{ "id": "prolia", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-16", "status": "published_traceable_archive" }, "names": { "brand": "Prolia", "generic": "地舒单抗", "aliases": [ "denosumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "骨骼健康", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "皮下注射液（60 mg/mL 单剂量预充注射器；FDA 2025 标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2010（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prolia-denosumab-60mg-1ml-single-dose-prefilled-syringe-ndc-55513-710-21", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v186；标签生效 2026-06-26", "en": "DailyMed SPL v186; label effective 26 Jun 2026" }, "dosageForm": { "zh": "地舒单抗注射液；单剂量预充注射器", "en": "denosumab injection; single-dose prefilled syringe" }, "route": { "zh": "皮下（标签所列途径；不由网页决定个人给药）", "en": "subcutaneous (labelled route; this page does not determine an individual's administration)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 55513-710-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "60 mg/1 mL（60 mg/mL）；1 支单剂量预充注射器纸盒", "en": "60 mg/1 mL (60 mg/mL); one single-dose prefilled-syringe carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prolia-09.jpg&setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地舒单抗", "en": "denosumab" }, "value": 60, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "60 mg/mL 标签浓度；不是个人注射量或换算指令", "en": "60 mg/mL labelled concentration; not an individual's injection amount or conversion instruction" } }, { "ingredient": { "zh": "地舒单抗", "en": "denosumab" }, "value": 60, "unit": "mg", "basisCode": "per_single_dose_syringe", "basisLabel": { "zh": "每支 1 mL 单剂量预充注射器标示量；不是个人注射指令", "en": "labelled amount in one 1 mL single-dose prefilled syringe; not an individual administration instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "60 mg/mL", "numerator": { "value": 60, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "60 mg/mL（标签浓度；不是个人注射量）", "en": "60 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器（带安全装置）", "en": "single-dose prefilled syringe with safety guard" }, "fill": { "value": 1, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringe per carton" } }, "deliveryDevice": { "typeCode": "safety_guard", "name": { "zh": "安全装置", "en": "safety guard" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringe per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（Amgen；SPL v186，标签生效 2026-06-26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prolia-denosumab-60mg-1ml-single-dose-prefilled-syringe-ndc-55513-710-21", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prolia-09.jpg&setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88&type=img", "alt": "PROLIA 60 mg/mL 单剂量预充注射器在美国 DailyMed 公开标签中的包装标签图", "archiveMarket": "美国", "labelVersion": "2026-06", "presentation": "PROLIA 60 mg/mL 单剂量预充注射器包装标签图（DailyMed 页面所列 2026-06 更新标签）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PROLIA 60 mg/mL 单剂量预充注射器的包装文字图，只帮助核对品牌、通用名、标示强度、给药途径、装置和来源；不用于鉴定真伪，也不证明其他市场标签、当前包装、目标市场批准或可售资格。", "source": { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROLIA 说明书放大阅读：60 mg/mL 是产品强度，不是自行安排注射的答案", "en": "PROLIA label reading: 60 mg/mL is product strength, not an answer for self-scheduling an injection" }, "summary": { "zh": "本模块以 FDA 2025 美国标签为阅读入口，帮助理解 PROLIA 预充注射器的通用名、强度和给药途径；它不制定个人注射、补钙/维生素 D、延后或停用方案。", "en": "This module uses the 2025 U.S. FDA label as a reading entry point. It helps read a PROLIA prefilled syringe's generic name, strength and route; it does not create an individual injection, calcium/vitamin D, delay or stopping plan." }, "checks": [ { "zh": "标签所列“60 mg/mL 单剂量预充注射器”同时描述强度、浓度和包装形式。它不是个人应何时注射、能否提前/延后或可否用另一盒注射剂替代的结论。", "en": "The label's “60 mg/mL single-dose prefilled syringe” describes strength, concentration and package form together. It does not determine when any individual should be injected, whether it can be advanced or delayed, or whether another injectable can replace it." }, { "zh": "该标签把低钙血症、肾功能相关风险及开始前评估列为重要内容。尤其存在晚期慢性肾病、近期检验变化或多种药物时，不应仅按网页、包装或既往习惯自行开始、延后、停用或补充产品。", "en": "The label identifies hypocalcaemia, kidney-related risk and assessment before initiation as important matters. Especially with advanced chronic kidney disease, recent test changes or multiple medicines, do not independently start, delay, stop or add products from a webpage, package or past routine alone." }, { "zh": "标签明确提示：正在使用 PROLIA 的人不应同时使用其他含地舒单抗的产品。这是需要对照完整药单与准确产品的安全核验点，不是读者自行判断另一药是否“同成分”或自行停换的依据。", "en": "The label states that people receiving PROLIA should not also receive another denosumab product. This is a safety check requiring the complete medicine list and exact product, not a basis for self-deciding whether another medicine is “the same ingredient” or for self-switching or stopping." }, { "zh": "照片、针筒颜色和包装文字只用于定位来源。