药物警戒风险评估委员会（PRAC）2026年10月26日至29日会议要点
正文 · 中文译文
PRAC 启动对抑郁症和焦虑症药物 Deanxit（氟哌噻吨/美利曲辛）的审查 在收到服用该药患者出现严重神经和精神方面副作用的报告后，PRAC 已启动对 Deanxit 的审查，Deanxit 是一种用于治疗抑郁症和焦虑症的固定剂量复方药物。 这些报告涉及运动障碍病例，例如震颤、僵硬、坐立不安和不自主运动，以及记忆和思维问题。在某些病例中，停止治疗后症状仍持续存在。 更多信息参见 EMA 的转介启动通讯。 PRAC 审查特定批次人正常免疫球蛋白药物过敏反应报告增加的情况 PRAC 已启动对一项安全信号的审查，该信号涉及与特定批次人正常免疫球蛋白药物相关的超敏（过敏）反应报告增加。 人正常免疫球蛋白用于帮助抗体不足的人群预防感染，包括某些免疫疾病或血液癌症患者。它们也用于治疗某些免疫系统攻击自身组织的疾病。 超敏反应是这些药物的已知副作用。其产品信息包含警告，指出即使既往耐受治疗的患者也可能发生严重超敏反应。然而，报告表明，某些批次的人正常免疫球蛋白药物中超敏反应的发生频率可能高于预期。 报告的病例包括严重程度不同的超敏反应，从皮疹和瘙痒到严重且可能危及生命的超敏反应。这些包括过敏性反应（一种突然、严重的过敏反应）和血管性水肿（皮下迅速肿胀，可影响面部和喉部等区域）。这些病例的聚集性出现已导致近几个月在某些欧盟成员国召回其中一些药物的特定批次，包括Flebogamma DIF、Yimmugo和Gamunex。在超敏反应报告增加后，这些批次已作为预防措施从市场撤回。 尽管迄今为止已进行调查，但这些超敏反应聚集性出现的原因尚未确定。目前也尚不清楚其他正常人免疫球蛋白药物是否会受到影响。因此，PRAC开展的审查将涵盖所有正常人免疫球蛋白药物，无论其给药方式如何，包括经静脉（静脉内）、皮下（皮下）或肌肉内（肌内）给药的药物。 PRAC将要求销售这些药物的公司提供所有相关数据，并将其与现有证据一并评估，以调查可能的原因并评估是否需要进一步措施来降低风险。 提醒医疗保健专业人员遵循产品信息中现有的警告和注意事项，包括在治疗期间监测患者的建议。如果患者出现超敏反应的体征，如皮疹、头晕、心悸、喘息或呼吸困难，即使他们在既往治疗中未出现过此类反应，也应立即就医。EMA将就PRAC审查结果的进一步情况予以通报。 关于其他正在进行的安全性转介的信息见下文“正在进行的转介”部分。 关于PRAC讨论的所有议题的信息可在议程中查阅。 基于议程草案的PRAC结果月度数据。 4项安全性信号：1项启动，3项正在进行或已结束 67份定期安全性更新报告（PSUR）单次评估：45项建议仅针对集中授权药品，20项建议仅针对国家授权药品，2项建议针对同时包含集中授权和国家授权药品的PSUR 42份集中授权药品的风险管理计划（RMP）：10份RMP为新药审查，32份RMP为已授权药品审查 18项上市后安全性研究（PASS）：13项强制性和非强制性研究方案已审查，5项强制性和非强制性研究结果已审查 1项转介讨论：1项启动，0项正在进行，0项已结束 程序：含氟哌噻吨/美利曲辛的药品——转介 程序：含胃肠外铁的药品——转介 安全性信号评估。安全性信号是指提示药物与不良事件之间可能存在新的潜在因果关系，或提示已知关联出现新方面的信息，值得进一步调查。安全性信号来源于多种渠道，如自发报告、临床研究和科学文献。更多信息可在“信号管理”下查阅。 定期安全性更新报告，缩写为PSURs，是由上市许可持有人编写的报告，用于描述药物在获授权后特定时期内全球范围内的安全性经验。含有相同活性物质或相同活性物质组合但具有不同上市许可并在不同欧盟成员国获授权的药品，其PSURs在单一评估程序中进行联合评估。更多信息可在“定期安全性更新报告：问答”下查阅。 风险管理计划，缩写为RMPs，是对旨在识别、表征、预防或最小化药物相关风险的活动和干预措施的详细描述。公司在申请上市许可时须向EMA提交RMP。随着新信息的获得，RMP在药物整个生命周期内持续更新。更多信息可在“风险管理计划”下查阅。 上市后安全性研究（Post-authorisation safety studies，缩写为PASS）是指在药品获批上市后开展的研究，旨在获取有关其安全性的进一步信息，或评估风险管理措施的有效性。药物警戒风险评估委员会（PRAC）评估PASS的研究方案（与研究组织相关的方面）及研究结果。更多信息可在“上市后安全性研究”项下查阅。 转介程序是用于解决诸如对某种药品或某类药品的安全性或以获益-风险平衡的担忧等问题的程序。在涉及药品安全性的转介程序中，成员国或欧盟委员会请求PRAC代表欧盟对某一特定药品或某类药品进行科学评估。更多信息可在转介程序项下查阅。 药物警戒风险评估委员会（PRAC）：2026年10月26日至29日 药物警戒风险评估委员会（PRAC） EMA科学委员会及互认与分散程序协调组（CMD）文件中以及与EMA监管活动相关的缩略语 电话：+31 (0)88 781 8427 电子邮箱：press@ema.europa.eu 含氟哌噻吨/美利曲辛的药品——转介
正文 · 英文原文
PRAC starts review of depression and anxiety medicine Deanxit (flupentixol/melitracen) PRAC has started a review of Deanxit, a fixed-dose combination medicine for treating depression and anxiety, following reports of serious neurological and psychiatric side effects in patients taking the medicine. The reports concern cases involving movement disorders, such as tremors, stiffness, restlessness and involuntary movements, and memory and thinking problems. In some cases, symptoms persisted after treatment was stopped. More information is available in EMA’s start of referral communication . PRAC reviews increased reporting of allergic reactions with specific batches of human normal immunoglobulin medicines PRAC has started a review of a safety signal concerning increased reporting of hypersensitivity (allergic) reactions associated with specific batches of human normal immunoglobulin medicines. Human normal immunoglobulins are used to help prevent infections in people who do not have enough antibodies, including those with certain immune disorders or blood cancers. They are also used to treat some conditions in which the immune system attacks the body’s own tissues. Hypersensitivity reactions are a known side effect of these medicines. Their product information includes warnings that serious hypersensitivity reactions can occur, even in patients who have previously tolerated treatment. However, reports indicate that hypersensitivity reactions may be occurring more frequently than expected with specific batches of some human normal