{ "id": "prograf-tacrolimus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "PROGRAF", "generic": "他克莫司胶囊", "aliases": [ "PROGRAF", "Prograf", "tacrolimus", "tacrolimus capsules", "他克莫司", "他克莫司胶囊", "普乐可复", "NDA 050708", "0469-0607-73", "0469-0617-73", "0469-0657-73" ], "marketBrandNames": [ { "name": "PROGRAF", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；监管记录不证明实时供应或个人适用。", "en": "Current brand label; a regulatory record does not prove live supply or individual suitability." }, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前 PROGRAF 品牌标签列出普通释放他克莫司胶囊 0.5 mg、1 mg、5 mg 三种强度及各自 100 粒瓶装 NDC。本页不从美国记录外推中国大陆或其他市场的批准、商品名、参比身份、供应、购买资格或个人适用性。", "dosageFormClass": "PROGRAF 普通释放他克莫司硬胶囊：0.5 mg、1 mg、5 mg 均为每粒含量，各展示 100 粒瓶装；不同强度、普通释放与缓释、胶囊与颗粒/注射剂不能只按名称或毫克数自行互换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1994-04-08（FDA 审评资料）", "archiveSponsorText": "Astellas Pharma US, Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "PROGRAF tacrolimus", "PROGRAF capsules", "他克莫司胶囊", "普乐可复" ], "excludedProductCues": [ "generic tacrolimus", "ASTAGRAF XL", "ENVARSUS XR", "MODIGRAF", "tacrolimus extended-release", "tacrolimus ointment", "PROTOPIC", "PROGRAF Granules", "tacrolimus injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prograf-tacrolimus-capsule-0-5mg-100-bottle-ndc-0469060773", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "en": "Current U.S. DailyMed brand label (SPL v30; August 2023)" }, "dosageForm": { "zh": "PROGRAF 他克莫司普通释放硬胶囊", "en": "PROGRAF tacrolimus immediate-release hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-0607-73", "pouchCode": null, "applicationNumber": "NDA 050708", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒他克莫司 0.5 mg；100 粒瓶装", "en": "Tacrolimus 0.5 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-23.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他克莫司", "en": "tacrolimus" }, "value": 0.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人颗数、频次、间隔、疗程或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "长圆硬胶囊，约 11 mm", "en": "oblong hard capsule, about 11 mm" }, "imprint": "f / 607 / 0.5 mg", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prograf-tacrolimus-capsule-1mg-100-bottle-ndc-0469061773", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "en": "Current U.S. DailyMed brand label (SPL v30; August 2023)" }, "dosageForm": { "zh": "PROGRAF 他克莫司普通释放硬胶囊", "en": "PROGRAF tacrolimus immediate-release hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-0617-73", "pouchCode": null, "applicationNumber": "NDA 050708", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒他克莫司 1 mg；100 粒瓶装", "en": "Tacrolimus 1 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-24.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他克莫司", "en": "tacrolimus" }, "value": 1, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人颗数、频次、间隔、疗程或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "长圆硬胶囊，约 11 mm", "en": "oblong hard capsule, about 11 mm" }, "imprint": "f / 617 / 1 mg", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prograf-tacrolimus-capsule-5mg-100-bottle-ndc-0469065773", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "en": "Current U.S. DailyMed brand label (SPL v30; August 2023)" }, "dosageForm": { "zh": "PROGRAF 他克莫司普通释放硬胶囊", "en": "PROGRAF tacrolimus immediate-release hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-0657-73", "pouchCode": null, "applicationNumber": "NDA 050708", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒他克莫司 5 mg；100 粒瓶装", "en": "Tacrolimus 5 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-25.