{ "id": "mucosolvan-ambroxol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Mucosolvan", "generic": "盐酸氨溴索", "aliases": [ "沐舒坦", "氨溴索", "盐酸氨溴索", "Mucosolvan", "ambroxol", "ambroxol hydrochloride" ], "marketBrandNames": [ { "name": "沐舒坦® / Mucosolvan", "market": { "zh": "中国大陆：品牌名称线索", "en": "Mainland China: brand-name cue" }, "evidenceStatus": "dated_public_record", "note": { "zh": "来源为 Opella 企业品牌页，不是现行批准、医保或库存证明。", "en": "Opella corporate brand page, not proof of current authorisation, reimbursement or stock." }, "source": { "id": "src_63d4f08ebd7a762a", "label": "Opella China: Mucosolvan Chinese brand-name information", "url": "https://www.opella.com/our-countries/zh-cn", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "MUCOSOLVAN", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "30 mg 片剂与 75 mg 长效胶囊有不同登记号。", "en": "30 mg tablets and 75 mg prolonged-release capsules have separate registrations." }, "source": { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "MUCOSOLVAN LIQUID", "market": { "zh": "马来西亚", "en": "Malaysia" }, "evidenceStatus": "dated_public_record", "note": { "zh": "30 mg/5 mL；本次登记页列 100 mL 包装。", "en": "30 mg/5 mL; the checked register lists a 100 mL pack." }, "source": { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "沐舒坦®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_63d4f08ebd7a762a", "label": "Opella China: Mucosolvan Chinese brand-name information", "url": "https://www.opella.com/our-countries/zh-cn", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "新加坡片剂与长效胶囊记录、马来西亚口服液原件；中国品牌名称线索另列。", "dosageFormClass": "口服制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "首发年份待核验", "archiveSponsorText": "Opella Healthcare Singapore / DKSH Malaysia (market-specific)" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "沐舒坦", "氨溴索", "盐酸氨溴索", "Mucosolvan", "ambroxol" ], "excludedProductCues": [ "bromhexine", "溴己新", "Spasmo-Mucosolvan", "clenbuterol", "克仑特罗" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "my-mucosolvan-30mg-5ml-100ml", "marketCode": "MY", "labelVersion": { "zh": "马来西亚说明书 2022-08-09", "en": "Malaysian leaflet 9 August 2022" }, "dosageForm": { "zh": "口服液", "en": "Oral liquid" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "MAL19987339XC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含盐酸氨溴索 30 mg；100 mL/瓶", "en": "30 mg ambroxol hydrochloride per 5 mL; 100 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸氨溴索", "en": "ambroxol hydrochloride" }, "value": 30, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 毫升的成分含量", "en": "Active amount per 5 mL" } } ], "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": "mL/瓶", "en": "mL/bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "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": "包装照片暂不展示", "en": "Exact pack photograph not yet available" }, "summary": { "zh": "本页有马来西亚包装文字记录，未取得与该规格对应的准确官方照片；不以其他市场图片代替，也不凭外观判断真伪。", "en": "The Malaysian pack has a text record but no verified exact official photograph. Other-market images are not substituted; appearance cannot authenticate it." }, "source": { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "大字读口服液说明书：先看浓度，再看量具", "en": "Large-print liquid leaflet: concentration and measuring device" }, "summary": { "zh": "对应马来西亚 30 mg/5 mL 原件，不是中国说明书或个人用量表。", "en": "For the Malaysian 30 mg/5 mL original, not a Chinese leaflet or personal dose chart." }, "checks": [ { "zh": "30 mg/5 mL 表示每 5 毫升含 30 毫克；等于 6 mg/mL 只是浓度换算，不表示一次喝多少。", "en": "30 mg/5 mL equals 6 mg/mL as concentration only, not the amount to take." }, { "zh": "使用原包装随附量杯；家用勺子不能代替。