{ "id": "cellcept", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "CellCept", "generic": "吗替麦考酚酯", "aliases": [ "CELLCEPT", "mycophenolate mofetil", "吗替麦考酚酯", "霉酚酸吗啉乙酯" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 CELLCEPT 吗替麦考酚酯当前公开标签（DailyMed SPL v1，2026-08-10 发布；标签涵盖口服胶囊、口服片、复溶后口服混悬液及静脉用制剂；本档案只建立口服阅读入口）", "dosageFormClass": "吗替麦考酚酯口服胶囊、口服片与复溶后口服混悬液（美国当前公开标签所列；不同剂型与霉酚酸肠溶片不建立自行换算或替换关系）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（美国当前公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Genentech, Inc.（所引美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "mycophenolic acid delayed-release tablet", "Myfortic", "mycophenolate sodium", "霉酚酸肠溶片", "麦考酚钠", "other mycophenolate product", "其他吗替麦考酚酯产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cellcept-mycophenolate-mofetil-capsule-250mg-current-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v1（2026-08-10 发布）", "en": "DailyMed SPL v1 (published 10 Aug 2026)" }, "dosageForm": { "zh": "CELLCEPT 吗替麦考酚酯口服胶囊", "en": "CELLCEPT mycophenolate mofetil oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Current public label — oral capsule; no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒吗替麦考酚酯 250 mg（美国当前标签的胶囊文字身份；未建立包装面板）", "en": "Mycophenolate mofetil 250 mg per capsule (current U.S. label text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吗替麦考酚酯（每粒）", "en": "mycophenolate mofetil (per capsule)" }, "value": 250, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、频率或换算指令", "en": "Labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cellcept-mycophenolate-mofetil-tablet-500mg-current-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v1（2026-08-10 发布）", "en": "DailyMed SPL v1 (published 10 Aug 2026)" }, "dosageForm": { "zh": "CELLCEPT 吗替麦考酚酯口服片", "en": "CELLCEPT mycophenolate mofetil oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Current public label — oral tablet; no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片吗替麦考酚酯 500 mg（美国当前标签的片剂文字身份；未建立包装面板）", "en": "Mycophenolate mofetil 500 mg per tablet (current U.S. label text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吗替麦考酚酯（每片）", "en": "mycophenolate mofetil (per tablet)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cellcept-mycophenolate-mofetil-oral-suspension-200mg-per-ml-current-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v1（2026-08-10 发布）", "en": "DailyMed SPL v1 (published 10 Aug 2026)" }, "dosageForm": { "zh": "CELLCEPT 吗替麦考酚酯复溶后口服混悬液", "en": "CELLCEPT mycophenolate mofetil oral suspension after reconstitution" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Current public label — oral suspension after reconstitution; no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "复溶后每 mL 含吗替麦考酚酯 200 mg（美国当前标签的混悬液文字身份；未建立包装面板）", "en": "Mycophenolate mofetil 200 mg per mL after reconstitution (current U.S. label text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吗替麦考酚酯（复溶后每 mL）", "en": "mycophenolate mofetil (per mL after reconstitution)" }, "value": 200, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "复溶后每 mL 的标签浓度；不是个人毫升数、量取或换算指令", "en": "Labelled concentration per mL after reconstitution; not an individual's millilitre amount, measuring or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验当前公开标签文字，但未保留与单一剂型、单一强度和单一包装一一对应的官方原品牌包装图，故不展示包装图片", "en": "Current public-label text was reviewed, but no official original-brand package image matching one exact dosage form, strength and package was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 CELLCEPT、吗替麦考酚酯、口服胶囊、口服片、复溶后口服混悬液、静脉用制剂、美国当前公开标签及文件日期。