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 24 – 27 November 2025. 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 semaglutide.
Semaglutide – OZEMPIC, RYBELSUS
Update of the section "Adverse reactions" of the instructions for medical use in order to add "dysesthesia" to the list of adverse reactions of the medicinal products Ozempic (semaglutide) and Rybelsus (semaglutide) following the PRAC request regarding the cumulative review "Changes in skin sensitivity" for semaglutide within periodic safety update reports (PSURs) (EMEA/H/C/PSUSA/00010671/202405).
Reference information
Based on the assessment of the latest periodic safety update reports (PSURs) for the above-mentioned medicinal products, the PRAC requested the registration certificate holder (RCH) to provide a cumulative review of cases of dysesthesia and to assess the need to update the instructions for medical use of the medicinal products Ozempic (semaglutide) and Rybelsus (semaglutide).
Summary of recommendations
- Based on the available data and the rapporteur’s assessment, PRAC concluded that the instructions for medical use of the medicinal product Ozempic (semaglutide)1 should be updated by adding “dysesthesia” to the list of adverse reactions with the frequency “not known.” In addition, the instructions for medical use of the medicinal product Rybelsus (semaglutide)2 should be supplemented with information that in phase 3a clinical studies no imbalance in the frequency of dysesthesia was found with low doses of Rybelsus (semaglutide), but such cases were reported in the post-registration period.
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1Update of the section “Adverse reactions” of the instructions for medical use.
2Update of the section “Adverse reactions” of the instructions for medical use.
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 semaglutide and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 24.04.2026). (13 KB) (Downloaded: 04.05.2026 11:02:37)
TO SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINK TO ANALYZE THE PUBLISHED INFORMATION:
