Archive

31 May DHCPL – Instruction for use for Sybrava Inclisiran single-dose pre-filled syringe

Posted at 14:42h in

This DHCP letter is initiated by Norvatis and is intended to inform healthcare professionals about important new user handling instructions for the Sybrava® (inclisiran) single-dose pre-filled syringe injection, to reduce the risks associated with administration of the product....

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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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21 May Risk of intrathecal administration error associated with intravenous (IV) tranexamic acid – Pfizer and other collaborators

Posted at 14:32h in

Healthcare professionals are drawn to the attention about the risk of error in the administration of IV tranexamic acid. Tranexamic acid is for IV use only. However, there is a potential for confusion of tranexamic acid with other injectables which could result in inadvertent intrathecal...

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02 May Recommended Calculations of Contraception Duration After Completion of Therapy with Genotoxic Anticancer Medicines (Sanofi and Other Collaborators)

Posted at 06:29h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the companies listed below would like to inform you about recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (including potential metabolites)....

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02 May Important Medicine Safety Information Section 36 Approval – Phenylephrine Hydrochloric Injectiontm

Posted at 06:25h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Abbott Laboratories SA (Pty) Ltd, would like to inform you that Phenylephrine hydrochloric injectionTM has been up scheduled from Schedule 1 to Schedule 4 status. However, Abbott is experiencing unforeseen delays in the implementation...

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30 Apr Recommended Calculations of Contraception Duration after Completion of Therapy with Genotoxic Anticancer Medicines (Sun Pharma and Other Collaborators)

Posted at 11:13h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the companies listed in the attached document would like to inform you about recommended calculations of contraception duration after completion of therapy with genotoxic anticancer medicines (Including potential genotoxic metabolites)....

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06 Mar Pharmacovigilance Process of Issuing Safety Recommendations to Applicants/HCRS For Implementation

Posted at 11:16h in

Kindly note that this communication serves to communicate two (2) processes that the SAHPRA Pharmacovigilance (PV) unit has revised. You are urged to take note of these revisions....

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