{ "id": "restasis", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Restasis", "generic": "环孢素", "aliases": [ "cyclosporine ophthalmic emulsion" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "眼科健康", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 页面 2024-09-09 更新；SPL v19 于 2024-12-30 发布）", "dosageFormClass": "眼用乳剂：0.05%（0.5 mg/mL）；精确展示 30 支、60 支单剂量小瓶纸盒面板；不并入 RESTASIS MULTIDOSE 5.5 mL 瓶", "dosageFormClassCode": "other", "route": "眼用", "routeCode": "other", "historicalApprovalEntry": "2002-12-23（FDA RESTASIS NDA 21-023 原始批准信）", "archiveSponsorText": "Allergan, Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "RESTASIS MULTIDOSE", "RESTASIS MultiDose", "RESTASIS 5.5 mL", "cyclosporine ophthalmic emulsion 5.5 mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-restasis-cyclosporine-ophthalmic-emulsion-0-05pct-0023916330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-09-09 更新；SPL v19 于 2024-12-30 发布", "en": "DailyMed updated 9 Sep 2024; SPL v19 published 30 Dec 2024" }, "dosageForm": { "zh": "环孢素眼用乳剂（单剂量小瓶）", "en": "cyclosporine ophthalmic emulsion (single-use vial)" }, "route": { "zh": "眼用（仅作标签产品身份字段）", "en": "ophthalmic use (label product-identity field only)" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 0023-9163-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.05%（0.5 mg/mL）；每支 0.4 mL 单剂量小瓶；30 支纸盒", "en": "0.05% (0.5 mg/mL); 0.4 mL per single-use vial; 30-vial carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89&name=restasis-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环孢素", "en": "cyclosporine" }, "value": 0.5, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人滴数、频次、开封处理或换算指令", "en": "labelled concentration; not an individual drop count, frequency, after-opening handling or conversion instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "0.5 mg/mL (0.05%)", "numerator": { "value": 0.5, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.5 mg/mL（0.05%；标签浓度）", "en": "0.5 mg/mL (0.05%; labelled concentration)" } }, "container": { "typeCode": "single_use_vial", "typeLabel": { "zh": "单剂量小瓶", "en": "single-use vial" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": 30, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "支单剂量小瓶/盒", "en": "single-use vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂 30 支单剂量小瓶精确美国公开纸盒面板（Allergan；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-restasis-cyclosporine-ophthalmic-emulsion-0-05pct-0023916360", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-09-09 更新；SPL v19 于 2024-12-30 发布", "en": "DailyMed updated 9 Sep 2024; SPL v19 published 30 Dec 2024" }, "dosageForm": { "zh": "环孢素眼用乳剂（单剂量小瓶）", "en": "cyclosporine ophthalmic emulsion (single-use vial)" }, "route": { "zh": "眼用（仅作标签产品身份字段）", "en": "ophthalmic use (label product-identity field only)" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 0023-9163-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.05%（0.5 mg/mL）；每支 0.4 mL 单剂量小瓶；60 支纸盒", "en": "0.05% (0.5 mg/mL); 0.4 mL per single-use vial; 60-vial carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89&name=restasis-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环孢素", "en": "cyclosporine" }, "value": 0.5, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人滴数、频次、开封处理或换算指令", "en": "labelled concentration; not an individual drop count, frequency, after-opening handling or conversion instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "0.5 mg/mL (0.05%)", "numerator": { "value": 0.5, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.5 mg/mL（0.05%；标签浓度）", "en": "0.5 mg/mL (0.05%; labelled concentration)" } }, "container": { "typeCode": "single_use_vial", "typeLabel": { "zh": "单剂量小瓶", "en": "single-use vial" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": 60, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "支单剂量小瓶/盒", "en": "single-use vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂 60 支单剂量小瓶精确美国公开纸盒面板（Allergan；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-restasis-cyclosporine-ophthalmic-emulsion-0-05pct-0023916360", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89&name=restasis-03.jpg", "alt": "RESTASIS 环孢素眼用乳剂 0.05%（0.5 mg/mL）、NDC 0023-9163-60、60 支单剂量小瓶的美国 DailyMed 公开标签纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v19（2024-12-30 发布）", "presentation": "RESTASIS 眼用乳剂：0.05%（0.5 mg/mL）；NDC 0023-9163-60；60 支单剂量小瓶；精确美国公开纸盒面板。", "notice": "此图是 Allergan / AbbVie 的美国 DailyMed SPL v19 公开纸盒面板，仅对应 RESTASIS、环孢素眼用乳剂 0.05%（0.5 mg/mL）、NDC 0023-9163-60 与 60 支单剂量小瓶；不用于鉴定真伪。它不代表 RESTASIS MULTIDOSE、其他 NDC、其他容量、其他市场、当前可得性、原研身份、可替代性或任何个人滴数、开封、储存、联用、漏用或转换方案。", "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 当前美国公开标签与精确 60 支单剂量小瓶纸盒面板（Allergan；SPL v19，2024-12-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RESTASIS 说明书放大阅读：0.05%、0.5 mg/mL 与单剂量小瓶是一起核对的身份线索", "en": "RESTASIS label reading: 0.05%, 0.5 mg/mL and single-use vials are identity clues checked together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 RESTASIS、环孢素眼用乳剂、0.05%/0.5 mg/mL、每支 0.4 mL 的 30 支或 60 支单剂量小瓶纸盒面板和眼用剂型。它不提供任何人的滴数、时间、开封后处理、漏用、联用、转换或干眼治疗方案。", "en": "This module uses the U.S. DailyMed public label to check RESTASIS, cyclosporine ophthalmic emulsion, 0.05%/0.5 mg/mL, the exact 30- or 60-single-use-vial carton panels with 0.4 mL per vial, and ophthalmic use. It does not provide an individual's drop count, timing, after-opening handling, missed-use, combination, switching or dry-eye treatment plan." }, "checks": [ { "zh": "0.05% 与 0.5 mg/mL 是这一眼用乳剂浓度的两种标签写法；60 支单剂量小瓶是该精确纸盒的包装身份。它们用于确认阅读对象，不是网页给任何人计算每次应滴几滴、一天如何安排、开封后如何处理或能用多久的答案。", "en": "0.05% and 0.5 mg/mL are two label formats for the concentration of this ophthalmic emulsion; 60 single-use vials identify the package on this exact carton. They help identify what is being read, not calculate anyone's drop count, daily timing, after-opening handling or how long a pack lasts." }, { "zh": "RESTASIS 与 RESTASIS MULTIDOSE 不是本页可以仅凭相同品牌或通用名自动合并、替代或换算的同一个包装。眼用乳剂的容器、一次性/多次使用信息、标签版本和目标市场都要分别对照手上准确产品的现行标签和专业人员说明。", "en": "RESTASIS and RESTASIS MULTIDOSE are not packaging forms this page can automatically merge, substitute or convert merely from a shared brand or generic name. The ophthalmic-emulsion container, single- versus multiple-use information, label version and target market must each be checked against the current label for the exact product in hand and professional guidance." }, { "zh": "包装图、NDC、浓度和单剂量文字只帮助比对来源，不能验证真伪、确认另一种环孢素眼用产品，或确认当前开封、储存、隐形眼镜与其他滴眼液的操作要求。相关问题必须按手上准确产品的现行标签和专业人员说明处理。", "en": "The package image, NDC, concentration and single-use wording only help compare a source. They cannot authenticate a medicine, identify another cyclosporine eye product or confirm current handling, storage, contact-lens or other-eye-drop requirements. Those questions must follow the current label and professional instructions for the exact product in hand." }, { "zh": "标签提示眼部刺激/灼热感、眼部感染或外伤时需谨慎处理。