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the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 16", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 16 mg、50 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-medrol-methylprednisolone-32mg-25-tablet-bottle-ndc-0009017601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2025)" }, "dosageForm": { "zh": "MEDROL 甲泼尼龙口服片", "en": "MEDROL methylprednisolone oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0176-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲泼尼龙 32 mg；25 片瓶装", "en": "Methylprednisolone 32 mg per tablet; 25-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-08.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲泼尼龙", "en": "methylprednisolone" }, "value": 32, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕只作外观核对，不是自行掰片许可", "en": "elliptical scored tablet; the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 32", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 32 mg、25 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-medrol-methylprednisolone-4mg-100-tablet-bottle-ndc-0009005602", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-03.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "alt": "MEDROL 甲泼尼龙 4 mg、NDC 0009-0056-02、100 片瓶装的美国 DailyMed 当前标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-11 修订）", "presentation": "MEDROL 甲泼尼龙 4 mg、NDC 0009-0056-02、100 片瓶装标签展示面。", "notice": "此图只对应当前美国 DailyMed 标签中的 MEDROL 4 mg、NDC 0009-0056-02、100 片瓶装。它不代表 2、8、16、32 mg、4 mg Dosepak、注射剂、其他包装或其他市场；不用于鉴定真伪，也不生成个人片数、递减、补服或停药方案。", "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 4 mg、NDC 0009-0056-02、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MEDROL 说明书放大阅读：毫克、片数、Dosepak 格子和停药不是一回事", "en": "MEDROL label reading: milligrams, tablet count, Dosepak rows and stopping are different questions" }, "summary": { "zh": "当前美国标签列有五种每片强度和一个 21 片 Dosepak。最重要的阅读边界是：包装身份不等于个人方案，糖皮质激素也不能因感觉好转、担心不良反应或看见另一盒规格就自行骤停、续用、递减或替换。", "en": "The current U.S. label lists five per-tablet strengths and one 21-tablet Dosepak. The key boundary is that package identity is not an individual regimen; a glucocorticoid must not be abruptly self-stopped, extended, tapered or replaced because symptoms improve, an adverse effect is feared or another strength is seen." }, "checks": [ { "zh": "2、4、8、16、32 mg 是每片甲泼尼龙的标签标示量；100、25、50 或 21 是包装数量。两类数字不能相乘、相除或按经验变成任何人的一天片数。", "en": "2, 4, 8, 16 and 32 mg are labelled amounts of methylprednisolone per tablet; 100, 25, 50 or 21 are package counts. These two kinds of numbers cannot be multiplied, divided or turned by experience into anyone's daily tablet count." }, { "zh": "4 mg Dosepak 纸盒印有分日格子，但这只属于该准确包装。不要把图上的格子抄给另一位使用者、另一种病情、另一盒甲泼尼龙、其他激素或其他市场产品；必须以本人处方和负责团队的说明为准。", "en": "The 4 mg Dosepak carton prints day rows, but they belong only to that exact pack. Do not copy the rows to another person, condition, methylprednisolone pack, corticosteroid or market product; follow the individual's prescription and treating team's instructions." }, { "zh": "标签提示感染风险、免疫抑制、疫苗、血糖、胃肠道、眼部、情绪与睡眠等多方面问题。高龄、多病或同时使用降糖药、抗凝/抗血小板药、止痛药、利尿剂、免疫抑制药及疫苗时，应带完整药单主动核对。", "en": "The label covers infection risk, immunosuppression, vaccines, glucose, gastrointestinal, eye, mood and sleep concerns. Older people, people with several conditions, or those using glucose-lowering, anticoagulant/antiplatelet, pain, diuretic or immunosuppressive medicines, or receiving vaccines, should bring the complete medicine list for active review." }, { "zh": "出现严重呼吸困难、面唇舌喉肿胀、意识改变、明显感染迹象、黑便/呕血、突发视力变化或其他严重快速加重情况时，应立即使用当地急救或紧急医疗渠道，不要等待网页回复。", "en": "Severe breathing difficulty; swelling of the face, lips, tongue or throat; altered consciousness; marked infection signs; black stools or vomiting blood; sudden vision change; or another severe rapidly worsening problem requires local emergency or urgent medical help immediately. Do not wait for a web response." } ], "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲泼尼龙怎样起作用：它是一种糖皮质激素，影响炎症与免疫反应", "en": "How methylprednisolone works: a glucocorticoid that affects inflammatory and immune responses" }, "summary": { "zh": "MEDROL 标签把甲泼尼龙列为糖皮质激素。糖皮质激素可产生广泛的代谢、抗炎和免疫相关作用；这能帮助理解为什么标签涉及多个器官系统，也说明不能从“消炎”两个字推导个人片数、疗程或停药方法。", "en": "The MEDROL label identifies methylprednisolone as a glucocorticoid. Glucocorticoids can produce broad metabolic, anti-inflammatory and immune-related effects. That helps explain why the label spans several organ systems and why the word “anti-inflammatory” cannot determine an individual's tablet count, duration or stopping method." }, "checks": [ { "zh": "它不是抗菌药，也不能仅凭发热、疼痛、皮疹、咳嗽或肿胀判断是否适合。抑制炎症反应可能同时影响感染表现，具体原因与处理需要临床评估。", "en": "It is not an antibacterial medicine, and fever, pain, rash, cough or swelling alone cannot establish suitability. Suppressing inflammatory responses may also affect infection presentation, so the cause and management require clinical assessment." }, { "zh": "与泼尼松、地塞米松、氢化可的松或注射型甲泼尼龙都属于激素相关产品，不表示可按毫克数自行换算、叠加或替换；成分、效价、剂型、途径与方案都需逐项核对。", "en": "Being corticosteroid-related, like prednisone, dexamethasone, hydrocortisone or injectable methylprednisolone, does not make products self-convertible, combinable or interchangeable by milligrams. Ingredient, potency, dosage form, route and regimen each require review." }, { "zh": "机制解释不了某个人应否递减、递减多快或何时停用。