{ "id": "razadyne-galantamine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "RAZADYNE / RAZADYNE ER", "generic": "氢溴酸加兰他敏", "aliases": [ "Razadyne", "Razadyne ER", "Reminyl", "galantamine", "galantamine hydrobromide", "加兰他敏", "氢溴酸加兰他敏", "加兰他敏缓释胶囊", "加兰他敏片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：RAZADYNE 普通片 NDA 021169、口服液 NDA 021224 与 RAZADYNE ER 缓释胶囊 NDA 021615 的历史品牌身份；六张准确历史包装面板；当前通用名安全标签作为补充语境。FDA 2025 审评资料说明三个品牌剂型均已不再销售，不能把仍可访问的旧标签写成当前供应。", "dosageFormClass": "历史品牌普通片 4/8/12 mg、缓释胶囊 8/16/24 mg；另有历史口服液申请，但本页尚未展示准确口服液包装面板", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（美国普通片最初营销记录；RAZADYNE ER 于 2004-12-24 开始营销）", "archiveSponsorText": "Janssen Pharmaceuticals, Inc.（历史美国品牌标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "RAZADYNE", "RAZADYNE ER", "Reminyl", "加兰他敏", "氢溴酸加兰他敏" ], "excludedProductCues": [ "donepezil", "Aricept", "rivastigmine", "Exelon", "memantine", "Namenda", "Namzaric" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-razadyne-galantamine-er-capsule-8mg-30-count-ndc-5045838730", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE ER 氢溴酸加兰他敏缓释胶囊", "en": "RAZADYNE ER galantamine hydrobromide extended-release capsule" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-387-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于加兰他敏 8 mg（以氢溴酸加兰他敏 10.25 mg 提供）；30 粒瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 8 mg per capsule (supplied as galantamine hydrobromide 10.25 mg); 30-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-14.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 8, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、换算或重新开始指令", "en": "labelled amount per capsule; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-05-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊，约 14 mm，无刻痕", "en": "hard-gelatin capsule, approximately 14 mm, unscored" }, "imprint": "GAL;8", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-er-capsule-16mg-30-count-ndc-5045838830", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE ER 氢溴酸加兰他敏缓释胶囊", "en": "RAZADYNE ER galantamine hydrobromide extended-release capsule" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-388-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于加兰他敏 16 mg（以氢溴酸加兰他敏 20.51 mg 提供）；30 粒瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 16 mg per capsule (supplied as galantamine hydrobromide 20.51 mg); 30-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-15.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 16, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、换算或重新开始指令", "en": "labelled amount per capsule; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-04-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色不透明", "en": "pink opaque" }, "shape": { "zh": "硬明胶胶囊，约 18 mm，无刻痕", "en": "hard-gelatin capsule, approximately 18 mm, unscored" }, "imprint": "GAL;16", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-er-capsule-24mg-30-count-ndc-5045838930", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE ER 氢溴酸加兰他敏缓释胶囊", "en": "RAZADYNE ER galantamine hydrobromide extended-release capsule" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-389-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于加兰他敏 24 mg（以氢溴酸加兰他敏 30.76 mg 提供）；30 粒瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 24 mg per capsule (supplied as galantamine hydrobromide 30.76 mg); 30-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-16.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 24, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、换算或重新开始指令", "en": "labelled amount per capsule; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-05-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "焦糖棕色不透明", "en": "caramel brown opaque" }, "shape": { "zh": "硬明胶胶囊，约 19 mm，无刻痕", "en": "hard-gelatin capsule, approximately 19 mm, unscored" }, "imprint": "GAL;24", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-tablet-4mg-60-count-ndc-5045839660", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE 氢溴酸加兰他敏薄膜衣普通片", "en": "RAZADYNE galantamine hydrobromide immediate-release film-coated tablet" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-396-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于加兰他敏 4 mg；60 片瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 4 mg per tablet; 60-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-17.