{ "id": "forlax-macrogol-4000", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Forlax", "generic": "聚乙二醇4000", "aliases": [ "福松", "聚乙二醇4000散", "macrogol 4000", "polyethylene glycol 4000", "Forlax", "聚乙二醇4000" ], "marketBrandNames": [ { "name": "FORLAX 10 g", "market": { "zh": "法国", "en": "France" }, "evidenceStatus": "dated_public_record", "note": { "zh": "法国参比组 736 指定的品牌产品。", "en": "Named reference product in French group 736." }, "source": { "id": "src_d1233b10aa106eac", "label": "France public medicines database: macrogol 4000 10 g reference group 736; updated 2026-08-31", "url": "https://m.base-donnees-publique.medicaments.gouv.fr/groupe-generique-736", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "FORLAX", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "SIN12419P；10 g/袋。", "en": "SIN12419P; 10 g/sachet." }, "source": { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "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": "福松®", "market": { "zh": "中国大陆：历史名称线索", "en": "Mainland China: historical name cue" }, "evidenceStatus": "dated_public_record", "note": { "zh": "2020 年益普生公告；不是现行批准、医保或在售证明。", "en": "Ipsen release from 2020; not current authorisation, reimbursement or stock evidence." }, "source": { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "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" } } ], "mainlandChinaTradeNameCue": { "value": "福松®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "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": "消化系统", "sourceArchiveMarket": "法国 10 g 粉末说明书、新加坡记录及中国品牌历史；中国现行批准原件待核验。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（法国批准记录）", "archiveSponsorText": "Mayoly Pharma France" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "福松", "聚乙二醇4000", "聚乙二醇4000散", "Forlax", "macrogol 4000" ], "excludedProductCues": [ "macrogol 3350", "polyethylene glycol 3350", "聚乙二醇3350", "乳果糖", "lactulose" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "fr-forlax-macrogol4000-10g-20-sachets", "marketCode": "FR", "labelVersion": { "zh": "法国说明书 2026-02-20", "en": "French leaflet 20 February 2026" }, "dosageForm": { "zh": "冲配为口服溶液的粉末", "en": "Powder for oral solution" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "3400933899783", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋聚乙二醇4000 10 g；整袋粉末 10.167 g；20 袋/盒", "en": "10 g macrogol 4000 per sachet; 10.167 g total powder; 20 sachets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇4000", "en": "macrogol 4000" }, "value": 10, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋成分含量", "en": "Active amount per sachet" } } ], "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": "袋/盒", "en": "sachets/carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "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": "准确包装的官方照片仍待补齐", "en": "Exact official pack photograph still needed" }, "summary": { "zh": "不以海外其他规格或电商图片代替中国药盒；这张法国文字卡不能鉴定真伪。", "en": "Other strengths or retail pictures do not stand in for a Chinese pack; this French text card cannot authenticate a medicine." }, "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "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": "大字读法国说明书：含量与老人用药核对", "en": "Large-print French leaflet: strength and older-person checks" }, "summary": { "zh": "先分清成分、粉末总重与盒内袋数。以下是法国原件阅读要点。", "en": "Separate active amount, total powder mass and pack count. These points refer to the French original." }, "checks": [ { "zh": "10 g 是每袋成分含量；10.167 g 包含辅料；20 是盒内袋数。实际用几袋要核对本人处方与本地说明书。", "en": "10 g is active amount per sachet; 10.167 g includes excipients; 20 is pack count. Check your prescription and local leaflet for your dose." }, { "zh": "老人、肾肝功能问题或使用利尿药者若发生腹泻，要注意水分与电解质丢失，并联系医护人员。", "en": "Diarrhoea needs attention to fluid and electrolyte loss, particularly in older people or those with kidney/liver problems or diuretic use." }, { "zh": "可能暂时影响其他口服药吸收；把完整药单交给药师核对，不能仅凭错开时间判定安全。", "en": "Other oral medicines may be absorbed less well temporarily. Ask a pharmacist to review the full list; spacing alone does not establish safety." }, { "zh": "怀疑肠梗阻、肠穿孔或不明原因腹痛时不要自行用药；呼吸困难或面喉肿胀应立即急救。", "en": "Do not self-treat suspected obstruction, perforation or unexplained abdominal pain; breathing difficulty or face/throat swelling needs emergency help." } ], "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帮助粪便保留水分，不是立刻催便", "en": "Helps stools retain water; not an instant effect" }, "summary": { "zh": "这是一种渗透性泻剂：让粪便中的水分增加，帮助改善便秘。", "en": "This osmotic laxative increases water in stools to help constipation." }, "checks": [ { "zh": "新加坡原件写明：粉末用水溶解后口服，一般需 24–48 小时起效。不要因尚未起效自行加量。", "en": "The Singapore original describes powder dissolved in water, usually working in 24–48 hours. Do not increase your dose just because it has not worked yet." }, { "zh": "该市场适应证为成人及 8 岁起儿童的便秘；更小儿童不能套用这款 10 g 产品。", "en": "Its local indication covers constipation in adults and children from eight; this 10 g product must not be extrapolated to younger children." }, { "zh": "新加坡原件限制自行用药不超过两周；持续或加重应咨询医护人员，严重腹泻、呕吐需尽快就医。", "en": "Singapore limits self-medication to two weeks. Persistent or worsening symptoms need review; severe diarrhoea or vomiting needs prompt care." } ], "source": { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "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": "Forlax", "generic": "聚乙二醇4000", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and 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_d1233b10aa106eac", "label": "France public medicines database: macrogol 4000 10 g reference group 736; updated 2026-08-31", "url": "https://m.base-donnees-publique.medicaments.gouv.fr/groupe-generique-736", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and 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": "福松的通用名是聚乙二醇4000散。