该标签覆盖多种剂型和产品展示面，未保留可同时准确对应单一剂型、单一规格和单一包装且可安全公开展示的官方原品牌图片；为避免把零售图、再包装图、版本不明图、其他市场图片或另一种吗替麦考酚酯/霉酚酸产品误作准确 CELLCEPT 外观，页面不展示包装图片，只保留一手标签供放大阅读。", "en": "This dossier retains CELLCEPT, mycophenolate mofetil, oral capsules, oral tablets, reconstituted oral suspension, intravenous formulation, the current U.S. public label and its date. The label spans several dosage forms and presentations, and no official original-brand image was retained that safely matches one exact form, strength and package; to avoid presenting a retail image, repackaged image, version-uncertain image, another-market image or another mycophenolate/mycophenolic-acid product as the exact CELLCEPT appearance, the page withholds package imagery and retains the primary label for enlarged reading." }, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CELLCEPT／吗替麦考酚酯说明书放大阅读：先分清准确剂型，再看重要警示", "en": "CELLCEPT label reading: identify the exact dosage form before reading important warnings" }, "summary": { "zh": "本模块使用美国 DailyMed 当前公开标签，帮助区分 CELLCEPT、吗替麦考酚酯、口服胶囊、口服片、复溶后口服混悬液与静脉用制剂。它不提供个人片数、毫升数、开始、停用、转换、联用或诊断建议。", "en": "This module uses the current U.S. DailyMed public label to distinguish CELLCEPT, mycophenolate mofetil, oral capsules, oral tablets, reconstituted oral suspension and intravenous formulation. It provides no individual capsule/tablet count, millilitre amount, starting, stopping, conversion, co-use or diagnostic advice." }, "checks": [ { "zh": "先把实际包装上的 CELLCEPT、吗替麦考酚酯、剂型、每单位标示量或浓度、包装和目标市场一起核对。mg 或 mg/mL 是明确单位中的标示量或浓度，不是网页给任何人的片数、胶囊数或混悬液体积。", "en": "Check CELLCEPT, mycophenolate mofetil, dosage form, labelled amount or concentration per defined unit, pack and target market together. mg or mg/mL is a labelled amount or concentration in a defined unit, not a website instruction for anyone's number of tablets/capsules or suspension volume." }, { "zh": "标签明确指出：CELLCEPT 口服剂型与霉酚酸延迟释放片的吸收速度不同，未经有免疫抑制治疗经验的医生监督不应自行互换。共同的“霉酚酸”字样、相近 mg、相同移植背景或相似药盒，都不能建立自行转换、叠加、轮换或替代关系。", "en": "The label states that CELLCEPT oral forms and mycophenolic-acid delayed-release tablets have different absorption rates and should not be interchanged without supervision by a physician experienced in immunosuppressive therapy. Shared “mycophenolic” wording, nearby mg numbers, the same transplant context or a similar pack do not establish self-conversion, combining, alternation or substitution." }, { "zh": "标签列有胚胎-胎儿毒性、恶性肿瘤和严重感染的加框警示。怀孕、备孕、感染、发热、接触水痘/带状疱疹、接种、血液检查或任何治疗变化，都需要把实际药盒和完整药单交给移植/专科团队或药师逐项核对；网页不能给出继续、暂停或更换结论。", "en": "The label carries a boxed warning for embryo-fetal toxicity, malignancies and serious infections. Pregnancy or planning, infection, fever, exposure to chickenpox/shingles, vaccination, blood tests or any treatment change require item-by-item review of the actual pack and full medicine list with the transplant/specialist team or pharmacist; this site cannot decide whether to continue, pause or change treatment." }, { "zh": "标签说明 CELLCEPT 片剂不应研碎，胶囊不应打开或研碎；复溶后口服混悬液也不应在服用前与其他液体混合。不要把“掰开、打开或混入”的问题理解为网页能替代实际说明书和专业人员的许可；若发生粉末接触皮肤、黏膜或眼部，或有急性严重担忧，应优先遵照现行标签并联系当地医疗支持。", "en": "The label says CELLCEPT tablets should not be crushed and capsules should not be opened or crushed; reconstituted oral suspension should not be mixed with other liquids before use. Do not treat a question about splitting, opening or mixing as website permission in place of the actual label and professional advice. With powder contact involving skin, mucosa or eyes, or an acute serious concern, follow the current label first and contact local medical support." } ], "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "吗替麦考酚酯怎样起作用：机制术语不是免疫抑制方案", "en": "How mycophenolate mofetil works: mechanism terminology is not an immunosuppression plan" }, "summary": { "zh": "所引标签描述吗替麦考酚酯在体内转化为霉酚酸，并涉及嘌呤合成途径。这帮助理解说明书术语；不能判断个人感染、排斥风险、血液检查异常、妊娠风险、联用、剂量、转换或停药方案。", "en": "The cited label describes conversion of mycophenolate mofetil to mycophenolic acid and a purine-synthesis pathway. This helps read label terminology; it cannot determine an individual's infection, rejection risk, abnormal blood tests, pregnancy risk, co-use, dose, conversion or stopping plan." }, "checks": [ { "zh": "“免疫抑制”或“嘌呤合成”不是把 CELLCEPT 与任何霉酚酸产品、其他移植药、激素、抗感染药、非处方药或补充剂自行叠加、轮换或替代的依据。", "en": "“Immunosuppression” or “purine synthesis” is not a basis for self-combining, alternating or substituting CELLCEPT with any mycophenolic-acid product, other transplant medicine, steroid, anti-infective medicine, OTC product or supplement." }, { "zh": "机制页不能解释个人发热、腹泻、皮疹、疲劳、感染迹象、检查结果或移植相关担忧的原因，也不能判断是否来自某一种药。出现这些问题时，应把实际药盒和完整药单带给当地移植/专科团队或药师。", "en": "A mechanism page cannot explain the cause of an individual's fever, diarrhoea, rash, fatigue, infection signs, test result or transplant-related concern, or decide whether it comes from one medicine. With such a concern, take the actual pack and full medicine list to a local transplant/specialist team or pharmacist." }, { "zh": "出现呼吸困难、面部或咽喉肿胀、昏厥、严重感染迹象、无法进食饮水、严重出血或其他急性严重担忧时，应优先使用当地紧急医疗支持；不要依据机制自行同时改变多种药物。", "en": "With breathing difficulty, swelling of the face or throat, fainting, signs of severe infection, inability to eat or drink, serious bleeding or another acute serious concern, prioritise local emergency medical support; do not change several medicines yourself from a mechanism explanation." } ], "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Clinical Pharmacology；Genentech；SPL v1）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CellCept", "generic": "吗替麦考酚酯", "dosageFormClass": "吗替麦考酚酯口服胶囊、口服片与复溶后口服混悬液（美国当前公开标签所列；不同剂型与霉酚酸肠溶片不建立自行换算或替换关系）" }, "labelSource": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "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": "2026-08-26", "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": "2026-08-26", "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": "美国 DailyMed 当前 CELLCEPT 公开标签涵盖吗替麦考酚酯的口服胶囊、口服片、复溶后口服混悬液及静脉用制剂。本页帮助读者先辨认准确产品和标签警示；不把包装、浓度、毫克数或网页文字换算成任何人的剂量、片数、混悬液体积、联用、停用、换药或照护决定。", "history": "所引当前美国公开标签列示 Initial U.S. Approval: 1995，SPL v1 于 2026-08-10 发布。标签明确指出 CELLCEPT 口服剂型与霉酚酸延迟释放片的吸收速度不同，不能在缺乏具有免疫抑制治疗经验的医生监督下自行互换；胶囊、片剂、混悬液和静脉制剂也必须按准确剂型、现行标签和专业团队分别核对。", "sourceDocuments": [ { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } ], "applicationNumber": "NDA 050722（CELLCEPT 美国当前公开标签所列）", "approvalTimeline": [ { "date": "1995", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1995。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1995. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed: CELLCEPT mycophenolate mofetil current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "DailyMed SPL v1, published 2026-08-10", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v1, published 2026-08-10 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v1, published 2026-08-10 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed: CELLCEPT mycophenolate mofetil current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cellcept/", "en": "https://origindrug.com/en/drugs/cellcept/" }, "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." ] }