尤其使用时间较长、反复疗程、多病共存或出现不适时，必须联系开方团队，不要从包装格子或网络范例制定方案。", "en": "Mechanism cannot determine whether, how quickly or when an individual should taper or stop. Especially after longer or repeated use, with multiple conditions or new symptoms, contact the prescribing team rather than building a plan from package rows or an online example." } ], "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Clinical Pharmacology 与警示阅读入口）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MEDROL", "generic": "甲泼尼龙", "dosageFormClass": "MEDROL 甲泼尼龙口服片：2、4、8、16、32 mg；另列 4 mg、21 片单位剂量 Dosepak 纸盒（当前美国公开标签所列）" }, "labelSource": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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_f57b2c410c7aaead", "label": "FDA Drugs@FDA：MEDROL NDA 011153 申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=011153", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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": "2026-08-28", "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": "MEDROL 是甲泼尼龙口服糖皮质激素品牌。当前美国 DailyMed 标签列出 2、4、8、16、32 mg 片剂，以及一板 21 片的 4 mg Dosepak。本页把每片毫克数、包装数量和准确 NDC 分开呈现；包装上的递减格子不是所有人的通用吃法，网页不计算个人片数、持续时间、递减、补服或停药方案。", "history": "FDA NDA 011153 和当前 DailyMed 标签为美国产品史与说明书入口。DEPO-MEDROL 注射混悬剂与 SOLU-MEDROL 注射用粉末是不同成分形式、给药途径和标签，不能仅凭 MEDROL 名称或甲泼尼龙成分并入本口服片档案。", "sourceDocuments": [ { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_f57b2c410c7aaead", "label": "FDA Drugs@FDA：MEDROL NDA 011153 申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=011153", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 011153（MEDROL / methylprednisolone oral tablets；美国监管与当前标签档案）", "approvalTimeline": [ { "date": "1957", "title": { "zh": "MEDROL 美国初始批准年份", "en": "MEDROL U.S. initial-approval year" }, "detail": { "zh": "当前 DailyMed 标签将 MEDROL 的 Initial U.S. Approval 列为 1957。该年份定位美国品牌历史，不自动建立中国大陆或其他市场的批准、商品名、包装、供应或可替代性。", "en": "The current DailyMed label lists 1957 as MEDROL's Initial U.S. Approval. This locates U.S. brand history and does not automatically establish approval, trade name, packaging, supply or interchangeability in Mainland China or another market." }, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2025-11", "title": { "zh": "当前 MEDROL 美国公开标签修订", "en": "Current U.S. MEDROL public label revised" }, "detail": { "zh": "当前标签分别列出 2、4、8、16、32 mg 口服片，以及 4 mg、21 片 Dosepak 的准确 NDC 与包装展示面。该日期只定位标签版本，不是个人开始、持续、递减或停药日期。", "en": "The current label separately lists 2, 4, 8, 16 and 32 mg oral tablets plus the exact NDC and package panel for the 4 mg 21-tablet Dosepak. The date identifies a label version, not an individual's start, duration, taper or stopping date." }, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 NDA 011153、当前标签及六个准确包装身份", "en": "NDA 011153, current label and six exact package identities linked" }, "detail": { "zh": "本页逐项保留五种每片强度、六个 NDC、瓶装片数及 4 mg Dosepak 纸盒。它用于产品身份与安全阅读，不用于鉴定真伪，也不建立库存、购买、个人片数、持续时间、递减、补服或停药方案。", "en": "The dossier separately retains five per-tablet strengths, six NDCs, bottle counts and the 4 mg Dosepak carton. It supports product identity and safety reading; it does not authenticate a product or establish stock, purchase, individual tablet count, duration, taper, missed-use or stopping instructions." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 NDA、MEDROL 名称、共同成分、片剂刻痕、毫克数、Dosepak 格子或包装图推定当地商品名、批准、包装、供应、原研/仿制关系、真伪或可替代性；每个市场须按当地现行监管资料单独核对。", "en": "No local trade name, approval, package, supply, originator/generic relationship, authenticity or interchangeability is inferred from the U.S. NDA, MEDROL name, shared ingredient, tablet score, milligrams, Dosepak rows or package image; each market requires separate review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "Dosepak 纸盒上的格子是否适用于每个人？", "en": "Do the rows on a Dosepak carton apply to everyone?" }, "answer": { "zh": "不是。格子属于 4 mg、21 片这一准确包装身份，不能抄给另一位使用者、另一种病情、另一盒甲泼尼龙或其他激素。个人方案必须以本人处方和负责团队说明为准。", "en": "No. The rows belong to the exact 4 mg 21-tablet package identity and cannot be copied to another person, condition, methylprednisolone pack or corticosteroid. An individual plan must come from that person's prescription and treating team." } }, { "question": { "zh": "片上有刻痕，能否自行掰片或按毫克换成另一种激素？", "en": "Does a tablet score permit self-splitting or milligram conversion to another corticosteroid?" }, "answer": { "zh": "不能从刻痕或毫克数得出这种结论。刻痕在本页只作外观线索；剂型、效价、处方、疗程、递减和停药都需按准确产品及个人情况由专业人员核对。", "en": "No such conclusion follows from a score or milligram number. The score is only an appearance clue here; dosage form, potency, prescription, course, taper and stopping all require professional review of the exact product and individual context." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/medrol/", "en": "https://origindrug.com/en/drugs/medrol/" }, "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." ] }