{ "id": "nolvadex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "NOLVADEX", "generic": "他莫昔芬", "aliases": [ "NOLVADEX", "ノルバデックス", "tamoxifen", "他莫昔芬", "他莫昔芬枸橼酸盐", "tamoxifen citrate", "21800AMX10347", "21800AMX10348" ], "marketBrandNames": [ { "name": "ノルバデックス", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示ノルバデックス錠10mg／20mg、他莫昔芬枸橼酸盐与日本制造销售方。此记录仅用于核对日文商品名、成分、强度、剂型和监管文件入口；不确认其他市场名称、包装、供应、购买资格、真伪或自行换药。", "en": "The current PMDA product page lists NOLVADEX 10 mg/20 mg tablets, tamoxifen citrate and the Japanese marketing authorisation holder. It only supports checking the Japanese trade name, ingredient, strength, form and regulatory-document entry points—not names, packs, supply, purchase eligibility, authenticity or self-directed switching in another market." }, "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "日本：PMDA 当前产品页列示ノルバデックス錠10mg／20mg、成分他莫昔芬枸橼酸盐、制造销售方及现行说明书/患者向医药品指南入口。本页不从这份日本记录推定中国大陆、美国、欧盟或其他市场的批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "日本 PMDA 当前说明书所列：他莫昔芬枸橼酸盐薄膜衣口服片，分别为每片他莫昔芬 10 mg、20 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "日本 PMDA 当前说明书记录：10 mg 于 1981-09 销售开始，20 mg 于 1990-06 销售开始（仅定位日本记录）", "archiveSponsorText": "アストラゼネカ株式会社／AstraZeneca K.K.（PMDA 当前产品页所列日本制造销售方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NORVASC", "ノルバスク", "络活喜", "amlodipine", "氨氯地平", "other tamoxifen package", "其他他莫昔芬包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-nolvadex-tamoxifen-tablet-10mg-21800amx10347", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前公开说明书（2026-03 修订）", "en": "Current PMDA public label (revised Mar 2026)" }, "dosageForm": { "zh": "ノルバデックス 他莫昔芬枸橼酸盐薄膜衣口服片", "en": "NOLVADEX tamoxifen citrate film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Japan approval No. 21800AMX10347", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片他莫昔芬 10 mg；日本 PMDA 当前说明书列示产品身份", "en": "Tamoxifen 10 mg per tablet; product identity listed in the current PMDA label" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他莫昔芬", "en": "tamoxifen" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "10 mg 是每片标签标示量；不是个人片数、疗程、换算或换药指令", "en": "10 mg is a labelled amount per tablet; not an individual's tablet count, treatment duration, conversion or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "薄膜衣片；外形与压印仅作辅助核对，不能鉴定真伪或作为自行分片依据", "en": "film-coated tablet; appearance and imprint are supporting checks only, not product authentication or self-splitting instructions" }, "imprint": "NOLVADEX 10", "scoreStatus": "not_established", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前公开说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-nolvadex-tamoxifen-tablet-20mg-21800amx10348", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前公开说明书（2026-03 修订）", "en": "Current PMDA public label (revised Mar 2026)" }, "dosageForm": { "zh": "ノルバデックス 他莫昔芬枸橼酸盐薄膜衣口服片", "en": "NOLVADEX tamoxifen citrate film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Japan approval No. 21800AMX10348", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片他莫昔芬 20 mg；日本 PMDA 当前说明书列示产品身份", "en": "Tamoxifen 20 mg per tablet; product identity listed in the current PMDA label" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他莫昔芬", "en": "tamoxifen" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "20 mg 是每片标签标示量；不是个人片数、疗程、换算或换药指令", "en": "20 mg is a labelled amount per tablet; not