This document provides an overview of the safety regulatory decisions taken by SAHPRA during July - December 2022....
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the listed companies (logo’s above), would like to inform you about the risk of serious breathing difficulty associated with the use of gabapentinoids (gabapentin and pregabalin)....
This document has been prepared to serve as a guideline to the holders of certificate of registration/applicants on the Authority’s requirements regarding risk management plans for medicines, including biological medicines, in South Africa. It represents SAHPRA’s current thinking on the safety, quality and efficacy of...
2022 Oct...
Adverse Drug Reactions and Quality Problem Reporting Form - for both public and private sector and includes herbal products....
Takeda (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....
Risk of serious adverse reactions, including encephalopathy, associated with MAXIPIME (cefepime hydrochloride) particularly in patients with renal impairment who received doses that exceeded the dosage recommendations. ...
Aspen Pharmacare, Brimpharm SA (Pty) Ltd, Adcock Ingram Limited, Sandoz SA (Pty) Ltd and Takeda (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA) would like to inform you of the risks related to the use of valproate containing medicines (sodium...
In collaboration with the South African Health Products Regulatory Authority (SAHPRA) Novartis, Litha Pharma and Aspen Pharmacare, would like to remind you of the following labelled safety information regarding the safe use of clozapine as contained in: ...