{ "id": "protonix", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Protonix", "generic": "泮托拉唑", "aliases": [ "pantoprazole", "泮托拉唑", "泮立苏" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 2026-05 版本）", "dosageFormClass": "口服延迟释放片：20 mg、40 mg；另有延迟释放口服混悬液，属于不同产品形态（本档案所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-protonix-dr-tablet-20mg-ndc-0008-0843-81", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-05 更新）", "en": "DailyMed public label (updated May 2026)" }, "dosageForm": { "zh": "泮托拉唑钠延迟释放口服片", "en": "pantoprazole sodium delayed-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0843-81", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；90 片瓶装", "en": "20 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-04.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泮托拉唑", "en": "pantoprazole" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆、双凸延迟释放片", "en": "oval biconvex delayed-release tablet" }, "imprint": { "zh": "P20（棕色油墨）", "en": "P20 (brown ink)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 20 mg 延迟释放片、90 片瓶装（NDC 0008-0843-81；2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-protonix-dr-tablet-40mg-ndc-0008-0841-81", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-05 更新）", "en": "DailyMed public label (updated May 2026)" }, "dosageForm": { "zh": "泮托拉唑钠延迟释放口服片", "en": "pantoprazole sodium delayed-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0841-81", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；90 片瓶装", "en": "40 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-05.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泮托拉唑", "en": "pantoprazole" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆、双凸延迟释放片", "en": "oval biconvex delayed-release tablet" }, "imprint": { "zh": "PROTONIX（棕色油墨）", "en": "PROTONIX (brown ink)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 40 mg 延迟释放片、90 片瓶装（NDC 0008-0841-81；2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-protonix-dr-oral-suspension-40mg-ndc-0008-0844-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-05 更新）", "en": "DailyMed public label (updated May 2026)" }, "dosageForm": { "zh": "泮托拉唑钠延迟释放口服混悬液颗粒（单剂量袋装）", "en": "pantoprazole sodium delayed-release oral-suspension granules (unit-dose packet)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0844-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋 40 mg；30 袋单剂量外盒", "en": "40 mg per packet; 30 unit-dose packets per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-07.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泮托拉唑", "en": "pantoprazole" }, "value": 40, "unit": "mg", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标示量", "en": "labelled amount per packet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "单剂量袋/外盒", "en": "unit-dose packets per carton" } }, "physicalClues": { "color": { "zh": "淡黄至深棕色", "en": "pale yellowish to dark brownish" }, "shape": { "zh": "肠溶颗粒单剂量袋装", "en": "enteric-coated granules in a unit-dose packet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 40 mg 延迟释放口服混悬液、30 袋单剂量外盒（NDC 0008-0844-02；2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-05.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "alt": "PROTONIX 40 mg 泮托拉唑钠延迟释放片在美国 DailyMed 公开标签中的 90 片瓶装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Wyeth/Pfizer，2026-05 更新）", "presentation": "PROTONIX 泮托拉唑钠 40 mg 延迟释放片、NDC 0008-0841-81、90 片瓶装主展示图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PROTONIX、泮托拉唑钠 40 mg 延迟释放片、NDC 0008-0841-81、90 片瓶装的 Wyeth/Pfizer 主展示图，只帮助核对品牌、通用名、标示强度、延迟释放片、包装数量和来源；不用于鉴定真伪，也不证明 20 mg、延迟释放口服混悬液、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROTONIX 说明书放大阅读：延迟释放、20 mg、40 mg 与口服混悬液先用于确认准确产品", "en": "PROTONIX label reading: delayed release, 20 mg, 40 mg and oral suspension first identify the exact product" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 PROTONIX、泮托拉唑钠、延迟释放片或延迟释放口服混悬液、每单位标示量和目标市场。它不提供任何人的片数、服用时间、疗程、联用、转换或停药方案。", "en": "This module uses the U.S. DailyMed public label to check PROTONIX, pantoprazole sodium, delayed-release tablets or delayed-release oral suspension, labelled amount per unit and target market. It does not provide an individual's tablet count, timing, course, combination, switching or stopping plan." }, "checks": [ { "zh": "20 mg、40 mg 是美国标签所列延迟释放片的每片标示量；它们是产品身份字段，不是网页为任何人计算今天应服几片、何时服或服多久的答案。先同时核对 PROTONIX、泮托拉唑、准确剂型、每单位量、实际包装和目标市场。", "en": "20 mg and 40 mg are labelled amounts per delayed-release tablet in the U.S. label. They are product-identity fields, not a webpage answer for how many tablets anyone should use today, when to use them or for how long. Check PROTONIX, pantoprazole, exact dosage form, amount per unit, actual pack and target market together." }, { "zh": "“延迟释放”描述制剂设计，不能简化为“掰一半就等于减半”或“另一种胃药都能互换”。