{ "id": "rosuvastatin-crestor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "CRESTOR", "generic": "瑞舒伐他汀钙", "aliases": [ "可定", "可定®", "瑞舒伐他汀", "瑞舒伐他汀钙片", "クレストール", "rosuvastatin", "rosuvastatin calcium" ], "marketBrandNames": [ { "name": "クレストール", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示クレストール普通片与 OD 口崩片的 2.5 mg、5 mg 规格；不同剂型和市场记录不能据此自行互换。", "en": "The current PMDA product page lists CRESTOR (クレストール) 2.5 mg and 5 mg conventional and orally disintegrating tablets; different forms and market records must not be self-interchanged." }, "source": { "id": "src_eb05083a584bc9be", "label": "PMDA：クレストール錠 2.5 mg／5 mg及 OD 錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189017F1022_1?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" } }, { "name": "可定®", "market": { "zh": "中国大陆（阿斯利康中国当前产品组合页）", "en": "Mainland China (current AstraZeneca China product-portfolio page)" }, "evidenceStatus": "current_first_party_product_listing", "note": { "zh": "阿斯利康中国当前心血管、肾脏及代谢产品组合页列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg。该企业页面建立品牌、通用名和规格线索，但不替代 NMPA 批准记录、现行说明书、批准文号、包装或供应核验。", "en": "AstraZeneca China's current cardiovascular, renal and metabolic product-portfolio page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This first-party page establishes brand, generic-name and strength cues, but does not replace NMPA approval records, the current leaflet, approval numbers, packaging or supply verification." }, "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：心血管、肾脏及代谢主要产品——可定®（瑞舒伐他汀钙片）5 mg／10 mg／20 mg（2026-08-30 复核）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "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" } } ], "mainlandChinaTradeNameCue": { "value": "可定®", "status": "discovery_cue_requires_target_market_verification", "source": null } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（SPL v14，2026-05-13 发布；本档案分别展示四个准确包装面板）；日本 PMDA 当前产品记录（クレストール錠／OD 錠）；阿斯利康中国当前心血管、肾脏及代谢产品组合页列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg，未据此推定批准文号、现行说明书、包装、库存或可售资格", "dosageFormClass": "美国 DailyMed 包衣片：5 mg、10 mg、20 mg、40 mg；阿斯利康中国产品组合页：可定® 瑞舒伐他汀钙片 5 mg、10 mg、20 mg；日本 PMDA：2.5 mg、5 mg 普通片与 OD 口崩片（市场、剂型和规格不得混写或自行换算）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2003", "archiveSponsorText": "AstraZeneca / DailyMed 公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-crestor-tablet-5mg-ndc-0310-7560-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7560-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；90 片瓶装", "en": "5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_5mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "value": 5, "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": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、双凸包衣片", "en": "round biconvex coated tablet" }, "imprint": "ZD4522 / 5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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-crestor-tablet-10mg-ndc-0310-7570-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7570-90", "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=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_10mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "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": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸包衣片", "en": "round biconvex coated tablet" }, "imprint": "ZD4522 / 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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-crestor-tablet-20mg-ndc-0310-7580-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7580-90", "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=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_20mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "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": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸包衣片", "en": "round biconvex coated tablet" }, "imprint": "ZD4522 / 20", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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-crestor-tablet-40mg-ndc-0310-7590-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7590-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR__40mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "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": 30, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形、双凸包衣片", "en": "oval biconvex coated tablet" }, "imprint": "ZD4522 / 40", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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-crestor-tablet-10mg-ndc-0310-7570-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_10mg.jpg", "alt": "CRESTOR 瑞舒伐他汀在美国 DailyMed AstraZeneca 当前公开标签中的 10 mg、NDC 0310-7570-90、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v14（2026-05-13 发布）", "presentation": "CRESTOR 瑞舒伐他汀：每片 10 mg，NDC 0310-7570-90，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 CRESTOR、瑞舒伐他汀 10 mg、NDC 0310-7570-90 与 90 片瓶装。