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。
EMA通报Merck Sharp & Dohme B.V.因商业原因永久停市止吐药Emend（aprepitant，80 mg与125 mg规格），欧盟/EEA短缺持续，预计2028年5月前在所有国家停市，停市与产品质量缺陷或安全问题无关。
关注理由：该通告确认aprepitant停市源于商业原因而非质量或安全问题，6月龄及以上儿童所需口服混悬剂型无替代品，是化疗支持用药供应需持续跟踪的关键缺口。
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：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：Yorvipath RSS Authorised This medicine is authorised for use in the European Union palopegteriparatide Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Yorvipath is a hormone replacement medicine fo … 37 KB - PDF) First published: 15/09/2023 View News on Yorvipath Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 More information on Yorvipath EU/3/20/2350 - orphan designation for treatment of hypoparathyroidism EMA/PE/0000241327 - paediatric investigation plan A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide) - post-authorisation study A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding - post-authorisation study This page was last updated on 06/11/2026
原文摘录：Aldurazyme RSS Authorised This medicine is authorised for use in the European Union laronidase Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment re … 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：Entyvio RSS Authorised This medicine is authorised for use in the European Union vedolizumab Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Entyvio is a medicine used to treat adult patients with … 73 KB - PDF) First published: 21/03/2014 Last updated: 21/03/2014 View News on Entyvio Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021 17/12/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020 28/02/2020 European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014 10/07/2014 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014 21/03/2014 European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease 21/03/2014 More information on Entyvio EMEA-000645-PIP03-18 - paediatric investigation plan EMEA-000645-PIP01-09-M09 - paediatric investigation plan EMEA-000645-PIP04-20-M02 - paediatric investigation plan Vedolizumab-4081: Infection Outcomes among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025 - post-authorisation study Vedolizumab-5001: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry - post-authorisation study Vedolizumab-5056: Clinical Effectiveness of Vedolizumab Used in Frames of Drug Program for Crohn’s Disease Treatment in Poland – Prospective, Observational Study Considering Fatigue and Other Patient-reported-outcomes (PROs) (POLONEZ II) - post-authorisation study Comparative Effectiveness of Tofacitinib Versus Ustekinumab and Vedolizumab among Ulcerative Colitis Patients With Prior Anti- Tumor Necrosis Factor (TNF) Failure - post-authorisation study Topics Medicines 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：Elaprase RSS Authorised This medicine is authorised for use in the European Union idursulfase Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment rep … 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
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。
EMA于2026年11月5日在“审评员模板”程序性指导页面新增PSUSA评估报告模板板块，含CAPs与NAPs两个模板，均为当日首次发布。页面另汇集PAM、信号评估、风险管理计划（RMP）、PRAC建议、II类变更及市场/数据保护延长等评估报告模板。此次为程序性指导文件增补，不涉及药物批准或疗效结论。
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：Image credit: © tadamichi | stock.adobe.com Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 - 29 October 2026 30 October 2026 PRAC starts review of depression and anxiety medicine Deanxit and a safety signal related to hu … eu All other enquiries please submit your request via the online form Follow us on Bluesky Related medicine information Flupentixol/melitracen-containing medicinal products - referral Topics Pharmacovigilance
关注理由：如果关注精神医学，这篇内容值得阅读其研究对象、方法设计和主要发现。
原文摘录：EMA closed on All Souls' Day, 2 November 29 October 2026 The European Medicines Agency's (EMA) office is closed from 18:00 on Friday 30 October until 08:30 on Tuesday 3 November News Corporate EMA’s office is closed on Monday 2 November, to mark All Souls
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：Image credit: © peterschreiber.media | stock.adobe.com AMA and EMA issue joint guidance on Ebola vaccine development 23 October 2026 Clinical trial requirements defined for rapid development of Bundibugyo virus vaccines News Human Clinical trials Research … eu All other enquiries Please submit your request via the online form
关注理由：这条儿科学资料涉及临床试验，入组条件、对照设置和研究阶段可以帮助判断结果适用于哪些人群。
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：Image credit: © Marcos Osorio/Stocksy | stock.adobe.com Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026 16 October 2026 Six new medicines recommended for approval; another five medicines recommended for … eu All other enquiries please submit your request via the online form Follow us on Bluesky Related medicine information Foundayo Rasonque Yuviwel Fovlussea Neuzafy Kizfizo Kyinsu Talvey Tukysa Tryngolza Yartemlea Mylotarg Truqap Ibrance
关注理由：这条内分泌与代谢资料涉及具体临床问题，研究人群、方法和结局指标可以结合原文进一步查看。
原文摘录：Image credit: © Chinnapong | stock.adobe.com EMA recommends authorisation of Rasonque for metastatic pancreatic cancer 15 October 2026 Phased review fast tracks assessment of medicine addressing unmet medical need News Human Innovation Medicines EMA’s hum … eu All other enquiries Please submit your request via the online form Follow us on Bluesky Related medicine information Rasonque
关注理由：这条肿瘤学内容涉及相关临床或研究问题，建议查看原文中的方法与适用范围。
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。
原文摘录：Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 October 2026 9 October 2026 Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting News Veterinary CVMP opinions on veterinary medicinal products The Co … eu All other enquiries Please submit your request via the online form Follow us on Bluesky Related medicine information Stemyca Bovilis Lumpyvax
关注理由：这篇临床指南资料涉及临床规范，阅读时应核对发布机构、版本和推荐适用范围。
原文摘录：Image credit: © Felix / peopleimages.com | stock.adobe.com Clinical trial applications advice pilot becomes permanent 8 October 2026 Technical and regulatory support for preparing clinical trial applications will continue from January 2027 News Human Clin