This document provides an overview of the safety regulatory decisions taken by SAHPRA during April - July 2022....
The DHCPL is intended to inform healthcare professionals (HCPs) about a typing error in the PI and PIL. The Synthroid products with PI and PIL with the typing error will not be distributed in the country for human use. Thus, Abbot applied for a Section...
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. ...