{ "id": "ganaton-itopride", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Ganaton / Elthon", "generic": "盐酸伊托必利", "aliases": [ "为力苏", "为力苏®", "盐酸伊托必利片", "伊托必利", "itopride", "itopride hydrochloride", "Elthon", "Ganaton", "ガナトン", "イトプリド", "盐酸伊托必利" ], "marketBrandNames": [ { "name": "为力苏® / Elthon®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "dated_public_record", "note": { "zh": "雅培中国产品页及说明书确认名称与 50 mg 规格。", "en": "Abbott China’s page and leaflet identify the brand and 50 mg strength." }, "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "ガナトン / Ganaton", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "dated_public_record", "note": { "zh": "PMDA 电子添文列 Ganaton 50 mg，批准编号 20700AMZ00550。", "en": "The PMDA label lists Ganaton 50 mg and authorisation 20700AMZ00550." }, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "为力苏®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "中国为力苏 50 mg 企业公开说明书；日本 Ganaton 50 mg PMDA 电子添文。品牌、持有人、辅料与批准编号按市场分列。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（日本销售开始）", "archiveSponsorText": "Abbott Laboratories (M) Sdn. Bhd. / Viatris Japan" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "为力苏", "盐酸伊托必利", "伊托必利", "itopride", "Elthon", "Ganaton", "ガナトン" ], "excludedProductCues": [ "domperidone", "多潘立酮", "mosapride", "莫沙必利", "metoclopramide", "甲氧氯普胺" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-ganaton-50mg-100-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 公开电子添文，2024 年 7 月第 4 版", "en": "Public PMDA label, July 2024, fourth revision" }, "dosageForm": { "zh": "盐酸伊托必利薄膜衣片", "en": "Itopride hydrochloride film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "20700AMZ00550", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸伊托必利 50 mg；100 片包装", "en": "50 mg itopride hydrochloride per tablet; 100-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸伊托必利", "en": "itopride hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-ganaton-50mg-1000-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 公开电子添文，2024 年 7 月第 4 版", "en": "Public PMDA label, July 2024, fourth revision" }, "dosageForm": { "zh": "盐酸伊托必利薄膜衣片", "en": "Itopride hydrochloride film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "20700AMZ00550", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸伊托必利 50 mg；1000 片包装", "en": "50 mg itopride hydrochloride per tablet; 1000-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸伊托必利", "en": "itopride hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "可核对片剂特征；暂不展示外盒照片", "en": "Tablet features can be checked; exact carton photo not shown" }, "summary": { "zh": "中国原件写白色薄膜衣片；日本写白色、有刻痕、HC803。日本 100／1000 片包装不是中国规格。没有用电商图或其他市场照片代替，外观也不能单独证明真伪。", "en": "China describes a white film-coated tablet; Japan specifies a white scored tablet marked HC803. Japanese 100/1000-tablet packs are not Chinese packs. No retail or other-market photograph is substituted, and appearance alone cannot authenticate a medicine." }, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "说明书大字阅读：先看规格、老人和分片", "en": "Large-print leaflet reading: strength, older adults and splitting" }, "summary": { "zh": "这里先读中国为力苏原件（2025-09-25 修订）。正面列用途、分片和禁忌；反面有老人、相互作用及批准编号，两面需要一起看。", "en": "Start with the Chinese Elthon original, revised 25 September 2025. Its front covers uses, splitting and contraindications; the reverse covers older adults, interactions and approval identifiers. Read both sides." }, "checks": [ { "zh": "每片 50 mg，说明书列 10 片／盒和 20 片／盒；片数是包装数量。一次多少、一天几次仍以你的处方和药师核对为准。", "en": "Each tablet contains 50 mg; the Chinese leaflet lists 10- and 20-tablet cartons. Pack count is not the dose. Confirm your individual amount and schedule against the prescription." }, { "zh": "中国这款说明书允许根据年龄和症状调整时分片服用。先确认医生是否要求分片；不要把这个许可套到所有胃药或缓释、肠溶药。", "en": "This Chinese product’s leaflet permits tablet division when adjusting for age and symptoms. Confirm whether your prescriber intends splitting; this does not apply to every stomach medicine or modified-release product." }, { "zh": "老人更容易出现不良反应，说明书要求留意变化。若头晕、激动或影响反应能力，先避免驾驶等危险活动并联系医生或药师。", "en": "Older adults may be more susceptible to adverse effects. If dizziness, agitation or impaired reactions occur, avoid hazardous activities such as driving and contact your clinician or pharmacist." }, { "zh": "胃肠出血、机械性梗阻或穿孔，以及对本药成分过敏者，不能使用中国这款产品。不要把持续腹痛或反复呕吐都当成“胃动力差”。", "en": "The Chinese product is contraindicated with gastrointestinal bleeding, mechanical obstruction, perforation or allergy to its ingredients. Persistent pain or vomiting should not simply be treated as poor gut motility." }, { "zh": "严重过敏可出现呼吸困难、喉头肿胀或晕厥，应立即求助急救；出现黄疸等异常应尽快就医。", "en": "Breathing difficulty, throat swelling or fainting with a severe allergic reaction requires emergency help; jaundice or other concerning changes require prompt assessment." } ], "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帮助胃肠推动内容物，不等于抑酸药", "en": "Helps gut movement; it is not an acid suppressant" }, "summary": { "zh": "伊托必利让乙酰胆碱这一“运动信号”更容易发挥作用：一方面阻断多巴胺 D2 受体，另一方面减少乙酰胆碱被分解，从而促进胃肠运动。", "en": "Itopride supports the acetylcholine signals that drive gut movement by blocking dopamine D2 receptors and reducing acetylcholine breakdown." }, "checks": [ { "zh": "它与多潘立酮、莫沙必利不是同一个成分。“都促进胃动力”不代表可以自行叠加、轮换或按 mg 替换。", "en": "It is not domperidone or mosapride. A shared prokinetic purpose does not justify combining, alternating or converting doses yourself." }, { "zh": "抗胆碱药可能抵消部分作用；促进胃肠运动还可能影响其他口服药的吸收，尤其要核对治疗窗窄、缓释或肠溶产品。", "en": "Anticholinergics may reduce its effect. Changed gut movement can also affect absorption of other oral medicines, especially narrow-therapeutic-index, prolonged-release or enteric-coated products." }, { "zh": "主要通过 FMO 相关途径代谢，不等于“没有相互作用”。中国说明书还提醒 QT 间期延长、肝功能异常等风险。", "en": "Predominant FMO-related metabolism does not mean no interactions. The Chinese leaflet also warns about QT prolongation and abnormal liver function." } ], "source": { "id": "src_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Ganaton / Elthon", "generic": "盐酸伊托必利", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "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_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "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_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "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": "2026-09-09", "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": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "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": "为力苏的成分是盐酸伊托必利，是帮助胃肠运动的药。50 mg 是每片的成分含量，不是整盒重量，也不是所有人一次该吃的量。老人或同时服多种药，先核对完整药单和医生给的用法。", "history": "日本 PMDA 标签记载 Ganaton 于 1995 年 9 月开始销售；中国雅培当前公开为力苏说明书的最新印载修订日期为 2025-09-25。这里保留两个市场各自的原件，不把国外批准范围或包装移植到中国。", "sourceDocuments": [ { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_15a9694f3270822b", "label": "Abbott China: digestive products and current Elthon leaflet downloads", "url": "https://www.abbott.com.cn/for-professionals/pharmaceuticals/Digestion.