片剂与延迟释放口服混悬液是标签中分别列出的产品形态；任何掰开、压碎、改成液体、换规格或换产品的问题，都需要准确产品的现行标签和药师确认。", "en": "“Delayed release” describes formulation design; it cannot be simplified to ‘half a tablet equals half’ or ‘any other stomach medicine is interchangeable.’ The label lists tablets and delayed-release oral suspension as separate product forms. Any splitting, crushing, changing to liquid, strength change or product change needs the current label for the exact product and pharmacist confirmation." }, { "zh": "标签包含与药物吸收、胃酸环境、肝功能、长期使用风险和其他药物相关的核对事项。正在使用处方药、非处方止痛药、补充剂或多种胃肠产品时，应把实际药盒和完整药单交由专业人员一起核对；不要按名称相近或“都是抑酸药”自行叠加、轮换或替代。", "en": "The label contains checks involving medicine absorption, gastric-acid environment, liver function, long-term-use risks and other medicines. With prescriptions, OTC pain medicines, supplements or multiple gastrointestinal products, have a professional review the actual packs and complete medicine list together; do not self-combine, alternate or substitute based on similar names or ‘acid medicine’ wording." }, { "zh": "吞咽困难、持续或加重的不适、呕血/黑便、体重明显变化、严重过敏表现或任何急性问题，不能由网页或包装数字处理。应及时使用当地医疗渠道，并将准确药盒、处方与完整药单交由专业人员判断。", "en": "Swallowing difficulty, persistent or worsening concerns, vomiting blood/black stools, marked weight change, severe allergic features or any acute problem cannot be handled from a webpage or package numbers. Use local medical pathways promptly and have professionals review the exact pack, prescription and complete medicine list." } ], "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "泮托拉唑怎样起作用：标签将其归为质子泵抑制剂", "en": "How pantoprazole works: the label classifies it as a proton-pump inhibitor" }, "summary": { "zh": "DailyMed 标签将 PROTONIX 描述为质子泵抑制剂；其临床药理部分说明泮托拉唑可抑制胃壁细胞分泌胃酸的末端步骤。它解释的是药理路径和为何延迟释放等产品身份重要，不判断个人症状原因、是否适用、片数、疗程、联用或转换方案。", "en": "The DailyMed label describes PROTONIX as a proton-pump inhibitor; its clinical-pharmacology section explains that pantoprazole inhibits the final step of gastric-acid secretion in parietal cells. This explains a pharmacologic pathway and why product identity such as delayed release matters; it does not determine an individual's symptom cause, suitability, tablet count, course, combination or switching plan." }, "checks": [ { "zh": "“抑制胃酸分泌”是作用路径，不是对胸痛、腹痛、反酸、吞咽困难或其他症状的自我诊断，也不证明某个人一定适合某种抑酸产品。是否需要检查、治疗或改变方案应由当地医疗专业人员和现行标签判断。", "en": "‘Inhibits gastric-acid secretion’ is an action pathway, not self-diagnosis for chest pain, abdominal pain, reflux, swallowing difficulty or another symptom, and does not establish that a particular acid-reducing product suits someone. The need for evaluation, treatment or a change requires local clinical judgement and the current label." }, { "zh": "共同属于质子泵抑制剂或都写有胃酸相关用途，不支持把 PROTONIX 与另一种同类产品自行叠加、隔天轮换、按 mg 换算或以另一剂型替代。准确产品、既往反应、其他药物、检查计划和完整药单需由专业人员一起核对。", "en": "A shared proton-pump-inhibitor class or acid-related wording does not support self-combining PROTONIX with another related product, alternating by day, converting by milligrams or substituting another form. The exact product, prior reactions, other medicines, evaluation plan and complete medicine list need professional review together." }, { "zh": "机制页面不能替代对长期不适、出血警讯、脱水、肝肾问题、营养状况或任何新症状的个人处理。出现急性或严重问题时，应优先使用当地紧急医疗支持，而不是依据本页自行开始、加量、停用或换药。", "en": "A mechanism page cannot replace personal management of persistent symptoms, bleeding warning signs, dehydration, liver/kidney concerns, nutritional status or any new concern. With an acute or serious problem, prioritise local urgent medical support rather than self-starting, increasing, stopping or switching from this page." } ], "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠公开标签（Clinical Pharmacology，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Protonix", "generic": "泮托拉唑", "dosageFormClass": "口服延迟释放片：20 mg、40 mg；另有延迟释放口服混悬液，属于不同产品形态（本档案所列）" }, "labelSource": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 PROTONIX（pantoprazole sodium）美国公开标签将其列为口服延迟释放片，并列示 20 mg、40 mg；同一标签还列有延迟释放口服混悬液。页面帮助读者把品牌、通用名、延迟释放这一剂型属性、每单位标示量、实际包装和目标市场一起核对；不据此生成个人片数、时间表、疗程、联用、转换或停药方案。", "history": "DailyMed 页面列示 PROTONIX 的 Initial U.S. approval: 2000，并将延迟释放片与延迟释放口服混悬液分别列示。相同通用名、同样写有“胃药”或包装上相近的 mg 数字，都不足以证明能够掰开、研碎、换剂型、互换或自行调整；均须回到手上准确产品的现行标签、处方和药师/医生核对。", "sourceDocuments": [ { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_49b7631ac5ba52a6", "label": "FDA：PROTONIX 美国 NDA 历史资料（20-987 片剂、22-020 延迟释放口服混悬液）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020s000_NameR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020987 / 022020", "approvalTimeline": [ { "date": "2000", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2000。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed: PROTONIX public label archive", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed: PROTONIX public label archive", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/protonix/", "en": "https://origindrug.com/en/drugs/protonix/" }, "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." ] }