The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) will meet from 6 to 9 July 2026 to evaluate new safety signals for several medicines, including migraine treatments atogepant (Aquipta) and a class of CGRP inhibitors, the antiviral oseltamivir (Tamiflu) and zanamivir (Dectova), the cancer drug sacituzumab govitecan (Trodelvy), the kinase inhibitor selpercatinib (Retsevmo), and the anaesthetic sevoflurane, according to the agenda published on 6 July 2026.
The meeting, which runs from 6 to 9 July 2026, will also review ongoing EU referral procedures for safety reasons, risk management plans for both pre- and post-authorisation medicines, and periodic safety update reports (PSURs) for dozens of centrally and nationally authorised products. The agenda includes the minutes of the previous PRAC meeting held on 8-11 June 2026.
Under signals assessment, PRAC will examine new potential safety issues detected from EU spontaneous reporting systems and other sources. For atogepant, the committee will assess data as a single agent and also as part of a broader class review including erenumab, eptinezumab, fremanezumab, galcanezumab, and rimegepant. The oseltamivir and zanamivir signal covers both centrally authorised products. Follow-up signals will be reviewed for desogestrel, etonogestrel, the levonorgestrel intrauterine device Jaydess/Fleree, and venlafaxine.
In the risk management plans section, PRAC will discuss pre-authorisation RMPs for 11 medicines, including denecimig, gefurulimab, navepegritide, pegfilgrastim, pertuzumab, povorcitinib, relacorilant, riociguat, ruxolitinib, tofacitinib, and zamtocabtagene autoleucel. Post-authorisation PRAC-led procedures cover adalimumab (Humira), cabozantinib (Cabometyx/Cometriq), and siponimod (Mayzent). A further 35 post-authorisation CHMP-led procedures are listed, including for Keytruda, Wegovy, and Trodelvy.
The PSUR section includes 56 single assessment procedures for centrally authorised products alone, covering drugs such as Paxlovid, Nuvaxovid, Enhertu, and Tezspire. Combined CAP/NAP and NAP-only PSUSAs are also scheduled, including for clopidogrel, apomorphine, and yellow fever vaccine. Follow-up to PSUR/PSUSA procedures includes a review of the rotavirus vaccine Rotarix, and a variation procedure resulting from PSUSA evaluation for zilucoplan (Zilbrysq).
Post-authorisation safety studies (PASS) to be discussed include protocols for beremagene geperpavec (Vyjuvek), cabotegravir (Apretude), chikungunya vaccine (Ixchiq), cladribine (Mavenclad), inebilizumab (Uplizna), levacetylleucine (Aqneursa), maribavir (Livtencity), and rimegepant (Vydura). Results of imposed PASS will be reviewed for blinatumomab (Blincyto) and sodium valproate.
The PRAC meeting will finalise several EU referral procedures and may trigger new ones. The outcomes of the meeting, including any recommendations for regulatory action, are expected to be published after the meeting concludes.