{ "id": "ativan-lorazepam", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "ATIVAN", "generic": "劳拉西泮片", "aliases": [ "Ativan", "lorazepam", "lorazepam tablets", "劳拉西泮", "劳拉西泮片", "罗拉", "NDA 017794", "ATIVAN", "0187-0063-01", "0187-0064-01", "0187-0065-01", "BPI 63", "BPI 64", "BPI 65" ], "marketBrandNames": [ { "name": "ATIVAN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 017794；当前标签列 0.5、1、2 mg 三个 100 片瓶装。监管标签不证明实时供应、可购买性或个人适用。", "en": "NDA 017794; the current label lists three 100-tablet bottles at 0.5, 1 and 2 mg. A regulatory label does not prove live supply, purchase availability or individual suitability." }, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 当前 ATIVAN 品牌标签列出 0.5 mg、1 mg、2 mg 三种口服片及各自 100 片瓶装面板，均属于 NDA 017794，并标示美国 C-IV。公开标签不等于其他国家批准、实时库存、购买资格或个人适用性。", "dosageFormClass": "ATIVAN 劳拉西泮普通口服片。0.5、1、2 mg 是每片标示量；100 Tablets 是整瓶数量。ATIVAN 注射剂、劳拉西泮口服浓缩液、LOREEV XR 缓释胶囊及其他苯二氮䓬类不是本档案的同一产品。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1977-09-30（FDA 审评资料所列美国初始批准日期）", "archiveSponsorText": "Bausch Health US LLC（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ATIVAN lorazepam", "lorazepam tablets", "劳拉西泮片" ], "excludedProductCues": [ "ATIVAN injection", "lorazepam injection", "LORazepam oral concentrate", "LOREEV XR", "diazepam", "VALIUM", "alprazolam", "XANAX", "clonazepam", "KLONOPIN" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ativan-lorazepam-tablet-0-5mg-100-bottle-ndc-0187006301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "en": "Current U.S. DailyMed brand label (label revised Jul 2025; SPL v24)" }, "dosageForm": { "zh": "ATIVAN 劳拉西泮普通口服片", "en": "ATIVAN lorazepam immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0063-01", "pouchCode": null, "applicationNumber": "NDA 017794", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片劳拉西泮 0.5 mg；100 片瓶装", "en": "Lorazepam 0.5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=a9d257a4-095d-49ff-9994-fab290d575d3-00.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "劳拉西泮", "en": "lorazepam" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、减量或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, taper or stop instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "五边形（盾形）", "en": "five-sided shield shape" }, "imprint": "A / BPI / 63", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ativan-lorazepam-tablet-1mg-100-bottle-ndc-0187006401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "en": "Current U.S. DailyMed brand label (label revised Jul 2025; SPL v24)" }, "dosageForm": { "zh": "ATIVAN 劳拉西泮普通口服片", "en": "ATIVAN lorazepam immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0064-01", "pouchCode": null, "applicationNumber": "NDA 017794", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片劳拉西泮 1 mg；100 片瓶装", "en": "Lorazepam 1 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "劳拉西泮", "en": "lorazepam" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、减量或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, taper or stop instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "五边形（盾形）", "en": "five-sided shield shape" }, "imprint": "A / BPI / 64", "scoreStatus": "scored_identity_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ativan-lorazepam-tablet-2mg-100-bottle-ndc-0187006501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "en": "Current U.S. DailyMed brand label (label revised Jul 2025; SPL