{ "id": "atorvastatin-lipitor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Lipitor", "generic": "阿托伐他汀", "aliases": [ "立普妥", "立普妥®", "阿托伐他汀钙片", "リピトール", "atorvastatin", "atorvastatin calcium" ], "marketBrandNames": [ { "name": "立普妥®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "current_first_party_leaflet", "note": { "zh": "晖致中国当前产品信息页列示立普妥［阿托伐他汀钙片］，其链接的 Version No. 20260119 企业说明书列示 10 mg、20 mg、40 mg。该企业公开资料可用于核对商品名、通用名、剂型、规格与说明书版本；不等于 NMPA 批准数据库、批准文号、准确包装、库存、可售资格或真伪鉴定。", "en": "Viatris China's current product-information page lists Lipitor (立普妥) [atorvastatin calcium tablets], and its linked first-party leaflet, Version No. 20260119, lists 10 mg, 20 mg and 40 mg. These company-published materials support checking the brand, generic name, form, strengths and leaflet version; they are not an NMPA approval-database record, approval number, exact package, stock, sale-eligibility record or authenticity determination." }, "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "name": "リピトール", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示リピトール錠 5 mg、10 mg及阿托伐他汀成分；仅用于核对日文名称、成分、剂型和市场记录，不确认其他剂型、包装、供应、可售资格或可自行换药。", "en": "The current PMDA product page lists LIPITOR (リピトール) 5 mg and 10 mg tablets with atorvastatin; it only supports checking the Japanese name, ingredient, form and market record—not another form, pack, supply, availability or self-directed switching." }, "source": { "id": "src_deb7f792025a47d6", "label": "PMDA：リピトール錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189015F1023_2?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "立普妥®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_104aa9169b36e4d2", "label": "Pfizer China：立普妥／络活喜品牌名历史公开资料（2019）", "url": "https://www.pfizer.com.cn/zh-hans/news/press-release/619", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed SPL v8 列示 10 mg、20 mg、40 mg、80 mg；晖致中国当前产品页及 Version No. 20260119 企业说明书列示中国大陆立普妥® 10 mg、20 mg、40 mg；日本 PMDA 当前产品记录列示リピトール錠 5 mg、10 mg。三地规格与文件必须分开阅读。", "dosageFormClass": "阿托伐他汀钙口服薄膜衣片：美国 10 mg、20 mg、40 mg、80 mg；中国大陆企业说明书 10 mg、20 mg、40 mg；日本 PMDA 5 mg、10 mg。不同市场规格不合并，也不转换为个人片数。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996", "archiveSponsorText": "晖致中国当前产品页与企业说明书；Viatris Specialty LLC / DailyMed 美国公开标签；日本 PMDA 当前产品记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "CADUET", "amlodipine and atorvastatin", "amlodipine/atorvastatin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lipitor-tablet-10mg-ndc-58151-155-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-155-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；90 片瓶装", "en": "10 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "10 / VLE 155", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-20mg-ndc-58151-156-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-156-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；90 片瓶装", "en": "20 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "20 / VLE 156", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-40mg-ndc-58151-157-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-157-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；90 片瓶装", "en": "40 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "40 / VLE 157", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-80mg-ndc-58151-158-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-158-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；90 片瓶装", "en": "80 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "80 / VLE 158", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lipitor-tablet-10mg-ndc-58151-155-77", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-05.jpg", "alt": "LIPITOR 阿托伐他汀在美国 DailyMed Viatris 当前公开标签中的 10 mg、NDC 58151-155-77、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v8（2026-07-15 发布）", "presentation": "LIPITOR 阿托伐他汀：每片 10 mg，NDC 58151-155-77，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 LIPITOR、阿托伐他汀 10 mg、NDC 58151-155-77 与 90 片瓶装。原始公开标签图在 GTIN／LOT／EXP 旁含黑色遮蔽区域，用于覆盖可变批号和效期字段，并非网页图片加载错误。图片只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 20 mg、40 mg、80 mg、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片数、联用、分片、开始、停用或换药方案。", "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "Lipitor 说明书放大阅读：不要把“同类药”当成可自行叠加", "en": "Lipitor label reading: a same-class medicine is not an automatic add-on" }, "summary": { "zh": "本模块把中国大陆 Version No. 20260119 企业说明书、美国当前标签与日本 PMDA 记录分开阅读，帮助识别品牌、通用名、每片规格、辅料和包装变化；它不判断个人应服几片、是否转换或能否与另一种他汀合用。", "en": "This module keeps the Mainland China first-party leaflet Version No. 20260119, the current U.S. label and the Japan PMDA record separate, helping readers check the brand, generic name, strength per tablet, excipients and packaging changes. It does not decide a personal tablet count, switch or combination with another statin." }, "checks": [ { "zh": "先把商品名 Lipitor／立普妥®、通用名阿托伐他汀钙片、每片标示强度、口服薄膜衣片和目标市场一起核对。中国大陆企业说明书列 10 mg、20 mg、40 mg，美国当前标签另有 80 mg，日本 PMDA 另有 5 mg；这些规格不能跨市场拼成同一套产品。", "en": "Check Lipitor / 立普妥®, atorvastatin calcium tablets, the stated strength per tablet, oral film-coated form and target market together. The Mainland China first-party leaflet lists 10 mg, 20 mg and 40 mg; the current U.S. label also has 80 mg, while Japan PMDA also has 5 mg. These market-specific strengths must not be merged into one product set." }, { "zh": "中国大陆 Version No. 20260119 企业说明书列示碳酸钙、微晶纤维素、乳糖、交联羧甲纤维素钠、聚山梨酯 80、羟丙纤维素、硬脂酸镁及包衣相关成分等辅料。辅料表用于核对手中产品和向医生或药师提出过敏、耐受或相互作用问题；不能据此断言另一厂牌疗效更差、把 40 mg 自动拆成两片 20 mg，或给出个人片数。", "en": "The Mainland China first-party leaflet Version No. 20260119 lists excipients including calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, magnesium stearate and coating-related ingredients. The excipient list helps check the exact product and frame allergy, tolerability or interaction questions for a clinician or pharmacist; it does not prove another manufacturer is less effective, turn 40 mg automatically into two 20 mg tablets, or provide a personal tablet count." }, { "zh": "晖致中国包装更新声明说明，Pfizer 与 VIATRIS 标识、企业名称、片剂文字和刻痕等可能随包装切换而变化，旧版与新版包装也可能在过渡期并存。外观不同不能单独证明是假药；应继续核对完整药盒、说明书版本、批准文号和官方查询入口。", "en": "Viatris China's packaging-update statement says Pfizer and VIATRIS branding, company names, tablet text and score may change during the packaging transition, and older and newer packs may coexist. A different appearance alone does not prove a medicine is counterfeit; continue by checking the complete pack, leaflet version, approval number and official lookup route." }, { "zh": "阿托伐他汀和瑞舒伐他汀都属于他汀类。没有开方医生或药师明确方案时，不应自行同日叠加、隔天轮换、把一盒替换另一盒，或因感觉变化自行加减；这类问题要连同全部用药清单一起复核。", "en": "Atorvastatin and rosuvastatin are both statins. Without a specific plan from the prescriber or pharmacist, do not self-combine them on the same day, alternate them, replace one pack with the other, or change use based on a feeling; review the complete medicine list instead." }, { "zh": "标签中的强度是每片产品身份的一部分，不是“每天该吃几片”的答案。任何强度、用药时间、能否掰开或与食物同服的问题，都要回到这一个市场、这一个版本、这一个产品的现行标签和处方。", "en": "The labelled strength is part of a tablet's identity, not an answer to “how many tablets per day.” Questions about strength, timing, splitting or food must go back to the current label and prescription for this exact product, version and market." }, { "zh": "若已做过药物基因检测，可带着原始报告与药品清单请专业人员解释其是否与当前治疗有关；网页不会据此建议每个人做筛查，也不会把基因结果替代肾肝功能、既往反应、合并疾病和联用药物的核对。", "en": "If pharmacogenomic testing has already been done, bring the original report and medicine list to a professional to ask whether it is relevant. This page does not recommend universal screening or let genetic results replace checks of kidney/liver function, prior reactions, conditions and co-medications." } ], "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿托伐他汀怎样起作用：它影响胆固醇合成路径中的一个酶", "en": "How atorvastatin works: it acts on one enzyme in the cholesterol-synthesis pathway" }, "summary": { "zh": "FDA 标签在临床药理部分将阿托伐他汀描述为 HMG‑CoA 还原酶的选择性、竞争性抑制剂。