{ "id": "motilium-domperidone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Motilium", "generic": "多潘立酮", "aliases": [ "吗丁啉", "吗丁啉®", "多潘立酮片", "domperidone", "Motilium", "多潘立酮" ], "marketBrandNames": [ { "name": "吗丁啉®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "dated_public_record", "note": { "zh": "多潘立酮片，企业公开说明书列国药准字 H10910003。", "en": "Domperidone tablets; the first-party leaflet lists Chinese approval identifier H10910003." }, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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": "Motilium", "market": { "zh": "爱尔兰", "en": "Ireland" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "HPRA 许可 PA23490/022/002；不能据此推定其他市场可售。", "en": "HPRA authorisation PA23490/022/002 does not establish sale eligibility elsewhere." }, "source": { "id": "src_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "吗丁啉®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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": "中国大陆：吗丁啉 10 mg 片企业公开说明书；爱尔兰：Motilium 10 mg 薄膜衣片 HPRA 记录。美国未批准人用。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国未批准", "archiveSponsorText": "Xi’an Janssen / JNTL Consumer Health I (Ireland) Limited" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "吗丁啉", "多潘立酮", "domperidone", "Motilium" ], "excludedProductCues": [ "metoclopramide", "甲氧氯普胺", "ondansetron", "昂丹司琼" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "cn-motilium-10mg-30-tablets", "marketCode": "CN", "labelVersion": { "zh": "中国企业公开说明书，2026-05-13 修订", "en": "Chinese first-party leaflet, revised 13 May 2026" }, "dosageForm": { "zh": "多潘立酮片", "en": "Domperidone tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H10910003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；30 片/盒", "en": "10 mg domperidone per tablet; 30 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "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": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-motilium-10mg-42-tablets", "marketCode": "CN", "labelVersion": { "zh": "中国企业公开说明书，2026-05-13 修订", "en": "Chinese first-party leaflet, revised 13 May 2026" }, "dosageForm": { "zh": "多潘立酮片", "en": "Domperidone tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H10910003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；42 片/盒", "en": "10 mg domperidone per tablet; 42 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "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": 42, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ie-motilium-10mg-10-tablets", "marketCode": "IE", "labelVersion": { "zh": "爱尔兰 HPRA，2026-01-26", "en": "Ireland HPRA, 26 Jan 2026" }, "dosageForm": { "zh": "多潘立酮薄膜衣片", "en": "Domperidone film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PA23490/022/002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；10 片/盒", "en": "10 mg domperidone per tablet; 10 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "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": 10, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "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": "ie-motilium-10mg-20-tablets", "marketCode": "IE", "labelVersion": { "zh": "爱尔兰 HPRA，2026-01-26", "en": "Ireland HPRA, 26 Jan 2026" }, "dosageForm": { "zh": "多潘立酮薄膜衣片", "en": "Domperidone film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PA23490/022/002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；20 片/盒", "en": "10 mg domperidone per tablet; 20 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "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": 20, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "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": "包装数量已核对，外盒照片尚未展示", "en": "Pack counts verified; exact carton photographs not shown" }, "summary": { "zh": "中国说明书列 30 片及 2×21 片；爱尔兰列 10 或 20 片且并非所有包装都在售。未用电商或其他国家包装图代替；外观本身也不能证明真伪。", "en": "China lists 30 and 2×21 tablets; Ireland lists 10 or 20, not necessarily all marketed. Retail or other-country images are not substitutes, and appearance cannot authenticate a pack." }, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "说明书大字阅读：先看年龄、心脏和药单", "en": "Large-print leaflet reading: age, heart history and the medicine list" }, "summary": { "zh": "中国吗丁啉公开说明书（2026-05-13）是这里的首选原件。