EMA 于 2025 年 12 月 22 日授予 Sanofi 的 rilzabrutinib（Wayrilz）欧盟上市授权，用于既往治疗无效的成人免疫性血小板减少症（ITP），并发布 Revision 1 的 EPAR。
关注理由：EMA 发布 rilzabrutinib（Wayrilz）欧盟上市授权 EPAR，含 202 名成人 ITP 随机对照试验数据及 12 周无效停药规则，可用于孤儿药治疗路径跟踪。
2026年9月11日，欧洲委员会应上市许可持有人Indivior Europe Limited申请撤回Suboxone（buprenorphine/naloxone）在欧盟的上市许可，原因为企业出于商业考虑永久停售。
EMA 发布 Vabysmo（faricimab）第11版 EPAR，该药于2022年9月15日获批，用于治疗湿性年龄相关性黄斑变性（AMD）、糖尿病性黄斑水肿及视网膜静脉阻塞（RVO）引起的黄斑水肿。
EMA更新teclistamab（Tecvayli）的EPAR：该药用于复发或难治性多发性骨髓瘤成人患者，2022年8月23日获欧盟条件性上市许可，2026年8月20日因公司提交额外数据转为标准上市许可。
关注理由：该EPAR第11版记录teclistamab由条件性上市许可转为标准许可这一监管证据升级，并汇总其单药及联合daratumumab研究的疗效与安全性数据，便于跟踪多发性骨髓瘤后续监管动作。
EMA发布Galafold（活性成分migalastat）欧洲公众评估报告（EPAR）摘要，该药2016年5月25日获欧盟上市许可，现行第19版，状态为Authorised，用于12岁及以上、携带特定α-半乳糖苷酶A基因突变的法布雷病患者。
2026年11月5日，EMA兽医药品委员会（CVMP）通过积极意见，推荐授予Boehringer Ingelheim Vetmedica GmbH申请的Scovella（15 mg/ml口服溶液。
2026年11月5日，EMA兽医药品委员会（CVMP）对Aniserve GmbH申请的犬淋巴瘤药Laverdia（活性成分verdinexor）作出积极意见，推荐授予上市许可，用于增加II、III、IV期淋巴瘤犬的进展时间（家庭环境用药）。
2026年11月5日，EMA兽医药品委员会（CVMP）对Intervet International B.V.的犬用疫苗Nobivac PLUS DHPPi/Leptos采纳积极意见，建议授予上市许可。
欧洲药品管理局兽药委员会（CVMP）于2026年11月5日对Elanco GmbH申请的犬用咀嚼片Credelio Quattro（lotilaner/moxidectin/pyrantel/praziquantel）采纳正面意见，认为效益-风险平衡有利，推荐授予上市许可。
2026年11月5日，EMA兽药产品委员会（CVMP）对Elanco GmbH兽药Credelio（lotilaner）上市许可变更采纳正面意见，该变更涉及猫适应症的新增或修改：治疗耳螨（Otodectes cynotis）感染。该意见尚待欧盟委员会批准，更新后的产品特性概要（SPC）将载于欧盟产品数据库（UPD）。
EMA 发布药品短缺通报（Medicine shortage communication），称 Emend（aprepitant）80 mg 硬胶囊、125 mg 硬胶囊和 125 mg 口服混悬用粉末三种制剂计划永久停止上市。该文件为计划性停售通知，性质属供应中断信号而非安全召回或疗效问题。材料仅含通报标题信息，未说明停售原因、生效时间表或替代供应安排。
EMA发布Entresto（沙库巴曲/缬沙坦）EPAR第28版：该药在欧盟已授权，用于成人及1岁以上儿童慢性心力衰竭。成人主研究中，Entresto组心血管死亡或心衰住院21.8%对依那普利26.5%，因优效提前停止。1个月至<18岁377例患儿主要结局未显示优于依那普利；常见不良事件为高钾血症、低血压、肾功能损害。
原文摘录：See all DONs related to this event Read more about Ebola disease Situation at a glance Since the publication of the previous Disease Outbreak News on 23 October 2026, the Bundibugyo virus disease (BVD) outbreak has expanded geographically in the Democrati … item/2026-DON625
原文摘录：See all DONs related to this event Read more about Yellow fever Situation at a glance Yellow fever transmission continues in the WHO African Region, with recent outbreak activity concentrated in parts of West Africa. … item/2026-DON624
原文摘录：Rivaroxaban Viatris (previously Rivaroxaban Mylan) RSS Authorised This medicine is authorised for use in the European Union rivaroxaban Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Rivaroxaban M … 21 MB - DOCX) First published: 04/06/2025 View This page was last updated on 06/11/2026
原文摘录：Bylvay RSS Authorised This medicine is authorised for use in the European Union odevixibat Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Bylvay is a medicine for treating patients from the age of … More information on Bylvay EU/3/12/1028 - orphan designation for treatment of progressive familial intrahepatic cholestasis EU/3/12/1040 - orphan designation for treatment of Alagille syndrome EMEA-002054-PIP01-16-M03 - paediatric investigation plan EMA/PE/0000240317 - paediatric investigation plan Bylvay - withdrawal of application for variation to marketing authorisation Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants with Progressive Familial Intrahepatic Cholestasis (PFIC) who take Odevixibat (Bylvay) - post-authorisation study Prospective Registry-Based Study Evaluating the Effectiveness and Safety of Odevixibat in Participants With Alagille Syndrome (ALGS) - post-authorisation study Prospective Registry-Based Study of the Long-Term Safety of Odevixibat in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) - post-authorisation study This page was last updated on 06/11/2026
原文摘录：Comirnaty RSS Authorised This medicine is authorised for use in the European Union COVID-19 mRNA vaccine Medicine Human Authorised Rolling review Application under evaluation CHMP opinion European Commission decision Overview Comirnaty is a vaccine for pr … 5-containing Covid-19 mRNA vaccines in the Nordic countries - post-authorisation study A Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Recipients of the Pfizer-BioNTech COVID-19 mRNA vaccine in the EU - post-authorisation study Real-world effectiveness of different COVID-19 vaccines in Spain: a cohort study based on public electronic health records (BIFAP) (effectiveness of COVID-19 vaccines in Spain) - post-authorisation study This page was last updated on 06/11/2026
