{ "id": "gleevec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Gleevec", "generic": "伊马替尼", "aliases": [ "imatinib" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 公开标签（Novartis，2026-07 更新）。本页仅建立 100 mg、90 片瓶装和两款 400 mg、30 片单元剂量纸盒的精确标签面板；其他 NDC、其他包装、其他市场与后续标签须逐项另行核对。", "dosageFormClass": "伊马替尼薄膜衣口服片：100 mg、400 mg；两种每片标示量与包装呈现须分开核对", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（DailyMed 2026 美国公开标签所列初始批准）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed 公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-gleevec-imatinib-tablet-100mg-90-bottle-ndc-0078-0401-34", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Novartis，2026-07 更新）", "en": "DailyMed U.S. public label (Novartis, updated July 2026)" }, "dosageForm": { "zh": "伊马替尼甲磺酸盐薄膜衣口服片", "en": "imatinib mesylate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0401-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg，90 片瓶装", "en": "100 mg per tablet, 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-07.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伊马替尼", "en": "imatinib" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或剂量", "en": "labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色至棕橙色", "en": "very dark yellow to brownish orange" }, "shape": { "zh": "圆形双凸、斜边薄膜衣片", "en": "round, biconvex, bevel-edged film-coated tablet" }, "imprint": "NVR / SA", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 100 mg、90 片瓶装（NDC 0078-0401-34；Novartis，2026-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-gleevec-imatinib-tablet-400mg-30-unit-dose-carton-ndc-0078-0649-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Novartis，2026-07 更新）", "en": "DailyMed U.S. public label (Novartis, updated July 2026)" }, "dosageForm": { "zh": "伊马替尼甲磺酸盐薄膜衣口服片", "en": "imatinib mesylate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0649-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg，30 片单元剂量纸盒（3 板 × 10 片）", "en": "400 mg per tablet, 30-tablet unit-dose carton (3 blisters × 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-08.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伊马替尼", "en": "imatinib" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或剂量", "en": "labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/单元剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "深黄色至棕橙色", "en": "very dark yellow to brownish orange" }, "shape": { "zh": "椭圆形双凸、斜边薄膜衣片", "en": "ovaloid, biconvex, bevel-edged film-coated tablet" }, "imprint": "GLEEVEC / score", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 400 mg、30 片单元剂量纸盒（NDC 0078-0649-13；Novartis，2026-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-gleevec-imatinib-tablet-400mg-30-unit-dose-carton-ndc-0078-1490-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Novartis，2026-07 更新）", "en": "DailyMed U.S. public label (Novartis, updated July 2026)" }, "dosageForm": { "zh": "伊马替尼甲磺酸盐薄膜衣口服片", "en": "imatinib mesylate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1490-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg，30 片单元剂量纸盒（3 板 × 10 片）", "en": "400 mg per tablet, 30-tablet unit-dose carton (3 blisters × 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-09.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伊马替尼", "en": "imatinib" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或剂量", "en": "labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/单元剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "深黄色至棕橙色", "en": "very dark yellow to brownish orange" }, "shape": { "zh": "椭圆形双凸、斜边薄膜衣片", "en": "ovaloid, biconvex, bevel-edged film-coated tablet" }, "imprint": "400 / score with SL", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 400 mg、30 片单元剂量纸盒（NDC 0078-1490-13；Novartis，2026-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-07.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "alt": "GLEEVEC 伊马替尼在美国 DailyMed Novartis 公开标签中的 100 mg、90 片装纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Novartis，2026-07 更新）", "presentation": "GLEEVEC 薄膜衣片：每片伊马替尼 100 mg、90 片装纸盒展开图（DailyMed Novartis 公开标签所列）。", "notice": "此为美国 DailyMed Novartis 公开标签中明确对应 GLEEVEC、伊马替尼 100 mg、90 片装的纸盒展开图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明 400 mg 或其他规格、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "GLEEVEC 说明书放大阅读：100 mg、400 mg 与吞咽困难时的处理都必须对应这一款标签", "en": "GLEEVEC label reading: 100 mg, 400 mg and swallowing questions must match this exact product label" }, "summary": { "zh": "本模块以 Novartis 的美国 DailyMed 2026-07 GLEEVEC 公开标签为阅读入口，帮助核对 GLEEVEC、伊马替尼、100 mg 或 400 mg 薄膜衣片、包装和目标市场；它不把标签中的数字或处理步骤变成个人剂量、停药、换药或联用方案。", "en": "This module uses Novartis' July 2026 U.S. DailyMed public label for GLEEVEC as a reading entry point. It helps check GLEEVEC, imatinib, 100 mg or 400 mg film-coated tablets, package and target market; it does not turn label numbers or handling steps into an individual dose, stopping, switching or combination plan." }, "checks": [ { "zh": "这份公开标签列出 100 mg 与 400 mg 薄膜衣片，且两种片剂均有刻痕。mg 是每片标示强度，刻痕是这份准确标签中的制剂信息；它们都不是自行掰开、拼凑、加减、按他人方案换算或替代另一种伊马替尼产品的许可。", "en": "This public label lists 100 mg and 400 mg film-coated tablets, both scored. mg identifies the stated strength per tablet, and the score is formulation information in this exact label; neither permits self-splitting, combining, adjusting, converting from another person's regimen or substituting another imatinib product." }, { "zh": "该标签为无法吞服薄膜衣片的情形列出这一个准确片剂在水或苹果汁中分散、完成分散后立即使用的特定程序。它不等于把所有肿瘤片剂都能压碎、久置、与食物混合或套用相同做法；实际药盒应由血液/肿瘤团队或药师按目标市场现行标签核对。", "en": "For inability to swallow film-coated tablets, the label gives a specific procedure for dispersing this exact tablet in water or apple juice and using it immediately after disintegration. It does not mean all oncology tablets may be crushed, stored, mixed with food or handled the same way; the actual pack needs review against the current target-market label by the haematology/oncology team or pharmacist." }, { "zh": "标签提示 CYP3A 诱导剂/抑制剂、其他经 CYP3A4 或 CYP2D6 代谢的药物、抗凝治疗和高剂量甲氨蝶呤等联用问题。抗感染药、抗凝药、甲状腺药、草本、补充剂和全部处方/非处方产品应连同实际包装交由团队核对；网页不能决定个人能否同服、如何错开或怎样调整。", "en": "The label flags CYP3A inducers/inhibitors, other medicines metabolised through CYP3A4 or CYP2D6, anticoagulation and high-dose methotrexate as co-medication issues. Anti-infectives, anticoagulants, thyroid medicine, herbs, supplements and every prescription/OTC product should be reviewed with the actual packages; a webpage cannot decide individual co-use, spacing or adjustment." }, { "zh": "出现快速体重增加或明显水肿、出血、发热、黄疸样变化、严重腹痛、呼吸或胸部不适、明显虚弱或其他急性问题时，应及时联系治疗团队或使用当地紧急医疗支持。不要仅凭网页、包装图、一次化验或另一位患者经验自行暂停、恢复或改用其他靶向药。", "en": "With rapid weight gain or marked swelling, bleeding, fever, jaundice-like changes, severe abdominal pain, breathing or chest symptoms, marked weakness or another acute concern, contact the treatment team promptly or use local urgent medical support. Do not self-pause, restart or change to another targeted medicine from a webpage, package image, one test result or another patient's experience." } ], "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "伊马替尼怎样起作用：标签描述其抑制 BCR-ABL、c-KIT 与 PDGFR 等酪氨酸激酶", "en": "How imatinib works: the label describes inhibition of BCR-ABL, c-KIT and PDGFR tyrosine kinases" }, "summary": { "zh": "FDA 的 GLEEVEC 标签描述伊马替尼抑制 BCR-ABL 酪氨酸激酶，并可抑制 c-KIT 与 PDGFR 等相关酪氨酸激酶。这解释部分分子靶点路径，不判断个人基因/分子检测是否符合、疾病是否适用、相互作用、剂量或换药。", "en": "The FDA GLEEVEC label describes imatinib as inhibiting BCR-ABL and related tyrosine kinases including c-KIT and PDGFR. This explains some molecular-target pathways, not whether individual genetic/molecular testing fits, disease suitability, interactions, dose or switching." }, "checks": [ { "zh": "“BCR-ABL”“KIT”或“靶向药”不是自己根据检测报告或相似病名选择 GLEEVEC 的依据。检测平台、融合/变异结果、疾病阶段、既往治疗、器官功能与现行标签须由血液/肿瘤专科团队综合解读。", "en": "“BCR-ABL,” “KIT” or “targeted medicine” is not a basis for selecting GLEEVEC from a test report or similar disease name. Test platform, fusion/variant result, disease setting, prior therapy, organ function and current label need haematology/oncology-team interpretation." }, { "zh": "共同抑制某种激酶不使不同靶向药、不同强度片剂或不同市场产品可自行换算、叠加、隔日轮换或替代。", "en": "Inhibiting a related kinase does not make different targeted medicines, tablet strengths or market products self-convertible, combinable, alternate-day options or substitutes." }, { "zh": "出现明显水肿、出血、发热、黄疸、严重乏力或其他急性不适时，应及时使用当地治疗团队或紧急医疗支持。", "en": "With marked oedema, bleeding, fever, jaundice, severe weakness or another acute concern, use the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_bc154cbf8d8e616b", "label": "FDA：GLEEVEC 2017 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Gleevec", "generic": "伊马替尼", "dosageFormClass": "伊马替尼薄膜衣口服片：100 mg、400 mg；两种每片标示量与包装呈现须分开核对" }, "labelSource": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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_bc154cbf8d8e616b", "label": "FDA：GLEEVEC 2017 美国标签（NDA 021588）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "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": "2026-08-23", "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 的 GLEEVEC（imatinib mesylate）公开标签由 Novartis Pharmaceuticals Corporation 列示 100 mg 与 400 mg 薄膜衣口服片。本页将已核对的 100 mg、NDC 0078-0401-34、90 片瓶装，以及两款 400 mg、30 片单元剂量纸盒分别列出，方便先核对品牌、通用名、每片标示量、NDC、容器与来源；不把包装数字变成个人片数、掰开、停用、联用、转换或购买结论。", "history": "本页的三个包装面板仅对应美国 DailyMed 公开标签：100 mg、NDC 0078-0401-34、90 片瓶装；400 mg、NDC 0078-0649-13、30 片单元剂量纸盒；以及 400 mg、NDC 0078-1490-13、30 片单元剂量纸盒。100 mg 与 400 mg 的刻痕仅为所引标签中的制剂外观线索，不能成为自行掰开、拼凑、加减、换药或将其他伊马替尼产品视作相同的许可。", "sourceDocuments": [ { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_bc154cbf8d8e616b", "label": "FDA：GLEEVEC 2017 美国标签（NDA 021588）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_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": "NDA 021588", "approvalTimeline": [ { "date": "2001", "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: 2001。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: 2001. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_bc154cbf8d8e616b", "label": "FDA: GLEEVEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2017 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 2017 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_bc154cbf8d8e616b", "label": "FDA: GLEEVEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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/gleevec/", "en": "https://origindrug.com/en/drugs/gleevec/" }, "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." ] }