出现视力变化、明显眼痛、红肿、外伤、分泌物变化或其他急性眼部问题时，应及时使用当地眼科或紧急医疗渠道；网页不判断是否自行继续、暂停或换药。", "en": "The label calls for care around eye irritation/burning, eye infection or injury. With vision change, marked eye pain, redness/swelling, injury, discharge change or another acute eye concern, use local ophthalmic or urgent-care pathways promptly; this page does not decide self-continuation, pause or switching." } ], "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "环孢素眼用乳剂怎样起作用：标签描述其为局部免疫调节相关作用，确切机制尚不清楚", "en": "How cyclosporine ophthalmic emulsion works: the label describes local immunomodulation and says the exact mechanism is not known" }, "summary": { "zh": "DailyMed 标签将 RESTASIS 描述为具有抗炎作用的局部免疫调节剂，并说明在相关干眼情形中被认为具有部分免疫调节作用、确切机制尚不清楚。这解释标签的药理边界，不判断任何人的干眼原因、是否适用、滴数、联用或转换方案。", "en": "The DailyMed label describes RESTASIS as a topical immunomodulator with anti-inflammatory effects and says it is thought to act as a partial immunomodulator in the labelled dry-eye context, while the exact mechanism is not known. This explains the label's pharmacologic boundary; it does not determine anyone's cause of dry eye, suitability, drop count, combination or switching plan." }, "checks": [ { "zh": "“免疫调节”“抗炎”是标签中的作用路径描述，不是从眼干、刺痛、红眼或一次检查结果就能判断是否需要该产品的依据。症状原因、眼表检查、既往眼病、其他滴眼液和目标市场现行标签都需要眼科专业人员一起核对。", "en": "“Immunomodulation” and “anti-inflammatory” describe a labelled action pathway; they do not determine a need for this product from dryness, stinging, red eye or one examination result. Symptom cause, ocular-surface examination, prior eye conditions, other drops and the current target-market label need joint ophthalmic review." }, { "zh": "同为环孢素、都与免疫或眼部炎症相关，不能证明口服环孢素、其他眼用产品或另一种干眼产品可自行叠加、轮换、替代或按浓度换算。剂型、给药途径、风险、完整眼用/全身药单和实际包装都必须逐项核对。", "en": "Sharing cyclosporine or an immune/ocular-inflammation context does not prove that oral cyclosporine, another eye product or another dry-eye product can be self-combined, alternated, substituted or concentration-converted. Dosage form, route, risks, the complete eye/systemic medicine list and actual packages must be checked item by item." }, { "zh": "机制页面不能处理突然视力变化、明显疼痛、外伤、感染担忧、手术前后或不确定如何使用准确容器的问题。出现急性或严重眼部问题，应优先联系当地眼科与紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page cannot manage sudden vision change, marked pain, injury, infection concern, before/after procedures or uncertainty about the exact container. With an acute or serious eye concern, prioritise local ophthalmic and urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Clinical Pharmacology；Allergan，2024-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Restasis", "generic": "环孢素", "dosageFormClass": "眼用乳剂：0.05%（0.5 mg/mL）；精确展示 30 支、60 支单剂量小瓶纸盒面板；不并入 RESTASIS MULTIDOSE 5.5 mL 瓶" }, "labelSource": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新；营销申请号 NDA050790）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新；营销申请号 NDA050790）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "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": "DailyMed 的 RESTASIS（cyclosporine ophthalmic emulsion）美国公开标签将其列为 0.05%（0.5 mg/mL）眼用乳剂，并展示 0.4 mL 单剂量小瓶的 30 支与 60 支精确纸盒面板。此页帮助把品牌、通用名、浓度、每支容量、包装数量、目标市场与说明书来源一起核对；不据此生成个人滴数、时间、开封处理、漏用、联用、转换或干眼处理方案。", "history": "FDA 于 2002-12-23 批准 RESTASIS 的原始申请 NDA 21-023；当前 DailyMed 标签的营销申请栏列示 NDA050790。两项均为美国公开记录中的不同标识，页面并不将其互换，也不据此推定中国大陆或其他市场的当前批准、商品名、包装、持有人、可获得性、原研/仿制关系或可售资格。", "sourceDocuments": [ { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新；营销申请号 NDA050790）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_319e19bbcdf5163f", "label": "FDA：RESTASIS 原始批准信（NDA 21-023；2002-12-23）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_fcc882baf79afdde", "label": "DailyMed（NLM）：RESTASIS MULTIDOSE 独立美国公开标签（仅作包装区分来源）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7224d810-bb96-4682-a942-3355e6e8061a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "documentRelation": "excluded_product_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FDA 原始批准申请：NDA 21-023；当前 DailyMed 标签营销申请号：NDA050790", "approvalTimeline": [ { "date": "2002-12-23", "title": { "zh": "RESTASIS 原始美国批准", "en": "Original U.S. RESTASIS approval" }, "detail": { "zh": "FDA 原始批准信记录 RESTASIS（环孢素眼用乳剂 0.05%）的 NDA 21-023 于 2002-12-23 获批。