原文摘录：Lacosamide Accord RSS Authorised This medicine is authorised for use in the European Union lacosamide Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assess … 56 KB - DOCX) First published: 28/05/2025 View This page was last updated on 06/11/2026
原文摘录：Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 November 2026 6 November 2026 Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting News Veterinary Medicines CVMP opinions on veterinary medicinal pro … Related content Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2026 Committee for Veterinary Medicinal Products (CVMP) Related medicine information Credelio Quattro Credelio Nobivac PLUS DHPPi / Leptos Laverdia Scovella
原文摘录：Background: Cancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump.
EMA 更新 secukinumab（Cosentyx）欧洲公众评估报告至第 44 版，该药 2015 年 1 月 14 日获欧盟上市许可，持证方 Novartis Europharm，状态为已批准。
EMA更新Ogsiveo（活性物质nirogacestat）的EPAR至第5版，该药于2025年8月14日获欧盟上市授权，用于需要全身治疗、肿瘤进展的成人硬纤维瘤患者单药治疗，此前为孤儿药。
EMA将Jyseleca（活性成分filgotinib）的EPAR更新至Revision 15，该药2020年9月24日在欧盟获批，现状态为Authorised；最新变更VR/0000325892的CHMP积极意见已采纳，评估报告与产品信息于2026年11月5日更新。
原文摘录：Truqap - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn capivasertib Post-authorisation Human Overview AstraZeneca AB withdrew its a … News on Truqap Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026 16/10/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 26/04/2024 More information on Truqap Truqap This page was last updated on 03/11/2026
关注理由：这篇临床试验内容涉及随机对照研究，阅读重点可以放在研究分组、主要终点和随访结果上。
原文摘录：Ibrance - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn palbociclib Post-authorisation Human Overview Pfizer Europe MA EEIG withdre … News on Ibrance Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026 16/10/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected) 21/09/2016 New treatment for breast cancer 16/09/2016 More information on Ibrance Ibrance This page was last updated on 28/10/2026
关注理由：这篇肿瘤学内容涉及临床试验，适合了解研究正在回答什么问题，试验阶段和主要终点需以原文为准。
原文摘录：Kaftrio - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn ivacaftor / tezacaftor / elexacaftor Post-authorisation Human Overview Vert … News on Kaftrio Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026 18/09/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025 28/02/2025 Combination of cystic fibrosis medicines to treat patients with rare mutations 28/02/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021 12/11/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 26/03/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020 26/06/2020 New medicine for cystic fibrosis patients 26/06/2020 More information on Kaftrio Kaftrio This page was last updated on 20/10/2026
关注理由：如果关注儿科学，这条临床试验动态可用于了解研究设计，主要终点和试验阶段建议查看原文。
原文摘录：Disease Outbreak News Pneumonia of undetermined etiology - Russian Federation 10 October 2026 See all DONs related to this event Situation at a glance On 2 October 2026, WHO became aware through media reports of the death of an employee of the Irkutsk Ant … item/2026-DON620 See all DONs related to this event
关注理由：这条感染病学资料适合作为深入阅读入口，尤其要关注研究方法与结论是否匹配。
原文摘录：Kalydeco - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn ivacaftor Post-authorisation Human Overview Vertex Pharmaceuticals (Irelan … News on Kalydeco Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026 18/09/2026 Combination of cystic fibrosis medicines to treat patients with rare mutations 28/02/2025 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024 23/02/2024 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021 12/11/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 26/03/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020 18/09/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020 24/07/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020 30/04/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019 18/10/2019 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018 19/10/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018 27/07/2018 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015 25/09/2015 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014 27/06/2014 More information on Kalydeco Kalydeco This page was last updated on 09/10/2026
关注理由：这条儿科学临床试验动态值得跟踪，后续可结合原文核对试验进度、研究设计与结果披露情况。