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或重新开始指令", "en": "labelled amount per tablet; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2020-09-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "类白色", "en": "off-white" }, "shape": { "zh": "圆形双凸薄膜衣片，约 5 mm，无刻痕", "en": "round biconvex film-coated tablet, approximately 5 mm, unscored" }, "imprint": "JANSSEN;G;4", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-tablet-8mg-60-count-ndc-5045839760", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE 氢溴酸加兰他敏薄膜衣普通片", "en": "RAZADYNE galantamine hydrobromide immediate-release film-coated tablet" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-397-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于加兰他敏 8 mg；60 片瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 8 mg per tablet; 60-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-18.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或重新开始指令", "en": "labelled amount per tablet; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2020-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形双凸薄膜衣片，约 7 mm，无刻痕", "en": "round biconvex film-coated tablet, approximately 7 mm, unscored" }, "imprint": "JANSSEN;G;8", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-tablet-12mg-60-count-ndc-5045839860", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE 氢溴酸加兰他敏薄膜衣普通片", "en": "RAZADYNE galantamine hydrobromide immediate-release film-coated tablet" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-398-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于加兰他敏 12 mg；60 片瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 12 mg per tablet; 60-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-19.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 12, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或重新开始指令", "en": "labelled amount per tablet; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2020-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙棕色", "en": "orange-brown" }, "shape": { "zh": "圆形双凸薄膜衣片，约 8 mm，无刻痕", "en": "round biconvex film-coated tablet, approximately 8 mm, unscored" }, "imprint": "JANSSEN;G;12", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-razadyne-galantamine-er-capsule-16mg-30-count-ndc-5045838830", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-15.jpg&archiveid=673830", "alt": "RAZADYNE ER 加兰他敏 16 mg、NDC 50458-388-30、30 粒历史瓶装在 DailyMed 标签中的准确展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 历史品牌标签 SPL v25（2022-10-11 生效）；该 16 mg 包装营销结束日为 2023-04-30", "presentation": "RAZADYNE ER 每粒相当于加兰他敏 16 mg（氢溴酸盐 20.51 mg），粉红色 GAL 16 胶囊，30 粒瓶装。", "notice": "此图只对应一个已停止销售的美国历史品牌包装，用于核对品牌、剂型、每粒标示量、盐量、NDC 与瓶装数量；不用于鉴定真伪，不证明另一规格、普通片、口服液、当前库存、购买资格或可替代性。", "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RAZADYNE 说明书放大阅读：先分清普通片、口服液与 ER 缓释胶囊", "en": "RAZADYNE label reading: first separate immediate-release tablets, oral solution and ER capsules" }, "summary": { "zh": "历史品牌有三种口服剂型，当前美国通用名标签继续提供安全信息。这里把产品身份、包装数字、停用后重新开始、心率／晕厥、体重与胃肠反应放在一起阅读，但不生成个人剂量或换剂型方案。", "en": "The historical brand had three oral forms, while a current U.S. generic label continues to provide safety information. This section reads product identity, pack numbers, restarting after interruption, heart-rate/fainting, weight and gastrointestinal effects together, but generates no individual dose or formulation-switch plan." }, "checks": [ { "zh": "4、8、12 mg 普通片和 8、16、24 mg ER 缓释胶囊均按每片或每粒标示加兰他敏当量；瓶装 30 或 60 是包装数量，不是每天数量。标签中的氢溴酸盐质量与加兰他敏当量也不是两份药量。", "en": "The 4, 8 and 12 mg immediate-release tablets and 8, 16 and 24 mg ER capsules state galantamine equivalent per tablet or capsule. Bottle counts of 30 or 60 are pack quantities, not daily counts. Galantamine-hydrobromide mass and galantamine equivalent are not two medicine amounts." }, { "zh": "即使官方标签提供专业人员使用的普通片与 ER 转换信息，也不能据网页自己换剂型、拼接小规格或改变频次。ER 胶囊、普通片和口服液的释放方式、使用说明及包装身份不同。", "en": "Even though official labels contain clinician-directed conversion information between tablets and ER capsules, a webpage cannot authorise self-switching forms, assembling smaller strengths or changing frequency. ER capsules, immediate-release tablets and oral solution differ in release, instructions and product identity." }, { "zh": "当前通用名标签说明，中断超过三天后需要从最低剂量重新开始并再次逐步调整。这不是让患者自行重启的时间表：漏用多日、刚出院、呕吐脱水或照护交接后，应先联系开方团队或药师，不要直接恢复原来的服法。", "en": "The current generic label says interruption for more than three days requires restarting at the lowest dosage and re-titration. This is not a self-restart timetable: after several missed days, hospital discharge, vomiting/dehydration or a care transition, contact the prescriber or pharmacist before resuming the old routine." }, { "zh": "标签提示心动过缓与传导阻滞、晕厥、恶心呕吐腹泻、食欲下降和体重下降、胃肠出血、排尿梗阻、严重皮肤反应及哮喘／慢阻肺等风险。老人出现晕倒、跌倒、脉搏异常、持续呕吐腹泻、黑便／呕血、广泛皮疹起疱、呼吸困难或明显脱水，应及时寻求当地医疗帮助；严重急性表现使用急救。", "en": "The label describes bradycardia and heart block, syncope, nausea/vomiting/diarrhoea, reduced appetite and weight, gastrointestinal bleeding, urinary obstruction, serious skin reactions and concerns in asthma/COPD. In an older adult, fainting, falls, an abnormal pulse, persistent vomiting/diarrhoea, black stool/vomiting blood, widespread blistering rash, breathing difficulty or marked dehydration needs prompt local medical care; severe acute features require emergency help." } ], "source": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "加兰他敏怎样起作用：可逆抑制乙酰胆碱酯酶，不会改变痴呆病程", "en": "How galantamine works: reversible acetylcholinesterase inhibition does not alter the course of dementia" }, "summary": { "zh": "标签将加兰他敏描述为竞争性、可逆性乙酰胆碱酯酶抑制剂，通过增加胆碱能功能解释其药理作用，同时明确没有证据证明它改变基础痴呆过程。机制不能替代诊断、获益评估或照护计划。", "en": "The label describes galantamine as a competitive, reversible acetylcholinesterase inhibitor that enhances cholinergic function, while stating there is no evidence that it alters the underlying dementing process. Mechanism cannot replace diagnosis, benefit assessment or a care plan." }, "checks": [ { "zh": "多奈哌齐、利斯的明和加兰他敏同属胆碱酯酶抑制相关治疗，但不是可以按 mg 自行换算、交替或叠加的同一种药；美金刚机制又不同。发现重复或准备更换时，应先核对完整药单和准确产品。", "en": "Donepezil, rivastigmine and galantamine are related cholinesterase-inhibitor treatments but are not one medicine that can be self-converted by milligrams, alternated or combined; memantine has another mechanism. Review the full medicine list and exact products before addressing duplication or a switch." }, { "zh": "抗胆碱药可能对抗加兰他敏作用；其他胆碱酯酶抑制剂、胆碱能激动剂及麻醉中的某些神经肌肉阻滞药也需优先核对。就医或手术前应主动展示完整药单，不要根据网页自己错开或停药。", "en": "Anticholinergic medicines may oppose galantamine, while other cholinesterase inhibitors, cholinergic agonists and some neuromuscular blockers used in anaesthesia require priority review. Show the complete medicine list before care or surgery; do not self-separate or stop medicines from the page." }, { "zh": "CYP2D6 遗传差异可影响暴露，但标签并未把全基因组筛查写成所有人的前置要求，也未要求仅凭慢代谢者身份自动改量。遗传信息、肾肝功能、耐受性和相互作用须由负责团队结合实际问题解释。", "en": "CYP2D6 genetic variation can affect exposure, but the label does not require whole-genome screening for everyone or automatic dose changes from poor-metaboliser status alone. Genetic information, kidney/liver function, tolerability and interactions require interpretation by the responsible team for the actual question." } ], "source": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RAZADYNE / RAZADYNE ER", "generic": "氢溴酸加兰他敏", "dosageFormClass": "历史品牌普通片 4/8/12 mg、缓释胶囊 8/16/24 mg；另有历史口服液申请，但本页尚未展示准确口服液包装面板" }, "labelSource": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "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": "2026-09-06", "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_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "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": "2026-09-06", "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_91dc773613047682", "label": "FDA：RAZADYNE ER NDA 021615 2015 美国处方信息", "url": "https://www.accessdata.fda.gov/Drugsatfda_docs/Label/2015/021615s021lbl.Pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "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": "2026-09-06", "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": "2026-09-06", "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": "RAZADYNE 是加兰他敏历史品牌，最初也曾使用 REMINYL 名称。普通片、口服液和 ER 缓释胶囊不是只看总毫克数就能自行换算的同一种包装。网页展示六个历史品牌瓶装，帮助核对每片／每粒 mg、盐与活性成分的关系、颜色、刻字和 NDC；当前安全阅读则参考仍在更新的通用名标签。品牌档案已停止销售，不代表当前库存或购买入口。", "history": "美国普通片历史记录从 2001 年开始，RAZADYNE ER 于 2004 年进入营销记录。DailyMed 历史标签保留了三种普通片和三种缓释胶囊包装。FDA 2025 年审评资料把片剂、口服液和缓释胶囊三个品牌申请均描述为不再销售，并指出当前仍有仿制产品；因此本页把历史品牌身份、当前通用名安全信息和实时供应严格分开。", "sourceDocuments": [ { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3099cb020f71fe2e", "label": "FDA：加兰他敏片 NDA 021169 与 RAZADYNE ER NDA 021615 的 RLD／RS 及停止销售状态（2025 Chemistry Review）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218549Orig1s000ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_review", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_4b96b8d5a4ed0441", "label": "FDA：RAZADYNE 品牌片剂、口服液和缓释胶囊的申请史与停止销售说明（2025 Medical Review）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218549Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_review", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_91dc773613047682", "label": "FDA：RAZADYNE ER NDA 021615 2015 美国处方信息", "url": "https://www.accessdata.fda.gov/Drugsatfda_docs/Label/2015/021615s021lbl.Pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } ], "applicationNumber": "NDA 021169（普通片）／NDA 021224（口服液）／NDA 021615（ER 缓释胶囊）；历史品牌申请均已停止销售", "approvalTimeline": [ { "date": "2001-03-01", "title": { "zh": "RAZADYNE 普通片美国历史营销起始记录", "en": "Historical U.S. marketing-start record for RAZADYNE tablets" }, "detail": { "zh": "DailyMed 的 4、8、12 mg 普通片产品表均记录 NDA 021169 与 2001-03-01；FDA 2025 审评资料说明品牌片剂现已不再销售。", "en": "DailyMed product tables for 4, 8 and 12 mg tablets list NDA 021169 and 1 Mar 2001; FDA's 2025 review says the brand tablets are no longer marketed." }, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2004-12-24", "title": { "zh": "RAZADYNE ER 美国历史营销起始记录", "en": "Historical U.S. marketing-start record for RAZADYNE ER" }, "detail": { "zh": "三种 ER 胶囊产品表均记录 NDA 021615 与 2004-12-24；品牌包装的营销结束日期分布在 2023-04 至 2023-05。", "en": "All three ER capsule product tables list NDA 021615 and 24 Dec 2004; brand-pack marketing end dates fall in Apr-May 2023." }, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2025", "title": { "zh": "FDA 审评资料确认品牌剂型停止销售与 RLD／RS 身份", "en": "FDA review confirms discontinued brand forms and RLD/RS identities" }, "detail": { "zh": "Chemistry Review 将 4/8/12 mg 片剂与 8/16/24 mg ER 胶囊列为 RLD／RS 并注明停止销售；Medical Review 还说明口服液品牌申请也不再销售。", "en": "The Chemistry Review lists the 4/8/12 mg tablets and 8/16/24 mg ER capsules as RLD/RS and discontinued; the Medical Review also says the brand oral-solution application is no longer marketed." }, "source": { "id": "src_3099cb020f71fe2e", "label": "FDA：加兰他敏片 NDA 021169 与 RAZADYNE ER NDA 021615 的 RLD／RS 及停止销售状态（2025 Chemistry Review）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218549Orig1s000ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_review", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌剂型已停止销售；当前存在通用名标签记录", "en": "Historical brand forms discontinued; current generic label records exist" }, "detail": { "zh": "本页展示六张历史品牌准确包装图，同时链接当前通用名安全标签；二者不能混写为当前品牌库存、购买资格或自动替代关系。", "en": "The page shows six exact historical brand pack images and separately links a current generic safety label. They do not establish current brand stock, purchase eligibility or automatic substitution." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立准确市场产品记录", "en": "Exact market-product records not established" }, "detail": { "zh": "不从美国 RAZADYNE／REMINYL 名称、NDA、颜色、刻字或共同通用名推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. RAZADYNE/REMINYL names, NDA, colour, imprint or shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RAZADYNE ER 16 mg 可以用两粒 8 mg 自行替代吗？", "en": "Can two RAZADYNE ER 8 mg capsules self-replace one 16 mg capsule?" }, "answer": { "zh": "不能由网页授权。数字相加不等于处方、包装、可获得性和个体安全性相同；漏用多日或要变更规格时，先让药师或开方团队核对准确产品和计划。", "en": "A webpage cannot authorise this. Arithmetic does not establish an equivalent prescription, pack, availability or individual safety. After missed days or before a strength change, ask the pharmacist or prescriber to review the exact product and plan." } }, { "question": { "zh": "为什么包装写 16 mg，又写氢溴酸盐 20.51 mg？", "en": "Why does the pack say 16 mg and also 20.51 mg hydrobromide?" }, "answer": { "zh": "16 mg 是每粒所含加兰他敏活性成分当量；20.51 mg 是提供该当量所需的氢溴酸加兰他敏盐质量。它们是同一粒药的两种成分表示，不是相加成 36.51 mg，也不是两份药。", "en": "16 mg is the galantamine active-moiety equivalent per capsule; 20.51 mg is the mass of galantamine hydrobromide salt supplying it. They are two expressions for the same capsule, not 36.51 mg in total and not two doses." } }, { "question": { "zh": "加兰他敏和多奈哌齐、美金刚可以自己一起用或互换吗？", "en": "Can galantamine be self-combined or switched with donepezil or memantine?" }, "answer": { "zh": "不能。药物机制、剂型、相互作用和个体情况不同；网页只提示药单核对，不提供合用、停用、换药或时间安排。请由熟悉病史和完整药单的专业人员判断。", "en": "No. Mechanisms, dosage forms, interactions and individual circumstances differ. The site only prompts medicine-list review and provides no combination, stopping, switching or timing plan. A professional familiar with the history and complete list should decide." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/razadyne-galantamine/", "en": "https://origindrug.com/en/drugs/razadyne-galantamine/" }, "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." ] }