它是对药物作用路径的解释，不是对任何个人 LDL‑C 变化、心血管风险、适用性或剂量的承诺。", "en": "In Clinical Pharmacology, the FDA label describes atorvastatin as a selective, competitive inhibitor of HMG‑CoA reductase. This explains a drug-action pathway; it is not a promise of any individual's LDL‑C change, cardiovascular risk, suitability or dose." }, "checks": [ { "zh": "可把 HMG‑CoA 还原酶理解为胆固醇合成路径中的一个关键“步骤”。标签描述的抑制作用与肝脏 LDL 受体等后续变化有关；这解释了为何它被归入他汀类，但不能替代血脂检查、风险评估或处方复核。", "en": "HMG‑CoA reductase can be read as one key “step” in cholesterol synthesis. The label links inhibition with downstream changes including hepatic LDL receptors; that explains its statin class, but does not replace lipid testing, risk assessment or prescription review." }, { "zh": "“同为他汀、都影响同一路径”不等于可把阿托伐他汀与瑞舒伐他汀自行叠加或交替。不同产品、强度、相互作用、肾肝功能、既往反应和目标市场标签都需要一起由专业人员核对。", "en": "“Both are statins and affect the same pathway” does not permit self-combining or alternating atorvastatin and rosuvastatin. Exact products, strengths, interactions, kidney/liver function, prior reactions and target-market labels must be reviewed together by a professional." }, { "zh": "药物基因组结果在少数场景可帮助专业人员理解暴露或不良反应风险，但机制本身不表示每个人都应做全基因筛查。已有报告应与完整药单和临床资料一并解释，不能作为自行开始、停用或换药的依据。", "en": "Pharmacogenomic results can help professionals interpret exposure or adverse-effect risk in defined situations, but the mechanism itself does not mean everyone should have broad genetic screening. An existing report must be interpreted with the full medicine list and clinical information, not used to self-start, stop or switch." } ], "source": { "id": "src_defe48d290569ed6", "label": "FDA：Lipitor 2024-04 处方信息（Clinical Pharmacology）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.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" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lipitor", "generic": "阿托伐他汀", "dosageFormClass": "阿托伐他汀钙口服薄膜衣片：美国 10 mg、20 mg、40 mg、80 mg；中国大陆企业说明书 10 mg、20 mg、40 mg；日本 PMDA 5 mg、10 mg。不同市场规格不合并，也不转换为个人片数。" }, "labelSource": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "晖致中国", "en": "Viatris China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书或产品资料", "en": "Manufacturer public leaflet or product material" }, "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_defe48d290569ed6", "label": "FDA：Lipitor 2024-04 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.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." } }, { "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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_deb7f792025a47d6", "label": "PMDA：リピトール錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189015F1023_2?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "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": "manufacturer_public_label_verified", "authority": { "zh": "晖致中国", "en": "Viatris China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书或产品资料", "en": "Manufacturer public leaflet or product material" }, "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": [ { "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" } }, { "id": "ema-2023-statin-myasthenia-gravis-atorvastatin", "issuedAt": "2023-02-06", "status": "ema_prac_product_information_signal", "title": { "zh": "EMA PRAC 产品信息安全信号：Lipitor（atorvastatin）所在他汀类与重症肌无力／眼肌型重症肌无力", "en": "EMA PRAC product-information signal: statins including Lipitor (atorvastatin) and myasthenia gravis / ocular myasthenia" }, "summary": { "zh": "EMA 药物警戒风险评估委员会（PRAC）于 2023-02-06 发布的产品信息措辞摘录，把 Lipitor（atorvastatin）列入他汀类范围。该文件说明：少数报告提示，他汀类可诱发新发或加重既有重症肌无力或眼肌型重症肌无力；同一种或不同他汀再次使用后也报告过症状复发。它是欧盟产品信息更新的、特定日期的信号沟通，不表示手中任何 Lipitor 包装、其他市场或任何个人已发生该问题，也不能据此自行停药、换药、减量、加量或交替服用。