Welcome to the first edition of the South African Health Products Regulatory Authority’s (SAHPRA’s) ReguLetter that will provide a quarterly overview of regulatory decisions relating to safety alerts, recalls, and rapid alerts. This edition will provide information for the period April to June 2025....
Haleon South Africa (SA), in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines....
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Zydus would like to inform you about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of Anviro® (valaciclovir) tablets....
Key Oncologies (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), wish to inform you about the risk of thrombosis, including cerebral infarction, upon abrupt treatment discontinuation of anagrelide hydrochloride....
Organon South Africa (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the risk of withdrawal reactions associated with inappropriate and long-term use of topical corticosteroids....
Reckitt Benckiser Pharmaceuticals (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA), wish to draw your attention to the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome associated with the use of pseudoephedrine-containing medicines....
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Johnson and Johnson (Pty) Ltd would like to inform you about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines....
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Ranbaxy Pharmaceuticals (Pty) Ltd South Africa, Zydus Healthcare SA (Pty) Ltd and, Trinity Pharma (Pty) Ltd wish to inform you about the risk of neurodevelopmental disorders in the children born to women exposed to...
Pfizer and Viatris Healthcare South Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the increased risk of meningioma associated with prolonged use....
Novartis, during its portfolio review (Tegretol S® oral suspension included) observed the possibility of exceeding defined permitted daily exposure (PDE) when the product is taken above 1200 mg/day in adult patients because of the quantity of sorbitol in the formulation. Sorbitol is one of the...