它只帮助核对品牌、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 5 mg、20 mg、40 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_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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": "CRESTOR 说明书放大阅读：规格、外观与联用要分开看", "en": "CRESTOR label reading: separate strength, appearance and combination questions" }, "summary": { "zh": "本模块以美国 DailyMed SPL v14（2026-05-13 发布）为阅读入口。它说明不同规格与外观是产品身份线索，但不替任何人决定应选哪种他汀、是否换药或是否需要基因检测。", "en": "This module uses the current U.S. DailyMed SPL v14, published 13 May 2026, as a reading entry point. Different strengths and appearances are identity clues, but they do not decide which statin an individual should use, whether to switch or whether genetic testing is needed." }, "checks": [ { "zh": "该美国标签把 5、10、20、40 mg 分别作为不同的片剂强度，并描述了颜色、形状和刻字。强度、外观和刻字共同帮助核对产品；不应仅凭一项或照片判断真伪、当前市场包装或可替代性。", "en": "The U.S. label lists 5, 10, 20 and 40 mg as different tablet strengths and describes colour, shape and debossing. Strength, appearance and debossing together help check a product; a single clue or photo cannot authenticate it, establish current market packaging or establish interchangeability." }, { "zh": "阿斯利康中国当前产品组合页列示可定®瑞舒伐他汀钙片 5、10、20 mg，但没有因此把美国 40 mg、日本 2.5 mg 或 OD 口崩片并入中国包装。看到“可定”后仍要继续核对实际药盒上的通用名、每片强度、剂型、批准文号、说明书版本与目标市场；企业产品列表不是个人片数或跨市场换算表。", "en": "AstraZeneca China's current product-portfolio page lists CRESTOR (可定®) rosuvastatin calcium tablets in 5, 10 and 20 mg strengths, but that does not merge the U.S. 40 mg tablet, Japanese 2.5 mg tablet or Japanese OD tablet into a Chinese package. After seeing the brand name, continue checking the actual pack's generic name, strength per tablet, dosage form, approval number, leaflet version and target market. A company product list is not an individual tablet count or a cross-market conversion table." }, { "zh": "阿托伐他汀与瑞舒伐他汀同属他汀类，但这不等于“今天各吃一颗”或可自行轮换。任何合用、转换、停用或调整，都需要按现行标签、完整用药清单、既往反应和临床资料由专业人员确认。", "en": "Atorvastatin and rosuvastatin are both statins, but that does not mean “one of each today” or self-directed alternation is appropriate. Any combination, switch, stop or adjustment needs professional confirmation using the current label, full medicine list, prior reactions and clinical information." }, { "zh": "标签会把某些联用药物列为需要避免、限制或额外核对的情况；这不能被简化为通用“安全/不安全”清单。每次新增或停用处方药、非处方药、保健品或草本时，都应主动请药师核对。", "en": "The label identifies some co-medications that need avoidance, limits or extra review; that cannot be simplified into a universal “safe/unsafe” list. When starting or stopping any prescription medicine, OTC product, supplement or herb, ask a pharmacist to review it." }, { "zh": "如已有基因检测报告，专业人员可结合报告、肾肝功能、既往肌肉症状和全部用药判断是否相关。OriginDrug 不把“做全基因筛查”作为自行选择、停用或改变他汀的前提。", "en": "If a genetic report already exists, a professional can assess whether it is relevant alongside kidney/liver function, prior muscle symptoms and all medicines. OriginDrug does not present universal genetic screening as a prerequisite for self-selecting, stopping or changing a statin." } ], "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "瑞舒伐他汀怎样起作用：同样作用于 HMG‑CoA 还原酶，但不等于与另一种他汀可自行互换", "en": "How rosuvastatin works: it also acts on HMG‑CoA reductase, which does not make it self-interchangeable with another statin" }, "summary": { "zh": "FDA 标签在临床药理部分将瑞舒伐他汀描述为 HMG‑CoA 还原酶的选择性、竞争性抑制剂。该机制帮助理解其药物类别；它不能单独回答某个人该选哪一种他汀、是否可联用、是否需调整或该做何种检测。", "en": "In Clinical Pharmacology, the FDA label describes rosuvastatin as a selective, competitive inhibitor of HMG‑CoA reductase. This mechanism helps explain its drug class; it cannot by itself answer which statin a person should use, whether products can be combined, whether an adjustment is needed or which testing is appropriate." }, "checks": [ { "zh": "标签描述的作用路径涉及抑制胆固醇合成中的 HMG‑CoA 还原酶，并与肝脏 LDL 受体等后续变化相关。把它理解为“药物在哪个环节起作用”即可，不应把这段说明读成个人疗效排序或剂量公式。", "en": "The label describes a pathway involving inhibition of HMG‑CoA reductase in cholesterol synthesis and downstream changes including hepatic LDL receptors. Read this as where a medicine acts—not as a personal efficacy ranking or dose formula." }, { "zh": "阿托伐他汀与瑞舒伐他汀都属于他汀类，但相同药理类别不能证明二者在某个市场、剂型、强度或个人情况下可等量替换，更不能支持同日各服一颗。", "en": "Atorvastatin and rosuvastatin are both statins, but a shared pharmacologic class does not prove equal substitution in a given market, formulation, strength or individual situation, and does not support taking one of each on the same day." }, { "zh": "若担心肌肉症状、相互作用、肾肝功能或已有药物基因检测结果，最有效的下一步是带上准确药盒和完整药单由专业人员按现行标签复核；机制说明不能替代这一步。", "en": "With concerns about muscle symptoms, interactions, kidney/liver function or an existing pharmacogenomic result, the most useful next step is review of the exact package and complete medicine list against the current label with a professional; a mechanism explanation cannot replace that step." } ], "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（Clinical Pharmacology；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CRESTOR", "generic": "瑞舒伐他汀钙", "dosageFormClass": "美国 DailyMed 包衣片：5 mg、10 mg、20 mg、40 mg；阿斯利康中国产品组合页：可定® 瑞舒伐他汀钙片 5 mg、10 mg、20 mg；日本 PMDA：2.5 mg、5 mg 普通片与 OD 口崩片（市场、剂型和规格不得混写或自行换算）" }, "labelSource": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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" }, "productRoutes": [ { "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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_4f777b38d4dbbdd4", "label": "FDA：CRESTOR 2024-07 标签档案", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021366s046lbl.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_eb05083a584bc9be", "label": "PMDA：クレストール錠 2.5 mg／5 mg及 OD 錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189017F1022_1?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": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2021-statin-pregnancy-breastfeeding-safety-communication", "issuedAt": "2021-07-20", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：他汀类药物在妊娠与哺乳期的标签变更", "en": "FDA Drug Safety Communication: labelling changes for statins in pregnancy and breastfeeding" }, "summary": { "zh": "FDA 于 2021-07-20 就整个他汀类发布安全通讯，明确列出 Lipitor（阿托伐他汀）和 Crestor（瑞舒伐他汀）。该通讯涉及美国处方信息中妊娠与哺乳相关警语的监管变更和个体化获益/风险判断；它不等于任何个人可以据此自行开始、停止、替换或调整药物。妊娠、疑似妊娠或哺乳相关问题应结合手中产品、目标市场现行说明书和开方团队意见核对。", "en": "On 2021-07-20, FDA issued a class Drug Safety Communication that explicitly lists Lipitor (atorvastatin) and Crestor (rosuvastatin). It concerns U.S. prescribing-information changes around pregnancy and breastfeeding and individualized benefit-risk review; it does not support self-starting, stopping, switching or adjusting any individual medicine. Pregnancy, suspected pregnancy or breastfeeding questions require the exact product, current target-market label and the prescribing team." }, "source": { "id": "src_e5fb970c597c7f50", "label": "FDA：2021-07-20 他汀类药物妊娠与哺乳期药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-2023-statin-myasthenia-gravis-rosuvastatin", "issuedAt": "2023-02-06", "status": "ema_prac_product_information_signal", "title": { "zh": "EMA PRAC 产品信息安全信号：Crestor（rosuvastatin）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 Crestor (rosuvastatin) 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 Crestor（rosuvastatin）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 Crestor 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 Crestor (rosuvastatin) 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 Crestor 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": "美国 DailyMed 的 CRESTOR（rosuvastatin calcium）有日期公开标签列有 5 mg、10 mg、20 mg、40 mg 口服包衣片。本页分别建立四个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡；不把包装数字变成个人片数、他汀之间的转换、联合用药、停用或购买结论。", "history": "FDA 原始 NDA 审评资料记录 NDA 021366；ANDA 079171 批准信记录其所列 CRESTOR® 参比制剂关系。历史资料与当前产品状态须分开核验。本页的 5 mg、10 mg、20 mg、40 mg 面板只对应 DailyMed SPL v14 所列的具体美国包装，不能延伸为任何其他市场、OD 口崩片、其他包装或当前库存结论。", "sourceDocuments": [ { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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_4f777b38d4dbbdd4", "label": "FDA：CRESTOR 2024-07 标签档案", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021366s046lbl.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_488f0af36bb0c4c7", "label": "FDA：ANDA 079171 批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079171Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_84cd60c2c43a17d6", "label": "FDA Drugs@FDA", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/about-drugsfda", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_eb05083a584bc9be", "label": "PMDA：クレストール錠 2.5 mg／5 mg及 OD 錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189017F1022_1?