肝肾问题、孕期或哺乳期先咨询医生或药师。", "en": "Use the supplied measuring cup, not a household spoon. Discuss liver/kidney problems, pregnancy or breastfeeding first." }, { "zh": "大量痰的呼吸疾病患者同时用抑制咳嗽的药，可能积痰；请把完整药单交给药师核对。", "en": "Cough suppressants can cause secretion accumulation in mucus-heavy respiratory disease; have the whole medicine list reviewed." }, { "zh": "出现新的皮肤或黏膜损伤应停用并立即就医；呼吸困难、面喉肿胀等严重过敏表现应立即急救。", "en": "Stop and seek immediate medical review for new skin/mucosal lesions; breathing difficulty or facial/throat swelling needs emergency care." } ], "source": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "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": "帮助黏痰变稀，不是所有咳嗽都用同一种药", "en": "Helps thin thick mucus; cough medicines differ" }, "summary": { "zh": "新加坡片剂记录的用途是帮助清除气道中的黏稠分泌物。", "en": "The Singapore tablet record describes clearing thick airway secretions." }, "checks": [ { "zh": "氨溴索有助于稀释黏液；“祛痰”和“抑制咳嗽反射”不是同一件事。", "en": "Ambroxol helps thin mucus; clearing mucus and suppressing the cough reflex are not the same task." }, { "zh": "该记录要求片剂整片吞服；30 mg 是每片含量，不是每个人都通用的服药指令。", "en": "The record instructs swallowing tablets whole; 30 mg is per-tablet strength, not universal dosing advice." }, { "zh": "症状加重或 4–5 天仍不改善应咨询医生；不足 2 岁儿童不要自行套用成人产品。", "en": "Consult a doctor if symptoms worsen or fail to improve after 4–5 days. Do not extrapolate adult products to children under two." } ], "source": { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "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": "Mucosolvan", "generic": "盐酸氨溴索", "dosageFormClass": "口服制剂" }, "labelSource": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "马来西亚药监 NPRA QUEST3+", "en": "Malaysia NPRA QUEST3+" }, "market": { "zh": "马来西亚", "en": "Malaysia" }, "recordType": { "zh": "监管产品登记或公开患者说明书", "en": "Regulatory product register or public patient 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_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "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_3cd64e4993990595", "label": "Singapore NDF: MUCOSOLVAN 24 HOURS CAPSULE 75MG, SIN13373P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin13373p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "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_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "马来西亚药监 NPRA QUEST3+", "en": "Malaysia NPRA QUEST3+" }, "market": { "zh": "马来西亚", "en": "Malaysia" }, "recordType": { "zh": "监管产品登记或公开患者说明书", "en": "Regulatory product register or public patient 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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "马来西亚药监 NPRA QUEST3+", "en": "Malaysia NPRA QUEST3+" }, "market": { "zh": "马来西亚", "en": "Malaysia" }, "recordType": { "zh": "监管产品登记或公开患者说明书", "en": "Regulatory product register or public patient 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": "沐舒坦的成分是氨溴索，用于帮助稀释黏痰。先看清是片剂、口服液还是长效胶囊，再核对每片或每毫升的含量。不同剂型不能只按数字自行换算服用。", "history": "本档案保留 2015 年有日期安全通报、2022 年马来西亚说明书与 2026 年新加坡产品记录。这些是文件日期，不是全球上市年份；中国现行批准号仍待独立核验。", "sourceDocuments": [ { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_3cd64e4993990595", "label": "Singapore NDF: MUCOSOLVAN 24 HOURS CAPSULE 75MG, SIN13373P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin13373p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_63d4f08ebd7a762a", "label": "Opella China: Mucosolvan Chinese brand-name information", "url": "https://www.opella.com/our-countries/zh-cn", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_08899bde40ddf372", "label": "Hong Kong Drug Office, 2015-01-13: EMA PRAC review of ambroxol/bromhexine allergy and severe skin reactions", "url": "https://www.drugoffice.gov.hk/eps/news/showNews/European%2BUnion%3A%2BPRAC%2Bconsiders%2Brisk%2Bof%2Bsevere%2Ballergic%2Breactions%2Bwith%2Bambroxol-%2Band%2Bbromhexine-containing%2Bmedicines%2Bto%2Bbe%2Bsmall/consumer/2015-01-13/en/24251.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "HK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "SG SIN02696P; SG SIN13373P; MY MAL19987339XC", "approvalTimeline": [ { "date": "2015-01-13", "title": { "zh": "药物警戒：严重过敏与皮肤反应", "en": "Safety: severe allergy and skin reactions" }, "detail": { "zh": "香港药物办公室转述 EMA PRAC 的类别安全审查，建议更新说明书。此为历史安全通报，不是当前沐舒坦召回或停产通知。", "en": "Hong Kong Drug Office relayed the EMA PRAC class review recommending label updates. This dated warning is not a current Mucosolvan recall or discontinuation." }, "source": { "id": "src_08899bde40ddf372", "label": "Hong Kong Drug Office, 2015-01-13: EMA PRAC review of ambroxol/bromhexine allergy and severe skin reactions", "url": "https://www.drugoffice.gov.hk/eps/news/showNews/European%2BUnion%3A%2BPRAC%2Bconsiders%2Brisk%2Bof%2Bsevere%2Ballergic%2Breactions%2Bwith%2Bambroxol-%2Band%2Bbromhexine-containing%2Bmedicines%2Bto%2Bbe%2Bsmall/consumer/2015-01-13/en/24251.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "HK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2022-08-09", "title": { "zh": "马来西亚口服液说明书修订", "en": "Malaysian liquid leaflet revision" }, "detail": { "zh": "三页英文原件，登记号 MAL19987339XC。", "en": "Three-page English original, MAL19987339XC." }, "source": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2026-07-28", "title": { "zh": "新加坡产品记录更新", "en": "Singapore product record update" }, "detail": { "zh": "NDF 提供产品与说明书节选，不冒充完整患者说明书。", "en": "NDF provides product information and leaflet excerpts, not a complete patient leaflet." }, "source": { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "两种口服剂型记录已核对", "en": "Two oral-form records checked" }, "detail": { "zh": "片剂 SIN02696P；75 mg 长效胶囊 SIN13373P。当地持有人为 Opella Healthcare Singapore；不套用其他市场销售分类。", "en": "Tablet SIN02696P; 75 mg prolonged-release capsule SIN13373P. Local holder: Opella Healthcare Singapore; supply classifications are market-specific." } }, { "market": { "zh": "马来西亚", "en": "Malaysia" }, "status": { "zh": "口服液登记与原件已核对", "en": "Liquid register and original checked" }, "detail": { "zh": "登记页列 DKSH Malaysia 持有、Delpharm Reims 制造及 100 mL 包装；登记不等于实时库存。", "en": "Register: DKSH Malaysia holder, Delpharm Reims manufacturer and 100 mL pack; registration is not live stock." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "品牌名称已核；现行批准原件待补", "en": "Brand name checked; current approval original pending" }, "detail": { "zh": "不编造中国批准号、原研首发年份或中国药盒图片。", "en": "No Chinese authorisation number, first-launch year or pack image is invented." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "75 mg 长效胶囊能按总毫克换成片剂吗？", "en": "Can I convert the 75 mg long-acting capsule into tablets by milligrams?" }, "answer": { "zh": "不能自行换算。新加坡 SIN13373P 正文写 prolonged-release，剂型字段为 delayed release，且要求整粒吞服。它不是 SIN02696P 30 mg 片剂的简单倍数；由药师核对具体产品。", "en": "Do not self-convert. SIN13373P describes prolonged-release capsules, has a delayed-release form field, and instructs swallowing whole. It is not simply a multiple of the SIN02696P 30 mg tablet; check the exact products with a pharmacist." } }, { "question": { "zh": "瓶上 100 mL 是一次喝的量吗？", "en": "Does 100 mL on the bottle mean one dose?" }, "answer": { "zh": "不是。这是登记包装的总液体体积；一次用量需要同时核对浓度、量具和本人用法。", "en": "No. It is total pack volume. A dose also requires the concentration, measuring device and your own instructions." } }, { "question": { "zh": "溴己新和氨溴索是同一种药名吗？", "en": "Are bromhexine and ambroxol the same medicine name?" }, "answer": { "zh": "不是。虽然溴己新在体内主要转为氨溴索，两者仍是不同成分名称，不能据此自行等量替换或叠加。", "en": "No. Bromhexine is largely converted to ambroxol in the body, but these remain different ingredient identities, not permission for equal-dose substitution or combination." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dose-unit-literacy", "medicine-label-for-everyday-questions", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mucosolvan-ambroxol/", "en": "https://origindrug.com/en/drugs/mucosolvan-ambroxol/" }, "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." ] }