{ "id": "linzess", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "LINZESS", "generic": "利那洛肽", "aliases": [ "Linzess", "linaclotide", "利那洛肽", "利那洛肽胶囊", "リンゼス", "リンゼス錠", "利那洛肽片", "リンゼス錠0.25mg", "NDA 202811", "0456-1203-30", "0456-1201-30", "0456-1202-30", "FL 72", "FL 145", "FL 290", "PMDA 2399017F1020" ], "marketBrandNames": [ { "name": "LINZESS", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 202811；72、145、290 mcg 胶囊均为处方 RLD，72 与 145 mcg 同时为 RS；当前 SPL 提供三个 30 粒瓶装面板。", "en": "NDA 202811; 72, 145 and 290 mcg capsules are prescription RLD products, with 72 and 145 mcg also listed as RS; the current SPL provides three 30-capsule bottle panels." }, "source": { "id": "src_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "Linzess Tablets 0.25 mg", "market": { "zh": "日本（官方日文名：リンゼス錠 0.25 mg）", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前记录为利那洛肽 0.25 mg 薄膜衣片；不是美国胶囊产品身份。", "en": "The current PMDA record is a linaclotide 0.25 mg film-coated tablet; it is not a U.S. capsule identity." }, "source": { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：DailyMed 当前 SPL v39 列出 LINZESS 72、145、290 mcg 口服胶囊及三个准确 30 粒瓶装面板；FDA Orange Book 将三个规格均列为处方 RLD，并将 72 与 145 mcg 列为 RS。日本：PMDA 当前记录为リンゼス錠 0.25 mg 薄膜衣片。胶囊、片剂、mcg、mg、适应症和当地文件必须分市场核对，不能只凭利那洛肽成分自行换算或替换。", "dosageFormClass": "美国为利那洛肽 72、145、290 mcg 口服胶囊；日本为利那洛肽 0.25 mg 薄膜衣口服片。美国标签允许在吞咽困难时按指定方法打开胶囊并使用一整粒的全部内容物，但不得咀嚼、压碎、目测分半或保存混合物", "dosageFormClassCode": "oral_solid", "route": "口服（跨市场准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2012-08-30（美国 FDA 初始批准）；2016-12-19（日本首次批准节点）", "archiveSponsorText": "AbbVie Inc.（FDA Orange Book 当前申请主体）；Allergan, Inc.（DailyMed 标签包装方）；アステラス製薬株式会社（日本 PMDA）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "generic linaclotide capsule", "其他厂牌利那洛肽胶囊", "plecanatide", "TRULANCE", "lubiprostone", "AMITIZA", "polyethylene glycol 3350", "MiraLAX", "lactulose", "senna", "bisacodyl" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-linzess-linaclotide-72mcg-30-capsule-bottle-ndc-0456120330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v39；2026-05-21 生效）", "en": "Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)" }, "dosageForm": { "zh": "LINZESS 利那洛肽口服胶囊", "en": "LINZESS linaclotide oral capsule" }, "route": { "zh": "口服（完整胶囊或标签明确的整粒内容物给药路径）", "en": "oral (whole capsule or the label-specified complete-contents route)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1203-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利那洛肽 72 mcg；30 粒瓶装", "en": "Linaclotide 72 mcg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-02.jpg&id=954190", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 72, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色不透明", "en": "white to off-white opaque" }, "shape": { "zh": "硬明胶胶囊；无刻痕；不得咀嚼或压碎", "en": "hard gelatin capsule; unscored; do not chew or crush" }, "imprint": "FL 72", "scoreStatus": "unscored_complete_contents_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-linzess-linaclotide-145mcg-30-capsule-bottle-ndc-0456120130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v39；2026-05-21 生效）", "en": "Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)" }, "dosageForm": { "zh": "LINZESS 利那洛肽口服胶囊", "en": "LINZESS linaclotide oral capsule" }, "route": { "zh": "口服（完整胶囊或标签明确的整粒内容物给药路径）", "en": "oral (whole capsule or the label-specified complete-contents route)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1201-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利那洛肽 145 mcg；30 粒瓶装", "en": "Linaclotide 