v24)" }, "dosageForm": { "zh": "ATIVAN 劳拉西泮普通口服片", "en": "ATIVAN lorazepam immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0065-01", "pouchCode": null, "applicationNumber": "NDA 017794", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片劳拉西泮 2 mg；100 片瓶装", "en": "Lorazepam 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "劳拉西泮", "en": "lorazepam" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、减量或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, taper or stop instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "五边形（盾形）", "en": "five-sided shield shape" }, "imprint": "A / 2 / BPI / 65", "scoreStatus": "scored_identity_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ativan-lorazepam-tablet-1mg-100-bottle-ndc-0187006401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "alt": "ATIVAN 劳拉西泮 1 mg、NDC 0187-0064-01、100 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "presentation": "ATIVAN 劳拉西泮：每片 1 mg，NDC 0187-0064-01，100 片瓶装；白色盾形、有刻痕，A / BPI / 64。", "notice": "此图只对应所引美国 1 mg、NDC 0187-0064-01、100 片瓶装，不代表 0.5 mg、2 mg、其他剂型、其他市场、实时库存或个人适用性，不用于鉴定真伪，也不授权自行掰片、加减量或停药。", "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ATIVAN 说明书放大阅读：先看每片 mg、镇静叠加、老人跌倒与突然停用", "en": "ATIVAN enlarged label: mg per tablet, additive sedation, older-adult falls and abrupt withdrawal" }, "summary": { "zh": "0.5、1、2 mg 是每片劳拉西泮含量；100 Tablets 是整瓶片数。1 mg 与 2 mg 标签列有刻痕，但刻痕只是产品身份线索，不是自行掰片、减量或停药许可。说明书把阿片类合用、滥用/误用/成瘾、身体依赖与停药反应置于黑框警告。", "en": "The 0.5, 1 and 2 mg figures are lorazepam per tablet; 100 Tablets is the bottle count. The 1 mg and 2 mg labels describe scores, but a score is an identity clue, not permission to self-split, taper or stop. The boxed warning covers opioid co-use, abuse/misuse/addiction, physical dependence and withdrawal reactions." }, "checks": [ { "zh": "与阿片类止痛药合用可导致深度镇静、呼吸抑制、昏迷和死亡。若出现呼吸浅慢、叫不醒、意识明显异常，应立即联系当地急救；不要先在网页上寻找错开时间或自行减量方案。", "en": "Co-use with an opioid can cause profound sedation, respiratory depression, coma and death. Shallow or slow breathing, inability to awaken or marked altered awareness requires local emergency help; do not first seek a web spacing or self-reduction plan." }, { "zh": "酒精、其他苯二氮䓬类、安眠药、镇静抗组胺药、抗精神病药、部分抗抑郁药、抗惊厥药和麻醉药都可能叠加中枢抑制；品牌不同不等于可以轮换或叠加。", "en": "Alcohol, another benzodiazepine, a sleep medicine, sedating antihistamine, antipsychotic, some antidepressants, anticonvulsants and anaesthetics can add CNS depression. Different brands do not permit rotation or combination." }, { "zh": "持续使用可能形成身体依赖；突然停用或快速减量可引发危及生命的停药反应，包括癫痫发作。不要照抄网页或他人的减量表，应由负责治疗的专业人员制定个体化方案并随访。", "en": "Continued use can cause physical dependence; abrupt discontinuation or rapid reduction can trigger life-threatening withdrawal, including seizures. Do not copy a web or another person's taper; the treating professional must individualise and follow it." }, { "zh": "老年人的镇静和站立不稳发生率会增加，也可能出现更强敏感性；一堆药时应同时核对嗜睡、步态、跌倒、记忆、呼吸、肝肾功能和全部非处方药。网页不因年龄直接给出片数。", "en": "Sedation and unsteadiness increase with age and some older people may be more sensitive. With many medicines, review sleepiness, gait, falls, memory, breathing, liver/kidney status and all OTC products together. The site does not derive a tablet count from age." }, { "zh": "说明书列出丙戊酸与丙磺舒可改变劳拉西泮暴露，氯氮平合用可出现明显镇静、低血压、共济失调、谵妄甚至呼吸停止；这类相互作用必须交给医生或药师核对，不能自行错开解决。", "en": "The label states that valproate and probenecid can alter lorazepam exposure and that clozapine co-use can cause marked sedation, hypotension, ataxia, delirium and respiratory arrest. A clinician or pharmacist must review these interactions; self-spacing is not a solution." } ], "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：苯二氮䓬类在 GABA 位点的作用不能证明联用安全", "en": "Mechanism reading: benzodiazepine action at GABA sites does not prove safe co-use" }, "summary": { "zh": "当前标签把 ATIVAN 归为苯二氮䓬类中枢抑制药，并在相互作用部分说明苯二氮䓬类作用于 GABA 位点。它解释为什么镇静和呼吸风险会与其他中枢抑制药叠加，但不能据此选择个人剂量、用药时点或替代药。", "en": "The current label identifies ATIVAN as a benzodiazepine CNS depressant and states in its interaction section that benzodiazepines act at GABA sites. This helps explain additive sedation and breathing risk with other CNS depressants, but cannot select an individual's dose, timing or substitute." }, "checks": [ { "zh": "ATIVAN、VALIUM、XANAX、KLONOPIN 与 LOREEV XR 不是同一个产品；共同涉及 GABA 或焦虑/镇静用途，不建立 mg 一比一换算或轮换表。", "en": "ATIVAN, VALIUM, XANAX, KLONOPIN and LOREEV XR are not one product. Shared GABA-related or anxiety/sedation use creates no one-for-one milligram conversion or rotation table." }, { "zh": "阿片类主要在 μ 受体系统作用，苯二氮䓬类在 GABA 位点作用；机制不同仍可共同压低呼吸与警觉，不能据此推断错开几小时就安全。", "en": "Opioids act mainly at mu-receptor systems while benzodiazepines act at GABA sites; different mechanisms can still jointly depress breathing and alertness, so a time gap cannot be inferred to make co-use safe." }, { "zh": "是否需要基因检测、是否改用另一种抗焦虑药或是否能掰片，不由这个机制段落回答；应回到诊断、准确药盒、处方、完整药单与专业评估。", "en": "This mechanism section cannot decide genetic testing, a switch to another anxiolytic or tablet splitting. Those decisions require the diagnosis, exact pack, prescription, full medicine list and professional assessment." } ], "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ATIVAN", "generic": "劳拉西泮片", "dosageFormClass": "ATIVAN 劳拉西泮普通口服片。0.5、1、2 mg 是每片标示量；100 Tablets 是整瓶数量。ATIVAN 注射剂、劳拉西泮口服浓缩液、LOREEV XR 缓释胶囊及其他苯二氮䓬类不是本档案的同一产品。" }, "labelSource": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "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": "2026-09-04", "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": "2026-09-04", "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": "ATIVAN 是劳拉西泮普通口服片的美国品牌档案。0.5、1、2 mg 是每片含量，不是应该吃几片；100 Tablets 是整瓶片数。老人、多药使用者及同时接触阿片类止痛药、酒精、安眠药或其他镇静药的人，应优先核对呼吸抑制、过度嗜睡、站立不稳、跌倒、依赖与突然停用风险；网页不生成个人片数或减停方案。", "history": "FDA 审评资料记录 ATIVAN 劳拉西泮片于 1977-09-30 获初始批准，NDA 为 017794。FDA 2023 年 S-049 补充批准涉及过量、新生儿停药以及妊娠和哺乳风险标签修订。当前 DailyMed 品牌标签修订于 2025-07，并列出三个 100 片瓶装面板。", "sourceDocuments": [ { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_bebe9d202c1f5c74", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮 FDA 批准患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_47d8cb230b8de84f", "label": "FDA：LORazepam ER（Loreev XR）多学科审评——ATIVAN NDA 017794 作为 listed drug 及 1977-09-30 初始批准记录", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214826Orig1s000MultidisciplineR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_f873cf117285c96d", "label": "FDA：ATIVAN NDA 017794/S-049 安全性标签补充批准函（过量、新生儿停药及妊娠哺乳风险）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017794Orig1s049ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 017794", "approvalTimeline": [ { "date": "1977-09-30", "title": { "zh": "ATIVAN 劳拉西泮片美国初始批准", "en": "Initial U.S. approval of ATIVAN lorazepam tablets" }, "detail": { "zh": "FDA 的后续多学科审评把 ATIVAN 片剂作为 listed drug，并记录 NDA 017794 与该初始批准日期。", "en": "A later FDA multidisciplinary