an individual's tablet count, treatment duration, conversion or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "薄膜衣片；外形与压印仅作辅助核对，不能鉴定真伪或作为自行分片依据", "en": "film-coated tablet; appearance and imprint are supporting checks only, not product authentication or self-splitting instructions" }, "imprint": "NOLVADEX 20", "scoreStatus": "not_established", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前公开说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [ { "id": "jp-nolvadex-tablet-10mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "NOLVADEX 他莫昔芬 10 mg 片：日本官方外观", "en": "NOLVADEX tamoxifen 10 mg tablet: official Japan appearance" }, "imageUrl": "/evidence/medicine/nolvadex/nolvadex-tablet-10mg-pmda-guide-2023.png", "alt": { "zh": "日本 PMDA 患者指南中的 NOLVADEX 10 白色圆片", "en": "White round tablet marked NOLVADEX 10 in the Japanese PMDA patient guide" }, "description": { "zh": "2023 年 5 月患者指南第 5 页原图：印记 NOLVADEX 10，直径 8.1 mm。2026-09-08 核验，保留原图，未增强或重绘。", "en": "Original image on page 5 of the May 2023 patient guide: imprint NOLVADEX 10, diameter 8.1 mm. Checked 2026-09-08; no enhancement or redrawing." }, "exclusions": { "zh": "仅供核对该日本指南的药片外观；不是外盒包装，也不代表中国市场。不能凭图片判断真伪、决定片数或自行掰片换药。", "en": "Tablet appearance in this Japanese guide only, not an outer package or a China-market reference. Images cannot authenticate a medicine or determine tablet count, splitting or switching." }, "source": { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-nolvadex-tablet-20mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "NOLVADEX 他莫昔芬 20 mg 片：日本官方外观", "en": "NOLVADEX tamoxifen 20 mg tablet: official Japan appearance" }, "imageUrl": "/evidence/medicine/nolvadex/nolvadex-tablet-20mg-pmda-guide-2023.png", "alt": { "zh": "日本 PMDA 患者指南中的 NOLVADEX 20 白色圆片", "en": "White round tablet marked NOLVADEX 20 in the Japanese PMDA patient guide" }, "description": { "zh": "2023 年 5 月患者指南第 5 页原图：印记 NOLVADEX 20，直径 10.1 mm。2026-09-08 核验，保留原图，未增强或重绘。", "en": "Original image on page 5 of the May 2023 patient guide: imprint NOLVADEX 20, diameter 10.1 mm. Checked 2026-09-08; no enhancement or redrawing." }, "exclusions": { "zh": "仅供核对该日本指南的药片外观；不是外盒包装，也不代表中国市场。不能凭图片判断真伪、决定片数或自行掰片换药。", "en": "Tablet appearance in this Japanese guide only, not an outer package or a China-market reference. Images cannot authenticate a medicine or determine tablet count, splitting or switching." }, "source": { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" } ], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 PMDA 当前说明书文字，但未保留与单一强度、单一包装一一对应的官方包装图，故不展示包装图片", "en": "The current PMDA label text was reviewed, but no official package image matching one exact strength and pack was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留日本 PMDA 当前文件中的 NOLVADEX／ノルバデックス、他莫昔芬枸橼酸盐、10 mg／20 mg、两个承认番号、说明书及患者向医药品指南入口。此次没有保留能与单一强度和单一包装逐一对应、可安全公开展示的官方包装图；为避免把版本不明图、零售图、其他市场图或另一强度图片误作准确产品，页面不展示包装图片，只保留可放大阅读的官方电子说明书。", "en": "This dossier retains NOLVADEX/ノルバデックス, tamoxifen citrate, 10 mg/20 mg, two approval numbers, the current PMDA label and patient-medicine-guide entry points. This review did not retain an official package image that can safely be matched one-to-one to a single strength and pack; to avoid presenting a version-uncertain image, retail image, another-market image or another-strength image as the exact product, the page withholds package imagery and retains the official electronic leaflet for enlarged reading." }, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NOLVADEX／他莫昔芬说明书放大阅读：先把完整名称、mg 与市场一起核对", "en": "NOLVADEX label reading: check the full name, mg and market together first" }, "summary": { "zh": "本模块只阅读日本 PMDA 当前 NOLVADEX 说明书和患者向医药品指南中的产品身份与安全阅读入口。