The South African Health Products Regulatory Authority (SAHPRA) provides the following key updates on the SAHPRA Engagement Portal....
This document is intended to provide communication to the HCRs for orally administered phenylephrine containing medicines regarding the Authority's intent to classify these medicines as undesirable due to concerns about their efficacy....
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Zydus would like to inform you about the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with the use of Anviro® (valaciclovir) tablets....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
Key Oncologies (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....
Organon South Africa (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), would like to inform you of the risk of withdrawal reactions associated with inappropriate and long-term use of topical corticosteroids....
The communication is directed at applicants or holders of certificates of registration (HCRs) using Synapse Labs Pvt. Ltd to conduct their bioequivalence (BE) studies. It provides information on deficiencies detected by the European Medicines Agency regarding critical deficiencies for BE studies conducted by Synapse Labs Pvt....
The South African Health Products Regulatory Authority (SAHPRA) is a statutory body established in terms of Section 2 of the Medicines and Related Substances Act, 101 of 1965, as amended. The objects of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection,...
MPXV molecular test kit/s that have not been listed, registered or authorised for use in a jurisdiction recognised by the South African Health Products Regulatory Authority (SAHPRA) or that have not been pre-qualified by the World Health Organisation (WHO) will be screened against the minimal...