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07 Dec

Posted at 11:11h in

As we publish our 3rd edition of the Medi-Guardian (previously VigiGuardian), let us reflect on the critical importance of pharmacovigilance as part of the product lifecycle management, our drive towards attaining maturity level three (ML3) for medicines and vaccines to effectively enable access to safe...

07 Dec

Posted at 09:20h in

Dear Healthcare Professional In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Products (Pty) Ltd would like to inform you of the potential missing PI and PIL in folding boxes of Hemlibra® (emicizumab) 60 mg/0,4 mL solution for injection. The purpose of this...

09 Oct

Posted at 10:55h in

This manual focuses on surveillance and response to Adverse Events Following Immunisation. It is guided by the policies of the National Department of Health and the South African Health Products Regulatory Authority, with recommendations from the World Health Organisation, to serve as guidelines for Vaccine Safety Surveillance. It provides guidelines and procedures for healthcare professionals at...