescribing-information changes around pregnancy and breastfeeding and individualized benefit-risk review; it does not support self-starting, stopping, switching or adjusting any individual medicine. Pregnancy, suspected pregnancy or breastfeeding questions require the exact product, current target-market label and the prescribing team." }, "source": { "id": "src_e5fb970c597c7f50", "label": "FDA：2021-07-20 他汀类药物妊娠与哺乳期药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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 ZOCOR（simvastatin）有日期美国公开标签列有 10 mg、20 mg、40 mg 口服薄膜衣片。本页分别建立三个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡；不把包装数字变成个人片数、他汀之间的转换、联合用药、停用或购买结论。", "history": "本页三个包装面板严格对应美国 DailyMed 的 ZOCOR 10 mg、20 mg、40 mg、各 30 片瓶装；该标签同时明确 ZOCOR 的 5 mg 与 80 mg 强度已不再营销。本页不把任一面板扩展为其他包装、其他市场或当前库存证明；VYTORIN 等辛伐他汀/依折麦布复方，以及阿托伐他汀、瑞舒伐他汀等其他他汀产品，不能按名称或类别相近自行叠加、轮换或互换。", "sourceDocuments": [ { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "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 019766", "approvalTimeline": [ { "date": "1991", "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: 1991。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: 1991. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed: ZOCOR public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-03 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 2025-03 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_1437e7f2acb734a6", "label": "DailyMed: ZOCOR public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zocor/", "en": "https://origindrug.com/en/drugs/zocor/" }, "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." ] }