In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend 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 ensure that the information on the medicinal product corresponds to current scientific knowledge.
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on June 08 – 11, 2026. Following the meeting, a decision was made that safety-related changes need to be introduced to the registration materials/instructions for medical use of medicinal products containing ranibizumab.
Ranibizumab – BYOOVIZ; EPRUVY; LUCENTIS; RANIVISIO; RIMMYRAH; XIMLUCI – PSUSA/00002609/202510
Based on the evaluation of periodic safety update reports (PSURs), PRAC reviewed the benefit/risk balance of the medicinal products BYOOVIZ; EPRUVY; LUCENTIS; RANIVISIO; RIMMYRAH; XIMLUCI, containing ranibizumab, and provided the relevant recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of the medicinal products BYOOVIZ; EPRUVY; LUCENTIS; RANIVISIO; RIMMYRAH; XIMLUCI, containing ranibizumab (ranibizumab), 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 “not known”. Accordingly, the current instructions for medical use must be updated appropriately1.
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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.) registered through the centralized procedure can be found in the Human medicines European public assessment report (EPAR) on the EMA website.
List of medicinal products containing ranibizumab and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 02.09.2026). (10 KB) (Downloaded: 11.09.2026 11:20:26)
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:
