{ "id": "pletal", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "PLETAL / Pletaal", "generic": "西洛他唑", "aliases": [ "PLETAL", "Pletaal", "プレタール", "プレタールOD", "cilostazol", "西洛他唑", "西洛他唑片", "NDA 020863", "22100AMX02276", "22100AMX02275", "59148-003-16", "59148-002-16", "OG18" ], "marketBrandNames": [ { "name": "Pletaal OD / プレタール OD", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前记录：50 mg 与 100 mg 口崩片，大塚制药。", "en": "Current PMDA record: 50 mg and 100 mg orally disintegrating tablets, Otsuka." }, "source": { "id": "src_507aafb6e9d8b752", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前专业用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "PLETAL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_public_record", "note": { "zh": "FDA 1999 原始批准及 2015/2017 历史标签；不是当前供应声明。", "en": "FDA original 1999 approval and 2015/2017 historical labels; not a current-supply claim." }, "source": { "id": "src_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "日本 PMDA 当前记录覆盖 Pletaal OD 50 mg 与 100 mg 口崩片；美国 FDA 资料仅作为 PLETAL 50 mg 与 100 mg 普通片的 1999 原始批准及 2015/2017 历史标签档案。美国历史标签不是当前标签、当前供应或任何其他市场状态的证明。", "dosageFormClass": "日本当前为 Pletaal OD 口崩片；美国档案为历史普通口服片。相同成分和毫克数不合并产品形态、包装或市场状态。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（美国 FDA 原始批准）；2010（日本 PMDA 当前 OD 片销售起始节点）", "archiveSponsorText": "Otsuka Pharmaceutical Co., Ltd.（日本 PMDA）；Otsuka America Pharmaceutical, Inc.（美国历史 FDA 记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "generic cilostazol", "other cilostazol product", "其他西洛他唑产品", "プレタール散20%", "cilostazol combination", "西洛他唑复方" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-pletaal-od-cilostazol-50mg-tablet-22100amx02276", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前电子添付文书（2023-02 修订；2026-08-29 核验）", "en": "Current PMDA electronic label (revised Feb 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "プレタール OD 西洛他唑口崩片", "en": "Pletaal OD cilostazol orally disintegrating tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "22100AMX02276", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 50 mg；日本口崩片", "en": "Cilostazol 50 mg per tablet; Japanese orally disintegrating tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、掰片或换算指令", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": null, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-pletaal-od-cilostazol-100mg-tablet-22100amx02275", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前电子添付文书（2023-02 修订；2026-08-29 核验）", "en": "Current PMDA electronic label (revised Feb 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "プレタール OD 西洛他唑口崩片", "en": "Pletaal OD cilostazol orally disintegrating tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "22100AMX02275", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 100 mg；日本口崩片", "en": "Cilostazol 100 mg per tablet; Japanese orally disintegrating tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、掰片或换算指令", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "OG18", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-pletal-cilostazol-50mg-60-tablet-bottle-ndc-59148-003-16", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2015 历史标签（不是当前标签或供应证明）", "en": "Historical 2015 U.S. FDA label (not a current label or supply claim)" }, "dosageForm": { "zh": "PLETAL 西洛他唑普通口服片（历史美国记录）", "en": "PLETAL cilostazol conventional oral tablet (historical U.S. record)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-003-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 50 mg；60 片瓶装（美国历史标签）", "en": "Cilostazol 50 mg per tablet; 60-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史美国标签标示量；不是当前供应、个人剂量或跨市场换算", "en": "Historical U.S. labelled amount per tablet; not current supply, an individual dose or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（历史）", "en": "bottle (historical)" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "三角形片", "en": "triangular tablet" }, "imprint": "PLETAL 50", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-pletal-cilostazol-100mg-60-tablet-bottle-ndc-59148-002-16", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2015 