世界卫生组织药品通讯-第2期，2025年

WHOpharmaceuticals NEWSLETTER WHO Vision for Safety ofMedicinal ProductsNo country left behind:worldwide pharmacovigilancefor safer medicinal products,safer patients The WHOpharmaceuticalsnewsletter provides youwith the latest information on the safety of medicinalproducts and regulatory actions taken by authoritiesaround the world. In addition, this edition includesrecommendations fromthe fourth joint meeting of the WHO AdvisoryCommittee on Safety of Medicinal Products (ACSOMP)and the WHO Global Advisory Committee on VaccineSafety (GACVS), 12-14 November 2024. The aim of thenewsletter isto disseminate regulatoryinformation on the safety ofmedicinal products,based on communicationsreceived from our network ofnational pharmacovigilance centresand other sources such asspecialized bulletins and journals,as well as partners in WHO. The information is produced inthe form of résumés in English, fulltexts of which may be obtained onrequest from: Contents Pharmacovigilance,MHP/RPQ,World Health Organization,1211 Geneva 27, Switzerland,E-mail address:pvsupport@who.intThisnewsletter is also available at:https://www.who.int/teams/regulation-prequalification RegulatorymattersSafety ofmedicinal productsFeature ISBN978-92-4-011422-7(electronic version)ISBN 978-92-4-011423-4 (print version) © World Health Organization2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGO licence (CCBY-NC-SA3.0IGO;https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercialpurposes, providedthe work is appropriately cited, as indicated below. In any use of this work, thereshould be no suggestion that WHO endorses any specific organization, products or services. The useof the WHO logo is not permitted. If you adapt the work, then you must license your work under thesame or equivalent Creative Commons licence. If you create a translation of this work, you shouldadd the following disclaimer along with the suggested citation:“This translation was not created bythe World Health Organization (WHO). WHO is not responsible for the content or accuracy of thistranslation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with themediation rules of the World Intellectual Property Organization(http://www.wipo.int/amc/en/mediation/rules/). Suggested citation.WHO Pharmaceuticals Newsletter No.2, 2025.Geneva: World HealthOrganization;2025. Licence:CCBY-NC-SA3.0IGO. Cataloguing-in-Publication (CIP) data.CIP data are available athttps://iris.who.int/. Sales, rights and licensing.To purchase WHO publications, seehttps://www.who.int/publications/book-orders. To submit requests for commercial use and queries onrights and licensing, seehttps://www.who.int/copyright. Third-party materials.If you wish to reuse material from this work that is attributed to a third party,such as tables, figures or images, it is your responsibility to determine whether permission is neededfor that reuse and to obtain permission from the copyright holder. Therisk of claims resulting frominfringement of any third-party-owned component in the work rests solely with the user. General disclaimers.The designations employed and the presentation of the material in thispublication do not imply the expression of any opinion whatsoever on the partof WHO concerningthe legal status of any country, territory, city or area or of its authorities, or concerning thedelimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximateborder lines for which there may not yetbe full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they areendorsed or recommended by WHOin preference to others of a similar nature that are not mentioned.Errors and omissions excepted, the names of proprietary products are distinguished by initial capitalletters. All reasonable precautions have been taken by WHOto verify the information contained in thispublication. However, the published material is being distributed without warranty of any kind, eitherexpressed or implied. The responsibility for the interpretation and use of the material lies with thereader.In no event shall WHObe liable for damages arising from its use. Contents Regulatorymatters Darvadstrocel........................................................................................................................4Glatiramer acetate................................................................................................................4GLP-1 and dual GIP/GLP-1 receptor agonists.......................................................................4HMG-CoA reductase inhibitors..............................................................................................5Isotre