它不提供个人片数、疗程、漏用处理、分片、同服、停用、换药或购买方案。", "en": "This module only reads product-identity and safety-reading entries in the current Japanese PMDA NOLVADEX label and patient guide. It provides no individual tablet count, treatment duration, missed-use handling, splitting, co-use, stopping, switching or purchase plan." }, "checks": [ { "zh": "先同时核对完整商品名 NOLVADEX／ノルバデックス、通用名他莫昔芬、每片 10 mg 或 20 mg、薄膜衣口服片、目标市场和现行处方。mg 是准确片剂的标签标示量，不是网页可计算的个人片数、疗程或两种强度间换算规则。", "en": "Check the full NOLVADEX/ノルバデックス name, generic tamoxifen, 10 mg or 20 mg per tablet, film-coated oral-tablet form, target market and current prescription together. mg is a labelled amount for an exact tablet, not a web calculation for an individual's tablet count, duration or conversion between strengths." }, { "zh": "ノルバデックス与ノルバスク（NORVASC）只相差少量文字，不能凭部分读音、颜色或“同为片剂”自行判断为同一种药。若名称、药盒、市场或强度有任何不清楚，应核对完整商品名、通用名、强度、剂型与可访问的来源文件，并把实际药盒和完整药单交给药师或开方团队。", "en": "ノルバデックス and ノルバスク (NORVASC) differ by only a small amount of text; a partial sound, colour or the fact that both are tablets cannot establish that they are the same medicine. If the name, pack, market or strength is unclear, check the full trade name, generic name, strength, form and accessible source document, and have a pharmacist or prescriber review the actual pack and complete medicine list." }, { "zh": "患者向医药品指南用于帮助患者和家属理解医药品及尽早识别可能的严重不良反应；它不能取代处方、治疗团队或个体化风险判断。怀孕/可能怀孕、哺乳、既往病史、其他处方药、非处方药和补充剂都应在实际使用前由负责团队逐项核对。", "en": "A patient medicine guide helps patients and families understand a medicine and recognise possible serious adverse reactions early; it does not replace a prescription, treatment team or individual risk assessment. Pregnancy/possible pregnancy, breast-feeding, history, other prescription medicines, OTC products and supplements require item-by-item review by the responsible team before actual use." }, { "zh": "出现呼吸困难、面部或喉部肿胀、胸痛、单侧肢体突然肿痛、突然神经系统变化或其他急性严重不适时，应优先使用当地紧急医疗支持；不要通过自行同时停换多种药来试探原因。", "en": "With breathing difficulty, swelling of the face or throat, chest pain, sudden one-sided limb swelling/pain, sudden neurologic change or another acute serious concern, prioritise local emergency medical support; do not test the cause by stopping or changing several medicines yourself." } ], "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书及患者向医药品指南", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "他莫昔芬怎样起作用：受体相关的说明不能替代个人治疗决定", "en": "How tamoxifen works: a receptor-related explanation cannot replace an individual treatment decision" }, "summary": { "zh": "PMDA 患者向医药品指南将本品归为内分泌治疗相关药物，并描述其通过作用于雌激素受体来抑制乳腺癌细胞增殖。它是监管文件中的机制阅读线索，不判断任何人的病理结果、是否适用、片数、疗程、与阿那曲唑/来曲唑或其他产品的衔接、同服或换药。", "en": "The PMDA patient guide classifies this medicine in endocrine-therapy-related treatment and describes action on estrogen receptors to suppress breast-cancer-cell proliferation. This is a regulatory-document mechanism-reading cue, not a decision about anyone's pathology, suitability, tablet count, duration, sequencing with anastrozole/letrozole or another product, co-use or switching." }, "checks": [ { "zh": "“雌激素受体”“内分泌治疗”或相同疾病名称，不能把 NOLVADEX、ARIMIDEX、FEMARA 或其他治疗产品变成可自行替换、叠加、交替或按 mg 换算的关系。