历史标签（不是当前标签或供应证明）", "en": "Historical 2015 U.S. FDA label (not a current label or supply claim)" }, "dosageForm": { "zh": "PLETAL 西洛他唑普通口服片（历史美国记录）", "en": "PLETAL cilostazol conventional oral tablet (historical U.S. record)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-002-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 100 mg；60 片瓶装（美国历史标签）", "en": "Cilostazol 100 mg per tablet; 60-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史美国标签标示量；不是当前供应、个人剂量或跨市场换算", "en": "Historical U.S. labelled amount per tablet; not current supply, an individual dose or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（历史）", "en": "bottle (historical)" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "PLETAL 100", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "四个来源可追溯文字身份已建立；没有用零售图或跨市场包装冒充准确产品", "en": "Four traceable text identities are established; no retail or cross-market pack is presented as the exact product" }, "summary": { "zh": "PMDA 当前文书可核对日本两种口崩片的形状、尺寸与 100 mg 片印字，FDA 历史标签可核对美国两种普通片及历史瓶装信息，但目前没有与四个身份逐一对应并可安全复用的准确公开包装主图。页面因此保留图片缺口，不用通用西洛他唑、零售图或另一市场包装代替。", "en": "The current PMDA document verifies shape, size and the 100 mg imprint for the two Japanese OD tablets, while historical FDA labels verify two U.S. conventional tablets and bottle information. No exact reusable public principal-display image is mapped one-to-one to all four identities, so the page discloses the image gap and does not substitute a generic cilostazol, retail or other-market pack." }, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLETAL / Pletaal 说明书放大阅读：先核对心衰、出血、联用药和准确剂型", "en": "PLETAL / Pletaal label reading: check heart failure, bleeding, co-medications and exact dosage form first" }, "summary": { "zh": "本模块帮助辨认日本当前 Pletaal OD 口崩片与美国历史 PLETAL 普通片，并把高风险核对点提前。它不判断个人是否适用，也不生成片数、频率、开始、停用、补服、换药、术前停药或联用方案。", "en": "This module distinguishes current Japanese Pletaal OD tablets from historical U.S. PLETAL conventional tablets and brings higher-risk review cues forward. It does not decide individual suitability or generate tablet count, frequency, initiation, stopping, missed-use, switching, peri-procedure stopping or co-use plans." }, "checks": [ { "zh": "日本 OD 是口崩片产品身份，不表示可以把药片任意压碎、溶成任意体积、分给他人或按美国历史普通片换算。应按手中准确产品的现行说明书和专业指示核对。", "en": "Japanese OD identifies an orally disintegrating product; it does not permit arbitrary crushing, dissolving into an arbitrary volume, sharing or conversion from historical U.S. conventional tablets. Check the current label for the exact product and professional instruction." }, { "zh": "日本 100 mg 片有刻痕和 OG18 印字，刻痕首先是外观核对线索，不是所有人都能掰片或用半片拼规格的通用许可。50 mg、100 mg 和其他厂家产品必须分别核对。", "en": "The Japanese 100 mg tablet has a score and OG18 imprint. A score is first an appearance clue, not universal permission for everyone to split a tablet or assemble a strength from halves. Check 50 mg, 100 mg and other manufacturers' products separately." }, { "zh": "PMDA 当前文书和 FDA 历史标签都把充血性/任何程度心力衰竭列为重要禁忌边界。已有心衰、原因不明的气促、水肿、胸痛、明显心悸或晕厥者，不要靠网页自行开始、继续、加量或停药，应尽快联系负责团队；严重胸痛、呼吸困难或晕厥应使用当地急救服务。", "en": "The current PMDA document and historical FDA label identify congestive/any-severity heart failure as a major contraindication boundary. With known heart failure, unexplained breathlessness, swelling, chest pain, marked palpitations or fainting, do not use a webpage to start, continue, increase or stop the medicine; contact the responsible team promptly. Severe chest pain, breathing difficulty or fainting requires local emergency care." }, { "zh": "阿司匹林、氯吡格雷、普拉格雷、替格瑞洛、华法林、阿哌沙班、利伐沙班、达比加群、依度沙班及 NSAID 止痛药等同在药单时，是需要优先完整核对的出血线索。不要自行叠加、轮换、错开时间或停掉其中一种。", "en": "Aspirin, clopidogrel, prasugrel, ticagrelor, warfarin, apixaban, rivaroxaban, dabigatran, edoxaban or NSAID pain medicines on the same list are priority bleeding-review cues. Do not self-combine, alternate, time-separate or stop one of them." }, { "zh": "黑便、呕血、无法止住的出血、突然偏瘫/言语不清、严重头痛、意识变化或严重过敏表现可能是急症，应立即使用当地急救服务；不要等待网页或自行补服、停换药来观察。", "en": "Black stool, vomiting blood, uncontrolled bleeding, sudden weakness or speech trouble, severe headache, altered consciousness or severe allergy may be emergencies. Use local emergency services immediately; do not wait for a webpage or self-take, stop or switch medicine to observe." }, { "zh": "历史 FDA 标签提示多种 CYP3A4 或 CYP2C19 抑制药可能影响西洛他唑暴露，例子包括部分抗真菌药、抗菌药、维拉帕米/地尔硫卓、奥美拉唑及葡萄柚相关产品。