{ "id": "mevacor-lovastatin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "MEVACOR", "generic": "洛伐他汀", "aliases": [ "Mevacor", "lovastatin", "洛伐他汀", "美降脂", "洛之达" ], "marketBrandNames": [ { "name": "MEVACOR", "market": { "zh": "美国（历史）", "en": "United States (historical)" }, "evidenceStatus": "historical_public_record", "note": { "zh": "历史原品牌 NDA 019643；10／20／40 mg 当前均列 DISCN，不代表在售。", "en": "Historical originator brand under NDA 019643; all 10/20/40 mg rows are currently DISCN and do not establish supply." }, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国历史 MEVACOR NDA 019643 的 10／20／40 mg 普通片在 FDA Orange Book 均列为 DISCN，且公开记录注明并非因安全性或有效性原因停产；2025 年 DailyMed 当前 PD-Rx 仿制品标签另列洛伐他汀 40 mg、NDC 43063-548-95、1000 片瓶装和 ANDA 075991。本页严格分开 historical originator brand 与 current generic comparator，不据此证明实时库存、中国大陆或其他市场批准、原研/仿制可替代性或个人适用性。", "dosageFormClass": "MEVACOR 历史产品与当前仿制品比较项均为洛伐他汀普通口服片；ALTOPREV 是另一个 NDA 下的洛伐他汀缓释片，ADVICOR 还含烟酸。普通片、缓释片与复方不能按商品名或总毫克数混同、拼接或替换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（Merck 历史页记录首个获 FDA 批准的商业化他汀）", "archiveSponsorText": "Merck Research Laboratories（历史 MEVACOR NDA 019643）；PD-Rx Pharmaceuticals（当前仿制品比较项）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MEVACOR", "Mevacor", "美降脂", "洛伐他汀片" ], "excludedProductCues": [ "ALTOPREV", "lovastatin extended release", "洛伐他汀缓释片", "NDC 021316", "ADVICOR", "lovastatin and niacin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mevacor-lovastatin-10mg-historical-nda-019643-002", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 历史品牌条目；2012 年品牌标签仅作历史阅读", "en": "Historical FDA Orange Book brand row; the 2012 brand label is retained only for historical reading" }, "dosageForm": { "zh": "MEVACOR 洛伐他汀 10 mg 普通口服片（历史原品牌）", "en": "MEVACOR lovastatin 10 mg conventional oral tablet (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 019643 / product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 10 mg；FDA 当前列为 DISCN", "en": "Lovastatin 10 mg per tablet; currently listed by FDA as DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌每片标示量；不是个人片数、频率、换药或强度换算", "en": "historical brand amount per tablet; not an individual's tablet count, frequency, switch or intensity conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mevacor-lovastatin-20mg-historical-nda-019643-003", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 历史品牌条目；2012 年品牌标签仅作历史阅读", "en": "Historical FDA Orange Book brand row; the 2012 brand label is retained only for historical reading" }, "dosageForm": { "zh": "MEVACOR 洛伐他汀 20 mg 普通口服片（历史原品牌）", "en": "MEVACOR lovastatin 20 mg conventional oral tablet (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 019643 / product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 20 mg；FDA 当前列为 DISCN", "en": "Lovastatin 20 mg per tablet; currently listed by FDA as DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌每片标示量；不是个人片数、频率、换药或强度换算", "en": "historical brand amount per tablet; not an individual's tablet count, frequency, switch or intensity conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mevacor-lovastatin-40mg-historical-nda-019643-004", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 历史品牌条目；2012 年品牌标签仅作历史阅读", "en": "Historical FDA Orange Book brand row; the 2012 brand label is retained only for historical reading" }, "dosageForm": { "zh": "MEVACOR 洛伐他汀 40 mg 普通口服片（历史原品牌）", "en": "MEVACOR lovastatin 40 mg conventional oral tablet (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 019643 / product 004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 40 mg；FDA 当前列为 DISCN", "en": "Lovastatin 40 mg per tablet; currently listed by FDA as DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌每片标示量；不是个人片数、频率、换药或强度换算", "en": "historical brand amount per tablet; not an individual's tablet count, frequency, switch or intensity conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-pdrx-lovastatin-40mg-1000-tablet-bottle-ndc-43063-548-95-current-anda", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2025-02-28 更新；2025-03-05 发布）", "en": "Current U.S. DailyMed generic label (updated 28 Feb 2025; published 5 Mar 2025)" }, "dosageForm": { "zh": "PD-Rx 洛伐他汀 40 mg 普通口服片（当前仿制品比较项）", "en": "PD-Rx lovastatin 40 mg conventional oral tablet (current generic comparator)" }, "route": { "zh": "口服（当前仿制品产品身份字段）", "en": "oral (current generic product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 43063-548-95", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 40 mg；1000 片瓶装；ANDA 075991 仿制品比较项", "en": "Lovastatin 40 mg per tablet; 1,000-tablet bottle; ANDA 075991 generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=43063548.jpg&setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "当前标签每片标示量；不是个人片数、频率、疗程或与其他他汀的换算", "en": "current labelled amount per tablet; not an individual's tablet count, frequency, course or conversion to another statin" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、无刻痕", "en": "round, unscored" }, "imprint": "CTI 143", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-pdrx-lovastatin-40mg-1000-tablet-bottle-ndc-43063-548-95-current-anda", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=43063548.jpg&setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80", "alt": "PD-Rx 洛伐他汀 40 mg、NDC 43063-548-95、1000 片瓶装当前美国仿制品标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前仿制品 SPL v26（2025-03-05 发布）", "presentation": "PD-Rx 洛伐他汀 40 mg；NDC 43063-548-95；1000 片瓶装；ANDA 075991 比较项", "notice": "此图是当前美国仿制品准确标签面板，不是历史 MEVACOR 原品牌包装。只对应所列 NDC、强度和瓶装，不用于鉴定真伪，也不证明库存、购买资格、个人适用或可与历史 MEVACOR、ALTOPREV、ADVICOR 或其他他汀自行替换。", "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MEVACOR／洛伐他汀说明书放大阅读：先核对相互作用、肌肉症状和准确剂型", "en": "MEVACOR / lovastatin label reading: first check interactions, muscle symptoms and exact dosage form" }, "summary": { "zh": "本模块用历史 MEVACOR 标签、Orange Book 与当前仿制品标签帮助识别洛伐他汀普通片及风险线索；不生成个人片数、服用时间、频率、换药、停药或强度换算。", "en": "This module uses the historical MEVACOR label, Orange Book and a current generic label to identify conventional lovastatin tablets and risk cues. It does not generate personal tablet counts, timing, frequency, switching, stopping or intensity conversion." }, "checks": [ { "zh": "克拉霉素、伊曲康唑、酮康唑等强 CYP3A 抑制剂与洛伐他汀存在重要相互作用边界；实际药单还可能包含其他需要核对的药物。不要凭网页自行错开时间、减量、停药或继续，先让开方团队或药师核对全部处方药、非处方药和保健品。", "en": "Clarithromycin, itraconazole, ketoconazole and other strong CYP3A inhibitors create important interaction boundaries with lovastatin. Other medicines may also require review. Do not self-separate times, reduce, stop or continue from this page; have the prescribing team or pharmacist check all prescription, OTC and supplement products." }, { "zh": "无法解释的肌肉痛、压痛、抽筋或无力，尤其伴明显乏力、发热或深色尿，可能需要尽快医疗评估；严重或迅速恶化时使用当地急救服务，不等待网页判定是否为横纹肌溶解。", "en": "Unexplained muscle pain, tenderness, cramps or weakness, especially with marked fatigue, fever or dark urine, may need prompt assessment. Use local emergency services for severe or rapidly worsening signs rather than waiting for a webpage to decide whether rhabdomyolysis is present." }, { "zh": "孕期、可能怀孕、备孕或哺乳期需要及时核对当前标签和临床计划。不要根据历史标签或网页自行继续、停用、隔日服用或换成另一种他汀。", "en": "Pregnancy, possible pregnancy, pregnancy planning or breastfeeding requires prompt review of the current label and clinical plan. Do not self-continue, stop, use alternate days or switch statins from a historical label or webpage." }, { "zh": "MEVACOR 历史 10／20／40 mg 与当前仿制 40 mg 都是普通片产品身份；ALTOPREV 是缓释片，ADVICOR 是含烟酸的复方。