先核对手中药盒，再看禁忌和注意事项；“非处方药”不等于适合所有人。", "en": "The Chinese Motilium leaflet (13 May 2026) is the primary original here. Match the pack, then read contraindications and precautions; OTC does not mean suitable for everyone." }, "checks": [ { "zh": "60 岁以上、心脏病、肝肾问题或多药合用，请先找医生或药师逐项核对。", "en": "If over 60, with heart, liver or kidney problems, or taking several medicines, ask a clinician or pharmacist to review the whole list." }, { "zh": "中国说明书提示：使用 3 天未缓解应咨询，通常不超过 1 周；这不是让所有人按网页自行开始一个疗程。", "en": "The Chinese leaflet advises consultation if symptoms persist after 3 days and usually limits use to one week; this is not an instruction to start a course." }, { "zh": "出现可能与心律异常有关的症状，说明书要求停用并迅速咨询。晕厥、严重胸部不适或呼吸困难应立即求助当地急救。", "en": "The leaflet calls for stopping and prompt consultation if symptoms may indicate arrhythmia. Fainting, severe chest discomfort or breathing difficulty needs emergency help." }, { "zh": "每片 10 mg 与整盒片数不同。是否能掰片、如何服用，按手中具体说明书和专业意见核对，不能从薄膜衣或外观猜测。", "en": "10 mg per tablet is different from the carton count. Check splitting and administration against the exact leaflet and professional advice, not appearance or coating alone." } ], "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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": "它帮助胃肠运动，不是所有“胃药”都一样", "en": "It helps gut movement; not all stomach medicines do the same thing" }, "summary": { "zh": "爱尔兰说明书解释：多潘立酮阻断多巴胺受体，促进胃排空并有止吐作用；这与减少胃酸分泌不是一回事。", "en": "The Irish SmPC describes dopamine-receptor blockade, faster gastric emptying and anti-emetic effects, rather than reduced acid secretion." }, "checks": [ { "zh": "作用在胃肠道，也可能影响心脏电活动。QT 是心电图上的时间指标，不能靠有没有胃痛判断风险。", "en": "Gut effects do not rule out cardiac electrical effects. QT is an ECG interval; stomach symptoms do not measure that risk." }, { "zh": "身体主要通过 CYP3A4 相关途径处理该药。某些药会干扰这一过程，使血中药量升高；错开一两个小时不能保证解决。", "en": "CYP3A4 contributes to its metabolism. Inhibiting it can raise drug exposure; separating doses by an hour or two is not a reliable solution." }, { "zh": "抗酸或抑酸药不应与其同时服用。让药师按具体药单安排，不从“都是胃药”推断可叠加。", "en": "Antacids and acid-suppressing medicines should not be taken simultaneously with it. A pharmacist should check the actual schedule rather than assume all stomach medicines can be combined." } ], "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "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": "Motilium", "generic": "多潘立酮", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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": "西安杨森", "en": "Xi’an Janssen" }, "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_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "爱尔兰药监 HPRA", "en": "HPRA" }, "market": { "zh": "爱尔兰", "en": "Ireland" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "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_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "爱尔兰药监 HPRA", "en": "HPRA" }, "market": { "zh": "爱尔兰", "en": "Ireland" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "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": "西安杨森", "en": "Xi’an Janssen" }, "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": "吗丁啉的成分是多潘立酮，属于胃肠促动力药。10 mg 是每片含量，30 片或 42 片是整盒数量。60 岁以上或正在吃其他药，先把药盒和完整药单交给医生或药师核对。", "history": "EMA 记录该成分在欧洲各国的使用历史，并在 2014 年因心脏风险限制适应症与使用期限。本页分别保留中国 2026-05-13 说明书和爱尔兰 2026-01 HPRA 说明书，不把各国用途、规格或供药条件合成一份全球说明书。", "sourceDocuments": [ { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_171e9167eada395b", "label": "EMA: domperidone referral and 2014 restrictions on nausea/vomiting use and cardiac risk", "url": "https://www.ema.europa.eu/en/medicines/human/referrals/domperidone-containing-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_4fbd8611c0fd0f3d", "label": "FDA: Information about domperidone; not FDA-approved for human use", "url": "https://www.fda.gov/drugs/information-drug-class/information-about-domperidone", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_guidance", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "CN H10910003 / IE PA23490/022/002", "approvalTimeline": [ { "date": "2007-10-05", "title": { "zh": "爱尔兰本许可首次批准", "en": "First authorisation of this Irish licence" }, "detail": { "zh": "仅为 PA23490/022/002 的日期，不是美国或全球首发日期。", "en": "This date belongs to PA23490/022/002, not U.S. approval or a global first launch." }, "source": { "id": "src_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2014-04-23", "title": { "zh": "欧洲限制使用建议", "en": "European