这个来源线索不能改写成网页剂量表；请把所有处方药、非处方药、补充剂和饮食相关产品交给药师核对。", "en": "The historical FDA label indicates that several CYP3A4 or CYP2C19 inhibitors may affect cilostazol exposure, including some antifungals, antibacterials, verapamil/diltiazem, omeprazole and grapefruit-related products. This source cue must not become a web dose table; have a pharmacist review every prescription medicine, OTC product, supplement and relevant dietary product." } ], "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西洛他唑怎样起作用：PDE3 抑制和血小板线索不能变成换药规则", "en": "How cilostazol works: PDE3 inhibition and platelet effects are not switching rules" }, "summary": { "zh": "官方标签描述西洛他唑抑制磷酸二酯酶 III、增加细胞内 cAMP，并影响血小板聚集及血管反应。这帮助理解为什么要优先核对出血、心率、心衰和完整药单，但“抗血小板”不是与阿司匹林、氯吡格雷或抗凝药可自行互换、叠加或停换的同义词。", "en": "Official labels describe cilostazol as inhibiting phosphodiesterase III, increasing intracellular cAMP and affecting platelet aggregation and vascular responses. This helps explain why bleeding, heart rate, heart failure and the complete medicine list need priority review. ‘Antiplatelet’ does not make it interchangeable or self-combinable with aspirin, clopidogrel or an anticoagulant." }, "checks": [ { "zh": "作用机制不能判断某个人是否该用西洛他唑，也不能根据步行距离、腿痛、血压或心率数字生成片数、频率或疗程。", "en": "Mechanism cannot decide whether an individual should use cilostazol or generate tablet count, frequency or duration from walking distance, leg pain, blood pressure or heart rate." }, { "zh": "同为抗血小板或影响凝血的药，不表示作用路径、获批用途、出血风险和停换边界相同。请由负责团队按诊断、准确药盒、完整药单和计划中的操作/手术逐项核对。", "en": "Medicines that are antiplatelet or affect clotting do not share the same pathway, approved use, bleeding risk or stopping/switching boundary. The responsible team must review the diagnosis, exact packs, full medicine list and any planned procedure or surgery." }, { "zh": "心悸或心率变化不能靠机制解释后自行补服或停药；严重胸痛、呼吸困难、晕厥、卒中或大出血表现应立即使用当地急救服务。", "en": "Do not use a mechanism explanation to self-take an extra tablet or stop after palpitations or heart-rate changes. Severe chest pain, breathing difficulty, fainting, stroke features or major bleeding require immediate local emergency care." } ], "source": { "id": "src_9cf5753b3132af87", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签（2017；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PLETAL / Pletaal", "generic": "西洛他唑", "dosageFormClass": "日本当前为 Pletaal OD 口崩片；美国档案为历史普通口服片。相同成分和毫克数不合并产品形态、包装或市场状态。" }, "labelSource": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "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_507aafb6e9d8b752", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前专业用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "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_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_9cf5753b3132af87", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签（2017；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "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": "PLETAL / Pletaal 是西洛他唑品牌档案。普通人首先要分清手中是日本 Pletaal OD 口崩片、美国历史 PLETAL 普通片，还是其他厂家西洛他唑；相同成分和 50/100 mg 不表示同一包装或可自行替换。西洛他唑会影响血小板聚集和血管反应；心力衰竭、胸痛/心悸、出血风险，以及与抗血小板药、抗凝药、止痛药和其他相互作用药同在药单时，都应优先让医生或药师核对完整药单与准确药盒。", "history": "美国 FDA 于 1999-01-15 批准 NDA 020863 的 Pletal 50 mg 与 100 mg 片。