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" }, { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：心血管、肾脏及代谢主要产品——可定®（瑞舒伐他汀钙片）5 mg／10 mg／20 mg（2026-08-30 复核）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "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" } ], "applicationNumber": "NDA 021366", "approvalTimeline": [ { "date": "2003", "title": { "zh": "FDA 原始 NDA 审评资料入口", "en": "FDA original NDA review entry point" }, "detail": { "zh": "FDA 公开审评资料记录 CRESTOR® 与 NDA 021366。该资料用于历史追溯，不能替代当前标签。", "en": "FDA public review material records CRESTOR® and NDA 021366. It is for historical traceability and does not replace the current label." }, "source": { "id": "src_8a621727628e5103", "label": "FDA: CRESTOR original NDA review", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor_Admindocs_P2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016", "title": { "zh": "ANDA 批准信所列参比制剂关系", "en": "Reference-drug relationship in an ANDA approval letter" }, "detail": { "zh": "FDA ANDA 079171 批准信记录其所列的 CRESTOR® 参比制剂关系。它不自动延伸为其他国家、剂型或产品的替代结论。", "en": "FDA ANDA 079171 records the CRESTOR® reference-drug relationship stated in that letter. It does not automatically extend to other countries, dosage forms or products." }, "source": { "id": "src_488f0af36bb0c4c7", "label": "FDA: ANDA 079171 approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079171Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05-13", "title": { "zh": "当前 DailyMed SPL v14 公开", "en": "Current DailyMed SPL v14 published" }, "detail": { "zh": "DailyMed 将当前 CRESTOR SPL v14 的发布日期列为 2026-05-13；目标市场、实际供应和个人用药仍须独立核对。", "en": "DailyMed lists 13 May 2026 as the published date for current CRESTOR SPL v14; target-market status, actual supply and individual use still require separate review." }, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed: current CRESTOR U.S. public label, SPL v14", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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" } }, { "date": "2026-08-30", "title": { "zh": "阿斯利康中国当前产品组合页完成复核", "en": "Current AstraZeneca China product-portfolio page reviewed" }, "detail": { "zh": "阿斯利康中国当前心血管、肾脏及代谢主要产品页列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg。该节点只建立企业当前公开的品牌、通用名与规格线索；不等于 NMPA 批准记录、批准文号、现行说明书、准确包装、库存或可售资格。", "en": "AstraZeneca China's current cardiovascular, renal and metabolic product page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This node establishes only the brand, generic-name and strength cues currently published by the company; it is not an NMPA approval record, approval number, current leaflet, exact package, stock or sale-eligibility record." }, "source": { "id": "src_74aa269ebb2ff692", "label": "AstraZeneca China: current cardiovascular, renal and metabolic product portfolio — CRESTOR / 可定 5 mg, 10 mg and 20 mg (reviewed 30 Aug 2026)", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开档案", "en": "Public archive linked" }, "detail": { "zh": "含 NDA 审评、ANDA 批准信及标签档案。", "en": "Includes the NDA review, an ANDA letter and a label archive." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "已链接阿斯利康中国当前产品组合页；监管记录仍待逐项核验", "en": "Current AstraZeneca China product-portfolio page linked; regulatory record still requires item-by-item verification" }, "detail": { "zh": "企业当前页面列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg。页面未在本档案中建立批准文号、现行说明书、包装、库存或可售资格，不能与美国 40 mg 或日本 2.5 mg／OD 片混写。", "en": "The current company page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This dossier has not established an approval number, current leaflet, packaging, stock or sale eligibility from that page, and the record must not be merged with the U.S. 40 mg tablet or Japanese 2.5 mg/OD products." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "待建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不能从美国、日本或中国企业页面外推欧盟批准、持有人、规格、说明书、供应或可售资格。", "en": "No EU approval, holder, strength, leaflet, supply or sale-eligibility conclusion is inferred from U.S., Japanese or Chinese company pages." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页", "en": "Current PMDA product page linked" }, "detail": { "zh": "PMDA 当前页列示 2.5 mg、5 mg 普通片和 OD 口崩片；仅适用于该日本监管页面所列产品。", "en": "The current PMDA page lists 2.5 mg and 5 mg conventional and OD tablets; this applies only to the products on that Japanese regulatory page." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "一天吃瑞舒伐他汀、一天吃阿托伐他汀，可以隔天轮换吗？", "en": "Can rosuvastatin and atorvastatin be alternated on different days?" }, "answer": { "zh": "不要自行隔天轮换，也不要同日叠加。共同的他汀类别并不建立 mg 换算、交替服用或直接替换关系；轮换还可能掩盖漏服、重复、相互作用和症状来源。请让开方团队或药师用两盒实际药品、处方、完整药单、既往反应和目标市场现行标签确认方案。", "en": "Do not self-alternate them by day or combine them on the same day. A shared statin class does not establish milligram conversion, alternating use or direct substitution, and rotation can obscure missed or duplicate use, interactions and the source of symptoms. Ask the prescriber or pharmacist to confirm the plan using both actual packs, the prescription, complete medicine list, prior reactions and current target-market labels." } }, { "question": { "zh": "为什么肾功能或族群信息会让专业人员单独核对 CRESTOR？", "en": "Why can kidney function or population information trigger a separate CRESTOR review?" }, "answer": { "zh": "当前美国 CRESTOR 标签对严重肾功能受损且未透析者以及亚洲患者列有特定的专业使用边界，并把肾功能受损、65 岁及以上、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因素。这些是专业核对线索，不是网页判断某个人一定适合或不适合瑞舒伐他汀、阿托伐他汀的规则；应结合准确产品、处方、检查结果、既往反应和完整药单。", "en": "The current U.S. CRESTOR label sets specific professional-use boundaries for severe renal impairment without haemodialysis and for Asian patients, and identifies renal impairment, age 65 or older, uncontrolled hypothyroidism, certain co-medications and higher dosage as myopathy risk factors. These are professional review cues, not web rules declaring that someone is or is not suited to rosuvastatin or atorvastatin. The exact product, prescription, test results, prior reactions and complete medicine list must be considered together." } }, { "question": { "zh": "标签提到 SLCO1B1，是不是人人都要做全基因筛查？", "en": "The label mentions SLCO1B1. Does everyone need whole-genome screening?" }, "answer": { "zh": "不是。当前标签的药物基因组学部分只报告：在非常小的受试者组（每组 3–5 人）中，携带两个 SLCO1B1 低功能等位基因者曾观察到较高瑞舒伐他汀浓度，而且该多态性对疗效或安全性的影响尚未明确建立。这不能推出人人做全基因筛查，也不能把已有结果直接变成停药、换药或剂量方案；如已有原始报告，应由专业人员结合全部临床资料解释。", "en": "No. The current label's pharmacogenomics section only reports higher rosuvastatin concentrations in very small groups (three to five people per group) with two reduced-function SLCO1B1 alleles, and states that the effect of this polymorphism on efficacy or safety has not been clearly established. That does not mean everyone needs whole-genome screening or turn an existing result directly into a stop, switch or dose plan. A professional should interpret any original report with the full clinical context." } }, { "question": { "zh": "老人同时吃很多药，出现肌肉痛、无力或深色尿时怎么办？", "en": "What should an older adult taking many medicines do about muscle pain, weakness or dark urine?" }, "answer": { "zh": "应及时联系当地医疗专业人员，并带齐实际药盒、处方药、非处方药、保健品、草本及近期用药变化。网页不能判断是否由他汀、相互作用、甲状腺、肾功能或其他原因造成，也不要自行骤停、补服、隔天轮换或换到阿托伐他汀。若症状严重，或伴发热、明显不适、尿色明显变深、行走困难或意识变化，应及时使用当地紧急医疗渠道。", "en": "Contact a local healthcare professional promptly and bring the actual packs, prescriptions, OTC products, supplements, herbs and recent medicine changes. The site cannot determine whether a statin, interaction, thyroid condition, kidney function or another cause is responsible, and it does not support abrupt self-stopping, catch-up use, alternating days or switching to atorvastatin. Severe symptoms, fever, marked malaise, clearly dark urine, difficulty walking or altered awareness needs prompt local urgent care." } }, { "question": { "zh": "能把这一页与另一种他汀直接做优劣排序吗？", "en": "Can this page rank it against another statin?" }, "answer": { "zh": "不能。比较必须先对齐目标市场、标签版本、剂型、规格、研究人群与价格记录口径。", "en": "No. A comparison must first align the market, label version, dosage form, strength, study population and price-record basis." } } ], "relatedMedicineChecks": [ { "target": { "id": "atorvastatin-lipitor", "brand": "Lipitor", "generic": "阿托伐他汀", "canonicalUrls": { "zh": "https://origindrug.com/drugs/atorvastatin-lipitor/", "en": "https://origindrug.com/en/drugs/atorvastatin-lipitor/" } }, "title": { "zh": "与 LIPITOR／阿托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 LIPITOR / atorvastatin is on the same list: do not treat same-class medicines as interchangeable tablets" }, "summary": { "zh": "CRESTOR 与 LIPITOR 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 CRESTOR and LIPITOR 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_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "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/rosuvastatin-crestor/", "en": "https://origindrug.com/en/drugs/rosuvastatin-crestor/" }, "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." ] }