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他克莫司", "en": "tacrolimus" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人颗数、频次、间隔、疗程或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "灰红色", "en": "grayish red" }, "shape": { "zh": "长圆硬胶囊，约 14 mm", "en": "oblong hard capsule, about 14 mm" }, "imprint": "f / 657 / 5 mg", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prograf-tacrolimus-capsule-1mg-100-bottle-ndc-0469061773", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-24.jpg", "alt": "PROGRAF 他克莫司 1 mg、NDC 0469-0617-73、100 粒瓶装的 DailyMed 官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "presentation": "PROGRAF 他克莫司普通释放胶囊：每粒 1 mg，NDC 0469-0617-73，100 粒瓶装；白色长圆胶囊，f / 617 / 1 mg。", "notice": "此图只对应所引美国 1 mg、100 粒瓶装面板。页面另将 0.5 mg 与 5 mg 包装逐项分开；图片不用于鉴定真伪，也不能证明实时库存，不授权换规格、换剂型、开胶囊或调整用法。", "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROGRAF 说明书放大阅读：每粒含量、血药浓度、肾毒性、感染与不可互换", "en": "PROGRAF enlarged label: per-capsule strength, blood levels, nephrotoxicity, infection and non-interchangeability" }, "summary": { "zh": "包装上的 0.5 mg、1 mg、5 mg 是每粒他克莫司含量；100 Capsules 是瓶内数量。个人颗数、间隔与目标血药浓度不能从包装数字推出。每次拿到新包装，都应核对品牌、释放方式、强度、外观和处方；不同他克莫司产品不得自行替换。", "en": "The 0.5 mg, 1 mg and 5 mg figures are tacrolimus amounts per capsule; 100 Capsules is the bottle count. Individual capsule counts, intervals and target blood levels cannot be inferred from pack numbers. With each new supply, check brand, release form, strength, appearance and prescription; tacrolimus products must not be self-substituted." }, "checks": [ { "zh": "说明书明确 PROGRAF 普通释放产品与缓释他克莫司不可互换；配药或替换错误曾导致排斥或暴露过高/过低。看到 ASTAGRAF XL、ENVARSUS XR、颗粒剂、注射剂或不同外观时，应在使用前联系移植团队或药师。", "en": "The label states that immediate-release PROGRAF is not interchangeable with extended-release tacrolimus. Dispensing or substitution errors have led to rejection or under-/overexposure. Contact the transplant team or pharmacist before use when ASTAGRAF XL, ENVARSUS XR, granules, injection or a different appearance is supplied." }, { "zh": "他克莫司需要结合全血谷浓度和临床情况监测；网页不能从一次化验、体重、年龄、基因或包装强度计算个人颗数、目标范围或调整量。", "en": "Tacrolimus requires whole-blood trough monitoring together with clinical context. The site cannot use one result, weight, age, genetics or pack strength to calculate capsule count, target range or adjustment." }, { "zh": "肾毒性、高钾、低镁、高血压、新发糖尿病、神经毒性和心律相关风险均需专业监测。尿量明显变化、严重头痛、意识或视觉异常、抽搐等急性问题应走当地紧急医疗与移植团队通道。", "en": "Nephrotoxicity, hyperkalaemia, hypomagnesaemia, hypertension, new-onset diabetes, neurotoxicity and rhythm-related risks require professional monitoring. Marked urine changes, severe headache, altered awareness or vision, seizure or another acute concern requires local urgent care and the transplant team." }, { "zh": "免疫抑制会增加严重感染、机会性感染、淋巴瘤和其他恶性肿瘤风险；发热、寒战、咳嗽、皮肤异常或新神经症状不能只靠网页判断，也不要自行停药。", "en": "Immunosuppression increases serious and opportunistic infection, lymphoma and other malignancy risks. Fever, chills, cough, skin change or new neurological symptoms cannot be assessed by a webpage, and treatment must not be self-stopped." }, { "zh": "强 CYP3A 抑制剂或诱导剂、其他肾毒性药、钾升高药、活疫苗及葡萄柚都可能影响风险或暴露；请一次性交给药师核对处方药、非处方药、中草药、补充剂、饮食与近期变更，不要自行错开或停换。", "en": "Strong CYP3A inhibitors or inducers, other nephrotoxic medicines, potassium-raising agents, live vaccines and grapefruit can alter exposure or risk. Give the pharmacist all prescriptions, OTC medicines, herbs, supplements, diet and recent changes together; do not self-separate, stop or switch." }, { "zh": "胶囊不应打开或压碎；颗粒剂有独立配制说明，不能把胶囊内容物当颗粒剂使用。妊娠、备孕、哺乳或接触粉末也需提前让专业团队评估。", "en": "Capsules should not be opened or crushed. Granules have separate preparation instructions and capsule contents are not granules. Pregnancy, pregnancy planning, breastfeeding or powder exposure also requires advance professional review." } ], "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：抑制钙调神经磷酸酶，不等于可以自行按机制换药", "en": "Mechanism reading: calcineurin inhibition does not permit mechanism-based self-switching" }, "summary": { "zh": "他克莫司与细胞内 FKBP-12 结合，形成的复合物抑制钙调神经磷酸酶，影响 NF-AT 等信号以及多种细胞因子表达，最终抑制 T 淋巴细胞激活和增殖。机制解释免疫抑制方向，却不能决定个人剂量、目标血药浓度、换用环孢素或改成缓释制剂。", "en": "Tacrolimus binds intracellular FKBP-12; the resulting complex inhibits calcineurin, affects NF-AT and other signalling and multiple cytokines, and ultimately suppresses T-lymphocyte activation and proliferation. This explains the immunosuppressive direction but cannot determine an individual dose, target blood level, switch to cyclosporine or conversion to an extended-release product." }, "checks": [ { "zh": "同为免疫抑制剂、同一通路或同一通用名，不代表剂型、暴露、风险和监测可以互换。", "en": "The same immune purpose, pathway or generic name does not make dosage form, exposure, risks or monitoring interchangeable." }, { "zh": "CYP3A 与转运相关相互作用可能显著改变暴露，但网页不会生成停药、错开时间、减量比例或换药方案。", "en": "CYP3A- and transporter-related interactions can materially change exposure, but the site generates no stopping, separation, reduction or switching plan." }, { "zh": "老人、多药使用、肝肾功能变化或感染时，必须将实际包装、处方、血药浓度与化验一起交给移植团队复核。", "en": "For older adults, polypharmacy, changed liver or kidney function or infection, the actual packs, prescription, blood levels and laboratory results require transplant-team review together." } ], "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PROGRAF", "generic": "他克莫司胶囊", "dosageFormClass": "PROGRAF 普通释放他克莫司硬胶囊：0.5 mg、1 mg、5 mg 均为每粒含量，各展示 100 粒瓶装；不同强度、普通释放与缓释、胶囊与颗粒/注射剂不能只按名称或毫克数自行互换。" }, "labelSource": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "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": "2026-09-04", "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": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "PROGRAF 是他克莫司普通释放胶囊的美国品牌档案。0.5 mg、1 mg、5 mg 都是每粒含量，100 Capsules 是整瓶数量，不是个人应该吃几颗。它是窄治疗窗免疫抑制剂，普通释放与缓释产品不可自行替换；血药浓度、肾功能、血糖、电解质、感染、神经症状和完整药单都须由移植团队持续管理。", "history": "FDA 审评资料记录 PROGRAF 胶囊 NDA 050708 于 1994-04-08 获批。当前 DailyMed SPL v30 列出 0.5 mg、1 mg、5 mg 普通释放胶囊、三个 100 粒瓶装面板，并明确剂型不可自行互换以及重要监测与相互作用边界。", "sourceDocuments": [ { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_5bd4100118700705", "label": "FDA：PROGRAF 名称审评资料，记录胶囊 NDA 050708 于 1994-04-08 获批", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210115Orig1s000NameR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 050708", "approvalTimeline": [ { "date": "1994-04-08", "title": { "zh": "PROGRAF 胶囊美国批准", "en": "U.S. approval of PROGRAF capsules" }, "detail": { "zh": "FDA 审评资料记录普通释放胶囊 NDA 050708 于该日获批。", "en": "The FDA review records approval of immediate-release capsules under NDA 050708 on this date." }, "source": { "id": "src_5bd4100118700705", "label": "FDA：PROGRAF 名称审评资料，记录胶囊 NDA 050708 于 1994-04-08 获批", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210115Orig1s000NameR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2023-08-25", "title": { "zh": "当前 DailyMed 标签版本生效", "en": "Current DailyMed label effective" }, "detail": { "zh": "SPL v30 列出三个胶囊强度、准确包装和现行安全信息。", "en": "SPL v30 lists the three capsule strengths, exact packs and current safety information." }, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "展示三个准确普通释放胶囊瓶装；不证明实时供应。", "en": "Three exact immediate-release capsule bottles are displayed; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、商品名、参比、包装和供应尚未逐市场确认", "en": "Local approval, brand, reference, pack and supply not yet established market by market" }, "detail": { "zh": "不从美国 NDA、NDC 或包装推定其他市场状态。", "en": "No other-market status is inferred from the U.S. NDA, NDC or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同样叫他克莫司，普通释放和缓释能自己换吗？", "en": "Can immediate- and extended-release tacrolimus be switched by myself?" }, "answer": { "zh": "不能。当前标签明确说明不可互换，转换必须由医生监督并结合血药浓度等监测。", "en": "No. The current label states they are not interchangeable; conversion requires physician supervision and monitoring including blood levels." } }, { "question": { "zh": "1 mg 胶囊是不是每次吃一粒？", "en": "Does a 1 mg capsule mean one capsule each time?" }, "answer": { "zh": "不是。1 mg 只说明每粒含量；个人颗数和间隔由准确处方及移植团队依据监测决定。", "en": "No. 1 mg is the amount per capsule; the exact prescription and transplant team determine capsule count and interval using monitoring." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prograf-tacrolimus/", "en": "https://origindrug.com/en/drugs/prograf-tacrolimus/" }, "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." ] }