世界卫生组织药品通讯-2025年第1期

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 includesa summary ofPharmacovigilance Partners’ Meetingheld inNewDelhi, Indiaon13 October 2024withasynopsisofWHO Global Smart Pharmacovigilance Strategy. 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 ISBN978-92-4-011075-5(electronic version)ISBN 978-92-4-011076-2 (print version) © World Health Organization2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGOlicence (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-commercial purposes, providedthework is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorsesany specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then youmust license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, youshould add the following disclaimer along with the suggested citation:“This translation was not created by the World HealthOrganization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English editionshall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of theWorld Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation.WHO Pharmaceuticals Newsletter No. 1, 2025.Geneva: World Health Organization;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 submitrequests for commercial use and queries on rights 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, figuresor images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission fromthe copyright holder. Therisk of claims resulting from infringement of any third-party-owned component in the work restssolely with the user. General disclaimers.The designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or areaor of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps representapproximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed orrecommended by WHOin preference to others of a similar nature that are not mentioned. Errors and omissions excepted, thenames of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHOto verify the information contained in this publication. However, thepublished material is being distributed without warranty of any kind, either expressed or implied. The responsibility for theinterpretation and use of the material lies with the reader.In no event shall WHObe liable for damages arising from its use. Contents Regulatorymatters Fluconazole..........................................................................................................................4Mebendazole........................................................................................................................4Medroxyprogesterone...........................................................................................................4Metamizole...........................................................................................................................5Metronidazoleand tetracycl