兽用药品委员会（CVMP）2026年10月6日至8日会议要点
正文 · 中文译文
委员会在特殊情况下，对Bovilis Lumpyvax（羊疙瘩皮肤病疫苗（活疫苗））的上市许可采纳了积极意见，该疫苗用于牛的活动免疫，以减少由羊疙瘩皮肤病病毒引起的临床症状和病毒血症。 委员会对Stemyca（马脐带间充质干细胞）的上市许可采纳了积极意见，用于减少犬非食物反应性慢性炎性肠病（CIE）的临床症状。 委员会对Mirataz（米氮平）的变更采纳了积极意见，以根据新的靶动物安全性数据更新产品信息。产品特性摘要和包装说明书已更新，以显示过量给予Mirataz与某些已知不良事件（如给药部位红斑和脱毛）相关。 特殊情况下的上市许可复审 委员会对Vaxxitek HVT+IBD+H5（一种禽流感疫苗）的复审采纳了积极意见。委员会建议将特殊情况下的上市许可有效期延长一年。 委员会得出结论，关于犬用Vetmedin 1.5 mg/ml口服溶液（匹莫苯丹）的程序。由于成员国在兽药协调组（CMDv）互认和分散程序审评程序中就疗效问题缺乏共识，欧洲委员会（EC）根据(EU) 2019/6号法规第54(8)条，就增加一项适应证的变更请求委员会予以澄清。CVMP在考虑了EC的请求及所有可用数据后，以多数票得出结论，认为犬用Vetmedin 1.5 mg/ml口服溶液针对所提议适应证的获益-风险平衡为阳性。CVMP的澄清意见将发送至EC供其考虑。 委员会通过了两份科学建议报告，分别涉及一种兽用药品和一种兽用免疫产品，均针对大西洋鲑。 根据(EU) 2019/6号法规第23条的有限市场分类和资格认定 在一次请求之后，CVMP将一种用于犬的产品（ATCvet分类：抗寄生虫产品、杀虫剂和驱避剂）归类为拟用于有限市场，且不符合(EU) 2019/6号法规第23条项下的授权资格。 委员会通过了当月的信号管理流程的结果。由上市许可持有人提交的信号按时间顺序列于IRIS公共门户：来自兽医信号管理的信号列表·IRIS。要访问该列表，应在“提交类型”类别中应用以下筛选器：“信号管理提交”。 关于上述药物（包括其完整适应症）、指南、反思文件、问答和其他文件（例如咨询期间收到的评论概述）的更多信息，可在下方“相关内容”中找到。 EMA建议授权用于牛结节性皮肤病的兽用疫苗 兽用药品委员会（CVMP）：2026年10月6-8日 兽用药品委员会（CVMP） 电话：+31 (0)88 781 8427 电子邮箱：press@ema.europa.eu
正文 · 英文原文
The Committee adopted a positive opinion, in exceptional circumstances, for a marketing authorisation for Bovilis Lumpyvax ( lumpy skin disease vaccine (live)) , for the active immunisation of cattle to reduce clinical signs and viraemia caused by lumpy skin disease virus. The Committee adopted a positive opinion for a marketing authorisation for Stemyca ( equine umbilical cord mesenchymal stem cells ), for reduction of clinical signs of non-food-responsive chronic inflammatory enteropathy (CIE) in dogs. The Committee adopted a positive opinion for a variation for Mirataz ( mirtazapine ) to update the product information on the basis of new target animal safety data. The SPC and package leaflet were updated to show that the administration of Mirataz at overdose was associated with some of the known adverse events (e.g. erythema and alopecia at the application site). Re-examinations of marketing authorisations in exceptional circumstances The Committee adopted a positive opinion on the re-examination of Vaxxitek HVT+IBD+H5 , an avian influenza vaccine. The Committee recommended the extension for one year of the validity of the marketing authorisation in exceptional circumstances. The Committee concluded the procedure for Vetmedin 1.5 mg/ml oral solution for dogs ( pimobendan ). Due to lack of consensus between Member States in the Veterinary Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv) review procedure on grounds of efficacy, the European Commission (EC) had requested clarifications from the Committee under Article 54(8) of Regulation (EU) 2019/6 on a variation to add an indication. The CVMP, having considered the request by the EC and all available data, concluded, by majority, that the benefit-risk balance of Vetmedin 1.5 mg/ml oral solution for dogs for the proposed indication is positive. The CVMP's clarifications will be sent to the EC for its consideration. The Committee adopted two scientific advice reports concerning a pharmaceutical and an immunological product, both for Atlantic salmon. Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6 Following one request, the CVMP classified a product (ATCvet classification: antiparasitic products, insecticides and repellents) for dogs as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6. 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 · IRIS . In order to access the list, the following filter should be applied in the ‘Submission type’ category: ‘Signal management submission’. 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”. EMA recommends authorisation of veterinary vaccine for lumpy skin disease in cattle Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 October 2026 Committee for Veterinary Medicinal Products (CVMP) Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu