Pharmacovigilance Archives - SAHPRA

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22 Oct

Posted at 10:38h in

CellCept, Mycocept, Mycophenolate Teva and Mycokem are medicines that contain the active ingredient mycophenolate mofetil (MMF). Roche Products (Pty) Ltd, Sandoz South Africa (Pty) Ltd, Teva Pharmaceuticals (Pty) Ltd, and Ascend Laboratories (Pty) Ltd, in collaboration with the South African Health Products Regulatory Authority (SAHPRA)...

30 Sep

Posted at 20:08h in

The aim of this newsletter is to disseminate regulatory information on post-marketing surveillance and pharmacovigilance activities rendered by SAHPRA, which includes responsibilities of the SAHPRA Pharmacovigilance unit, reporting tools and pharmacovigilance systems in the country....

30 Sep

Posted at 11:00h in

This manual is guided by the policies of the NDoH and SAHPRA, with recommendations from the World Health Organization (WHO), to serve as guidelines for vaccine safety surveillance. It provides guidelines and procedures to healthcare professionals at all levels within the healthcare sector in South Africa in the...

30 Sep

Posted at 10:55h in

The SAHPRA Pharmacovigilance Reference Manual for Healthcare Professionals in South Africa, used in tandem with the Training Manual for Healthcare Professionals on Pharmacovigilance in South Africa, will facilitate the early detection of health product-related adverse reactions and enable the identification of previously unknown adverse drug...

30 Sep

Posted at 10:53h in

SAHPRA has developed this manual to facilitate training of HCPs in pharmacovigilance. We hope that this training manual will effectively prepare the facilitators to train other HCPs in the science of pharmacovigilance....

29 Sep

Posted at 12:28h in

This document is intended to provide communication to industry and guide stakeholders on how to prepare and distribute “Dear Veterinary Professional” (DVP) letters for safety concerns associated with the use of registered veterinary medicines. It gives details on the format and content to effectively communicate...

15 Sep

Posted at 14:41h in

The National Immunisation Safety Expert Committee (NISEC), formerly a National Department of Health (NDoH) Ministerial Advisory Committee on vaccine safety, now serves as a Technical Advisory Committee within the South African Health Products Regulatory Authority (SAHPRA). This transition integrates NISEC's specialised vaccine-safety expertise into SAHPRA’s...

30 Jun

Posted at 13:38h in

This document serves as a guideline for those reporting adverse drug reactions. It represents the South African Health Products Regulatory Authority’s (SAHPRA)’s current thinking on the safety, quality and efficacy of medicines. The Authority reserves the right to request any additional information to establish the...