Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 November 2026
正文 · 中文译文
在2026年6月会议上委员会通过的意见经重新审查后,委员会进一步通过了Scovella(velagliflozin)的上市许可正面意见,该药用于减少对饲养和运动方案调整无应答的马匹代谢综合征患马的高胰岛素血症及降低相关蹄叶炎风险。Scovella是自2022年欧盟第2019/6号法规生效以来,委员会在有限市场监管框架下推荐的首个兽药产品。该框架允许基于定制化的文件要求和有利的获益-风险评估授予有限市场许可。 委员会通过了Credelio Quattro(lotilaner/moxidectin/pyrantel/praziquantel)的上市许可正面意见,该药用于治疗犬体外寄生虫、绦虫和线虫引起的混合性体外和体内寄生虫侵染/感染。该兽药产品仅在需要同时针对体外寄生虫、绦虫和线虫使用时才被指示使用。 委员会通过了Laverdia(verdinexor)的上市许可正面意见,该药用于延长II期、III期和IV期淋巴瘤犬的疾病进展时间,适用于在家庭环境中使用的情况,该产品根据本上市许可申请适用的法律依据被归类为次要用途、次要物种/有限市场产品。 委员会对Streptoporc的上市许可采纳了正面意见,该产品用于通过对妊娠母猪和后备母猪进行主动免疫来对其后代进行被动免疫,以减少与猪链球菌Ide Ssuis基因型1.1相关的临床症状、死亡率、细菌载量以及浆膜、关节和器官的病理病变。 委员会对Nobivac PLUS DHPPi / Leptos的上市许可采纳了正面意见,该产品用于对6周龄及以上犬只进行主动免疫,以预防或减少由CDV、CAV1、CAV2、CPV、CPi、问号钩端螺旋体和基尔施纳钩端螺旋体引起的症状或病变。 委员会对Syvazul BTV 3(蓝舌病病毒疫苗(灭活))的一项变更采纳了正面意见,以满足两项具体义务:完成BTV 3抗原ELISA效力试验的开发,以及提供绵羊免疫持续期研究。 委员会对Hepizovac(流行性出血病疫苗(灭活))的一项变更采纳了正面意见,以满足一项关于稳定性研究(长达21个月)的具体义务,以确认成品在推荐储存条件下18个月的可接受保质期。 委员会通过对Orbyk EHD(流行性出血病疫苗(重组蛋白))一项变更的正面意见,以满足两项具体义务:提供成品效力试验的完整验证报告,并通过效力数据支持10小时的使用中保质期。 委员会通过对Zenrelia(ilunocitinib)一项变更的正面意见,以落实上市许可持有人信号管理流程的结果,将“攻击性”作为极罕见不良事件纳入产品信息。 委员会通过对Credelio(lotilaner)一项变更的正面意见,新增治疗适应症或修改已批准适应症:治疗耳螨感染(犬耳痒螨)。 特殊情况下的上市许可重新审查 委员会通过对禽流感疫苗Vaxxinact H5上市许可重新审查的意见,该意见基于对上市许可持有人所提交数据的评估。委员会建议将上述兽药产品在特殊情况下上市许可的有效期延长一年。 委员会通过了一项关于再审查禽流感疫苗Vaxxitek HVT+IBD+H5上市许可的意见,该意见是在对上市许可持有人提交的数据进行评估后进一步形成的。委员会建议,将上述兽药在特殊情况下上市许可的有效期延长一年。 委员会通过了一份针对马用生物制品的科学建议报告。 委员会通过了本月信号管理流程的结果。上市许可持有人提交的信号按时间顺序列于IRIS公共门户网站:兽医信号管理信号清单。为访问该清单,应在“提交类型”类别中应用以下筛选条件:“信号管理提交”。 委员会通过了对关于使用热处理灭活活免疫兽药中内源性逆转录病毒的反思文件(EMA/CVMP/IWP/37924/2014)的行政修订。该文件概述了证明灭活处理对疫苗无负面影响所需满足的要求。 委员会通过了修订后的VGVP模块:医学重要(MI)VeDDRA术语清单,以发布进行为期2个月的公开咨询。 委员会通过了《第五次机构间联合报告:欧盟/欧洲经济区人类和食用动物源细菌中抗菌药物消耗与抗菌药物耐药性发生情况的综合分析》(JIACRA V)。与以往报告相比,本报告引入了更强的一体化健康(One Health)方法,纳入了环境数据以及来自欧洲环境署的专业知识,分析了新冠疫情后的趋势(2022-2024年),并提供了新的长期证据,表明抗菌药物使用的持续减少与国家层面细菌敏感性的改善相关。该报告将于12月10日在ECDC、EFSA和EMA网站上发布。 委员会通过了VICH GL49(R2)《残留消除研究中分析方法验证》,并发布为期六个月的公开咨询,截止至2027年4月底。 委员会选举Jana Pantzke为3Rs工作组(3RsWP)副主席,任期3年。 委员会任命Sarah Buckley为科学建议工作组成员,任期3年。 委员会任命Susana Casado为新型疗法与技术工作组成员,任期3年。 关于上述药品(包括其完整适应症)、指南、反思文件、问答和其他文件(如咨询期间收到的意见概述)的更多信息,可在下方“相关内容”中查阅。 兽用药品委员会(CVMP):2026年11月3-5日 兽医药品委员会(CVMP)
正文 · 英文原文
Further to the re-examination of the opinion adopted by the Committee during its June 2026 meeting, the Committee adopted a positive opinion for a marketing authorisation for Scovella (velagliflozin) , intended for the reduction of hyperinsulinaemia and reduction of associated risk of laminitis in horses with Equine Metabolic Syndrome not responsive to changes in husbandry and exercise regimen. Scovella is the first veterinary medicinal product recommended by the Committee under the limited market regulatory framework, since Regulation (EU) 2019/6 came into effect in 2022. This framework permits to grant authorisation based on customised requirements for documentation and a favourable benefit-risk assessment for a limited market authorisation. The Committee adopted a positive opinion for a marketing authorisation for Credelio Quattro (lotilaner/moxidectin/pyrantel/praziquantel) for the treatment of mixed external and internal parasitic infestations/infections by ectoparasites, cestodes and nematodes in dogs. The veterinary medicinal product is only indicated when use against ectoparasites, cestodes and nematodes is indicated at the same time. The Committee adopted a positive opinion for a marketing authorisation for Laverdia (verdinexor) for increasing time to progression in dogs with stage II, III and IV lymphoma where use in a home setting is indicated, a product classified as minor use, minor species/limited market in accordance with the applicable legal basis of this marketing authorisation application. The Committee adopted a positive opinion for a marketing authorisation for Streptoporc , for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce clinical signs, mortality, bacterial load and pathological lesions in serosae, joints and organs which are associated with Streptococcus suis belonging to Ide Ssuis genotype 1.1. The Committee adopted a positive opinion for a marketing authorisation for Nobivac PLUS DHPPi / Leptos , for the active immunisation of dogs from 6 weeks of age onwards to prevent or reduce symptoms or lesions caused by CDV, CAV1, CAV2, CPV, CPi, Leptospira interrogans and L. kirschneri . The Committee adopted a positive opinion for a variation for Syvazul BTV 3 (Bluetongue virus vaccine (inactivated)) to fulfil two specific obligations regarding completion of the development of the