剂型、成分、强度、NDA／ANDA、NDC 和目标市场必须一起核对。", "en": "Historical MEVACOR 10/20/40 mg and the current 40 mg generic comparator are conventional-tablet identities. ALTOPREV is extended-release and ADVICOR also contains niacin. Form, ingredients, strength, NDA/ANDA, NDC and target market must be checked together." }, { "zh": "老年人、肝肾功能异常、甲状腺问题、既往肌肉不良反应、同时使用其他降脂药或大量饮酒等情况可能改变专业判断。网页不会从年龄、一次化验或一个药名决定个人选药。", "en": "Older age, liver or kidney dysfunction, thyroid disease, previous muscle reactions, other lipid-lowering medicines or heavy alcohol use may change professional judgement. The site does not select an individual medicine from age, one laboratory result or one name." } ], "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "洛伐他汀怎样起作用：HMG-CoA 还原酶抑制不是他汀等量表", "en": "How lovastatin works: HMG-CoA reductase inhibition is not a statin equivalence table" }, "summary": { "zh": "洛伐他汀经体内转化后的活性形式抑制 HMG-CoA 还原酶，影响胆固醇合成通路。这个机制解释药物类别，但不能把洛伐他汀、阿托伐他汀、瑞舒伐他汀、普伐他汀、氟伐他汀或辛伐他汀按 mg 直接换算。", "en": "Lovastatin is converted in the body to an active form that inhibits HMG-CoA reductase in the cholesterol-synthesis pathway. This explains the class but does not make lovastatin, atorvastatin, rosuvastatin, pravastatin, fluvastatin or simvastatin directly milligram-convertible." }, "checks": [ { "zh": "同属他汀不表示剂量等量，也不允许一天一种、隔日轮换、叠加或用旧药顶替新处方。需要结合准确产品、完整药单、适应症、化验、肝肾功能和治疗目标。", "en": "A shared statin class does not mean dose equivalence or permit day-by-day use, alternate-day rotation, combination or substitution with leftover medicine. Exact product, full medicine list, indication, laboratory results, liver/kidney function and treatment goal all matter." }, { "zh": "共同机制不能证明原研一定更适合个人，也不能仅凭品牌、价格或外观判断仿制品是否可替代；监管批准、剂型、质量标准与开方计划要分开核对。", "en": "A shared mechanism does not prove that an originator is always more suitable for an individual, nor can brand, price or appearance alone decide generic substitution. Regulatory approval, dosage form, quality standards and prescribing plan require separate checks." }, { "zh": "药物基因信息可能在特定临床问题中有价值，但洛伐他汀或‘他汀’三个字不等于人人需要全基因组筛查。检测与解释应由合格专业人员结合具体药物与病史决定。", "en": "Pharmacogenetic information may matter for a specific clinical question, but lovastatin or the word statin does not mean everyone needs whole-genome screening. Testing and interpretation require a qualified professional using the exact medicine and history." } ], "source": { "id": "src_b86cc783b48ebd3f", "label": "FDA：MEVACOR（lovastatin）NDA 019643 历史标签（2012；明确提示不是最新标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MEVACOR", "generic": "洛伐他汀", "dosageFormClass": "MEVACOR 历史产品与当前仿制品比较项均为洛伐他汀普通口服片；ALTOPREV 是另一个 NDA 下的洛伐他汀缓释片，ADVICOR 还含烟酸。普通片、缓释片与复方不能按商品名或总毫克数混同、拼接或替换。" }, "labelSource": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b86cc783b48ebd3f", "label": "FDA：MEVACOR（lovastatin）NDA 019643 历史标签（2012；明确提示不是最新标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MEVACOR 是洛伐他汀的美国历史原品牌，20 mg 于 1987 年获批；FDA 当前把 10／20／40 mg 历史品牌条目均列为停产。页面同时展示一个当前美国仿制洛伐他汀 40 mg 的准确包装比较项，但不会把它冒充原品牌。不同他汀、普通片与缓释片不能只按 mg 自行换算；克拉霉素、部分唑类抗真菌药、其他强 CYP3A 抑制剂，以及多种完整药单因素都需要专业核对。", "history": "洛伐他汀从真菌来源化合物研究发展为药物。Merck 记录 1987 年推出洛伐他汀；Orange Book 记载 MEVACOR 20 mg 于 1987-08-31 获批、40 mg 于 1988-12-14 获批、10 mg 于 1991-03-28 获批。三项历史品牌记录目前均为 DISCN，不能当作实时品牌供应证据。", "sourceDocuments": [ { "id": "src_f6fe27de971841ca", "label": "Merck：1987 年推出洛伐他汀——首个获 FDA 批准的商业化他汀历史记录", "url": "https://www.merck.com/company-overview/history/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_product_history", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b86cc783b48ebd3f", "label": "FDA：MEVACOR（lovastatin）NDA 019643 历史标签（2012；明确提示不是最新标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 019643（历史 MEVACOR）／ANDA 075991（当前仿制品比较项）", "approvalTimeline": [ { "date": "1987-08-31", "title": { "zh": "MEVACOR 20 mg 美国获批", "en": "U.S. approval of MEVACOR 20 mg" }, "detail": { "zh": "Orange Book 记录 NDA 019643 product 003；Merck 将 1987 年洛伐他汀写入其首个商业化他汀历史。", "en": "Orange Book records NDA 019643 product 003; Merck places lovastatin in its 1987 first-commercial-statin history." }, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "1988-12-14／1991-03-28", "title": { "zh": "40 mg 与 10 mg 历史规格获批", "en": "Historical 40 mg and 10 mg strength approvals" }, "detail": { "zh": "这些日期定位历史品牌规格，不表示今天可购买、适合个人或可以互换。", "en": "These dates identify historical brand strengths and do not establish current purchase availability, individual suitability or interchangeability." }, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "历史品牌与当前仿制品状态复核", "en": "Historical-brand and current-generic status review" }, "detail": { "zh": "MEVACOR 三个规格均为 DISCN；当前 DailyMed 仿制品 40 mg 比较项另行展示，不冒充品牌。", "en": "All three MEVACOR strengths are DISCN; a current DailyMed 40 mg generic comparator is displayed separately and is not presented as the brand." }, "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史原品牌已停产；当前仿制品标签比较项已建立", "en": "Historical originator brand discontinued; current generic label comparator established" }, "detail": { "zh": "DISCN、标签存在和 NDC 记录都不等于实时有货。", "en": "DISCN status, label availability and an NDC record do not establish real-time stock." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐市场建立", "en": "Current regulatory records require market-by-market review" }, "detail": { "zh": "不从美国历史品牌或仿制包装推定当地批准、品牌名、供应、原研／仿制关系或合法购药渠道。", "en": "No local approval, brand name, supply, originator/generic relationship or lawful purchasing route is inferred from a U.S. historical brand or generic pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "MEVACOR 现在还能买到原品牌吗？", "en": "Is originator-brand MEVACOR currently available?" }, "answer": { "zh": "本页不能这样证明。FDA Orange Book 当前把 10／20／40 mg MEVACOR 条目列为 DISCN；网页展示的是历史原品牌档案和一个当前仿制品标签比较项，不提供库存或购买承诺。", "en": "This page cannot establish that. FDA currently lists the 10/20/40 mg MEVACOR rows as DISCN. The page shows a historical originator archive and one current generic-label comparator, not stock or a purchase promise." } }, { "question": { "zh": "洛伐他汀 40 mg 能直接换成另一种他汀 40 mg 吗？", "en": "Can lovastatin 40 mg be directly switched to 40 mg of another statin?" }, "answer": { "zh": "不能只按数字这样换算。不同他汀的强度、相互作用、剂型、适应症和处方目标不同；不要自行替换、轮换或叠加，应让开方团队或药师核对。", "en": "Not from the number alone. Statin intensity, interactions, dosage form, indication and prescribing goal differ. Do not self-substitute, rotate or combine; ask the prescribing team or pharmacist to review." } }, { "question": { "zh": "正在吃克拉霉素，还能继续洛伐他汀吗？", "en": "Can lovastatin be continued while taking clarithromycin?" }, "answer": { "zh": "这是需要尽快由专业人员核对的重要相互作用场景。网页不会替个人决定继续、暂停、减量或错开时间；请联系开具任一药物的团队或药师，带上全部药盒和药单。出现严重肌肉症状或深色尿时及时就医。", "en": "This is an important interaction scenario requiring prompt professional review. The site will not decide whether an individual should continue, pause, reduce or separate timing. Contact the team prescribing either medicine or a pharmacist with all packs and the complete list. Seek prompt care for severe muscle symptoms or dark urine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "polypharmacy-safety-guide", "statin-gene-testing-what-labels-can-and-cannot-say" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mevacor-lovastatin/", "en": "https://origindrug.com/en/drugs/mevacor-lovastatin/" }, "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." ] }