restrictions endorsed" }, "detail": { "zh": "监管复核支持在限制条件下用于恶心和呕吐，重点关注心脏风险。", "en": "Regulatory review supported restricted nausea/vomiting use with cardiac-risk precautions." }, "source": { "id": "src_171e9167eada395b", "label": "EMA: domperidone referral and 2014 restrictions on nausea/vomiting use and cardiac risk", "url": "https://www.ema.europa.eu/en/medicines/human/referrals/domperidone-containing-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2026-05-13", "title": { "zh": "中国公开说明书修订", "en": "Chinese public leaflet revised" }, "detail": { "zh": "官网当前下载文件列明这一修订日期。", "en": "The current first-party download prints this revision date." }, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.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": "企业公开非处方药说明书", "en": "Public first-party OTC leaflet" }, "detail": { "zh": "吗丁啉／多潘立酮片，10 mg；本次未独立完成 NMPA 当前数据库记录核验，不作库存结论。", "en": "Motilium / domperidone tablets, 10 mg. A separate current NMPA database check is not completed; no stock claim is made." } }, { "market": { "zh": "爱尔兰", "en": "Ireland" }, "status": { "zh": "HPRA 已授权记录；供药条件按包装区分", "en": "HPRA-authorised record; supply conditions vary by pack" }, "detail": { "zh": "本许可小包装可经药房非处方供应；超过 10 片的包装需处方。说明书列包装不等于实时有货。", "en": "The licence permits non-prescription pharmacy supply for the small pack; packs above 10 tablets require a prescription. Listed packs are not live inventory." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "FDA 未批准人用", "en": "Not FDA-approved for human use" }, "detail": { "zh": "FDA 公开页面明确未批准；不得把其他国家说明书当作美国上市或可购买依据。", "en": "FDA states it is unapproved. Other countries’ leaflets do not establish U.S. marketing or purchasing eligibility." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "中国说明书与爱尔兰用途为什么不同？", "en": "Why do the Chinese and Irish indications differ?" }, "answer": { "zh": "各市场批准范围不同。中国企业产品页列消化不良等症状；爱尔兰当前说明书只列恶心和呕吐。按所在地、具体产品的现行说明书核对，不取更宽的一份自行使用。", "en": "Authorised scope differs by market. The Chinese first-party product page includes dyspepsia symptoms; the current Irish label lists nausea and vomiting. Follow the actual local product, not whichever wording is broader." } }, { "question": { "zh": "能用来催乳吗？", "en": "Can it be used to increase milk supply?" }, "answer": { "zh": "不要自行用于催乳。FDA 提示该用途疗效未确立并有严重心脏风险，停减药也有神经精神不良事件报告；若已在用，请让医疗团队评估。", "en": "Do not self-use it to increase milk supply. FDA describes unestablished benefit, serious cardiac risks and reports of neuropsychiatric events during withdrawal; if already using it, seek clinical review." } }, { "question": { "zh": "掰半就一定变成安全的小剂量吗？", "en": "Does half a tablet guarantee a safer dose?" }, "answer": { "zh": "不是。是否适用、能否分片及该吃多少是不同问题；有禁忌时掰半不能把药变安全。", "en": "No. Suitability, splittability and the prescribed amount are separate questions. Halving does not remove a contraindication." } } ], "relatedMedicineChecks": [ { "target": { "id": "levaquin", "brand": "Levaquin", "generic": "左氧氟沙星", "canonicalUrls": { "zh": "https://origindrug.com/drugs/levaquin/", "en": "https://origindrug.com/en/drugs/levaquin/" } }, "title": { "zh": "药单里还有可乐必妥／左氧氟沙星？", "en": "Also taking levofloxacin / Cravit / Levaquin?" }, "summary": { "zh": "爱尔兰 Motilium 说明书将左氧氟沙星列入不能合用的延长 QT 药物示例。把两盒药交给医生或药师立即核对，不靠错开时间自行处理。", "en": "The Irish Motilium SmPC lists levofloxacin among QT-prolonging medicines contraindicated with domperidone. Have both packs reviewed promptly; do not solve it by self-spacing doses." }, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "target": { "id": "biaxin", "brand": "BIAXIN", "generic": "克拉霉素", "canonicalUrls": { "zh": "https://origindrug.com/drugs/biaxin/", "en": "https://origindrug.com/en/drugs/biaxin/" } }, "title": { "zh": "还有克拉霉素等抗感染药？", "en": "Also taking clarithromycin or another anti-infective?" }, "summary": { "zh": "爱尔兰说明书将克拉霉素等强 CYP3A4 抑制剂列为合用禁忌。该清单不是全部相互作用；带完整药单核对。", "en": "The Irish SmPC contraindicates potent CYP3A4 inhibitors such as clarithromycin. This is not an exhaustive interaction list; bring every medicine for review." }, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "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/motilium-domperidone/", "en": "https://origindrug.com/en/drugs/motilium-domperidone/" }, "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." ] }