In April 2025, the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) released fourth version of the electronic bulletin.
The PRAC Committee, at its monthly meetings and as part of its regular tasks covering all aspects of risk management in the use of medicines, reviewed the assessment of safety signals, risk management plans, regular updated safety reports, and post-marketing safety studies.
During this period, no referral procedures were initiated or concluded, and the committee did not identify any safety issues requiring additional public communication.
The latest version of the bulletin, covered the following highlights:
- Changes in Product information for NP/MRP/DCP medicines (from December 2024 to February 2025)
- Changes in Product information for CP medicines (positive opinion from the CHMP committee from October 2024 to January 2025)
- Direct healthcare professional communications, published on the JAZMP website between January and April 2025
- New and updated (or withdrawn) educational materials, part of additional risk-reduction measures approved between January and March 2025
- Increase in the use of GLP-1 analogues and side effects: The use of GLP-1 analogues, intended for the treatment of type 2 diabetes and obesity, is growing rapidly in Slovenia. There has been an increase in reports of side effects, most commonly nausea and vomiting. Serious complications, including pancreatitis, have also been observed. Counterfeit and illegal online sales have also emerged. Experts warn of responsible use and regular reporting of side effects
Pharmacovigilance Bulletin is available on the JAZMP website, and it is free of charge. Healthcare professionals can also subscribe to the Pharmacovigilance Bulletin and receive the newsletter directly to their e-mail.