日本 PMDA 当前产品记录列示 Pletaal OD 50 mg（22100AMX02276）与 100 mg（22100AMX02275），电子添付文书修订于 2023-02；这两个日本口崩片产品不能用美国历史普通片包装替代展示。", "sourceDocuments": [ { "id": "src_507aafb6e9d8b752", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前专业用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_4f7aae23e8d8b5bf", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前公众用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_af01f4636e5e5e87", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 患者向医药品指南（2022-10 更新）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/180078_3399002F3020_1_02G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9cf5753b3132af87", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签（2017；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国 NDA 020863；日本 22100AMX02276 / 22100AMX02275", "approvalTimeline": [ { "date": "1999-01-15", "title": { "zh": "美国 FDA 原始批准", "en": "Original U.S. FDA approval" }, "detail": { "zh": "FDA 批准信将 Pletal 50 mg 与 100 mg 片、NDA 020863 和 Otsuka 对应。该历史节点不证明 2026 年美国当前标签或供应。", "en": "The FDA letter connects Pletal 50 mg and 100 mg tablets, NDA 020863 and Otsuka. This historical node does not establish a current 2026 U.S. label or supply." }, "source": { "id": "src_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2010-04", "title": { "zh": "日本 Pletaal OD 片销售起始节点", "en": "Japanese Pletaal OD sales-start node" }, "detail": { "zh": "PMDA 当前电子添付文书列示 50 mg 与 100 mg OD 片的销售起始月份为 2010-04；不据此推定药房库存。", "en": "The current PMDA electronic label lists Apr 2010 as the sales-start month for 50 mg and 100 mg OD tablets; this does not establish pharmacy stock." }, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-02", "title": { "zh": "日本当前电子添付文书修订节点", "en": "Current Japanese electronic-label revision" }, "detail": { "zh": "页面以此当前 PMDA 文书为日本标签入口，并另提供 2022-10 患者指南。", "en": "The page uses this current PMDA document as the Japanese label entry point and separately links the Oct 2022 patient guide." }, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "Pletaal OD 50 mg / 100 mg 当前 PMDA 记录已链接", "en": "Current PMDA records linked for Pletaal OD 50 mg / 100 mg" }, "detail": { "zh": "监管记录不等于具体库存、购买资格、个人适用性或可自行换药。", "en": "A regulatory record does not establish stock, purchasing eligibility, individual suitability or self-switching." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "1999 批准及 2015/2017 历史档案已链接；当前状态未建立", "en": "1999 approval and 2015/2017 historical archives linked; current status not established" }, "detail": { "zh": "历史标签中的 60 片瓶装 NDC 仅用于档案身份，不声称当前销售或供应。", "en": "The 60-tablet bottle NDCs in historical labels are archival identities only and do not claim current marketing or supply." } }, { "market": { "zh": "中国大陆、欧盟及其他市场", "en": "Mainland China, EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从日本或美国资料外推当地品牌、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local brand, approval, pack, supply, originator/generic relationship or interchangeability is inferred from Japanese or U.S. documents." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "Pletaal OD 和 PLETAL 普通片是同一包装吗？", "en": "Are Pletaal OD and conventional PLETAL the same pack?" }, "answer": { "zh": "不是。本页日本当前记录是口崩片，美国资料是历史普通片；名称和毫克数接近也不能合并剂型、包装、市场状态或自行换药。", "en": "No. The current Japanese record is an orally disintegrating tablet, while the U.S. sources describe historical conventional tablets. Similar names and milligram numbers do not merge dosage form, pack, market status or permit self-switching." } }, { "question": { "zh": "100 mg 片有刻痕，能自己掰成 50 mg 吗？", "en": "Can a scored 100 mg tablet be self-split into 50 mg?" }, "answer": { "zh": "网页不能这样判断。刻痕是产品外观线索，不是通用分片或换算许可；应按手中准确产品的现行说明书、处方和药师/开方团队指示核对。", "en": "A webpage cannot make that decision. A score is a product-appearance clue, not universal splitting or conversion permission; check the current label, prescription and professional instruction for the exact product." } }, { "question": { "zh": "正在用阿司匹林或抗凝药，可以加西洛他唑吗？", "en": "Can cilostazol be added to aspirin or an anticoagulant?" }, "answer": { "zh": "不能由网页决定，也不要自行添加、停用或错开。请把所有处方药、非处方止痛药、补充剂和实际药盒交给负责团队核对出血风险、用途与监测计划。", "en": "A webpage cannot decide this. Do not self-add, stop or time-separate. Have the responsible team review every prescription medicine, OTC pain product, supplement and actual pack for bleeding risk, purpose and monitoring." } } ], "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/pletal/", "en": "https://origindrug.com/en/drugs/pletal/" }, "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." ] }