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 ensure that the information about 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 10 – 13 February 2025. Based on the results of the meeting, a decision was made on the need to introduce safety-related changes to the registration materials/instructions for medical use of medicinal products containing cladribine.
Cladribine1 – MAVENCLAD – PSUSA/00010634/202407
Based on the evaluation of periodic safety update reports (PSURs), PRAC reviewed the benefit/risk balance of the medicinal product MAVENCLAD (cladribine) and made the following recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of the medicinal product MAVENCLAD (cladribine) for the approved indications remains unchanged.
- Notwithstanding this, the instructions for medical use should be updated by amending the existing wording on breastfeeding to reflect that there are limited data on the excretion of the medicinal product into breast milk. Therefore, the existing provisions of the instructions for medical use must be amended2.
- In the next PSUR, the marketing authorization holder (MAH) must provide a cumulative review of cases of autoimmune hemolytic anemia and discuss the need to update the package leaflet. In addition, the MAH must provide a comprehensive analysis of off-label use cases, and also continue to review medication errors and analyze the effectiveness of the updated educational materials. The MAH must also discuss and propose an update to the package leaflet regarding cases of liver injury in the post-authorization period, and add to the PSUR the issue of “use in breastfed infants whose mothers received this medicinal product” as a safety concern and propose an update to the package leaflet for the lactation period.
_________________________________________________________________________
1For the treatment of multiple sclerosis only.
2Update of the section “Use during pregnancy or breastfeeding” of the package insert. The risk assessment report and the PRAC recommendation are forwarded to the CHMP for a decision.
Comprehensive and up-to-date information on an individual medicinal product (summary of product characteristics, post-authorization procedural steps, risk management plan summary, additional risk minimization measures, etc.) authorized 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 cladribine and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 06.05.2025).
TO SUBMIT THE CORRESPONDING APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINK, FOR ANALYSIS OF THE PUBLISHED INFORMATION:
