In accordance with paragraph 8 of Section IV of the Procedure for Conducting Expert Evaluation, the applicant must make amendments to the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and must ensure that the information on the medicinal product is consistent with current scientific knowledge.
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 06 – 09 July 2026. Following the meeting, it was decided that safety-related changes need to be made to the registration materials/instructions for medical use of medicinal products containing aflibercept.
Aflibercept – AFIVEG; AFQLIR; AHZANTIVE; BAIAMA; EIYZEY; EYDENZELT; EYLEA; EYLUXVI; MYNZEPLI; OPUVIZ; PAVBLU; VGENFLI; YESAFILI – PSUSA/00010020/202511
Based on the assessment of periodic safety update reports (PSURs), PRAC reviewed the benefit/risk balance of medicinal products containing aflibercept [ophthalmological indications] and issued the corresponding recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit / risk ratio of medicinal products containing aflibercept for the approved indications remains unchanged.
- At the same time, the instructions for medical use should be updated to include retinal vasculitis and retinal occlusive vasculitis as adverse reactions with the frequency «rare» and «unknown», respectively. Thus, the current instructions for medical use must be updated accordingly1.
- In the next PSUR, registration certificate holders (RCHs) marketing the medicinal product at a dose of 8 mg must provide a cumulative review of all preferred terms (PT – Preferred term) associated with intraocular inflammation, indicating seriousness, severity, and outcomes, and compare them with the corresponding data for the medicinal product at a dose of 2 mg.
- Registration certificate holders (RCHs) should review the current list of safety concerns and re-assess the key elements of the guide for healthcare professionals and the patient guide for aflibercept, and also address these issues in the next update of the risk management plan (RMP), which is to be submitted as part of an upcoming regulatory procedure concerning the RMP.
__________________________________________________________________
1Update of the “Adverse reactions” section of the package insert. The risk assessment report and PRAC recommendations are forwarded to CHMP for a decision.
Comprehensive and up-to-date information on an individual medicinal product (summary of product characteristics, post-registration procedural steps, RMP summary, additional risk minimization measures, etc.) that is registered under the centralized procedure can be found in the Human medicines European public assessment report (EPAR) on the EMA website.
List of medicinal products containing aflibercept that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 02.10.2026). (9.5 KB) (Downloaded: 12.10.2026 06:29:15)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINK:
