To ensure continuity of supply of MeasBio for use in South Africa. Biovac obtained a Section 36 exemption from SAHPRA to supply the MeasBIO vaccine and the diluent for MeasBio packed in Indonesian National Agency for Food and Drug Control (NA-DFC) approved labelling with the...
The following pharmaceutical companies, Adcock Ingram Limited, Teva Pharmaceuticals, Acino Pharma and Ranbaxy Pharmaceuticals, in collaboration with the South African Health Products Regulatory Authority (SAHPRA), would like to draw your attention to the following important safety information associated with bupropion-containing medicines registered in South Africa. The...
GSK South Africa, in collaboration with the SAHPRA, would like to draw your attention to the following important safety information associated with bupropion-containing medicines, registered in South Africa....
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...