出现新的或加重的肌无力相关疑问，应带上实际包装和完整用药清单尽快联系开方团队或药师；紧急症状应使用当地急救服务。", "en": "In its product-information wording extract dated 2023-02-06, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) includes Lipitor (atorvastatin) within the statin class. The document says that, in a few reported cases, statins may induce new-onset or aggravate pre-existing myasthenia gravis or ocular myasthenia, and that recurrence after re-administration of the same or a different statin has been reported. This is a dated EU product-information signal; it does not mean that any Lipitor pack, another market, or any individual has this problem, and it does not support self-stopping, switching, reducing, increasing, or alternating treatment. New or worsening muscle-weakness questions need the actual pack and complete medicine list reviewed promptly by the prescribing team or pharmacist; emergencies require local emergency services." }, "source": { "id": "src_0fd36b48b08adb04", "label": "EMA PRAC：2023-02-06 他汀类（含 atorvastatin、rosuvastatin）与重症肌无力产品信息安全信号", "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-9-12-january-2023-prac_bg.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_information_signal", "market": "EU", "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": "中国大陆可从晖致当前产品页进入立普妥® Version No. 20260119 企业说明书，核对阿托伐他汀钙片 10 mg、20 mg、40 mg；美国 DailyMed 当前标签另列 10 mg、20 mg、40 mg、80 mg，日本 PMDA 另列 5 mg、10 mg。本页把三地规格、来源与包装线索分开，不把标签数字变成个人片数、换药比例、联合用药、停用或购买结论。", "history": "LIPITOR 的美国上市信息可在 Drugs@FDA 相关批准文件中追溯；中国大陆当前企业说明书版本号为 20260119。晖致中国包装更新声明说明，品牌从 Pfizer 向 VIATRIS 过渡时，旧包装与新包装可能在流通环节并存，且包装文字、企业名称、片剂文字与刻痕等会变化；外观差异本身不能用于判定真伪。CADUET（氨氯地平/阿托伐他汀）是独立复方产品，不能混入本单方档案。", "sourceDocuments": [ { "id": "src_17a2d15fb5fe843b", "label": "晖致中国：立普妥®／阿托伐他汀钙片产品信息页（2026-08-30 复核）", "url": "https://viatris.cn/products/product-information", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_5eab1043fc8a5837", "label": "晖致中国：关于立普妥®等产品包装更新的声明（更新于 2025-04）", "url": "https://viatris.cn/newsroom/news-20240802", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_defe48d290569ed6", "label": "FDA：Lipitor 2024-04 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.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_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀独立美国公开标签（Viatris；SPL v2，2026-06-26 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "documentRelation": "excluded_product_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_deb7f792025a47d6", "label": "PMDA：リピトール錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189015F1023_2?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020702", "approvalTimeline": [ { "date": "1996", "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": "FDA 2024-04 LIPITOR 标签列示 Initial U.S. Approval: 1996。该历史信息不等同于其他市场的批准、现行包装、供应或可售资格。", "en": "The Apr 2024 FDA LIPITOR label lists Initial U.S. Approval: 1996. This historical information does not establish approval, current packaging, supply or sale eligibility in another market." }, "source": { "id": "src_defe48d290569ed6", "label": "FDA: Lipitor prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.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": "2024-04", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-04 的 FDA 标签档案，作为追溯入口；美国当前产品身份与包装面板另以 DailyMed SPL v8 核对。", "en": "This page links the Apr 2024 FDA label archive as a traceability entry point; current U.S. product identity and package panels are checked separately against DailyMed SPL v8." }, "source": { "id": "src_defe48d290569ed6", "label": "FDA: Lipitor prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.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": "2025-04", "title": { "zh": "晖致中国更新立普妥®包装变更声明", "en": "Viatris China updated its Lipitor packaging-change statement" }, "detail": { "zh": "声明说明 Pfizer 与 VIATRIS 标识、企业名称、片剂文字和刻痕等可能随包装切换而变化，旧版与新版包装可能在过渡期并存。