不同市场、标签版本和包装可能不同；图片不能鉴定真伪、确认当前批准或代替出现抽搐、麻刺感、严重不适等情况的及时医疗评估。", "en": "Photos, syringe colour and package wording only help locate a source. Markets, label versions and packages can differ; an image cannot authenticate a product, confirm current approval or replace prompt medical assessment for symptoms such as spasms, tingling or severe illness." } ], "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 处方信息（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地舒单抗怎样起作用：它阻断 RANKL 与 RANK 的结合", "en": "How denosumab works: it blocks the RANKL-RANK interaction" }, "summary": { "zh": "DailyMed 的 PROLIA 标签说明，地舒单抗与 RANKL 结合，阻止其激活破骨细胞及其前体表面的 RANK；由此抑制破骨细胞的形成、功能和存活，并减少骨吸收。它解释的是一条骨重塑相关路径，不判断个人是否需要注射、何时注射、钙和维生素 D 如何补充、是否停用或如何衔接其他骨骼用药。", "en": "The DailyMed PROLIA label says denosumab binds RANKL and prevents activation of RANK on osteoclasts and their precursors; this inhibits osteoclast formation, function and survival and reduces bone resorption. It explains a bone-remodelling pathway, not whether an individual needs injection, when to inject, how to use calcium or vitamin D, whether to stop, or how to sequence another bone medicine." }, "checks": [ { "zh": "“影响破骨细胞”不能决定个人是否适合开始、延后、漏用后补用或停止 PROLIA，也不能替代对骨折风险、肾功能、钙/维生素 D、牙科问题、既往治疗和完整药单的评估。", "en": "“Affects osteoclasts” cannot decide whether an individual should start, delay, redose after a missed treatment or stop PROLIA, and cannot replace assessment of fracture risk, kidney function, calcium/vitamin-D status, dental issues, prior treatment and the complete medicine list." }, { "zh": "同样作用于骨骼，或名称中都含“抗骨吸收”，不表示 PROLIA 能与双膦酸盐、其他地舒单抗产品、钙剂或维生素制剂自行叠加、轮换或替代。每个产品、给药途径、时间安排和实验室检查都需由专业团队确认。", "en": "Acting on bone, or having a name that suggests antiresorption, does not make PROLIA self-combinable, alternatable or substitutable with a bisphosphonate, another denosumab product, calcium or vitamin preparation. Every product, route, timing plan and laboratory check requires professional confirmation." }, { "zh": "标签对进展期肾病相关低钙风险有特别警示。抽搐、明显肌肉痉挛/抽动、麻木刺痛、意识改变或其他急性严重不适，应及时使用当地紧急医疗支持；不要从机制页面自行补钙、改药或跳过评估。", "en": "The label gives a particular warning about hypocalcaemia risk related to advanced kidney disease. With seizure, marked muscle spasm/twitching, numbness or tingling, mental-status change or another acute severe concern, use timely local emergency support; do not self-supplement calcium, change medicine or skip evaluation from a mechanism page." } ], "source": { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（Amgen，2026-06 修订；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Prolia", "generic": "地舒单抗", "dosageFormClass": "皮下注射液（60 mg/mL 单剂量预充注射器；FDA 2025 标签所列）" }, "labelSource": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 美国标签（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 美国标签（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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": [ { "id": "fda-2024-prolia-advanced-ckd-severe-hypocalcemia-boxed-warning", "issuedAt": "2024-01-19", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：Prolia（地舒单抗）在晚期慢性肾病患者中的严重低钙血症黑框警告", "en": "FDA Drug Safety Communication: Boxed Warning for severe hypocalcemia with Prolia (denosumab) in advanced chronic kidney disease" }, "summary": { "zh": "FDA 于 2024-01-19 发布安全通讯，说明其完成审查后在美国 Prolia（地舒单抗）处方信息中加入晚期慢性肾病患者严重低钙血症风险的黑框警告；公告特别讨论透析患者及伴慢性肾病矿物质和骨异常者。这是美国、特定产品和特定人群的监管信息，不可据此判断任何人是否属于该人群、是否应接受检测/监测或是否应开始、延后、停止或改用产品。请以目标市场现行说明书、实际产品和负责团队核对。", "en": "On 2024-01-19, after completing its review, FDA added a Boxed Warning to U.S. Prolia (denosumab) prescribing information about severe hypocalcemia risk in patients with advanced chronic kidney disease; the communication specifically discusses dialysis patients and people with CKD-mineral and bone disorder. This is U.S. regulatory information for a named product and population. It cannot determine whether any person is in that population, needs testing or monitoring, or should start, defer, stop or change a product. Check the current target-market label, actual product and responsible care team." }, "source": { "id": "src_7d3704e2d032f4ee", "label": "FDA：2024-01-19 Prolia（地舒单抗）晚期慢性肾病患者严重低钙血症黑框警告药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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": "FDA 的 PROLIA（denosumab）2025 美国标签列示其为皮下注射用制剂，并列出美国初始批准年份为 2010。页面仅提供美国公开监管资料阅读入口；不据此推定其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "骨代谢相关注射产品需要同时核对商品名、通用名、规格、注射途径、目标市场和现行标签。单一包装、历史文件或“补钙/骨质”文字不能建立个人适用性、开始/停用或与其他产品的替代关系。", "sourceDocuments": [ { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 美国标签（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "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": "BLA 125320", "approvalTimeline": [ { "date": "2010", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2010。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2010. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA: PROLIA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA: PROLIA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prolia/", "en": "https://origindrug.com/en/drugs/prolia/" }, "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." ] }