Summary of Medicines Safety Regulatory Decisions

This document provides an overview of the medicines’ safety regulatory decisions made by the South African Health Products Regulatory Authority (SAHPRA) during Apr – Jun 2025. This includes decisions where safety concerns were reviewed and concluded, as well as those safety concerns that remain unresolved but warrant immediate action. At the same time, SAHPRA continues to monitor and review the safety issue(s). Safety concerns arise from any potential safety issue linked to a medicine. This includes known safety problems, changes in the reporting pattern of known problems, new problems, and coincidental events.