当前 DailyMed 标签另列营销申请号 NDA050790；两项不应互换。该历史节点不自动说明其他市场的批准、供应或可售状态。", "en": "FDA's original approval letter records approval of RESTASIS (cyclosporine ophthalmic emulsion 0.05%) under NDA 21-023 on 23 Dec 2002. The current DailyMed label separately lists marketing application NDA050790; the two identifiers are not interchangeable. This historical node does not establish approval, supply or sale status in another market." }, "source": { "id": "src_319e19bbcdf5163f", "label": "FDA：RESTASIS 原始批准信（NDA 21-023；2002-12-23）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-09-09", "title": { "zh": "DailyMed 当前标签页面更新", "en": "Current DailyMed label page updated" }, "detail": { "zh": "DailyMed 当前 RESTASIS 标签页面列示 2024-09-09 更新；页面不将此日期解释为个人用药、可得性或供应结论。", "en": "The current DailyMed RESTASIS label page lists an update on 9 Sep 2024; this page does not interpret that date as an individual-use, availability or supply conclusion." }, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-12-30", "title": { "zh": "DailyMed 当前 SPL v19 公开", "en": "Current SPL v19 published on DailyMed" }, "detail": { "zh": "DailyMed 媒体目录列示 RESTASIS 当前 SPL v19 于 2024-12-30 发布。该日期不代表个人用药、包装供应或其他市场状态。", "en": "The DailyMed media listing shows the current RESTASIS SPL v19 published on 30 Dec 2024. That date does not represent individual use, package availability or another-market status." }, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 当前美国公开标签与精确 60 支单剂量小瓶纸盒面板（Allergan；SPL v19，2024-12-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签、FDA 原始批准资料与两张精确单剂量纸盒面板", "en": "Current label, FDA original-approval material and two exact single-use carton panels linked" }, "detail": { "zh": "两张展示面板仅对应 0.05%（0.5 mg/mL）、每支 0.4 mL 的 NDC 0023-9163-30（30 支）和 NDC 0023-9163-60（60 支）单剂量小瓶；不据此建立实际在售、库存、个人操作或 RESTASIS MULTIDOSE 状态。", "en": "The two display panels correspond only to 0.05% (0.5 mg/mL), 0.4 mL per vial, NDC 0023-9163-30 (30 vials) and NDC 0023-9163-60 (60 vials); they do not establish actual marketing, stock, individual handling or RESTASIS MULTIDOSE status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.05% 与 0.5 mg/mL 是不是两种不同浓度？", "en": "Are 0.05% and 0.5 mg/mL two different concentrations?" }, "answer": { "zh": "不是，它们是这个准确美国眼用乳剂浓度的两种标签写法；但这不把网页变成任何人的滴数、频次、开封后处理或转换计算器。", "en": "No. They are two label formats for the concentration of this exact U.S. ophthalmic emulsion; that does not turn this page into anyone's drop-count, frequency, after-opening-handling or conversion calculator." } }, { "question": { "zh": "RESTASIS 与 RESTASIS MULTIDOSE 能否只凭品牌名互换？", "en": "Can RESTASIS and RESTASIS MULTIDOSE be interchanged from the brand name alone?" }, "answer": { "zh": "不能。品牌名或通用名相同不足以判断容器、单剂量/多次使用信息、标签、包装和实际处理要求。请带手上准确产品和完整眼用/全身药单请专业人员核对。", "en": "No. A shared brand or generic name is insufficient to determine container, single- versus multiple-use information, label, package or actual handling requirements. Have a professional review the exact product in hand and the complete eye/systemic medicine list." } } ], "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/restasis/", "en": "https://origindrug.com/en/drugs/restasis/" }, "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." ] }