immunoglobulin medicines. The reported cases include hypersensitivity reactions of varying severity, from rash and itching to serious and potentially life-threatening hypersensitivity reactions. These included anaphylaxis (a sudden, severe allergic reaction) and angioedema (rapid swelling under the skin that can affect areas such as the face and throat). Clusters of these cases have led to recalls of specific batches of some of these medicines in recent months, including Flebogamma DIF, Yimmugo and Gamunex, in certain EU Member States. These batches have already been withdrawn from the market as a precautionary measure following increased reporting of hypersensitivity reactions. Despite investigations to date, the cause of these clusters of hypersensitivity reactions has not yet been established. It is also not yet clear whether other human normal immunoglobulin medicines could be affected. The review undertaken by PRAC will therefore cover all human normal immunoglobulin medicines, regardless of how they are given, including those given into a vein (intravenously), under the skin (subcutaneously) or into a muscle (intramuscularly). PRAC will request all relevant data from the companies marketing these medicines and assess it alongside the available evidence to investigate possible causes and evaluate whether further measures are needed to reduce the risk. Healthcare professionals are reminded to follow the existing warnings and precautions in the product information, including recommendations to monitor patients during treatment. Patients should seek medical attention without delay if they experience signs of a hypersensitivity reaction, such as rash, dizziness, palpitations, wheezing or difficulty breathing, even if they have not experienced such reactions during previous treatment. EMA will communicate further on the outcome of PRAC’s review. Information on other ongoing safety referrals is provided in the ‘Ongoing referrals’ section below. Information on all topics discussed by the PRAC is available in the agenda. Monthly figures for PRAC outcomes based on the draft agenda. 4 safety signals: 1 started, 3 ongoing or concluded 67 periodic safety update reports (PSURs) single assessments: 45 recommendations for centrally authorised medicines only, 20 recommendations for nationally authorised medicines only, 2 recommendations for PSURs including both centrally and nationally authorised medicines 42 risk management plans (RMPs) for centrally authorised medicines: 10 RMPs reviewed for new medicines, 32 RMPs reviewed for authorised medicines 18 post-authorisation safety studies (PASSs): 13 protocols for imposed and non-imposed studies reviewed, 5 results from imposed and non-imposed studies reviewed 1 referral discussed: 1 started, 0 ongoing, 0 concluded Procedure: Flupentixol/melitracen-containing medicinal products - referral Procedure: Parenteral iron-containing medicinal products - referral Safety signal assessments . A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under ' Signal management '. Periodic safety update reports , abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under ' Periodic safety update reports: questions and answers '. Risk management plans , abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans '. Post-authorisation safety studies , abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under ' Post-authorisation safety studies '. Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures . Pharmacovigilance Risk Assessment Committee (PRAC): 26 - 29 October 2026 Pharmacovigilance Risk Assessment Committee (PRAC) Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu Flupentixol/melitracen-containing medicinal products - referral