{ "id": "remeron", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "REMERON", "generic": "米氮平", "aliases": [ "REMERON", "REMERONSolTab", "mirtazapine", "米氮平", "mirtazapine orally disintegrating tablet" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国：DailyMed 当前 REMERON / REMERONSolTab 公开标签（Organon；SPL v8，2025-08-06 生效）分别列示 REMERON 15/30 mg 普通片瓶装及 REMERONSolTab 15/30/45 mg 口腔崩解片泡罩包装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "米氮平普通薄膜衣口服片与口腔崩解片（美国当前公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Organon LLC（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "other mirtazapine package", "其他米氮平包装", "other antidepressant", "其他抗抑郁药" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-remeron-mirtazapine-tablet-15mg-ndc-78206-160-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERON 米氮平薄膜衣口服片", "en": "REMERON mirtazapine film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-160-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 15 mg；30 片瓶装", "en": "Mirtazapine 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-02.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形薄膜衣片；刻痕仅为准确产品外观线索，不是自行分片指示", "en": "oval film-coated tablet; scoring is an exact-product appearance clue, not a self-splitting instruction" }, "imprint": "MSD / T3Z", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeron-mirtazapine-tablet-30mg-ndc-78206-161-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERON 米氮平薄膜衣口服片", "en": "REMERON mirtazapine film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-161-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 30 mg；30 片瓶装", "en": "Mirtazapine 30 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-03.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红棕色", "en": "red-brown" }, "shape": { "zh": "椭圆形薄膜衣片；刻痕仅为准确产品外观线索，不是自行分片指示", "en": "oval film-coated tablet; scoring is an exact-product appearance clue, not a self-splitting instruction" }, "imprint": "MSD / T5Z", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeronsoltab-mirtazapine-odt-15mg-ndc-78206-156-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERONSolTab 米氮平口腔崩解片", "en": "REMERONSolTab mirtazapine orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-156-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 15 mg；30 片泡罩包装纸盒", "en": "Mirtazapine 15 mg per tablet; 30-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-04.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩包装纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形口腔崩解片；标签明确不可掰开、咀嚼或压碎", "en": "round orally disintegrating tablet; the label says not to split, chew or crush" }, "imprint": "15", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeronsoltab-mirtazapine-odt-30mg-ndc-78206-158-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERONSolTab 米氮平口腔崩解片", "en": "REMERONSolTab mirtazapine orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-158-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 30 mg；30 片泡罩包装纸盒", "en": "Mirtazapine 30 mg per tablet; 30-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-05.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩包装纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形口腔崩解片；标签明确不可掰开、咀嚼或压碎", "en": "round orally disintegrating tablet; the label says not to split, chew or crush" }, "imprint": "30", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeronsoltab-mirtazapine-odt-45mg-ndc-78206-159-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERONSolTab 米氮平口腔崩解片", "en": "REMERONSolTab mirtazapine orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-159-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 45 mg；30 片泡罩包装纸盒", "en": "Mirtazapine 45 mg per tablet; 30-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-06.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 45, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩包装纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形口腔崩解片；标签明确不可掰开、咀嚼或压碎", "en": "round orally disintegrating tablet; the label says not to split, chew or crush" }, "imprint": "45", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-remeron-mirtazapine-tablet-15mg-ndc-78206-160-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-02.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "alt": "REMERON 米氮平 15 mg、NDC 78206-160-01、30 片瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v8（2025-08-06 生效）", "presentation": "REMERON 米氮平：每片 15 mg，NDC 78206-160-01，30 片瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 REMERON、米氮平 15 mg、NDC 78206-160-01 与 30 片瓶装。它只帮助核对品牌、通用名、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表 REMERONSolTab、其他米氮平包装、其他精神健康相关产品、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的片数、停用、联用、换药或分片方案。", "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "REMERON／REMERONSolTab 说明书放大阅读：先分清普通片和口腔崩解片", "en": "REMERON / REMERONSolTab label reading: distinguish regular tablets from orally disintegrating tablets first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 REMERON、REMERONSolTab、米氮平、准确剂型、每片标示量、NDC、包装、外形与警示。它不提供个人片数、用药时间、停用、联用、换药、分片或购买方案。", "en": "This module reads only REMERON, REMERONSolTab, mirtazapine, the exact dosage form, labelled amount per tablet, NDC, package, appearance and warnings in the current U.S. DailyMed label. It provides no individual tablet count, timing, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "先将 REMERON 或 REMERONSolTab、米氮平、普通片或口腔崩解片、每片 mg、实际 NDC、包装及目标市场一起核对。共同成分或相同 mg 数字不能建立自行互换、叠加、轮换或按比例换算。", "en": "Check REMERON or REMERONSolTab, mirtazapine, regular tablet or orally disintegrating tablet, milligrams per tablet, actual NDC, package and target market together. A shared ingredient or matching milligram number does not establish self-switching, combining, alternating or proportional conversion." }, { "zh": "当前标签所示 REMERON 普通片有刻痕；刻痕是这款准确普通片的外观线索，不是网页对任何人的分片、减量或转换许可。", "en": "The displayed REMERON regular tablets are scored. A score is an appearance clue for this exact regular tablet, not webpage permission for anyone to split, reduce or convert." }, { "zh": "当前标签对 REMERONSolTab 口腔崩解片明确写有不要掰开、咀嚼或压碎。该句话只适用于所引准确标签产品；也不应反过来把任何普通片、其他口崩片或其他药物当作可按同一方式处理。", "en": "The current label explicitly says not to split, chew or crush REMERONSolTab orally disintegrating tablets. This wording applies only to the exact cited label product; it also cannot be reversed into a rule for any regular tablet, another ODT or another medicine." }, { "zh": "标签对自杀意念或行为、血清素综合征、低钠、嗜睡和其他警示提供阅读入口。出现新的或加重的自伤/自杀想法、意识改变、呼吸困难、晕厥或其他急性令人担心的问题时，应优先使用当地紧急医疗支持；不要依据网页自行骤停、补用、加量或换成另一种产品。", "en": "The label provides reading entry points for suicidal thoughts or behaviours, serotonin syndrome, low sodium, somnolence and other warnings. With new or worsening thoughts of self-harm or suicide, mental-status change, breathing difficulty, fainting or another acute worrying problem, prioritise local urgent medical support; do not abruptly stop, make up, increase or change to another product from this webpage." } ], "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Warnings, Precautions and Patient Counseling；Organon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "机制阅读：标签所述中枢 α2 受体相关药理，不是个人用药决策", "en": "Mechanism reading: central alpha-2-related pharmacology in the label is not a personal medication decision" }, "summary": { "zh": "当前标签说明米氮平用于重性抑郁障碍的作用机制尚不清楚，并描述其可能与中枢突触前 α2 肾上腺素能抑制性自身受体/异受体拮抗及去甲肾上腺素能、血清素能活性有关。这帮助理解标签术语；不回答个人诊断、是否应使用、如何与其他精神健康相关药物衔接、联用、调整或停用。", "en": "The current label says mirtazapine's mechanism for major depressive disorder is unclear and describes possible involvement of antagonism at central presynaptic alpha-2 adrenergic inhibitory autoreceptors and heteroreceptors with enhanced noradrenergic and serotonergic activity. This helps explain label terms; it does not answer an individual diagnosis, whether to use it, how to relate it to another mental-health medicine, co-use, adjustment or stopping." }, "checks": [ { "zh": "机制术语不能把 REMERON、REMERONSolTab 或另一种精神健康相关药物变成可自行选择、叠加、交替、换算或替代的产品。准确包装、现行标签和完整药单都需要专业人员一起核对。", "en": "Mechanism terms cannot turn REMERON, REMERONSolTab or another mental-health medicine into products that can be self-selected, combined, alternated, converted or substituted. The exact pack, current label and complete medicine list need professional review together." }, { "zh": "机制页不能解释个人的情绪、睡眠、食欲、眩晕或其他症状原因，也不能替代对既往反应、合并疾病、检查资料、酒精/非处方产品和完整药单的临床核对。", "en": "A mechanism page cannot explain the cause of an individual's mood, sleep, appetite, dizziness or another symptom, nor replace clinical review of prior reactions, coexisting conditions, test information, alcohol/OTC products and the complete medicine list." }, { "zh": "对任何急性安全担忧，尤其出现自伤/自杀想法、意识改变、呼吸困难、晕厥或严重不适时，应走当地紧急医疗渠道；不要靠包装、mg 或机制文字自行变更产品。", "en": "For any acute safety concern, especially thoughts of self-harm or suicide, mental-status change, breathing difficulty, fainting or severe illness, use local urgent medical pathways; do not change a product yourself from packaging, milligrams or mechanism wording." } ], "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Clinical Pharmacology；Organon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "REMERON", "generic": "米氮平", "dosageFormClass": "米氮平普通薄膜衣口服片与口腔崩解片（美国当前公开标签所列）" }, "labelSource": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "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": "2026-08-25", "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": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 REMERON / REMERONSolTab（mirtazapine）美国公开标签分别列示普通薄膜衣口服片与口腔崩解片。普通片 15/30 mg 的展示包装与 ODT 15/30/45 mg 的展示泡罩包装是不同的准确产品身份；本页帮助读者核对名称、通用名、剂型、每片标示量、NDC、包装、公开电子说明书及药物警戒阅读路径，不把任何字段转成个人片数、停用、联用、换药、分片或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 1996，SPL v8 的 Effective Time 为 2025-08-06。普通片与 REMERONSolTab 即使通用名相同或 mg 数字相同，也须按准确剂型、包装和现行目标市场标签分别核对；不从共同成分推导自行互换、合并、轮换、压碎、咀嚼、掰开或停用。", "sourceDocuments": [ { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（REMERON；NDA 020415 / 021208）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020415；NDA 021208", "approvalTimeline": [ { "date": "1996", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 REMERON / REMERONSolTab 美国公开标签列示 Initial U.S. Approval: 1996。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current U.S. REMERON / REMERONSolTab public label lists Initial U.S. Approval: 1996. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2025-08-06", "title": { "zh": "当前 DailyMed SPL v8 生效日期", "en": "Current DailyMed SPL v8 effective date" }, "detail": { "zh": "DailyMed 当前 REMERON / REMERONSolTab 公开标签的 Effective Time 为 2025-08-06。本站分别展示两组普通片瓶装及三组口腔崩解片泡罩包装身份；不建立实际在售、库存、购买、个人片数、停用、联用、换药或其他市场状态。", "en": "The effective time of the current DailyMed REMERON / REMERONSolTab public label is 6 Aug 2025. This site separately displays two regular-tablet bottle identities and three ODT blister-pack identities; it does not establish actual availability, stock, purchase, individual tablet count, stopping, co-use, switching or another-market status." }, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签、两组普通片瓶装及三组口腔崩解片泡罩包装身份", "en": "Current public label, two regular-tablet bottle identities and three ODT blister-pack identities linked" }, "detail": { "zh": "本页分别记录 REMERON 15 mg、NDC 78206-160-01；30 mg、NDC 78206-161-01 的 30 片瓶装，以及 REMERONSolTab 15 mg、NDC 78206-156-01；30 mg、NDC 78206-158-01；45 mg、NDC 78206-159-01 的 30 片泡罩包装纸盒。它们只用于标签身份阅读，不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、停用、联用、换药或可替代性。", "en": "This page records REMERON 15 mg/NDC 78206-160-01 and 30 mg/NDC 78206-161-01 30-tablet bottles, plus REMERONSolTab 15 mg/NDC 78206-156-01, 30 mg/NDC 78206-158-01 and 45 mg/NDC 78206-159-01 30-tablet blister-pack cartons. They are for label-identity reading only; they do not authenticate a product or establish actual availability, stock, purchase, individual tablet count, stopping, co-use, switching or interchangeability." } }, { "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": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "普通片与口腔崩解片都写米氮平、也可能有相同 mg，能否自己互换？", "en": "Both regular tablets and ODTs say mirtazapine and may show the same mg. Can they be self-switched?" }, "answer": { "zh": "不能。普通片与口腔崩解片是这份标签中分别列出的准确产品形态；共同成分、相同 mg、刻痕、颜色、包装图或品牌家族均不建立自行互换、叠加、交替、掰开、压碎、咀嚼、停用或转换关系。请把实际包装、NDC、现行处方和完整药单交给药师或开方团队核对。", "en": "No. Regular tablets and orally disintegrating tablets are distinct exact product forms in this label. A shared ingredient, matching mg, score, colour, package image or brand family does not establish self-switching, combining, alternating, splitting, crushing, chewing, stopping or conversion. Have a pharmacist or prescribing team review the actual package, NDC, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面写出自杀意念、血清素综合征等警示，却不告诉我是否该停药？", "en": "Why does the page mention suicidal thoughts and serotonin syndrome without telling me whether to stop?" }, "answer": { "zh": "这些是当前美国标签中警示、注意事项和患者咨询段落的阅读入口，不是个体化风险判断或治疗决策。出现新的或加重的自伤/自杀想法、意识改变、呼吸困难、晕厥或其他急性令人担心的问题时，应优先使用当地紧急医疗支持；任何产品变更须由了解实际处方、病史和完整药单的专业人员核对。", "en": "These are reading entry points for warnings, precautions and patient-counselling sections in the current U.S. label, not an individual risk assessment or treatment decision. With new or worsening thoughts of self-harm or suicide, mental-status change, breathing difficulty, fainting or another acute worrying problem, prioritise local urgent medical support; any product change requires review by a professional who knows the actual prescription, history and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/remeron/", "en": "https://origindrug.com/en/drugs/remeron/" }, "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." ] }