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。
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。
原文摘录：Truqap - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn capivasertib Post-authorisation Human Overview AstraZeneca AB withdrew its a … News on Truqap Meeting highlights from the Committee for Medicinal Products for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
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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原文摘录：Ibrance - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn palbociclib Post-authorisation Human Overview Pfizer Europe MA EEIG withdre … News on Ibrance Meeting highlights from the Committee for Medicinal Products for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
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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
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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
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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
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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
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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。