Covid-19 | Subscribe

Archive

Home >  (Page 9)

17 Aug

Posted at 11:43h in

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...

17 Aug

Posted at 11:42h in

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...

02 Aug

Posted at 10:20h in

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....

17 Jun

Posted at 09:03h in

This document provides an overview of the safety regulatory decisions taken by SAHPRA on the safety concerns discussed during January – March 2022. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are not concluded...

10 May

Posted at 10:20h in

This document provides guidance to the applicants/holders of Certificate of Registration on the pharmacovigilance system requirements. It is meant to facilitate compliance by applicants/HCRs with the regulatory authority on pharmacovigilance requirements....

06 May

Posted at 16:23h in

This document has been prepared to serve as a guideline to those involved in the conduct of Pharmacovigilance inspections. It is meant to facilitate compliance with Good Pharmacovigilance Practice relating to the conduct and monitoring of Pharmacovigilance inspections. It is not intended as an exclusive...

21 Apr

Posted at 09:41h in

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....