ELISA potency test for the BTV 3 antigen and to provide the study of duration of immunity in sheep. The Committee adopted a positive opinion for a variation for Hepizovac (epizootic haemorrhagic disease vaccine (inactivated)) to fulfil a specific obligation regarding the stability studies (up to 21 months) to confirm the accepted shelf life of 18 months under the recommended storage conditions for the finished product. The Committee adopted a positive opinion for a variation for Orbyk EHD (epizootic haemorrhagic disease vaccine (recombinant protein)) to fulfil two specific obligations: to provide the complete validation report for the potency test in the finished product and to support the in-use shelf life of 10 hours by potency data. The Committee adopted a positive opinion for a variation for Zenrelia (ilunocitinib), to implement the outcome of the MAH’s signal management process to include “aggression” as a very rare adverse event in the product information. The Committee adopted a positive opinion for a variation for Credelio ( lotilaner ) to add a new therapeutic indication or modification of an approved one: treatment of ear mite infestations ( Otodectes cynotis ). Re-examinations of marketing authorisations in exceptional circumstances The Committee adopted an opinion on the re-examination of the marketing authorization for the avian influenza vaccine Vaxxinact H5 , further to the evaluation of the data submitted by the marketing authorisation holder. The Committee recommended that the validity of the marketing authorisation in exceptional circumstances for the above-mentioned veterinary medicinal product be extended for one year. The Committee adopted an opinion on the re-examination of the marketing authorization for the avian influenza vaccine Vaxxitek HVT+IBD+H5 , further to the evaluation of the data submitted by the marketing authorisation holder. The Committee recommended that the validity of the marketing authorisation in exceptional circumstances for the above-mentioned veterinary medicinal product be extended for one year. The Committee adopted one scientific advice report for a biological product for horses. The Committee adopted the outcomes of the signal management process for the current month. The signals submitted by marketing authorisation holders are listed, in chronological order, in the IRIS public portal: List of signals from Veterinary Signal Management . In order to access the list, the following filter should be applied in the ‘Submission type’ category: ‘Signal management submission’. The Committee adopted an administrative revision of the reflection paper on the use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products (EMA/CVMP/IWP/37924/2014). This document outlines the requirements that need to be fulfilled to demonstrate that the inactivation treatment has no negative impact on the vaccine. The Committee adopted the revised VGVP Module: Medically Important (MI) VeDDRA terms list for release for a 2-month period of public consultation. The Committee adopted the ‘Fifth joint inter-agency report on integrated analysis of antimicrobial agent consumption and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals in the EU/EEA’ (JIACRA V). Compared with previous reports, a stronger One Health approach is introduced by incorporating environmental data and expertise from the European Environment Agency, analysing post-COVID trends (2022-2024), and providing new long-term evidence that sustained reductions in antimicrobial use are associated with improvements in bacterial susceptibility at country level. The report will be published on 10 December on the websites of the ECDC, EFSA and EMA. The Committee adopted VICH GL49(R2) on validation of analytical methods used in residue depletion studies for release for a six-month public consultation, until the end of April 2027. The Committee elected Jana Pantzke as vice-chair of the 3Rs Working Party (3RsWP) for a 3-year mandate. The Committee appointed Sarah Buckley as a member of the Scientific Advice Working Party for a 3-year mandate. The Committee appointed Susana Casado as a member of the Novel Therapy and Technologies Working Party for a 3-year mandate. More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”. Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2026 Committee for Veterinary Medicinal Products (CVMP)
摘要 待译
CVMP opinions on veterinary medicinal products Further to the re-examination of the opinion adopted by the Committee during its June 2026 meeting, the Committee adopted a…