该信息用于解释外观变化，不构成真伪鉴定、库存或可售资格证明。", "en": "The statement says Pfizer and VIATRIS branding, company names, tablet text and score may change during the packaging transition, and older and newer packs may coexist. It explains appearance changes; it is not an authenticity determination, stock record or evidence of sale eligibility." }, "source": { "id": "src_5eab1043fc8a5837", "label": "晖致中国：关于立普妥®等产品包装更新的声明（更新于 2025-04）", "url": "https://viatris.cn/newsroom/news-20240802", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-01-19", "title": { "zh": "中国大陆企业说明书 Version No. 20260119", "en": "Mainland China first-party leaflet Version No. 20260119" }, "detail": { "zh": "晖致中国当前产品信息页链接的 25 页说明书列示立普妥®、阿托伐他汀钙片及 10 mg、20 mg、40 mg，并提供辅料与外观等阅读字段。它是企业公开说明书，不替代 NMPA 批准数据库、批准文号、准确包装、库存或可售资格核验。", "en": "The 25-page leaflet linked from Viatris China's current product-information page lists Lipitor (立普妥®), atorvastatin calcium tablets and 10 mg, 20 mg and 40 mg strengths, with excipient and appearance fields. It is a first-party leaflet and does not replace an NMPA approval-database, approval-number, exact-package, stock or sale-eligibility check." }, "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签与四个精确包装面板已链接", "en": "Current public label and four exact package panels linked" }, "detail": { "zh": "DailyMed SPL v8 列示 10 mg、20 mg、40 mg、80 mg；不据此声称实际在售、库存或可获得性。", "en": "DailyMed SPL v8 lists 10 mg, 20 mg, 40 mg and 80 mg; this does not establish actual marketing, stock or availability." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "当前企业产品页与 Version No. 20260119 说明书已链接", "en": "Current first-party product page and leaflet Version No. 20260119 linked" }, "detail": { "zh": "企业资料列示立普妥®、阿托伐他汀钙片及 10 mg、20 mg、40 mg；仍需从 NMPA 官方入口另行核对批准记录、批准文号与目标产品，且不推定库存或可售资格。", "en": "The company materials list Lipitor (立普妥®), atorvastatin calcium tablets and 10 mg, 20 mg and 40 mg; the approval record, approval number and target product still require a separate NMPA check, and stock or sale eligibility is not inferred." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "当前 PMDA 产品记录已链接", "en": "Current PMDA product record linked" }, "detail": { "zh": "PMDA 产品页列示リピトール錠 5 mg、10 mg；不把日本规格并入中国大陆或美国规格。", "en": "The PMDA product page lists LIPITOR 5 mg and 10 mg tablets; Japanese strengths are not merged into Mainland China or U.S. strengths." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "待建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国、中国大陆企业资料或日本记录推定欧盟批准、持有人、规格、供应或可售资格。", "en": "No EU approval, holder, strength, supply or sale-eligibility inference is made from U.S., Mainland China company or Japan records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "一天吃阿托伐他汀、一天吃瑞舒伐他汀，可以隔天轮换吗？", "en": "Can atorvastatin and rosuvastatin be alternated on different days?" }, "answer": { "zh": "不要自行隔天轮换，也不要同日各吃一颗。两者虽然都属于他汀类，但不是按药名或 mg 自动换算的同一种产品；轮换还会让漏服、重复、相互作用和不适反应更难追溯。请把两盒实际药品、处方和完整药单交给开方团队或药师确认真正的现行方案，不要自行停一种、补一种或交替使用。", "en": "Do not self-alternate them by day or take one of each on the same day. Both are statins, but they are not one product that can be converted by name or milligrams. Alternation also makes omissions, duplication, interactions and adverse symptoms harder to trace. Take both actual packs, the prescription and complete medicine list to the prescriber or pharmacist to confirm the current plan; do not self-stop one, add the other or rotate them." } }, { "question": { "zh": "为什么有些人的完整药单会让专业人员特别核对阿托伐他汀？", "en": "Why can a person's complete medicine list trigger extra atorvastatin review?" }, "answer": { "zh": "当前 LIPITOR 标签说明阿托伐他汀是 CYP3A4 和多种转运体的底物，并列出某些抗病毒药、抗真菌药、抗菌药、环孢素、吉非贝齐及大量葡萄柚汁等需要避免、限制或额外管理的情形。这解释了为什么必须看完整药单，却不能由网页据此宣布某个人“适合瑞舒伐他汀”或自行换药；准确产品、疾病、肝肾功能、既往反应和目标市场标签仍要一起判断。", "en": "The current LIPITOR label identifies atorvastatin as a substrate of CYP3A4 and several transporters and lists circumstances involving certain antivirals, antifungals, antibacterials, cyclosporine, gemfibrozil and large quantities of grapefruit juice that need avoidance, limits or added management. This explains why the complete medicine list matters, but it does not let a webpage declare that someone is ‘suited to rosuvastatin’ or self-switch. The exact product, conditions, liver/kidney function, prior reactions and target-market label still need review together." } }, { "question": { "zh": "选择阿托伐他汀前，每个人都需要做全基因筛查吗？", "en": "Does everyone need whole-genome screening before atorvastatin is considered?" }, "answer": { "zh": "不是。