它用于便秘，帮助粪便保留水分。先核对所在市场、每袋含量和说明书；“10 g”不是每个人都适用的服药指令。", "history": "法国本产品批准日期为 1995-05-05。益普生 2020-08-18 企业公告记载福松（聚乙二醇4000散）在中国的合作历史；企业公告仅作为中文品牌线索，不代替现行药监批准原件。", "sourceDocuments": [ { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_d1233b10aa106eac", "label": "France public medicines database: macrogol 4000 10 g reference group 736; updated 2026-08-31", "url": "https://m.base-donnees-publique.medicaments.gouv.fr/groupe-generique-736", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "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_7e3d3c3985cb3695", "label": "MHRA Drug Safety Update, 2021-04-27: PEG laxatives and starch-based thickeners, aspiration risk", "url": "https://www.gov.uk/drug-safety-update/polyethylene-glycol-peg-laxatives-and-starch-based-thickeners-potential-interactive-effect-when-mixed-leading-to-an-increased-risk-of-aspiration", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "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" } ], "applicationNumber": "FR CIS 69298346; CIP 3400933899783; SG SIN12419P", "approvalTimeline": [ { "date": "1995-05-05", "title": { "zh": "法国批准记录", "en": "French authorisation record" }, "detail": { "zh": "这是该产品在法国的日期，不代表全球所有剂型的首发。", "en": "Product-specific French date, not a global first-launch claim for all forms." }, "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2020-08-18", "title": { "zh": "中国中文品牌历史线索", "en": "Chinese brand-history evidence" }, "detail": { "zh": "益普生发布福松与上药控股合作公告。", "en": "Ipsen announced a Forlax partnership with Shanghai Pharma." }, "source": { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "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" } }, { "date": "2021-04-27", "title": { "zh": "药物警戒：淀粉增稠剂与误吸风险", "en": "Safety: starch thickeners and aspiration risk" }, "detail": { "zh": "英国 MHRA 提示：PEG 泻剂不要直接混入淀粉增稠的液体，可能使其变稀、增加吞咽困难者误吸风险。这是类药物安全提示，不是本品召回。", "en": "MHRA warns against directly mixing PEG laxatives with starch-thickened liquids: thinning may increase aspiration risk in dysphagia. This is a class warning, not a Forlax recall." }, "source": { "id": "src_7e3d3c3985cb3695", "label": "MHRA Drug Safety Update, 2021-04-27: PEG laxatives and starch-based thickeners, aspiration risk", "url": "https://www.gov.uk/drug-safety-update/polyethylene-glycol-peg-laxatives-and-starch-based-thickeners-potential-interactive-effect-when-mixed-leading-to-an-increased-risk-of-aspiration", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "法国", "en": "France" }, "status": { "zh": "参比组与说明书已核对", "en": "Reference group and leaflet checked" }, "detail": { "zh": "本页展示 20 袋包装文字记录，不代表实时库存。", "en": "The 20-sachet text record is not live inventory." } }, { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "政府产品记录已核对", "en": "Government product record checked" }, "detail": { "zh": "持有人 DKSH Singapore；当地 GSL 分类不可直接套用中国。", "en": "Holder DKSH Singapore; local GSL classification does not establish Chinese supply status." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "现行批准与说明书待核验", "en": "Current authorisation and leaflet unverified" }, "detail": { "zh": "福松为历史品牌线索；本页未编造中国批准号或中国包装卡。", "en": "福松 is a historical brand cue; no Chinese authorisation number or pack is inferred." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "老人吃饭要用增稠剂，可以一起混吗？", "en": "Can a person using swallowing thickeners mix it in?" }, "answer": { "zh": "先让药师与吞咽照护人员核对增稠剂成分。淀粉增稠液遇 PEG 泻剂可能变稀，增加误吸风险；不要自行混配或据此调整液体稠度。见上方 2021 年 MHRA 原文。", "en": "Ask the pharmacist and swallowing-care team to check the thickener. PEG can thin starch-thickened liquids and increase aspiration risk. Do not improvise mixtures or thickness; see the dated MHRA source above." } }, { "question": { "zh": "聚乙二醇3350和4000是同一个包装吗？", "en": "Are PEG 3350 and 4000 the same presentation?" }, "answer": { "zh": "不能只凭“聚乙二醇”认定相同。请核完整成分、是否含电解质、剂型和本地说明书，再由药师判断具体产品关系。", "en": "Do not identify products by PEG alone. Check the full ingredient, electrolytes, form and local leaflet with a pharmacist." } }, { "question": { "zh": "参比药是否说明其他品牌都不能用？", "en": "Does reference status mean other brands cannot be used?" }, "answer": { "zh": "不是。法国参比组同时列有仿制产品，且部分辅料不同；身份与辅料信息不能单独替你决定换药。", "en": "No. The French group also lists generics, with some excipient differences. Identity and excipients alone do not decide a switch for you." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dose-unit-literacy", "medicine-label-for-everyday-questions", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/forlax-macrogol-4000/", "en": "https://origindrug.com/en/drugs/forlax-macrogol-4000/" }, "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." ] }