Archive

30 May A Signal Of Myocarditis / Pericarditis Associated With Pfizer-BioNTech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)

Posted at 15:23h in

The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis/pericarditis associated with Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty® (BNT162b2). The Pfizer/BioNTech Comirnaty® Vaccine was approved by SAHPRA in March 2021. The authorisation was done in terms of Section 21...

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30 May SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 Vaccines

Posted at 15:21h in

The South African Health Products Regulatory Authority (SAHPRA) has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines. The National Department of Health (NDoH) Expanded Programme on Immunisation (EPI) is responsible for the COVID-19 vaccination programme,...

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27 May Communication to Industry – Summary of Medicine Safety Regulatory Decisions

Posted at 12:20h in

This document provides an overview of the safety regulatory decisions taken by the South African Health Products Regulatory Authority (SAHPRA) during April to June 2023. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are...

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23 May Communication to Industry – Summary of Medicine Safety Regulatory Decisions

Posted at 11:48h in

This document provides an overview of the safety regulatory decisions taken by the South African Health Products Regulatory Authority (SAHPRA) during July - September 2023. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are...

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02 Jun Communication to Industry – Summary of Medicine Safety Regulatory Decisions

Posted at 13:22h in

This document provides an overview of the safety regulatory decisions taken by SAHPRA during April - July 2022....

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24 Apr Summary of Medicine Safety Regulatory Decisions

Posted at 09:59h in

This document provides an overview of the safety regulatory decisions taken by SAHPRA during July - December 2022....

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17 Aug SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals

Posted at 12:28h in

SAHPRA is pleased to announce the launch of the Med Safety App. The Med Safety App is a mobile application (App) that is designed to simplify and promote the reporting of suspected adverse drug reactions (ADRs), including adverse events following immunisation (AEFIs) by both the...

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17 Jun Summary of Medicines Safety Regulatory Decisions

Posted at 09:03h in

This document provides an overview of the safety regulatory decisions taken by SAHPRA on the safety concerns discussed during January – March 2022. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are not concluded...

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