当前 LIPITOR 标签首先要求核对准确产品、风险因素、症状和相互作用；它没有把全基因筛查写成所有人的普遍前置条件。若已经有药物基因报告，或专业团队认为某个特定检测会改变判断，应由其解释检测范围、证据限制和结果；不要自行购买宽泛检测后按报告停药、换药或改量。", "en": "No. The current LIPITOR label first requires review of the exact product, risk factors, symptoms and interactions; it does not state whole-genome screening as a universal prerequisite. If a pharmacogenomic report already exists, or the clinical team believes a specific test could change a decision, that team should explain the test scope, evidence limits and result. Do not buy broad testing and then self-stop, switch or adjust a medicine from the report." } }, { "question": { "zh": "老人同时吃很多药，出现肌肉痛或无力时怎么办？", "en": "What should an older adult taking many medicines do about muscle pain or weakness?" }, "answer": { "zh": "应及时联系当地医疗专业人员，并携带所有处方药、非处方药、保健品、草本、近期新增或停用药物以及实际药盒。当前标签把 65 岁及以上、肾功能受损、未控制的甲状腺功能减退、某些联用药和较高规格列为肌病风险核对线索。网页不能判断原因，也不要自行骤停、隔天轮换、补服或换成另一种他汀；若伴明显不适、发热、深色尿、严重无力或意识变化，应及时使用当地紧急医疗渠道。", "en": "Contact a local healthcare professional promptly and bring every prescription, OTC product, supplement, herb, recent start/stop change and actual pack. The current label identifies age 65 or older, renal impairment, uncontrolled hypothyroidism, certain co-medications and higher dosage as myopathy risk-review cues. The site cannot diagnose the cause, and the medicine should not be abruptly self-stopped, alternated, made up or replaced by another statin. Marked malaise, fever, dark urine, severe weakness or altered awareness needs prompt local urgent care." } }, { "question": { "zh": "这份档案能证明“原研”或“可替代”吗？", "en": "Does this archive prove originator status or interchangeability?" }, "answer": { "zh": "不能。它仅提供公开文件的阅读入口；原研/仿制关系与任何替代判断必须按具体市场、剂型和现行监管记录核验。", "en": "No. It is a public-document reading entry point. Originator/generic relationships and any substitution question require a specific market, dosage form and current regulatory record." } }, { "question": { "zh": "为什么不直接列出价格？", "en": "Why is no price shown here?" }, "answer": { "zh": "公开价格必须同时锁定产品、规格、包装、市场、币种、日期和价格含义；这些字段未完整复核前不会发布比较结论。", "en": "A public price needs a verified product, strength, pack, market, currency, date and price meaning. No comparison is published before those fields are complete." } } ], "relatedMedicineChecks": [ { "target": { "id": "rosuvastatin-crestor", "brand": "CRESTOR", "generic": "瑞舒伐他汀钙", "canonicalUrls": { "zh": "https://origindrug.com/drugs/rosuvastatin-crestor/", "en": "https://origindrug.com/en/drugs/rosuvastatin-crestor/" } }, "title": { "zh": "与 CRESTOR／瑞舒伐他汀同在药单上时：不要把同类药当作可互换的两颗药", "en": "When CRESTOR / rosuvastatin is on the same list: do not treat same-class medicines as interchangeable tablets" }, "summary": { "zh": "LIPITOR 与 CRESTOR 的公开标签都说明其属于他汀类；这只是药物类别线索，不支持同日各服一颗、隔天轮换、按毫克换算、直接替换或自行加减。请把两种实际药盒、全部处方药、非处方药和补充剂交给药师或开方团队核对；本卡片不判断谁更适合哪一种药，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "Public LIPITOR and CRESTOR labels identify both medicines as statins. That is a class clue only; it does not support taking one of each on the same day, alternating days, milligram conversion, direct replacement or self-adjustment. Have a pharmacist or prescriber review both actual packs, every prescription medicine, OTC product and supplement; this card does not decide which medicine suits someone or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "originator-vs-generic", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/atorvastatin-lipitor/", "en": "https://origindrug.com/en/drugs/atorvastatin-lipitor/" }, "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." ] }