review identifies ATIVAN tablets as the listed drug and records NDA 017794 with this initial approval date." }, "source": { "id": "src_47d8cb230b8de84f", "label": "FDA：LORazepam ER（Loreev XR）多学科审评——ATIVAN NDA 017794 作为 listed drug 及 1977-09-30 初始批准记录", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214826Orig1s000MultidisciplineR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2023-01-13", "title": { "zh": "FDA 批准 S-049 安全性标签补充", "en": "FDA approved the S-049 safety-label supplement" }, "detail": { "zh": "补充批准涉及过量、新生儿停药综合征以及妊娠和哺乳相关风险的标签修订。", "en": "The supplement revised labeling for overdose, neonatal withdrawal syndrome and pregnancy/lactation-related risks." }, "source": { "id": "src_f873cf117285c96d", "label": "FDA：ATIVAN NDA 017794/S-049 安全性标签补充批准函（过量、新生儿停药及妊娠哺乳风险）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017794Orig1s049ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-07-09", "title": { "zh": "当前品牌说明书修订日期", "en": "Current brand-label revision date" }, "detail": { "zh": "DailyMed 当前标签与患者用药指南列出三种准确 100 片瓶装、黑框警告和老年人阅读重点。", "en": "The current DailyMed label and Medication Guide list three exact 100-tablet bottles, boxed warnings and older-adult reading priorities." }, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 017794；0.5、1、2 mg 三种 100 片瓶装；美国 C-IV。标签状态不等于实时供应或个人适用。", "en": "NDA 017794; 0.5, 1 and 2 mg in three 100-tablet bottles; U.S. C-IV. Label status is not live supply or individual suitability." } }, { "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": "当地商品名、批准、参比、管制分类、包装和供应尚未逐市场确认", "en": "Local brand, approval, reference, controlled-drug class, pack and supply are not yet established market by market" }, "detail": { "zh": "不从美国 ATIVAN 商品名、NDA、NDC、C-IV 或包装外观推定其他市场状态。", "en": "No other-market status is inferred from the U.S. ATIVAN name, NDA, NDC, C-IV class or package appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.5 mg、1 mg、2 mg 是应该吃几片吗？", "en": "Do 0.5 mg, 1 mg and 2 mg tell me how many tablets to take?" }, "answer": { "zh": "不是。它们是每片标示含量；100 Tablets 是整瓶片数。个人片数、频次、疗程与减停方式必须以实际处方和负责治疗的专业人员为准。", "en": "No. They are labelled amounts per tablet; 100 Tablets is the bottle count. Individual tablet count, frequency, course and taper/stop plan must come from the actual prescription and treating professional." } }, { "question": { "zh": "1 mg 或 2 mg 有刻痕，能自己掰半吗？", "en": "The 1 mg and 2 mg tablets are scored. Can I split one myself?" }, "answer": { "zh": "不能从刻痕直接得出许可。刻痕首先用于核对准确产品外观；是否可以分割以及怎样改变剂量或停药，必须让开方团队结合实际处方确认。", "en": "A score does not itself grant permission. It first helps identify the exact product; the prescriber must confirm whether it may be split and how any dose change or stop is handled." } }, { "question": { "zh": "和止痛药、安眠药或酒错开几个小时就安全吗？", "en": "Is it safe if separated from a pain medicine, sleep medicine or alcohol by a few hours?" }, "answer": { "zh": "网页不能给出这个结论。阿片类和其他中枢抑制药的作用可能持续并叠加；请把完整药单、饮酒情况和使用时间交给医生或药师核对。出现呼吸浅慢、叫不醒等表现应立即急救。", "en": "The site cannot make that conclusion. Opioid and other CNS-depressant effects can persist and add. Give the full list, alcohol use and timing to a clinician or pharmacist. Shallow breathing or inability to awaken requires immediate emergency help." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ativan-lorazepam/", "en": "https://origindrug.com/en/drugs/ativan-lorazepam/" }, "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." ] }