145 mcg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-03.jpg&id=954190", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 145, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色不透明", "en": "white to off-white opaque" }, "shape": { "zh": "硬明胶胶囊；无刻痕；不得咀嚼或压碎", "en": "hard gelatin capsule; unscored; do not chew or crush" }, "imprint": "FL 145", "scoreStatus": "unscored_complete_contents_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-linzess-linaclotide-290mcg-30-capsule-bottle-ndc-0456120230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v39；2026-05-21 生效）", "en": "Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)" }, "dosageForm": { "zh": "LINZESS 利那洛肽口服胶囊", "en": "LINZESS linaclotide oral capsule" }, "route": { "zh": "口服（完整胶囊或标签明确的整粒内容物给药路径）", "en": "oral (whole capsule or the label-specified complete-contents route)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1202-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利那洛肽 290 mcg；30 粒瓶装", "en": "Linaclotide 290 mcg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-04.jpg&id=954190", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 290, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色不透明", "en": "white to off-white opaque" }, "shape": { "zh": "硬明胶胶囊；无刻痕；不得咀嚼或压碎", "en": "hard gelatin capsule; unscored; do not chew or crush" }, "imprint": "FL 290", "scoreStatus": "unscored_complete_contents_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-linzess-linaclotide-0-25mg-film-coated-tablet-pmda-2399017f1020", "marketCode": "JP", "labelVersion": { "zh": "日本 PMDA 当前产品页（2026-08-27 电子说明书入口）", "en": "Current Japan PMDA product page (electronic-label route dated 27 Aug 2026)" }, "dosageForm": { "zh": "リンゼス錠 0.25 mg 利那洛肽薄膜衣口服片", "en": "Linzess linaclotide 0.25 mg film-coated oral tablet" }, "route": { "zh": "口服（日本片剂产品身份字段）", "en": "oral (Japanese tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 2399017F1020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利那洛肽 0.25 mg；日本薄膜衣片", "en": "Linaclotide 0.25 mg per tablet; Japanese film-coated tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 0.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；0.25 mg 等于 250 mcg 只是单位换算，不是与美国胶囊互换的依据", "en": "labelled amount per tablet; 0.25 mg equals 250 mcg as unit conversion only, not as a basis for interchange with a U.S. capsule" } } ], "concentration": null, "container": { "typeCode": "package_not_established", "typeLabel": { "zh": "本轮未建立准确公开包装图", "en": "exact public package image not established in this review" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "包装数量须回到当前日本文件核对", "en": "pack count requires checking against the current Japanese document" } }, "physicalClues": { "color": { "zh": "须回到当前日本电子说明书核对", "en": "check the current Japanese electronic label" }, "shape": { "zh": "薄膜衣片，不是美国胶囊", "en": "film-coated tablet, not a U.S. capsule" }, "imprint": "not asserted", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-linzess-linaclotide-145mcg-30-capsule-bottle-ndc-0456120130", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-03.jpg&id=954190", "alt": "LINZESS 利那洛肽 145 mcg 每粒、30 粒、NDC 0456-1201-30 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前 SPL v39；2026-05-21 生效", "presentation": "LINZESS 利那洛肽胶囊，每粒 145 mcg，30 粒瓶装，NDC 0456-1201-30。", "notice": "此图只对应所引美国当前标签中的 145 mcg、30 粒瓶装；不代表 72 或 290 mcg、其他包装、日本 0.25 mg 片剂、其他厂牌、其他市场或实时库存。它不用于鉴定真伪，也不生成个人粒数、频率或疗程。", "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LINZESS 说明书放大阅读：mcg 不是粒数；可打开不等于可分半", "en": "LINZESS label reading: mcg is not a capsule count, and opening does not mean dividing" }, "summary": { "zh": "美国标签首先建议整粒吞服。吞咽困难时可以按标签指定方法打开胶囊，把一整粒的全部内容物用于苹果酱或水的路径；不得咀嚼、压碎、目测分半或把混合物留到以后。网页只解释标签边界，不替个人选择规格、频率或疗程。", "en": "The U.S. label first states to swallow the capsule whole. For swallowing difficulty, it describes opening the capsule and using the complete contents of one capsule through specified applesauce or water routes. Do not chew, crush, visually divide or store a mixture for later. The site explains label boundaries but does not choose an individual strength, frequency or duration." }, "checks": [ { "zh": "72、145、290 mcg 是每粒胶囊的标签标示量；30 是瓶内粒数。mcg（微克）不是 mg（毫克），1 mg 等于 1,000 mcg。单位换算不能替个人决定吃几粒、是否换规格或补服。", "en": "72, 145 and 290 mcg are labelled amounts per capsule, while 30 is the bottle count. A microgram (mcg) is not a milligram (mg): 1 mg equals 1,000 mcg. Unit conversion cannot decide an individual's capsule count, strength change or make-up use." }, { "zh": "标签允许的不是‘倒一半’：若按吞咽困难路径打开胶囊，必须使用一整粒的全部内容物，并按标签规定立即使用；不能咀嚼或压碎药珠，也不能凭眼睛把药珠分成两份。", "en": "The label does not permit ‘pouring out half’. If the capsule is opened through the swallowing-difficulty route, the complete contents of one capsule are used and administered immediately as specified. Do not chew or crush the beads or split them visually into portions." }, { "zh": "严重腹泻可导致脱水。明显口渴、少尿、头晕、乏力、晕厥或意识变化，尤其在老人、儿童或同时使用利尿药等情况下，需要尽快联系专业人员；严重时使用当地急救服务。", "en": "Severe diarrhoea can cause dehydration. Marked thirst, reduced urination, dizziness, weakness, fainting or mental-status change needs prompt professional help, particularly in an older person, child or someone also using a diuretic; use local emergency services when severe." }, { "zh": "已知或疑似机械性胃肠道梗阻是美国标签禁忌。持续严重腹痛、明显腹胀、反复呕吐或不能排气排便不能只当作普通便秘继续自行加药。", "en": "Known or suspected mechanical gastrointestinal obstruction is a U.S. label contraindication. Persistent severe pain, marked distension, repeated vomiting or inability to pass gas or stool must not be treated as ordinary constipation by simply adding more medicine." }, { "zh": "美国标签对 2 岁以下儿童有严重脱水黑框警告并列为禁忌。网页不会由年龄、体重或症状生成儿童用法；涉及儿童必须核对当前当地标签与负责治疗的专业人员。", "en": "The U.S. label has a boxed warning for serious dehydration and a contraindication in children under 2 years. The site does not generate paediatric use from age, weight or symptoms; current local labelling and the treating professional are required." }, { "zh": "MiraLAX、乳果糖、比沙可啶、番泻叶、镁盐、其他处方便秘药和所谓清肠产品不是同一种产品。不要因都用于排便问题就自行叠加、轮换、错开或停止；老人应把处方药、非处方药、补充剂和实际排便变化放进同一张药单核对。", "en": "MiraLAX, lactulose, bisacodyl, senna, magnesium salts, other prescription constipation medicines and bowel-cleansing products are not one product. A shared bowel-related use does not permit self-combination, alternation, time-separation or stopping. Older adults should review prescriptions, OTC products, supplements and actual bowel changes together." } ], "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利那洛肽怎样起作用：在肠腔表面激活 GC-C，不等于所有便秘都相同", "en": "How linaclotide works: luminal GC-C activation does not make all constipation the same" }, "summary": { "zh": "美国标签把利那洛肽描述为鸟苷酸环化酶 C（GC-C）激动剂，在肠上皮腔面局部作用，增加 cGMP，并促进氯离子、碳酸氢根和肠腔液体分泌、加快转运。机制解释产品作用环节，但不能诊断便秘原因、排除梗阻或决定某位老人应选哪个规格。", "en": "The U.S. label describes linaclotide as a guanylate cyclase-C (GC-C) agonist acting locally on the luminal surface of intestinal epithelium, increasing cGMP and promoting chloride, bicarbonate and intestinal-fluid secretion with faster transit. This explains an action pathway but cannot diagnose constipation, exclude obstruction or choose a strength for an older person." }, "checks": [ { "zh": "利那洛肽与聚乙二醇 3350、乳果糖、刺激性泻药或软便剂的作用方式不同。‘都是通便药’不表示可以按微克、毫克、克或起效快慢自行换算。", "en": "Linaclotide works differently from polyethylene glycol 3350, lactulose, stimulant laxatives or stool softeners. ‘All constipation medicines’ does not permit self-conversion by micrograms, milligrams, grams or perceived speed." }, { "zh": "美国 72/145/290 mcg 胶囊和日本 0.25 mg 片剂虽含同一成分，但剂型、规格、标签适应症和给药说明不同。0.25 mg 等于 250 mcg 的算术事实不能建立可替代性。", "en": "U.S. 72/145/290 mcg capsules and the Japanese 0.25 mg tablet share an ingredient but differ in dosage form, strength, labelled indications and administration instructions. The arithmetic fact that 0.25 mg equals 250 mcg does not establish interchangeability." }, { "zh": "全基因筛查不是本站为便秘药选择设定的通用前提。实际核对更需要准确症状与诊断、梗阻警示、年龄、脱水和跌倒风险、肾脏与心血管情况、全部药物及既往反应。", "en": "Whole-genome screening is not a universal prerequisite set by this site for constipation-medicine choice. Review more directly needs the exact symptoms and diagnosis, obstruction warnings, age, dehydration and fall risk, kidney and cardiovascular context, all medicines and prior responses." } ], "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LINZESS", "generic": "利那洛肽", "dosageFormClass": "美国为利那洛肽 72、145、290 mcg 口服胶囊；日本为利那洛肽 0.25 mg 薄膜衣口服片。美国标签允许在吞咽困难时按指定方法打开胶囊并使用一整粒的全部内容物，但不得咀嚼、压碎、目测分半或保存混合物" }, "labelSource": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "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_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "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": "2026-08-29", "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": "LINZESS 是利那洛肽的跨市场品牌档案。普通人先看三件事：美国 72、145、290 mcg 是每粒胶囊的标示量，不是一次吃几粒；吞咽困难时，美国标签允许打开胶囊，但必须按标签路径使用一整粒的全部内容物，不能倒一半；日本リンゼス是 0.25 mg 片剂，0.25 mg 等于 250 mcg 只是单位换算，不代表能替换美国胶囊。严重腹泻、脱水迹象、疑似肠梗阻或多种通便药同用需要优先核对。", "history": "FDA 资料将 LINZESS NDA 202811 的初始批准日期列为 2012-08-30；72 mcg 产品于 2017-01-25 批准。DailyMed 当前 SPL v39 于 2026-05-21 生效，并保留三种 30 粒瓶装面板。PMDA 当前产品页列示リンゼス錠 0.25 mg、电子说明书和患者资料入口。页面把文件版本、产品身份和市场分开，不把批准史写成实时供应。", "sourceDocuments": [ { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_cc83a70818622b1c", "label": "FDA：LINZESS NDA 202811/S-022 补充批准信（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202811Orig1s022ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_a621e5729cd27f86", "label": "FDA：LINZESS NDA 202811 原始申请公开审评资料（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 202811（LINZESS / linaclotide capsules）", "approvalTimeline": [ { "date": "2012-08-30", "title": { "zh": "FDA 初始批准 LINZESS", "en": "FDA initially approved LINZESS" }, "detail": { "zh": "FDA 公开资料把 145 与 290 mcg 胶囊和 NDA 202811 相连。该日期不表示当前个人应使用任何规格。", "en": "FDA public records link 145 and 290 mcg capsules to NDA 202811. The date does not indicate that any current individual should use a strength." }, "source": { "id": "src_a621e5729cd27f86", "label": "FDA：LINZESS NDA 202811 原始申请公开审评资料（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2017-01-25", "title": { "zh": "美国 72 mcg 产品批准节点", "en": "U.S. 72 mcg product approval node" }, "detail": { "zh": "当前 Orange Book 将 72 mcg 列为产品 003、RLD 与 RS。", "en": "The current Orange Book lists 72 mcg as product 003, RLD and RS." }, "source": { "id": "src_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-05-21", "title": { "zh": "DailyMed 当前 SPL v39 生效", "en": "Current DailyMed SPL v39 effective" }, "detail": { "zh": "当前标签提供三种胶囊、三个 30 粒瓶装面板、吞咽困难路径、黑框警告、腹泻和机制信息。", "en": "The current label provides three capsules, three 30-capsule bottle panels, swallowing-difficulty routes, boxed warning, diarrhoea and mechanism information." }, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-27", "title": { "zh": "PMDA 日本产品资料更新入口", "en": "Japan PMDA product-information update route" }, "detail": { "zh": "PMDA 当前页列示リンゼス錠 0.25 mg、电子说明书和患者资料；日本片剂与美国胶囊分开呈现。", "en": "The current PMDA page lists Linzess 0.25 mg tablets, electronic labelling and patient information; the Japanese tablet is kept separate from U.S. capsules." }, "source": { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 胶囊；72 与 145 mcg 为 RS", "en": "Current prescription RLD capsules; 72 and 145 mcg are RS" }, "detail": { "zh": "三个 30 粒瓶装面板已逐项建立。监管和包装记录不证明实时库存、购买资格、个人适用性或与其他产品可替代。", "en": "Three 30-capsule bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "PMDA 当前 0.25 mg 薄膜衣片记录", "en": "Current PMDA 0.25 mg film-coated tablet record" }, "detail": { "zh": "本轮建立来源文字身份和官方电子说明书入口，未展示未经核对的包装图；不得用美国胶囊替代推断日本片剂。", "en": "This review establishes a source-text identity and official electronic-label route without showing an unverified package image; the U.S. capsule must not be used to infer the Japanese tablet." } }, { "market": { "zh": "中国大陆、欧盟及其他市场", "en": "Mainland China, EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国或日本名称、同一成分或单位换算推定当地批准、剂型、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, dosage form, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. or Japanese names, a shared ingredient or unit conversion." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "145 mcg 胶囊能打开倒一半，当成较小规格吗？", "en": "Can a 145 mcg capsule be opened and half used as a smaller strength?" }, "answer": { "zh": "不能自行这样做。美国标签允许打开仅是吞咽困难给药路径，并要求使用一整粒的全部内容物、不得咀嚼或压碎，也没有把目测分药珠写成减量方法。需要调整时应核对准确处方和现有产品。", "en": "Do not do this yourself. The U.S. label permits opening only as a swallowing-difficulty administration route and uses the complete contents of one capsule without chewing or crushing. It does not describe visually dividing beads as dose reduction. Any adjustment requires review of the exact prescription and available product." } }, { "question": { "zh": "日本 0.25 mg 等于 250 mcg，能换成美国 145 或 290 mcg 胶囊吗？", "en": "Does Japanese 0.25 mg equal 250 mcg and permit switching to a U.S. 145 or 290 mcg capsule?" }, "answer": { "zh": "0.25 mg 等于 250 mcg 只是单位换算。日本产品是片剂，美国产品是胶囊，规格、说明书适应症、给药说明和监管身份不同；不能据此自行换药、拼粒或跨境替代。", "en": "0.25 mg equals 250 mcg as unit conversion only. The Japanese product is a tablet and the U.S. products are capsules, with different strengths, labelled indications, administration instructions and regulatory identities. This does not permit self-switching, capsule assembly or cross-border substitution." } }, { "question": { "zh": "已经用了其他通便药，可以再加 LINZESS 吗？", "en": "Can LINZESS be added to another constipation medicine?" }, "answer": { "zh": "网页不能仅凭用途决定。多种通便药可能叠加腹泻、脱水、电解质或跌倒风险；老人还可能同时使用利尿药、降压药或影响肠动力的药。请把所有处方药、非处方药和实际症状交给药师或开方团队核对。", "en": "The site cannot decide from purpose alone. Multiple bowel medicines may compound diarrhoea, dehydration, electrolyte or fall risk, and an older person may also use diuretics, blood-pressure medicines or medicines affecting gut motility. Have all prescriptions, OTC products and actual symptoms reviewed." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/linzess/", "en": "https://origindrug.com/en/drugs/linzess/" }, "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." ] }