准确产品、市场、检查资料与完整药单须由肿瘤团队整体核对。", "en": "“Estrogen receptor”, “endocrine therapy” or a shared disease name does not make NOLVADEX, ARIMIDEX, FEMARA or another treatment self-switchable, combinable, alternatable or convertible by mg. Exact products, market, test materials and the complete medicine list require oncology-team review together." }, { "zh": "机制说明不是解释个人乳腺影像、病理、激素受体、基因报告或复发风险的工具，也不能替代对既往治疗、妊娠可能性、合并疾病、器官功能和全部联用药物的评估。", "en": "A mechanism explanation is not a tool for interpreting an individual's breast imaging, pathology, hormone receptors, genetic report or recurrence risk, and cannot replace assessment of prior treatment, pregnancy possibility, coexisting conditions, organ function and all co-medications." }, { "zh": "不要用机制或说明书数字处理急性症状、漏用、停用、补用、联用或换药。实际问题必须回到准确产品的现行目标市场标签和负责治疗团队或药师。", "en": "Do not use mechanism or label numbers to handle an acute symptom, missed use, stopping, make-up use, co-use or switching. Real questions must return to the current target-market label for the exact product and the responsible treatment team or pharmacist." } ], "source": { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NOLVADEX", "generic": "他莫昔芬", "dosageFormClass": "日本 PMDA 当前说明书所列：他莫昔芬枸橼酸盐薄膜衣口服片，分别为每片他莫昔芬 10 mg、20 mg" }, "labelSource": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-26", "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_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-26", "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": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-26", "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": "日本 PMDA 当前记录列示 NOLVADEX（ノルバデックス）他莫昔芬枸橼酸盐 10 mg、20 mg 薄膜衣口服片及患者向医药品指南。页面帮助读者把品牌、通用名、每片标示量、目标市场和官方电子说明书放在一起阅读；不把 mg、产品名、历史年份或肿瘤类型转成个人片数、疗程、同服、停用、换药、替代或购买结论。", "history": "PMDA 现行说明书（2026-03 修订）列示日本销售开始时间：10 mg 为 1981-09，20 mg 为 1990-06。该时间线只定位日本监管文件中的产品历史；10 mg 与 20 mg 是各自片剂的标示量，不建立个人片数、强度换算、不同内分泌治疗产品的互换或跨市场包装结论。", "sourceDocuments": [ { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" } ], "applicationNumber": "日本 PMDA 承认番号：ノルバデックス錠10mg 21800AMX10347；ノルバデックス錠20mg 21800AMX10348（当前 PMDA 说明书所列；只定位日本监管记录）", "approvalTimeline": [ { "date": "1981-09", "title": { "zh": "日本 PMDA 当前说明书所列：10 mg 销售开始", "en": "10 mg marketing start listed in the current Japanese PMDA label" }, "detail": { "zh": "PMDA 当前说明书列示ノルバデックス錠10mg 的销售开始为 1981-09。该历史节点只定位日本说明书中的产品记录；不建立当前供应、可售资格、其他市场状态、原研/仿制关系、可替代性或个人适用性。", "en": "The current PMDA label lists Sep 1981 as the marketing start for NOLVADEX 10 mg. This historical node only locates the product record in the Japanese label; it does not establish current supply, sale eligibility, another-market status, originator/generic relationship, interchangeability or individual suitability." }, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "1990-06", "title": { "zh": "日本 PMDA 当前说明书所列：20 mg 销售开始", "en": "20 mg marketing start listed in the current Japanese PMDA label" }, "detail": { "zh": "PMDA 当前说明书列示ノルバデックス錠20mg 的销售开始为 1990-06。该历史节点只定位日本说明书中的产品记录；不建立当前供应、可售资格、其他市场状态、原研/仿制关系、可替代性或个人适用性。", "en": "The current PMDA label lists Jun 1990 as the marketing start for NOLVADEX 20 mg. This historical node only locates the product record in the Japanese label; it does not establish current supply, sale eligibility, another-market status, originator/generic relationship, interchangeability or individual suitability." }, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "2026-03-17", "title": { "zh": "PMDA 当前说明书修订记录", "en": "Current PMDA label revision record" }, "detail": { "zh": "PMDA 当前产品页指向 2026-03-17 的说明书文件与患者向医药品指南入口。