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "JP 20700AMZ00550; CN leaflet lists HJ20160414 / HJ20160415", "approvalTimeline": [ { "date": "1995-09", "title": { "zh": "日本 Ganaton 开始销售", "en": "Ganaton sales began in Japan" }, "detail": { "zh": "日本标签记载的本市场销售日期，不是全球首发结论。", "en": "A market-specific sales date printed in the Japanese label, not a global-first claim." }, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2025-09-25", "title": { "zh": "中国为力苏说明书修订", "en": "Chinese Elthon leaflet revised" }, "detail": { "zh": "本次从雅培现行产品页打开的正反面文件，编号 10-014R7。", "en": "The front and reverse reached from Abbott’s current product page carry artwork code 10-014R7." }, "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "企业公开说明书已核对", "en": "First-party public leaflet checked" }, "detail": { "zh": "说明书列两项批准编号 HJ20160414／HJ20160415，以及 10／20 片包装，但未逐一映射编号与包装；本页不自行配对，也未完成独立的 NMPA 当前记录核验。", "en": "The leaflet lists HJ20160414/HJ20160415 and 10/20-tablet cartons without mapping each identifier to a pack. No pairing is invented, and a separate current NMPA database check is not completed." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "PMDA 公开电子添文已核对", "en": "Public PMDA electronic label checked" }, "detail": { "zh": "原件修订日期为 2024 年 7 月，列 50 mg、100／1000 片包装；核查访问日期不改写为说明书修订日期，也不代表实时库存。", "en": "The original is revised July 2024 and lists 50 mg in 100/1000-tablet packs. Access verification is not a new label revision or live inventory check." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50 mg 是药片总重量吗？", "en": "Is 50 mg the total tablet weight?" }, "answer": { "zh": "不是，是每片盐酸伊托必利的标示含量。日本标签另外列整片重量 130 mg，其中还包含辅料；130 mg 不是更大剂量的伊托必利。", "en": "No. It is the labelled itopride hydrochloride content per tablet. The Japanese label separately gives a 130 mg tablet weight including excipients; that does not mean a 130 mg itopride dose." } }, { "question": { "zh": "有刻痕，就能自己减半吃吗？", "en": "Does a score mean I should halve my dose?" }, "answer": { "zh": "能否分片与该吃多少是两件事。中国为力苏说明书允许在调整剂量时分片，但是否调整由医生结合情况决定。其他厂牌须另核说明书。", "en": "Whether a tablet can be divided and what dose you need are separate questions. The Chinese Elthon leaflet permits division for dose adjustment, but the clinical decision is individual. Check other brands separately." } }, { "question": { "zh": "“胃药”是不是可以长期自行吃？", "en": "Can I keep taking it indefinitely as a stomach medicine?" }, "answer": { "zh": "不能这样理解。中国说明书提示尚无长期用药数据，用药两周后症状改善不明显时宜停药；请联系开方团队复评，不自行加量或叠加别的促动力药。", "en": "No. The Chinese leaflet notes the lack of long-term use data and advises discontinuation if improvement is unclear after two weeks. Contact the prescribing team for reassessment rather than increasing or adding another prokinetic yourself." } } ], "relatedMedicineChecks": [ { "target": { "id": "motilium-domperidone", "brand": "Motilium", "generic": "多潘立酮", "canonicalUrls": { "zh": "https://origindrug.com/drugs/motilium-domperidone/", "en": "https://origindrug.com/en/drugs/motilium-domperidone/" } }, "title": { "zh": "还有吗丁啉／多潘立酮？", "en": "Also using Motilium / domperidone?" }, "summary": { "zh": "两者成分不同。用途相近不能推出适合叠加或轮换；把实际药盒、服药时间和症状交给医生或药师核对，不由网页判断个人联合用药。", "en": "These contain different ingredients. Similar uses do not establish suitability for combination or alternation; have the actual packs, schedule and symptoms reviewed professionally." }, "source": { "id": "src_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ganaton-itopride/", "en": "https://origindrug.com/en/drugs/ganaton-itopride/" }, "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." ] }