Janssen Pharmaceutica (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about the risk of thrombosis in combination with thrombocytopenia, associated with the use of COVID-19 Vaccine Janssen...
MSD (Pty) Ltd, as directed by the South African Health Products Regulatory (SAHPRA) would like to inform healthcare professionals about the risk of dopamine dysregulation syndrome (DDS) associated with the use of dopamine containing medicines in the treatment of Parkinson’s Disease. The Professional...
Novartis as directed by the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about the increased incidence of intraocular inflammation (IOI) and related adverse events including retinal vasculitis (RV) and retinal vascular occlusion (RO) associated with (brolucizumab) when administered at 4...
Janssen Pharmaceutica (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA) would like to inform you about new safety information that has resulted in contraindication of the COVID-19 Vaccine Janssen in individuals with a history of Capillary Leak Syndrome (CLS). ...
The South African Health Products Regulatory Authority (SAHPRA) has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines....
Pfizer South Africa, in collaboration with the South African Health Products Regulatory Authority (SAHPRA) wish to inform you of the warning regarding rare cases of myocarditis and pericarditis reports that were noted following the use of COVID-19 mRNA vaccines, including Comirnaty® (Covid- 19 mRNA vaccine)....
Novartis, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to inform you about the requirement to discontinue treatment with Vsiqq® in patients who develop retinal vasculitis and/or retinal vascular occlusion. Retinal vasculitis and retinal vascular occlusion are immune-mediated events, which...
The following holders of certificates of registration (HCRs), Aspen Pharmacare, GlaxoSmithKline (Pty) Ltd and Glenmark Pharmaceuticals South Africa (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), wish to draw your attention to the following important safety information associated with topical...
For over a decade, ADR reports have been submitted to the National Adverse Drug Events Monitoring Centre (NADEMC) via fax. These reports were previously captured on the ADRI database. The ADRI database restricted electronic reporting by both applicants and healthcare professionals, and direct uploading of...
The aim of this newsletter is to disseminate regulatory information on post-marketing surveillance and pharmacovigilance activities rendered by SAHPRA, which includes responsibilities of the SAHPRA Pharmacovigilance unit, reporting tools and pharmacovigilance systems in the country....