此日期用于定位可复核文件版本，不是个人用药、包装供应、购买或其他市场状态的结论。", "en": "The current PMDA product page links the 17 Mar 2026 label and patient-medicine-guide entry point. This date locates a reviewable document version; it is not a conclusion about individual use, package supply, purchase or another-market status." }, "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页、说明书、患者向医药品指南及两个片剂身份", "en": "Current PMDA product page, label, patient guide and two tablet identities linked" }, "detail": { "zh": "本页只分别记录日本 PMDA 当前文件中的ノルバデックス錠10mg（承认番号 21800AMX10347）与20mg（21800AMX10348）、每片标签标示量和官方文件入口；不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、疗程、联用、停用、换药或可替代性。", "en": "This page separately records only NOLVADEX 10 mg (approval No. 21800AMX10347) and 20 mg (21800AMX10348), labelled amount per tablet and official-document entry points in current Japanese PMDA materials; it does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, duration, co-use, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆、美国、欧盟及其他市场", "en": "Mainland China, the United States, the EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从日本 PMDA 的品牌、承认番号、历史销售开始时间、说明书、患者指南或制造销售方推定当地商品名、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, package, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from Japanese PMDA brand, approval numbers, historical marketing-start dates, label, patient guide or marketing-authorisation holder; each market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10 mg、20 mg 与日本承认番号能否告诉我该吃几片、能否换成其他内分泌治疗药？", "en": "Can 10 mg, 20 mg and Japanese approval numbers tell me how many to take or whether I can change to another endocrine treatment?" }, "answer": { "zh": "不能。这些字段只识别 PMDA 当前文件中的准确日本片剂。共同治疗领域、相近 mg 数字、相似名称、说明书或包装外观都不建立自行开始、增加、补用、停用、联用、交替、换算或替代关系；请带实际药盒、现行处方和完整药单请肿瘤团队或药师核对。", "en": "No. These fields only identify the exact Japanese tablets in current PMDA materials. A shared treatment area, nearby mg number, similar name, label or package appearance does not establish self-initiation, increase, make-up use, stopping, co-use, alternation, conversion or substitution; have the oncology team or pharmacist review the actual pack, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面提示ノルバデックス与ノルバスク名称相似，却不告诉我是否可以停药或换药？", "en": "Why does the page flag similar NOLVADEX/NORVASC names without telling me whether to stop or change medicine?" }, "answer": { "zh": "名称相似提醒的作用是防止把不确定的药盒误读成另一种药，不是治疗决定。不要根据部分读音、颜色、网络照片或网页自行停、换、合用或增加任何药；若怀疑拿错、出现急性严重不适或需要核对实际处方，应优先联系当地医疗支持或负责团队。", "en": "A similar-name reminder helps prevent an uncertain pack from being misread as another medicine; it is not a treatment decision. Do not self-stop, change, combine or increase any medicine from a partial sound, colour, online photo or webpage; with a suspected mix-up, acute serious concern or need to check an actual prescription, prioritise local medical support or the responsible team." } } ], "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/nolvadex/", "en": "https://origindrug.com/en/drugs/nolvadex/" }, "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." ] }